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Increasing the Odds for Success With VBAC
Vaginal birth after cesarean gained widespread acceptance in the 1980s after a National Institutes of Health Consensus Development Conference panel questioned the necessity of routine repeat cesarean deliveries and described situations in which a VBAC should be offered. Some insurers even mandated that physicians attempt a VBAC prior to a repeat cesarean delivery.
Since 1996, however, the VBAC rate has dropped substantially while cesarean delivery rates have risen steadily. The overall cesarean delivery rate was approximately 32% when last measured in 2007, up from 21% in 1996. The VBAC rate was less than 10% in 2007, compared with 28% in 1996, according to the Centers for Disease Control and Prevention.
Indeed, pregnant women now have limited access to VBAC services, and many are not even offered the option of having a trial of labor after cesarean. Some hospitals have declined to provide VBAC services, and the most recent medical liability survey conducted by the American College of Obstetricians and Gynecologists showed that almost 20% of responding fellows stopped offering or performing VBACs between 2006 and 2008. (In the prior survey, completed in 2006, these numbers were even higher—upward of 26%.)
The exact causes of the decline in VBAC deliveries are unclear, but the shift likely involves a mix of concerns about the possibility of uterine rupture, patient preferences, medicolegal pressures, guidelines that call for the immediate availability of personnel to perform an emergency cesarean, and other clinical and nonclinical factors.
It is a complex and concerning trend—one considered important enough to the health of women in the United States for the NIH to recently convene another Consensus Development Conference panel on the topic. The panel was asked to examine the causes of VBAC decline as well as the available research on the benefits and harms of attempting a trial of labor after a patient has had a cesarean delivery.
In a draft statement titled, “Vaginal Birth After Cesarean: New Insights,” released in March, the panel affirmed that a trial of labor is a reasonable option for many women with a prior cesarean delivery. It also urged that current VBAC guidelines be reconsidered and more research conducted.
Although guidelines are being revisited and research ensues, we owe it to the patients in our own practices to thoroughly consider what is known about the short- and long-term safety of VBAC, the selection of candidates, and the most reasonable approaches to intrapartum management.
Short-Term Safety of VBAC
In the past decade, there have been two large observational studies in the United States that have shed much light on the efficacy and safety of a trial of labor after cesarean. Both studies involved upwards of 20,000 women, and both showed rates of uterine rupture under 1%. This finding is significant, because some have suggested that uterine rupture is on the rise in the United States.
In one of these studies—a prospective cohort study conducted from 1999 through 2002 at 19 academic medical centers belonging to the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network—there were 124 cases of uterine rupture among 17,898 women who underwent a trial of labor after cesarean, and no cases of uterine rupture among 15,801 women who underwent elective repeat cesarean delivery.
The rate of uterine rupture was 0.7% for women with a prior low transverse incision, 2.0% for those with a prior low vertical incision, and 0.5% for those with an unknown type of prior incision. Overall, the rate of uterine rupture in this study was 0.7% (N. Engl. J. Med. 2004;351:2581-9).
The second study, which I led, revealed a rate of uterine rupture in women who attempted VBAC of 0.9%, compared with a rate of 0.004% in women who underwent elective repeat cesarean section. This study was a multicenter observational study in which records of approximately 25,000 women with a prior low-transverse cesarean section were reviewed (Am. J. Obstet. Gynecol. 2005;193:1656-62).
Just as uterine rupture is more common in women who have a VBAC attempt than in those who choose elective repeat cesarean section, so are adverse perinatal outcomes. The MFMU study found 12 cases of hypoxic ischemic encephalopathy (HIE) among the term infants whose mothers underwent trials of labor. Seven of the cases of HIE were associated with uterine rupture.
Perspective is important. Although uterine rupture and HIE—the complications of most concern—are higher among those who attempt VBAC, the absolute rates are quite low and are comparable to, if not lower than, the complication rates of most other obstetrical procedures we perform on a daily basis.
Considering that the risks of pregnancy and childbirth overall are often underappreciated, it is important to share these data with patients and explain that the risks of VBAC are similar in magnitude to complications observed with any vaginal delivery. Certainly, these large observational studies—which provide a broader, more representative look at outcomes than prior studies—provide short-term safety evidence that overall favors VBAC as a standard part of practice.
Selecting Candidates
Patient selection is important, as most of the major complications in women who attempt a trial of labor occur in association with a failed VBAC attempt.
At least several investigators, myself included, have attempted to develop models or scoring systems to predict which women are most likely to be delivered vaginally with a VBAC attempt. Many of these models have incorporated factors that can be ascertained early in prenatal care as well as those that are not known until admission for delivery. Other models focus on factors available at the first prenatal visit, such as maternal age, prepregnancy body mass index, ethnicity, and prior vaginal delivery.
Unfortunately, these models have not been shown to accurately predict who is going to succeed and who is going to fail in a VBAC attempt.
Thus far, the one clinically useful predictive factor we have for VBAC success is prior vaginal delivery, whether it's a prior successful VBAC attempt or a vaginal delivery that predated a cesarean section. Indeed, numerous studies have supported the predictive value of a prior vaginal delivery.
In 2005, for instance, the MFMU reported that a previous vaginal delivery was the most significant predictor of VBAC delivery success in a cohort of 29,661 women with a history of one prior cesarean delivery. Women with a prior vaginal birth had a VBAC delivery success rate of 86.6%, compared with 60.9% in women without a prior vaginal delivery (Am. J. Obstet. Gynecol. 2005;193:1016-23).
A secondary analysis of our large, retrospective observational study on maternal complications with VBAC (discussed above) similarly showed that VBAC candidates with a prior vaginal birth were significantly more successful in achieving vaginal delivery than women with no prior vaginal delivery. The success rate was 89.9%, compared with 67% (Am. J. Obstet. Gynecol. 2006;195:1143-7).
Women with a history of vaginal delivery also appear to have lower rates of major complications, making a VBAC attempt safer in these patients than a planned repeat cesarean section (whether the attempt is successful or not). In our observational study, a prior vaginal delivery was associated with significant reductions in major morbidity.
Clearly, not all women with a history of cesarean delivery are the same, and women with a prior vaginal delivery should be counseled about their more favorable benefit-risk ratio.
Overall, the vaginal delivery rate after a trial of labor is high in women who have had prior cesareans. In our large observational study, the vaginal delivery rate among those women who attempted VBAC was 75.5%. Furthermore, in the draft of its consensus development conference statement, the NIH panel reported that there is a “high grade of evidence” showing that a trial of labor is successful in nearly 75% of cases.
Even in the least favorable groups—among women who might appear to have unfavorable risk profiles for VBAC attempts—the success rate for VBAC is consistently higher than 50%.
Intrapartum Management
We can make a relatively safe and reasonable process even safer by carefully and conservatively managing the intrapartum period in women attempting VBAC.
Here are several tips for managing a trial of labor after cesarean:
▸ Induce labor only when absolutely necessary. Research from both large observational studies on a trial of labor after cesarean has shown that the risk of uterine rupture is two- to threefold higher in women who have their labor induced than in women who are delivered spontaneously. We should therefore refrain from inducing labor unless we have solid medical reasons to do so.
▸ Try to avoid the use of multiple induction agents. If you're considering induction for a VBAC candidate who has an unfavorable cervical exam, reconsider it. Research has also shown that women who require multiple agents for induction have the highest rates of uterine rupture—rates that are almost four- to fivefold higher than those for women who labor spontaneously.
▸ Avoid higher doses of oxytocin. There does not appear to be an increased risk of rupture with oxytocin augmentation of spontaneous labor—unless the dose is in excess of 20 mU/min. An analysis by Dr. A.G. Cahill (Am. J. Obstet. Gynecol. 2007;197:495.e1-5), for example, found a dose-response relationship of maximum oxytocin administration and uterine rupture. Some institutions have already decided not to go above this amount in women attempting VBAC.
If your institution allows higher levels, be extra vigilant as the dosage increases.
▸ Be leery of intrauterine pressure catheters. Old data had suggested that intrauterine pressure catheters could be useful for predicting uterine rupture during trials of labor after cesarean. However, these data have not been supported by further research. I do not recommend the routine use of these catheters to try to predict uterine rupture in women attempting VBAC.
▸ Be aware of signs of possible rupture. Clinical suspicion should be high in women who have unusual pain when epidural anesthesia is already in place and in women who need frequent epidural dosing during a VBAC trial.
Research has shown that both conditions are markers for possible impending uterine rupture during VBAC attempts. An analysis of 504 women who had epidural anesthetic during attempted VBAC, for instance, showed that women who had a uterine rupture received more epidural doses on average, especially during the final 90 minutes of labor, than women who did not have a uterine rupture (Am. J. Obstet. Gynecol. 2010;202:355.e1-5).
▸ Keep patients informed. Keeping your patient informed and comfortable with her options for delivery after cesarean section involves counseling throughout the course of prenatal care and could even include the use of an actual informed consent form for a trial of labor, which can help facilitate thorough discussions about the risks and benefits of attempting VBAC. Informed consent should extend into labor, however. Patients can be told that it is acceptable to inquire about stopping a trial of labor at any point. Giving patients the opportunity to “opt out” can be a good thing; it gives them more control over what's happening.
Consequences of Not Doing VBACs
There is a danger to too easily dismissing VBAC. Although most research has focused on uterine rupture and the index pregnancy, there is also research that clearly shows that serious maternal morbidity increases progressively with each repeat cesarean delivery. With multiple cesareans, each delivery becomes more complicated and carries more risk. The effect on maternal health can be profound.
A prospective observational study of approximately 30,000 women who had cesarean delivery without labor showed that the risks of cystotomy, bowel injury, ureteral injury, hysterectomy, and the need for postoperative ventilation, intensive care unit admission, and significant blood transfusion all were significantly increased with increasing numbers of cesarean deliveries (Obstet. Gynecol. 2006;107:1226-32).
Even more concerning is the risk of abnormal placentation. In this study, placenta accreta occurred in 0.24%, 0.31%, 0.57%, 2.13%, 2.33%, and 6.74% of women who were undergoing their first, second, third, fourth, fifth, and sixth or more cesarean deliveries. In women with placenta previa, the risk for placenta accreta rose progressively with each cesarean delivery—3.3% with the first cesarean, 11% with the second, 40% with the third, 61% with the fifth, and up to 67% with the fifth and sixth cesareans.
Because the rates of abnormal placentation are rising in the United States, it is extremely important that we consider not only the short-term complications of VBAC, such as uterine rupture, but also the long-term consequences of multiple repeat cesarean deliveries.
This part of the overall safety profile of VBAC is discussed in the NIH's draft consensus conference statement. The statement points out that women who have had VBAC have reduced abnormalities of placental growth and position in subsequent pregnancies, and that the incidence of placenta previa significantly increases in women with each additional cesarean delivery.
In counseling about elective repeat cesarean delivery versus a trial of labor, I often talk with women about the number of children they intend to have. If a woman has had a prior cesarean delivery and desires a large family, I am very inclined to strongly encourage her to pursue a trial of labor.
Vitals
Source Elsevier Global Medical News
Key Points
Dr. Macones offered these take-home points:
▸ Rates of uterine rupture and hypoxic ischemic encephalopathy are higher in women who attempt VBAC, but the absolute rates are quite low and similar to the complication rates of most other obstetrical procedures we do.
▸ Prior vaginal delivery is the only clinically useful predictive factor for VBAC success.
▸ VBAC outcomes can be maximized by inducing labor only when necessary, avoiding the use of multiple induction agents, avoiding higher doses of oxytocin, and being aware of signs of possible rupture.
▸ The long-term impact of multiple repeat cesareans should be factored into decision making, as serious maternal morbidity increases with each repeat cesarean delivery.
VBAC: Should We or Shouldn't We?
The surgical approach to infant delivery is not new. Indeed, a variety of approaches have been used to extract fetuses from the uterus when, for various reasons, a vaginal delivery is not possible.
The old notion that “once a cesarean section, always a cesarean section,” moreover, has been a dogma that has existed in obstetrics and medicine for decades. Although this has worked well, many a time, for the convenience of the mother or the physician, it is also problematic. Over time, multiple repeat cesarean sections can pose a hazard, either because the scar becomes weak and at risk of rupture or because the surgical intervention becomes very challenging.
Concerns about possible rupture with repeat cesarean sections were particularly acute in the early years before it was appreciated that there was a difference between a vertical uterine incision and a transverse uterine incision. Following the realization that the lower uterine segment is less prone to active contraction and therefore less likely to rupture, transverse uterine incisions were encouraged in virtually all circumstances, and rupture of the uterus with repeat cesarean section became less of an issue.
In more recent times, reports of trials of labor following prior cesarean delivery resulting in successful vaginal delivery began to appear, and the notion of vaginal birth after cesarean (VBAC) took off, with a wave of success, across the country and indeed around the world. However, as the number of vaginal deliveries after cesarean sections increased, the rate of uterine rupture increased as well.
The rate of uterine rupture has remained low. Still, no matter when it occurs, uterine rupture is always a challenge—a challenge to the surgeon, a problem for the mother or baby, and unfortunately, sometimes a cause of litigation. Because of this complicating set of circumstances, the issue of advisability of VBAC has become a real medical dilemma.
Should we do them? Or should we not? If we should, when should we do them? Are there any guidelines? These are just some of the questions that have arisen over the years that we have had to grapple with. It is in this light that a Master Class to address these issues seemed appropriate. We have invited Dr. George A. Macones, an expert in maternal-fetal medicine who has studied VBAC for many years, to serve as our guest author.
Dr. Macones is the Mitchell and Elaine Yanow Professor and chair of the department of obstetrics and gynecology at Washington University in St. Louis. He recently was invited to speak at a National Institutes of Health consensus development conference on VBAC. In this column, he offers us some insight into why VBAC is a reasonable option for many women, how we can select candidates and counsel our patients, and what we can do to effectively manage our patients' attempts to achieve vaginal delivery after cesarean.
Vaginal birth after cesarean gained widespread acceptance in the 1980s after a National Institutes of Health Consensus Development Conference panel questioned the necessity of routine repeat cesarean deliveries and described situations in which a VBAC should be offered. Some insurers even mandated that physicians attempt a VBAC prior to a repeat cesarean delivery.
Since 1996, however, the VBAC rate has dropped substantially while cesarean delivery rates have risen steadily. The overall cesarean delivery rate was approximately 32% when last measured in 2007, up from 21% in 1996. The VBAC rate was less than 10% in 2007, compared with 28% in 1996, according to the Centers for Disease Control and Prevention.
Indeed, pregnant women now have limited access to VBAC services, and many are not even offered the option of having a trial of labor after cesarean. Some hospitals have declined to provide VBAC services, and the most recent medical liability survey conducted by the American College of Obstetricians and Gynecologists showed that almost 20% of responding fellows stopped offering or performing VBACs between 2006 and 2008. (In the prior survey, completed in 2006, these numbers were even higher—upward of 26%.)
The exact causes of the decline in VBAC deliveries are unclear, but the shift likely involves a mix of concerns about the possibility of uterine rupture, patient preferences, medicolegal pressures, guidelines that call for the immediate availability of personnel to perform an emergency cesarean, and other clinical and nonclinical factors.
It is a complex and concerning trend—one considered important enough to the health of women in the United States for the NIH to recently convene another Consensus Development Conference panel on the topic. The panel was asked to examine the causes of VBAC decline as well as the available research on the benefits and harms of attempting a trial of labor after a patient has had a cesarean delivery.
In a draft statement titled, “Vaginal Birth After Cesarean: New Insights,” released in March, the panel affirmed that a trial of labor is a reasonable option for many women with a prior cesarean delivery. It also urged that current VBAC guidelines be reconsidered and more research conducted.
Although guidelines are being revisited and research ensues, we owe it to the patients in our own practices to thoroughly consider what is known about the short- and long-term safety of VBAC, the selection of candidates, and the most reasonable approaches to intrapartum management.
Short-Term Safety of VBAC
In the past decade, there have been two large observational studies in the United States that have shed much light on the efficacy and safety of a trial of labor after cesarean. Both studies involved upwards of 20,000 women, and both showed rates of uterine rupture under 1%. This finding is significant, because some have suggested that uterine rupture is on the rise in the United States.
In one of these studies—a prospective cohort study conducted from 1999 through 2002 at 19 academic medical centers belonging to the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network—there were 124 cases of uterine rupture among 17,898 women who underwent a trial of labor after cesarean, and no cases of uterine rupture among 15,801 women who underwent elective repeat cesarean delivery.
The rate of uterine rupture was 0.7% for women with a prior low transverse incision, 2.0% for those with a prior low vertical incision, and 0.5% for those with an unknown type of prior incision. Overall, the rate of uterine rupture in this study was 0.7% (N. Engl. J. Med. 2004;351:2581-9).
The second study, which I led, revealed a rate of uterine rupture in women who attempted VBAC of 0.9%, compared with a rate of 0.004% in women who underwent elective repeat cesarean section. This study was a multicenter observational study in which records of approximately 25,000 women with a prior low-transverse cesarean section were reviewed (Am. J. Obstet. Gynecol. 2005;193:1656-62).
Just as uterine rupture is more common in women who have a VBAC attempt than in those who choose elective repeat cesarean section, so are adverse perinatal outcomes. The MFMU study found 12 cases of hypoxic ischemic encephalopathy (HIE) among the term infants whose mothers underwent trials of labor. Seven of the cases of HIE were associated with uterine rupture.
Perspective is important. Although uterine rupture and HIE—the complications of most concern—are higher among those who attempt VBAC, the absolute rates are quite low and are comparable to, if not lower than, the complication rates of most other obstetrical procedures we perform on a daily basis.
Considering that the risks of pregnancy and childbirth overall are often underappreciated, it is important to share these data with patients and explain that the risks of VBAC are similar in magnitude to complications observed with any vaginal delivery. Certainly, these large observational studies—which provide a broader, more representative look at outcomes than prior studies—provide short-term safety evidence that overall favors VBAC as a standard part of practice.
Selecting Candidates
Patient selection is important, as most of the major complications in women who attempt a trial of labor occur in association with a failed VBAC attempt.
At least several investigators, myself included, have attempted to develop models or scoring systems to predict which women are most likely to be delivered vaginally with a VBAC attempt. Many of these models have incorporated factors that can be ascertained early in prenatal care as well as those that are not known until admission for delivery. Other models focus on factors available at the first prenatal visit, such as maternal age, prepregnancy body mass index, ethnicity, and prior vaginal delivery.
Unfortunately, these models have not been shown to accurately predict who is going to succeed and who is going to fail in a VBAC attempt.
Thus far, the one clinically useful predictive factor we have for VBAC success is prior vaginal delivery, whether it's a prior successful VBAC attempt or a vaginal delivery that predated a cesarean section. Indeed, numerous studies have supported the predictive value of a prior vaginal delivery.
In 2005, for instance, the MFMU reported that a previous vaginal delivery was the most significant predictor of VBAC delivery success in a cohort of 29,661 women with a history of one prior cesarean delivery. Women with a prior vaginal birth had a VBAC delivery success rate of 86.6%, compared with 60.9% in women without a prior vaginal delivery (Am. J. Obstet. Gynecol. 2005;193:1016-23).
A secondary analysis of our large, retrospective observational study on maternal complications with VBAC (discussed above) similarly showed that VBAC candidates with a prior vaginal birth were significantly more successful in achieving vaginal delivery than women with no prior vaginal delivery. The success rate was 89.9%, compared with 67% (Am. J. Obstet. Gynecol. 2006;195:1143-7).
Women with a history of vaginal delivery also appear to have lower rates of major complications, making a VBAC attempt safer in these patients than a planned repeat cesarean section (whether the attempt is successful or not). In our observational study, a prior vaginal delivery was associated with significant reductions in major morbidity.
Clearly, not all women with a history of cesarean delivery are the same, and women with a prior vaginal delivery should be counseled about their more favorable benefit-risk ratio.
Overall, the vaginal delivery rate after a trial of labor is high in women who have had prior cesareans. In our large observational study, the vaginal delivery rate among those women who attempted VBAC was 75.5%. Furthermore, in the draft of its consensus development conference statement, the NIH panel reported that there is a “high grade of evidence” showing that a trial of labor is successful in nearly 75% of cases.
Even in the least favorable groups—among women who might appear to have unfavorable risk profiles for VBAC attempts—the success rate for VBAC is consistently higher than 50%.
Intrapartum Management
We can make a relatively safe and reasonable process even safer by carefully and conservatively managing the intrapartum period in women attempting VBAC.
Here are several tips for managing a trial of labor after cesarean:
▸ Induce labor only when absolutely necessary. Research from both large observational studies on a trial of labor after cesarean has shown that the risk of uterine rupture is two- to threefold higher in women who have their labor induced than in women who are delivered spontaneously. We should therefore refrain from inducing labor unless we have solid medical reasons to do so.
▸ Try to avoid the use of multiple induction agents. If you're considering induction for a VBAC candidate who has an unfavorable cervical exam, reconsider it. Research has also shown that women who require multiple agents for induction have the highest rates of uterine rupture—rates that are almost four- to fivefold higher than those for women who labor spontaneously.
▸ Avoid higher doses of oxytocin. There does not appear to be an increased risk of rupture with oxytocin augmentation of spontaneous labor—unless the dose is in excess of 20 mU/min. An analysis by Dr. A.G. Cahill (Am. J. Obstet. Gynecol. 2007;197:495.e1-5), for example, found a dose-response relationship of maximum oxytocin administration and uterine rupture. Some institutions have already decided not to go above this amount in women attempting VBAC.
If your institution allows higher levels, be extra vigilant as the dosage increases.
▸ Be leery of intrauterine pressure catheters. Old data had suggested that intrauterine pressure catheters could be useful for predicting uterine rupture during trials of labor after cesarean. However, these data have not been supported by further research. I do not recommend the routine use of these catheters to try to predict uterine rupture in women attempting VBAC.
▸ Be aware of signs of possible rupture. Clinical suspicion should be high in women who have unusual pain when epidural anesthesia is already in place and in women who need frequent epidural dosing during a VBAC trial.
Research has shown that both conditions are markers for possible impending uterine rupture during VBAC attempts. An analysis of 504 women who had epidural anesthetic during attempted VBAC, for instance, showed that women who had a uterine rupture received more epidural doses on average, especially during the final 90 minutes of labor, than women who did not have a uterine rupture (Am. J. Obstet. Gynecol. 2010;202:355.e1-5).
▸ Keep patients informed. Keeping your patient informed and comfortable with her options for delivery after cesarean section involves counseling throughout the course of prenatal care and could even include the use of an actual informed consent form for a trial of labor, which can help facilitate thorough discussions about the risks and benefits of attempting VBAC. Informed consent should extend into labor, however. Patients can be told that it is acceptable to inquire about stopping a trial of labor at any point. Giving patients the opportunity to “opt out” can be a good thing; it gives them more control over what's happening.
Consequences of Not Doing VBACs
There is a danger to too easily dismissing VBAC. Although most research has focused on uterine rupture and the index pregnancy, there is also research that clearly shows that serious maternal morbidity increases progressively with each repeat cesarean delivery. With multiple cesareans, each delivery becomes more complicated and carries more risk. The effect on maternal health can be profound.
A prospective observational study of approximately 30,000 women who had cesarean delivery without labor showed that the risks of cystotomy, bowel injury, ureteral injury, hysterectomy, and the need for postoperative ventilation, intensive care unit admission, and significant blood transfusion all were significantly increased with increasing numbers of cesarean deliveries (Obstet. Gynecol. 2006;107:1226-32).
Even more concerning is the risk of abnormal placentation. In this study, placenta accreta occurred in 0.24%, 0.31%, 0.57%, 2.13%, 2.33%, and 6.74% of women who were undergoing their first, second, third, fourth, fifth, and sixth or more cesarean deliveries. In women with placenta previa, the risk for placenta accreta rose progressively with each cesarean delivery—3.3% with the first cesarean, 11% with the second, 40% with the third, 61% with the fifth, and up to 67% with the fifth and sixth cesareans.
Because the rates of abnormal placentation are rising in the United States, it is extremely important that we consider not only the short-term complications of VBAC, such as uterine rupture, but also the long-term consequences of multiple repeat cesarean deliveries.
This part of the overall safety profile of VBAC is discussed in the NIH's draft consensus conference statement. The statement points out that women who have had VBAC have reduced abnormalities of placental growth and position in subsequent pregnancies, and that the incidence of placenta previa significantly increases in women with each additional cesarean delivery.
In counseling about elective repeat cesarean delivery versus a trial of labor, I often talk with women about the number of children they intend to have. If a woman has had a prior cesarean delivery and desires a large family, I am very inclined to strongly encourage her to pursue a trial of labor.
Vitals
Source Elsevier Global Medical News
Key Points
Dr. Macones offered these take-home points:
▸ Rates of uterine rupture and hypoxic ischemic encephalopathy are higher in women who attempt VBAC, but the absolute rates are quite low and similar to the complication rates of most other obstetrical procedures we do.
▸ Prior vaginal delivery is the only clinically useful predictive factor for VBAC success.
▸ VBAC outcomes can be maximized by inducing labor only when necessary, avoiding the use of multiple induction agents, avoiding higher doses of oxytocin, and being aware of signs of possible rupture.
▸ The long-term impact of multiple repeat cesareans should be factored into decision making, as serious maternal morbidity increases with each repeat cesarean delivery.
VBAC: Should We or Shouldn't We?
The surgical approach to infant delivery is not new. Indeed, a variety of approaches have been used to extract fetuses from the uterus when, for various reasons, a vaginal delivery is not possible.
The old notion that “once a cesarean section, always a cesarean section,” moreover, has been a dogma that has existed in obstetrics and medicine for decades. Although this has worked well, many a time, for the convenience of the mother or the physician, it is also problematic. Over time, multiple repeat cesarean sections can pose a hazard, either because the scar becomes weak and at risk of rupture or because the surgical intervention becomes very challenging.
Concerns about possible rupture with repeat cesarean sections were particularly acute in the early years before it was appreciated that there was a difference between a vertical uterine incision and a transverse uterine incision. Following the realization that the lower uterine segment is less prone to active contraction and therefore less likely to rupture, transverse uterine incisions were encouraged in virtually all circumstances, and rupture of the uterus with repeat cesarean section became less of an issue.
In more recent times, reports of trials of labor following prior cesarean delivery resulting in successful vaginal delivery began to appear, and the notion of vaginal birth after cesarean (VBAC) took off, with a wave of success, across the country and indeed around the world. However, as the number of vaginal deliveries after cesarean sections increased, the rate of uterine rupture increased as well.
The rate of uterine rupture has remained low. Still, no matter when it occurs, uterine rupture is always a challenge—a challenge to the surgeon, a problem for the mother or baby, and unfortunately, sometimes a cause of litigation. Because of this complicating set of circumstances, the issue of advisability of VBAC has become a real medical dilemma.
Should we do them? Or should we not? If we should, when should we do them? Are there any guidelines? These are just some of the questions that have arisen over the years that we have had to grapple with. It is in this light that a Master Class to address these issues seemed appropriate. We have invited Dr. George A. Macones, an expert in maternal-fetal medicine who has studied VBAC for many years, to serve as our guest author.
Dr. Macones is the Mitchell and Elaine Yanow Professor and chair of the department of obstetrics and gynecology at Washington University in St. Louis. He recently was invited to speak at a National Institutes of Health consensus development conference on VBAC. In this column, he offers us some insight into why VBAC is a reasonable option for many women, how we can select candidates and counsel our patients, and what we can do to effectively manage our patients' attempts to achieve vaginal delivery after cesarean.
Vaginal birth after cesarean gained widespread acceptance in the 1980s after a National Institutes of Health Consensus Development Conference panel questioned the necessity of routine repeat cesarean deliveries and described situations in which a VBAC should be offered. Some insurers even mandated that physicians attempt a VBAC prior to a repeat cesarean delivery.
Since 1996, however, the VBAC rate has dropped substantially while cesarean delivery rates have risen steadily. The overall cesarean delivery rate was approximately 32% when last measured in 2007, up from 21% in 1996. The VBAC rate was less than 10% in 2007, compared with 28% in 1996, according to the Centers for Disease Control and Prevention.
Indeed, pregnant women now have limited access to VBAC services, and many are not even offered the option of having a trial of labor after cesarean. Some hospitals have declined to provide VBAC services, and the most recent medical liability survey conducted by the American College of Obstetricians and Gynecologists showed that almost 20% of responding fellows stopped offering or performing VBACs between 2006 and 2008. (In the prior survey, completed in 2006, these numbers were even higher—upward of 26%.)
The exact causes of the decline in VBAC deliveries are unclear, but the shift likely involves a mix of concerns about the possibility of uterine rupture, patient preferences, medicolegal pressures, guidelines that call for the immediate availability of personnel to perform an emergency cesarean, and other clinical and nonclinical factors.
It is a complex and concerning trend—one considered important enough to the health of women in the United States for the NIH to recently convene another Consensus Development Conference panel on the topic. The panel was asked to examine the causes of VBAC decline as well as the available research on the benefits and harms of attempting a trial of labor after a patient has had a cesarean delivery.
In a draft statement titled, “Vaginal Birth After Cesarean: New Insights,” released in March, the panel affirmed that a trial of labor is a reasonable option for many women with a prior cesarean delivery. It also urged that current VBAC guidelines be reconsidered and more research conducted.
Although guidelines are being revisited and research ensues, we owe it to the patients in our own practices to thoroughly consider what is known about the short- and long-term safety of VBAC, the selection of candidates, and the most reasonable approaches to intrapartum management.
Short-Term Safety of VBAC
In the past decade, there have been two large observational studies in the United States that have shed much light on the efficacy and safety of a trial of labor after cesarean. Both studies involved upwards of 20,000 women, and both showed rates of uterine rupture under 1%. This finding is significant, because some have suggested that uterine rupture is on the rise in the United States.
In one of these studies—a prospective cohort study conducted from 1999 through 2002 at 19 academic medical centers belonging to the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network—there were 124 cases of uterine rupture among 17,898 women who underwent a trial of labor after cesarean, and no cases of uterine rupture among 15,801 women who underwent elective repeat cesarean delivery.
The rate of uterine rupture was 0.7% for women with a prior low transverse incision, 2.0% for those with a prior low vertical incision, and 0.5% for those with an unknown type of prior incision. Overall, the rate of uterine rupture in this study was 0.7% (N. Engl. J. Med. 2004;351:2581-9).
The second study, which I led, revealed a rate of uterine rupture in women who attempted VBAC of 0.9%, compared with a rate of 0.004% in women who underwent elective repeat cesarean section. This study was a multicenter observational study in which records of approximately 25,000 women with a prior low-transverse cesarean section were reviewed (Am. J. Obstet. Gynecol. 2005;193:1656-62).
Just as uterine rupture is more common in women who have a VBAC attempt than in those who choose elective repeat cesarean section, so are adverse perinatal outcomes. The MFMU study found 12 cases of hypoxic ischemic encephalopathy (HIE) among the term infants whose mothers underwent trials of labor. Seven of the cases of HIE were associated with uterine rupture.
Perspective is important. Although uterine rupture and HIE—the complications of most concern—are higher among those who attempt VBAC, the absolute rates are quite low and are comparable to, if not lower than, the complication rates of most other obstetrical procedures we perform on a daily basis.
Considering that the risks of pregnancy and childbirth overall are often underappreciated, it is important to share these data with patients and explain that the risks of VBAC are similar in magnitude to complications observed with any vaginal delivery. Certainly, these large observational studies—which provide a broader, more representative look at outcomes than prior studies—provide short-term safety evidence that overall favors VBAC as a standard part of practice.
Selecting Candidates
Patient selection is important, as most of the major complications in women who attempt a trial of labor occur in association with a failed VBAC attempt.
At least several investigators, myself included, have attempted to develop models or scoring systems to predict which women are most likely to be delivered vaginally with a VBAC attempt. Many of these models have incorporated factors that can be ascertained early in prenatal care as well as those that are not known until admission for delivery. Other models focus on factors available at the first prenatal visit, such as maternal age, prepregnancy body mass index, ethnicity, and prior vaginal delivery.
Unfortunately, these models have not been shown to accurately predict who is going to succeed and who is going to fail in a VBAC attempt.
Thus far, the one clinically useful predictive factor we have for VBAC success is prior vaginal delivery, whether it's a prior successful VBAC attempt or a vaginal delivery that predated a cesarean section. Indeed, numerous studies have supported the predictive value of a prior vaginal delivery.
In 2005, for instance, the MFMU reported that a previous vaginal delivery was the most significant predictor of VBAC delivery success in a cohort of 29,661 women with a history of one prior cesarean delivery. Women with a prior vaginal birth had a VBAC delivery success rate of 86.6%, compared with 60.9% in women without a prior vaginal delivery (Am. J. Obstet. Gynecol. 2005;193:1016-23).
A secondary analysis of our large, retrospective observational study on maternal complications with VBAC (discussed above) similarly showed that VBAC candidates with a prior vaginal birth were significantly more successful in achieving vaginal delivery than women with no prior vaginal delivery. The success rate was 89.9%, compared with 67% (Am. J. Obstet. Gynecol. 2006;195:1143-7).
Women with a history of vaginal delivery also appear to have lower rates of major complications, making a VBAC attempt safer in these patients than a planned repeat cesarean section (whether the attempt is successful or not). In our observational study, a prior vaginal delivery was associated with significant reductions in major morbidity.
Clearly, not all women with a history of cesarean delivery are the same, and women with a prior vaginal delivery should be counseled about their more favorable benefit-risk ratio.
Overall, the vaginal delivery rate after a trial of labor is high in women who have had prior cesareans. In our large observational study, the vaginal delivery rate among those women who attempted VBAC was 75.5%. Furthermore, in the draft of its consensus development conference statement, the NIH panel reported that there is a “high grade of evidence” showing that a trial of labor is successful in nearly 75% of cases.
Even in the least favorable groups—among women who might appear to have unfavorable risk profiles for VBAC attempts—the success rate for VBAC is consistently higher than 50%.
Intrapartum Management
We can make a relatively safe and reasonable process even safer by carefully and conservatively managing the intrapartum period in women attempting VBAC.
Here are several tips for managing a trial of labor after cesarean:
▸ Induce labor only when absolutely necessary. Research from both large observational studies on a trial of labor after cesarean has shown that the risk of uterine rupture is two- to threefold higher in women who have their labor induced than in women who are delivered spontaneously. We should therefore refrain from inducing labor unless we have solid medical reasons to do so.
▸ Try to avoid the use of multiple induction agents. If you're considering induction for a VBAC candidate who has an unfavorable cervical exam, reconsider it. Research has also shown that women who require multiple agents for induction have the highest rates of uterine rupture—rates that are almost four- to fivefold higher than those for women who labor spontaneously.
▸ Avoid higher doses of oxytocin. There does not appear to be an increased risk of rupture with oxytocin augmentation of spontaneous labor—unless the dose is in excess of 20 mU/min. An analysis by Dr. A.G. Cahill (Am. J. Obstet. Gynecol. 2007;197:495.e1-5), for example, found a dose-response relationship of maximum oxytocin administration and uterine rupture. Some institutions have already decided not to go above this amount in women attempting VBAC.
If your institution allows higher levels, be extra vigilant as the dosage increases.
▸ Be leery of intrauterine pressure catheters. Old data had suggested that intrauterine pressure catheters could be useful for predicting uterine rupture during trials of labor after cesarean. However, these data have not been supported by further research. I do not recommend the routine use of these catheters to try to predict uterine rupture in women attempting VBAC.
▸ Be aware of signs of possible rupture. Clinical suspicion should be high in women who have unusual pain when epidural anesthesia is already in place and in women who need frequent epidural dosing during a VBAC trial.
Research has shown that both conditions are markers for possible impending uterine rupture during VBAC attempts. An analysis of 504 women who had epidural anesthetic during attempted VBAC, for instance, showed that women who had a uterine rupture received more epidural doses on average, especially during the final 90 minutes of labor, than women who did not have a uterine rupture (Am. J. Obstet. Gynecol. 2010;202:355.e1-5).
▸ Keep patients informed. Keeping your patient informed and comfortable with her options for delivery after cesarean section involves counseling throughout the course of prenatal care and could even include the use of an actual informed consent form for a trial of labor, which can help facilitate thorough discussions about the risks and benefits of attempting VBAC. Informed consent should extend into labor, however. Patients can be told that it is acceptable to inquire about stopping a trial of labor at any point. Giving patients the opportunity to “opt out” can be a good thing; it gives them more control over what's happening.
Consequences of Not Doing VBACs
There is a danger to too easily dismissing VBAC. Although most research has focused on uterine rupture and the index pregnancy, there is also research that clearly shows that serious maternal morbidity increases progressively with each repeat cesarean delivery. With multiple cesareans, each delivery becomes more complicated and carries more risk. The effect on maternal health can be profound.
A prospective observational study of approximately 30,000 women who had cesarean delivery without labor showed that the risks of cystotomy, bowel injury, ureteral injury, hysterectomy, and the need for postoperative ventilation, intensive care unit admission, and significant blood transfusion all were significantly increased with increasing numbers of cesarean deliveries (Obstet. Gynecol. 2006;107:1226-32).
Even more concerning is the risk of abnormal placentation. In this study, placenta accreta occurred in 0.24%, 0.31%, 0.57%, 2.13%, 2.33%, and 6.74% of women who were undergoing their first, second, third, fourth, fifth, and sixth or more cesarean deliveries. In women with placenta previa, the risk for placenta accreta rose progressively with each cesarean delivery—3.3% with the first cesarean, 11% with the second, 40% with the third, 61% with the fifth, and up to 67% with the fifth and sixth cesareans.
Because the rates of abnormal placentation are rising in the United States, it is extremely important that we consider not only the short-term complications of VBAC, such as uterine rupture, but also the long-term consequences of multiple repeat cesarean deliveries.
This part of the overall safety profile of VBAC is discussed in the NIH's draft consensus conference statement. The statement points out that women who have had VBAC have reduced abnormalities of placental growth and position in subsequent pregnancies, and that the incidence of placenta previa significantly increases in women with each additional cesarean delivery.
In counseling about elective repeat cesarean delivery versus a trial of labor, I often talk with women about the number of children they intend to have. If a woman has had a prior cesarean delivery and desires a large family, I am very inclined to strongly encourage her to pursue a trial of labor.
Vitals
Source Elsevier Global Medical News
Key Points
Dr. Macones offered these take-home points:
▸ Rates of uterine rupture and hypoxic ischemic encephalopathy are higher in women who attempt VBAC, but the absolute rates are quite low and similar to the complication rates of most other obstetrical procedures we do.
▸ Prior vaginal delivery is the only clinically useful predictive factor for VBAC success.
▸ VBAC outcomes can be maximized by inducing labor only when necessary, avoiding the use of multiple induction agents, avoiding higher doses of oxytocin, and being aware of signs of possible rupture.
▸ The long-term impact of multiple repeat cesareans should be factored into decision making, as serious maternal morbidity increases with each repeat cesarean delivery.
VBAC: Should We or Shouldn't We?
The surgical approach to infant delivery is not new. Indeed, a variety of approaches have been used to extract fetuses from the uterus when, for various reasons, a vaginal delivery is not possible.
The old notion that “once a cesarean section, always a cesarean section,” moreover, has been a dogma that has existed in obstetrics and medicine for decades. Although this has worked well, many a time, for the convenience of the mother or the physician, it is also problematic. Over time, multiple repeat cesarean sections can pose a hazard, either because the scar becomes weak and at risk of rupture or because the surgical intervention becomes very challenging.
Concerns about possible rupture with repeat cesarean sections were particularly acute in the early years before it was appreciated that there was a difference between a vertical uterine incision and a transverse uterine incision. Following the realization that the lower uterine segment is less prone to active contraction and therefore less likely to rupture, transverse uterine incisions were encouraged in virtually all circumstances, and rupture of the uterus with repeat cesarean section became less of an issue.
In more recent times, reports of trials of labor following prior cesarean delivery resulting in successful vaginal delivery began to appear, and the notion of vaginal birth after cesarean (VBAC) took off, with a wave of success, across the country and indeed around the world. However, as the number of vaginal deliveries after cesarean sections increased, the rate of uterine rupture increased as well.
The rate of uterine rupture has remained low. Still, no matter when it occurs, uterine rupture is always a challenge—a challenge to the surgeon, a problem for the mother or baby, and unfortunately, sometimes a cause of litigation. Because of this complicating set of circumstances, the issue of advisability of VBAC has become a real medical dilemma.
Should we do them? Or should we not? If we should, when should we do them? Are there any guidelines? These are just some of the questions that have arisen over the years that we have had to grapple with. It is in this light that a Master Class to address these issues seemed appropriate. We have invited Dr. George A. Macones, an expert in maternal-fetal medicine who has studied VBAC for many years, to serve as our guest author.
Dr. Macones is the Mitchell and Elaine Yanow Professor and chair of the department of obstetrics and gynecology at Washington University in St. Louis. He recently was invited to speak at a National Institutes of Health consensus development conference on VBAC. In this column, he offers us some insight into why VBAC is a reasonable option for many women, how we can select candidates and counsel our patients, and what we can do to effectively manage our patients' attempts to achieve vaginal delivery after cesarean.
Managing Posterior Vaginal Wall Prolapse
Patients with pelvic organ prolapse present with a variety of symptoms and anatomical findings. In the case of posterior vaginal wall prolapse, one must first determine what part of the patient's support mechanism has failed. It is important to decide in the clinical examination whether her prolapse is related to a loss of apical support, a weakness in the distal vaginal wall, a separation or weakness in the perineal body, or some combination of these support failures.
Like anterior wall prolapse, loss of apical support can lead to prolapse of the upper and mid vagina. Elevating the top of the vagina with a ring forceps or Kelly clamp to a more physiologically normal position in the office or operating room can determine the role of apical failure in the posterior wall prolapse. Once that determination is made, the surgeon then can decide on the type of repair the patient requires.
Occasionally, if the clinical examination does not match the patient's symptoms, radiologic studies such as a defecography can help identify the support defects.
If the prolapse stems predominantly from a loss of apical support, treatment can be addressed through one of several procedures, from a sacral colpopexy to a uterosacral suspension or a sacrospinous vaginal vault suspension. If the prolapse involves a more traditional type of rectocele, where there is loss of support in the distal vaginal wall, one must decide what type of repair—site specific or standard posterior colporrhaphy—will result in the best anatomic and functional outcomes.
Finally, weakness in the perineal body or perineocele is determined by palpating the thickness and integrity of the perineal body on rectal exam.
Equally important to the anatomic considerations and prior to any surgery, the patient's symptoms as well as her current and future sexual function should be addressed. Women with posterior compartment prolapse frequently have symptoms related to bowel dysfunction, including straining, incomplete bowel emptying, painful bowel movements, and fecal incontinence. The extent or severity of symptoms is not necessarily related to the severity of prolapse, and frequently her bowel function is most dependent on upper GI function and the type and frequency of her stool.
Studies have generally shown that most bowel symptoms—particularly straining and incomplete emptying—are resolved or improved with posterior wall repair. In some cases, surgical treatment may not necessarily correct bowel dysfunction, and occasionally it may contribute to bowel dysfunction.
Before surgical therapy, it is critical to understand which symptoms are bothering the patient, if they are related to the physical findings, and if surgical correction of the anatomy will improve her symptoms. Each patient should be appropriately counseled about the possible impact of prolapse surgery on both bowel and sexual function. Depending on the aggressiveness of the repair, approximately 15% of patients may experience some discomfort with intercourse after a colpoperineorrhaphy. Not plicating the levators can decrease but not totally alleviate this risk (Obstet. Gynecol. 2004;104:1403-21).ht
Traditional Repair Yields Best Outcomes
The approach to rectocele repair has evolved over the years, but the literature still suggests that a more traditional type of repair, with side-to-side plication and the use of delayed absorbable suture yields the best results with the least morbidity.
This surgical technique generally involves a two-layer repair, with minimal trimming of some of the vaginal wall and closure of the vaginal mucosa with an interrupted or running polyglactin suture.
Authors of a 2007 Cochrane Review of the Surgical Management of Pelvic Organ Prolapse in Women reported that for posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele and/or enterocele compared with the transanal approach (relative risk 0.24), a type of rectocele repair performed commonly performed by colorectal surgeons. However, data on the effect of surgery on bowel symptoms and the use of polyglactin mesh inlay or porcine small intestine graft inlay on the risk of recurrent rectocele were insufficient for meta-analysis. There also were no randomized trials using permanent mesh for rectocele repairs, either as an inlay or as a “suspension kit” (Cochrane Database Syst. Rev. 2007;3:CD004014).h
In one well-conducted, randomized controlled study, the traditional posterior colporrhaphy was found to have a lower failure rate compared with the site-specific repair alone, or a site-specific repair with the addition of a porcine small intestine submucosa graft for rectoceles. Symptomatically, if the anatomical repair was successful, there were no significant differences between the posterior colporrhaphy, site-specific repair, or site-specific repair augmented with porcine small intestine submucosa in terms of perioperative and postoperative morbidity, functional outcomes, quality of life, and bowel and sexual function (Am. J. Obstet. Gynecol. 2006;195:1762-71).
Currently there is little evidence to support the use of absorbable or permanent mesh in the posterior wall. Case series of mesh inlays or mesh kits without native tissue controls are still needed to determine the risks and benefits of these procedures. The caution is to not consider the posterior vaginal wall as a mirror image of the anterior vaginal wall. While one type of graft may improve the surgical cure for cystoceles, it may not add any benefit for rectocele repairs.
Additionally, stiffness in the posterior vaginal wall can lead to dyspareunia and defecation disorders, primarily fecal urgency and fecal incontinence. If the rectum is not expandable because the posterior vaginal wall is stiff and nonpliable, the patient feels a constant urge to defecate, and if she has poor anal sphincter function, a noncompliant rectal reservoir can lead to fecal or flatal loss.
In my practice, when a patient complains of splinting or incomplete evacuation, I suspect a distal rectocele and a deficient perineal body. Perineal body defects are often found in patients who have an enlarged vaginal introitus or a history of straining or prior episiotomy, for instance, and addressing these defects is a key part of posterior wall repair that is too often neglected.
When a perineorrhaphy is performed, the bulbocavernosus muscles must be identified and plicated in the midline with care so as not to narrow the introitus so significantly that coital activity would be impaired. Caudad to the bulbocavernosus muscles, mobilization of the lateral tissues will enable plication of the medial portions of the puboperineus muscles. This compensatory repair will help bulk and strengthen the perineal body.
I use 3-0 prolonged, delayed, absorbable sutures, in one or two layers. This step increases the length and thickness of the perineal body and can also increase the functional length of the posterior vaginal wall.
Technique for Traditional Colporrhaphy
As described by Dr. B.H. Goff and later Dr. David Nichols, the traditional posterior colporrhaphy involves opening the posterior vaginal wall epithelium in the midline and dissecting laterally and superiorly, then plicating the posterior vaginal wall muscularis—or rectovaginal septum, as the endopelvic fascia is termed—in the midline. The excess of the epithelium is then trimmed and brought back together in the midline.
With the Goff method, the rectovaginal septum is not dissected “off” the posterior vaginal wall. In contrast, with the Bullard modification, the rectovaginal septum is dissected off the posterior vaginal wall. This mobilizes the connective tissue layer to the lateral sidewalls and allows a separate layer to be plicated between the vagina and rectum.
I prefer this technique for two reasons. First, it allows one to decrease the size of a dilated rectal ampulla by inverting the dilated rectal wall into the rectal lumen similar to a transrectal rectocele repair. Also with this method, any “ridge” created is directed posterior for less dyspareunia. The levator muscles should never be plicated, unless an obliterative procedure is being performed, because of the impact on sexual function.
To begin, two Allis clamps are placed on the hymen at approximately the 5 o'clock and 7 o'clock positions. The position of these clamps should be modified, however, depending on the size of the genital hiatus, so that three finger breaths can be easily admitted to ensure enough room for sexual intercourse. As patients age, this becomes increasingly important as the incidence of erectile dysfunction in male partners precludes penetration in a very narrow genital hiatus.
Since rectocele repair is usually done after other apical or anterior wall compartment defects are corrected (rectoceles are rarely isolated problems, and high rectoceles are usually associated with apical defects or enteroceles), it is important to appreciate that the introitus may tighten during the healing process.
Once the Allis clamps are placed on the hymenal ring, with a finger placed in the rectum, the surgeon must identify the extent of the weakness in the vaginal wall. This is accomplished by a thorough examination of the vagina with palpation between the finger and thumb. For example, with a finger in the rectum, palpate transrectally the thickness of the perineal body. This will enable you to determine if the bulbocavernosus muscles are separated or retracted, generally from childbirth or chronic straining or constipation, and will give you an assessment of the perineal body integrity.
Further, by elevating the vaginal wall rectally, the point of weakness and placement of the apical limit of the repair can be determined. At that point, another Allis clamp is then placed accordingly in the vagina to mark the top of the repair.
Once you have determined the size of your dissection, use a dilute vasopressin solution to infiltrate underneath the posterior vaginal wall along the dissection margins (we use vasopressin 20 U in 50 cc of normal saline). An incision along those margins is made with a knife through the mucosa. Metzenbaum scissors or a knife can then be used to excise the vaginal mucosa.
I prefer to keep a finger in the rectum at all times. This helps prevent inadvertent placement of a stitch in the rectum. I generally grasp the edges of the incision with Allis clamps and mobilize the “rectovaginal septum” off the posterior vaginal wall.
Prolonged delayed absorbable sutures are used to plicate the fibromuscularis tissue in the midline in a side-to-side fashion. I generally use a 2-0 polydioxanone (PDS) absorbable suture on a CT-2 needle, oplaced in interrupted horizontal mattress stitches to the level of the hymen. I try to create a ridge of tissue that is directed posterior toward the rectum.
If the rectal ampulla is enlarged, it will often invert as the dense connective tissue is plicated, thus reducing the size of the rectum. Depending on the size of the rectocele and how high I have gone with the rectocele repair, I place two to eight stitches.
Generally, before placing those sutures, I will place a stitch using a 3-0 Vicryl suture at the apex of the incision so that once I finish the deep layer I can easily run a 3-0 Vicryl suture interlocking with about every third stitch to the level of the hymen. I have found interlocking every few stitches prevents shortening of the wall.
When applicable, the perineal body must be addressed next. With the extent of the deficiency taken into account, I mobilize and dissect the mucosa with Metzenbaum scissors so that I can identify or at least attempt to palpate the ends of the retracted bulbocavernosus muscles.
I will grasp these muscles with an Allis clamp and place a horizontal mattress of stitch using a 2-0 PDS suture on a CT-2 needle. The assistant frequently will assist by grabbing the needle with a tonsil clamp. A finger in the rectum can also help stabilize the needle.
Depending on the tissue, I will place one or two layers at this point. I will then close with the 3-0 Vicryl suture that I'd placed above and held, with a deep layer down and a subcuticular layer back up, with the knot just inside of the hymenal ring, similar to an episiotomy closure.
Although not glamorous, repair of a posterior wall defect can often be life changing for a patient. The ability to have bowel movements without manual manipulation, wear a tampon, or just regain confidence as a consequence of improved body image is invaluable.
Often, at the end of a long reconstructive case, the relative importance of a good colpoperineorrhaphy can be hard to appreciate. Yet, for the completion of pelvic floor function and anatomical outcomes, it is often a necessity.
Seventy-five to 95% of women will have good anatomical outcomes with this type of repair with similar improvements in splinting for defecation.
Allis clamps are placed on the hymen at approximately the 5 o'clock and 7 o'clock positions. Clamps are adjusted to desired introital size. Figure 2: Mobilize the “rectovaginal septum” off the posterior vaginal wall. Figure 3: Plicate the fibromuscularis tissue in the midline in a side-to-side fashion. Figure 4: A tonsil clamp is used to invert the enlarged rectal ampulla as the dense connective tissue is plicated. Figure 5: Mobilize and dissect the mucosa of the perineal body to identify or at least attempt to palpate the ends of the retracted bulbocavernosus muscles. Figure 6: Grasp the retracted bulbocavernosus muscles, and place a horizontal mattress stitch. Figure 7: Close the repair with Vicryl suture that was placed above and held, with a deep layer down and a subcuticular layer back up, with the knot just inside of the hymenal ring.
Source Photos courtesy Dr. Dee E. Fenner
Revisiting Symptomatic Rectocele Repair
Concerns have been raised about the use of mesh and subsequent erosion in rectocele repair via posterior colporrhaphy, although many still advocate the use of mesh. Furthermore, it has been noted in several studies that vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy. Given this issue, it is pertinent to revisit posterior colporrhaphy and perineorrhaphy for rectocele repair without mesh augmentation.
Approximately 200,000 women undergo surgery for pelvic prolapse each year in the United States. According to the Department of Health and Human Services' Administration on Aging, three-quarters of women with prolapse have a rectocele. It has now been nearly a century since approaches to the posterior compartment to treat symptomatic rectoceles were first described. Through much of this time period, posterior colporrhaphy and perineorrhaphy have proven to be the gold standard. By plicating the posterior vaginal muscularis or medial aspect of the levator ani muscles in the midline, and when prudent performing a perineorrhaphy, cure rates of 76%-96% have been noted.
In this Master Class in Gynecologic Surgery, I have asked Dr. Dee E. Fenner, Harold A. Furlong Professor of Women's Health and director of gynecology at the University of Michigan, Ann Arbor, to discuss the technique of posterior colporrhaphy and perineorrhaphy. Dr. Fenner's current research includes mechanisms of vaginal wall support failure; she is a nationally known expert in urogynecology and travels throughout the country as an invited lecturer. It is an honor to have Dr. Fenner's recommendations on this very pertinent topic.
Patients with pelvic organ prolapse present with a variety of symptoms and anatomical findings. In the case of posterior vaginal wall prolapse, one must first determine what part of the patient's support mechanism has failed. It is important to decide in the clinical examination whether her prolapse is related to a loss of apical support, a weakness in the distal vaginal wall, a separation or weakness in the perineal body, or some combination of these support failures.
Like anterior wall prolapse, loss of apical support can lead to prolapse of the upper and mid vagina. Elevating the top of the vagina with a ring forceps or Kelly clamp to a more physiologically normal position in the office or operating room can determine the role of apical failure in the posterior wall prolapse. Once that determination is made, the surgeon then can decide on the type of repair the patient requires.
Occasionally, if the clinical examination does not match the patient's symptoms, radiologic studies such as a defecography can help identify the support defects.
If the prolapse stems predominantly from a loss of apical support, treatment can be addressed through one of several procedures, from a sacral colpopexy to a uterosacral suspension or a sacrospinous vaginal vault suspension. If the prolapse involves a more traditional type of rectocele, where there is loss of support in the distal vaginal wall, one must decide what type of repair—site specific or standard posterior colporrhaphy—will result in the best anatomic and functional outcomes.
Finally, weakness in the perineal body or perineocele is determined by palpating the thickness and integrity of the perineal body on rectal exam.
Equally important to the anatomic considerations and prior to any surgery, the patient's symptoms as well as her current and future sexual function should be addressed. Women with posterior compartment prolapse frequently have symptoms related to bowel dysfunction, including straining, incomplete bowel emptying, painful bowel movements, and fecal incontinence. The extent or severity of symptoms is not necessarily related to the severity of prolapse, and frequently her bowel function is most dependent on upper GI function and the type and frequency of her stool.
Studies have generally shown that most bowel symptoms—particularly straining and incomplete emptying—are resolved or improved with posterior wall repair. In some cases, surgical treatment may not necessarily correct bowel dysfunction, and occasionally it may contribute to bowel dysfunction.
Before surgical therapy, it is critical to understand which symptoms are bothering the patient, if they are related to the physical findings, and if surgical correction of the anatomy will improve her symptoms. Each patient should be appropriately counseled about the possible impact of prolapse surgery on both bowel and sexual function. Depending on the aggressiveness of the repair, approximately 15% of patients may experience some discomfort with intercourse after a colpoperineorrhaphy. Not plicating the levators can decrease but not totally alleviate this risk (Obstet. Gynecol. 2004;104:1403-21).ht
Traditional Repair Yields Best Outcomes
The approach to rectocele repair has evolved over the years, but the literature still suggests that a more traditional type of repair, with side-to-side plication and the use of delayed absorbable suture yields the best results with the least morbidity.
This surgical technique generally involves a two-layer repair, with minimal trimming of some of the vaginal wall and closure of the vaginal mucosa with an interrupted or running polyglactin suture.
Authors of a 2007 Cochrane Review of the Surgical Management of Pelvic Organ Prolapse in Women reported that for posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele and/or enterocele compared with the transanal approach (relative risk 0.24), a type of rectocele repair performed commonly performed by colorectal surgeons. However, data on the effect of surgery on bowel symptoms and the use of polyglactin mesh inlay or porcine small intestine graft inlay on the risk of recurrent rectocele were insufficient for meta-analysis. There also were no randomized trials using permanent mesh for rectocele repairs, either as an inlay or as a “suspension kit” (Cochrane Database Syst. Rev. 2007;3:CD004014).h
In one well-conducted, randomized controlled study, the traditional posterior colporrhaphy was found to have a lower failure rate compared with the site-specific repair alone, or a site-specific repair with the addition of a porcine small intestine submucosa graft for rectoceles. Symptomatically, if the anatomical repair was successful, there were no significant differences between the posterior colporrhaphy, site-specific repair, or site-specific repair augmented with porcine small intestine submucosa in terms of perioperative and postoperative morbidity, functional outcomes, quality of life, and bowel and sexual function (Am. J. Obstet. Gynecol. 2006;195:1762-71).
Currently there is little evidence to support the use of absorbable or permanent mesh in the posterior wall. Case series of mesh inlays or mesh kits without native tissue controls are still needed to determine the risks and benefits of these procedures. The caution is to not consider the posterior vaginal wall as a mirror image of the anterior vaginal wall. While one type of graft may improve the surgical cure for cystoceles, it may not add any benefit for rectocele repairs.
Additionally, stiffness in the posterior vaginal wall can lead to dyspareunia and defecation disorders, primarily fecal urgency and fecal incontinence. If the rectum is not expandable because the posterior vaginal wall is stiff and nonpliable, the patient feels a constant urge to defecate, and if she has poor anal sphincter function, a noncompliant rectal reservoir can lead to fecal or flatal loss.
In my practice, when a patient complains of splinting or incomplete evacuation, I suspect a distal rectocele and a deficient perineal body. Perineal body defects are often found in patients who have an enlarged vaginal introitus or a history of straining or prior episiotomy, for instance, and addressing these defects is a key part of posterior wall repair that is too often neglected.
When a perineorrhaphy is performed, the bulbocavernosus muscles must be identified and plicated in the midline with care so as not to narrow the introitus so significantly that coital activity would be impaired. Caudad to the bulbocavernosus muscles, mobilization of the lateral tissues will enable plication of the medial portions of the puboperineus muscles. This compensatory repair will help bulk and strengthen the perineal body.
I use 3-0 prolonged, delayed, absorbable sutures, in one or two layers. This step increases the length and thickness of the perineal body and can also increase the functional length of the posterior vaginal wall.
Technique for Traditional Colporrhaphy
As described by Dr. B.H. Goff and later Dr. David Nichols, the traditional posterior colporrhaphy involves opening the posterior vaginal wall epithelium in the midline and dissecting laterally and superiorly, then plicating the posterior vaginal wall muscularis—or rectovaginal septum, as the endopelvic fascia is termed—in the midline. The excess of the epithelium is then trimmed and brought back together in the midline.
With the Goff method, the rectovaginal septum is not dissected “off” the posterior vaginal wall. In contrast, with the Bullard modification, the rectovaginal septum is dissected off the posterior vaginal wall. This mobilizes the connective tissue layer to the lateral sidewalls and allows a separate layer to be plicated between the vagina and rectum.
I prefer this technique for two reasons. First, it allows one to decrease the size of a dilated rectal ampulla by inverting the dilated rectal wall into the rectal lumen similar to a transrectal rectocele repair. Also with this method, any “ridge” created is directed posterior for less dyspareunia. The levator muscles should never be plicated, unless an obliterative procedure is being performed, because of the impact on sexual function.
To begin, two Allis clamps are placed on the hymen at approximately the 5 o'clock and 7 o'clock positions. The position of these clamps should be modified, however, depending on the size of the genital hiatus, so that three finger breaths can be easily admitted to ensure enough room for sexual intercourse. As patients age, this becomes increasingly important as the incidence of erectile dysfunction in male partners precludes penetration in a very narrow genital hiatus.
Since rectocele repair is usually done after other apical or anterior wall compartment defects are corrected (rectoceles are rarely isolated problems, and high rectoceles are usually associated with apical defects or enteroceles), it is important to appreciate that the introitus may tighten during the healing process.
Once the Allis clamps are placed on the hymenal ring, with a finger placed in the rectum, the surgeon must identify the extent of the weakness in the vaginal wall. This is accomplished by a thorough examination of the vagina with palpation between the finger and thumb. For example, with a finger in the rectum, palpate transrectally the thickness of the perineal body. This will enable you to determine if the bulbocavernosus muscles are separated or retracted, generally from childbirth or chronic straining or constipation, and will give you an assessment of the perineal body integrity.
Further, by elevating the vaginal wall rectally, the point of weakness and placement of the apical limit of the repair can be determined. At that point, another Allis clamp is then placed accordingly in the vagina to mark the top of the repair.
Once you have determined the size of your dissection, use a dilute vasopressin solution to infiltrate underneath the posterior vaginal wall along the dissection margins (we use vasopressin 20 U in 50 cc of normal saline). An incision along those margins is made with a knife through the mucosa. Metzenbaum scissors or a knife can then be used to excise the vaginal mucosa.
I prefer to keep a finger in the rectum at all times. This helps prevent inadvertent placement of a stitch in the rectum. I generally grasp the edges of the incision with Allis clamps and mobilize the “rectovaginal septum” off the posterior vaginal wall.
Prolonged delayed absorbable sutures are used to plicate the fibromuscularis tissue in the midline in a side-to-side fashion. I generally use a 2-0 polydioxanone (PDS) absorbable suture on a CT-2 needle, oplaced in interrupted horizontal mattress stitches to the level of the hymen. I try to create a ridge of tissue that is directed posterior toward the rectum.
If the rectal ampulla is enlarged, it will often invert as the dense connective tissue is plicated, thus reducing the size of the rectum. Depending on the size of the rectocele and how high I have gone with the rectocele repair, I place two to eight stitches.
Generally, before placing those sutures, I will place a stitch using a 3-0 Vicryl suture at the apex of the incision so that once I finish the deep layer I can easily run a 3-0 Vicryl suture interlocking with about every third stitch to the level of the hymen. I have found interlocking every few stitches prevents shortening of the wall.
When applicable, the perineal body must be addressed next. With the extent of the deficiency taken into account, I mobilize and dissect the mucosa with Metzenbaum scissors so that I can identify or at least attempt to palpate the ends of the retracted bulbocavernosus muscles.
I will grasp these muscles with an Allis clamp and place a horizontal mattress of stitch using a 2-0 PDS suture on a CT-2 needle. The assistant frequently will assist by grabbing the needle with a tonsil clamp. A finger in the rectum can also help stabilize the needle.
Depending on the tissue, I will place one or two layers at this point. I will then close with the 3-0 Vicryl suture that I'd placed above and held, with a deep layer down and a subcuticular layer back up, with the knot just inside of the hymenal ring, similar to an episiotomy closure.
Although not glamorous, repair of a posterior wall defect can often be life changing for a patient. The ability to have bowel movements without manual manipulation, wear a tampon, or just regain confidence as a consequence of improved body image is invaluable.
Often, at the end of a long reconstructive case, the relative importance of a good colpoperineorrhaphy can be hard to appreciate. Yet, for the completion of pelvic floor function and anatomical outcomes, it is often a necessity.
Seventy-five to 95% of women will have good anatomical outcomes with this type of repair with similar improvements in splinting for defecation.
Allis clamps are placed on the hymen at approximately the 5 o'clock and 7 o'clock positions. Clamps are adjusted to desired introital size. Figure 2: Mobilize the “rectovaginal septum” off the posterior vaginal wall. Figure 3: Plicate the fibromuscularis tissue in the midline in a side-to-side fashion. Figure 4: A tonsil clamp is used to invert the enlarged rectal ampulla as the dense connective tissue is plicated. Figure 5: Mobilize and dissect the mucosa of the perineal body to identify or at least attempt to palpate the ends of the retracted bulbocavernosus muscles. Figure 6: Grasp the retracted bulbocavernosus muscles, and place a horizontal mattress stitch. Figure 7: Close the repair with Vicryl suture that was placed above and held, with a deep layer down and a subcuticular layer back up, with the knot just inside of the hymenal ring.
Source Photos courtesy Dr. Dee E. Fenner
Revisiting Symptomatic Rectocele Repair
Concerns have been raised about the use of mesh and subsequent erosion in rectocele repair via posterior colporrhaphy, although many still advocate the use of mesh. Furthermore, it has been noted in several studies that vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy. Given this issue, it is pertinent to revisit posterior colporrhaphy and perineorrhaphy for rectocele repair without mesh augmentation.
Approximately 200,000 women undergo surgery for pelvic prolapse each year in the United States. According to the Department of Health and Human Services' Administration on Aging, three-quarters of women with prolapse have a rectocele. It has now been nearly a century since approaches to the posterior compartment to treat symptomatic rectoceles were first described. Through much of this time period, posterior colporrhaphy and perineorrhaphy have proven to be the gold standard. By plicating the posterior vaginal muscularis or medial aspect of the levator ani muscles in the midline, and when prudent performing a perineorrhaphy, cure rates of 76%-96% have been noted.
In this Master Class in Gynecologic Surgery, I have asked Dr. Dee E. Fenner, Harold A. Furlong Professor of Women's Health and director of gynecology at the University of Michigan, Ann Arbor, to discuss the technique of posterior colporrhaphy and perineorrhaphy. Dr. Fenner's current research includes mechanisms of vaginal wall support failure; she is a nationally known expert in urogynecology and travels throughout the country as an invited lecturer. It is an honor to have Dr. Fenner's recommendations on this very pertinent topic.
Patients with pelvic organ prolapse present with a variety of symptoms and anatomical findings. In the case of posterior vaginal wall prolapse, one must first determine what part of the patient's support mechanism has failed. It is important to decide in the clinical examination whether her prolapse is related to a loss of apical support, a weakness in the distal vaginal wall, a separation or weakness in the perineal body, or some combination of these support failures.
Like anterior wall prolapse, loss of apical support can lead to prolapse of the upper and mid vagina. Elevating the top of the vagina with a ring forceps or Kelly clamp to a more physiologically normal position in the office or operating room can determine the role of apical failure in the posterior wall prolapse. Once that determination is made, the surgeon then can decide on the type of repair the patient requires.
Occasionally, if the clinical examination does not match the patient's symptoms, radiologic studies such as a defecography can help identify the support defects.
If the prolapse stems predominantly from a loss of apical support, treatment can be addressed through one of several procedures, from a sacral colpopexy to a uterosacral suspension or a sacrospinous vaginal vault suspension. If the prolapse involves a more traditional type of rectocele, where there is loss of support in the distal vaginal wall, one must decide what type of repair—site specific or standard posterior colporrhaphy—will result in the best anatomic and functional outcomes.
Finally, weakness in the perineal body or perineocele is determined by palpating the thickness and integrity of the perineal body on rectal exam.
Equally important to the anatomic considerations and prior to any surgery, the patient's symptoms as well as her current and future sexual function should be addressed. Women with posterior compartment prolapse frequently have symptoms related to bowel dysfunction, including straining, incomplete bowel emptying, painful bowel movements, and fecal incontinence. The extent or severity of symptoms is not necessarily related to the severity of prolapse, and frequently her bowel function is most dependent on upper GI function and the type and frequency of her stool.
Studies have generally shown that most bowel symptoms—particularly straining and incomplete emptying—are resolved or improved with posterior wall repair. In some cases, surgical treatment may not necessarily correct bowel dysfunction, and occasionally it may contribute to bowel dysfunction.
Before surgical therapy, it is critical to understand which symptoms are bothering the patient, if they are related to the physical findings, and if surgical correction of the anatomy will improve her symptoms. Each patient should be appropriately counseled about the possible impact of prolapse surgery on both bowel and sexual function. Depending on the aggressiveness of the repair, approximately 15% of patients may experience some discomfort with intercourse after a colpoperineorrhaphy. Not plicating the levators can decrease but not totally alleviate this risk (Obstet. Gynecol. 2004;104:1403-21).ht
Traditional Repair Yields Best Outcomes
The approach to rectocele repair has evolved over the years, but the literature still suggests that a more traditional type of repair, with side-to-side plication and the use of delayed absorbable suture yields the best results with the least morbidity.
This surgical technique generally involves a two-layer repair, with minimal trimming of some of the vaginal wall and closure of the vaginal mucosa with an interrupted or running polyglactin suture.
Authors of a 2007 Cochrane Review of the Surgical Management of Pelvic Organ Prolapse in Women reported that for posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele and/or enterocele compared with the transanal approach (relative risk 0.24), a type of rectocele repair performed commonly performed by colorectal surgeons. However, data on the effect of surgery on bowel symptoms and the use of polyglactin mesh inlay or porcine small intestine graft inlay on the risk of recurrent rectocele were insufficient for meta-analysis. There also were no randomized trials using permanent mesh for rectocele repairs, either as an inlay or as a “suspension kit” (Cochrane Database Syst. Rev. 2007;3:CD004014).h
In one well-conducted, randomized controlled study, the traditional posterior colporrhaphy was found to have a lower failure rate compared with the site-specific repair alone, or a site-specific repair with the addition of a porcine small intestine submucosa graft for rectoceles. Symptomatically, if the anatomical repair was successful, there were no significant differences between the posterior colporrhaphy, site-specific repair, or site-specific repair augmented with porcine small intestine submucosa in terms of perioperative and postoperative morbidity, functional outcomes, quality of life, and bowel and sexual function (Am. J. Obstet. Gynecol. 2006;195:1762-71).
Currently there is little evidence to support the use of absorbable or permanent mesh in the posterior wall. Case series of mesh inlays or mesh kits without native tissue controls are still needed to determine the risks and benefits of these procedures. The caution is to not consider the posterior vaginal wall as a mirror image of the anterior vaginal wall. While one type of graft may improve the surgical cure for cystoceles, it may not add any benefit for rectocele repairs.
Additionally, stiffness in the posterior vaginal wall can lead to dyspareunia and defecation disorders, primarily fecal urgency and fecal incontinence. If the rectum is not expandable because the posterior vaginal wall is stiff and nonpliable, the patient feels a constant urge to defecate, and if she has poor anal sphincter function, a noncompliant rectal reservoir can lead to fecal or flatal loss.
In my practice, when a patient complains of splinting or incomplete evacuation, I suspect a distal rectocele and a deficient perineal body. Perineal body defects are often found in patients who have an enlarged vaginal introitus or a history of straining or prior episiotomy, for instance, and addressing these defects is a key part of posterior wall repair that is too often neglected.
When a perineorrhaphy is performed, the bulbocavernosus muscles must be identified and plicated in the midline with care so as not to narrow the introitus so significantly that coital activity would be impaired. Caudad to the bulbocavernosus muscles, mobilization of the lateral tissues will enable plication of the medial portions of the puboperineus muscles. This compensatory repair will help bulk and strengthen the perineal body.
I use 3-0 prolonged, delayed, absorbable sutures, in one or two layers. This step increases the length and thickness of the perineal body and can also increase the functional length of the posterior vaginal wall.
Technique for Traditional Colporrhaphy
As described by Dr. B.H. Goff and later Dr. David Nichols, the traditional posterior colporrhaphy involves opening the posterior vaginal wall epithelium in the midline and dissecting laterally and superiorly, then plicating the posterior vaginal wall muscularis—or rectovaginal septum, as the endopelvic fascia is termed—in the midline. The excess of the epithelium is then trimmed and brought back together in the midline.
With the Goff method, the rectovaginal septum is not dissected “off” the posterior vaginal wall. In contrast, with the Bullard modification, the rectovaginal septum is dissected off the posterior vaginal wall. This mobilizes the connective tissue layer to the lateral sidewalls and allows a separate layer to be plicated between the vagina and rectum.
I prefer this technique for two reasons. First, it allows one to decrease the size of a dilated rectal ampulla by inverting the dilated rectal wall into the rectal lumen similar to a transrectal rectocele repair. Also with this method, any “ridge” created is directed posterior for less dyspareunia. The levator muscles should never be plicated, unless an obliterative procedure is being performed, because of the impact on sexual function.
To begin, two Allis clamps are placed on the hymen at approximately the 5 o'clock and 7 o'clock positions. The position of these clamps should be modified, however, depending on the size of the genital hiatus, so that three finger breaths can be easily admitted to ensure enough room for sexual intercourse. As patients age, this becomes increasingly important as the incidence of erectile dysfunction in male partners precludes penetration in a very narrow genital hiatus.
Since rectocele repair is usually done after other apical or anterior wall compartment defects are corrected (rectoceles are rarely isolated problems, and high rectoceles are usually associated with apical defects or enteroceles), it is important to appreciate that the introitus may tighten during the healing process.
Once the Allis clamps are placed on the hymenal ring, with a finger placed in the rectum, the surgeon must identify the extent of the weakness in the vaginal wall. This is accomplished by a thorough examination of the vagina with palpation between the finger and thumb. For example, with a finger in the rectum, palpate transrectally the thickness of the perineal body. This will enable you to determine if the bulbocavernosus muscles are separated or retracted, generally from childbirth or chronic straining or constipation, and will give you an assessment of the perineal body integrity.
Further, by elevating the vaginal wall rectally, the point of weakness and placement of the apical limit of the repair can be determined. At that point, another Allis clamp is then placed accordingly in the vagina to mark the top of the repair.
Once you have determined the size of your dissection, use a dilute vasopressin solution to infiltrate underneath the posterior vaginal wall along the dissection margins (we use vasopressin 20 U in 50 cc of normal saline). An incision along those margins is made with a knife through the mucosa. Metzenbaum scissors or a knife can then be used to excise the vaginal mucosa.
I prefer to keep a finger in the rectum at all times. This helps prevent inadvertent placement of a stitch in the rectum. I generally grasp the edges of the incision with Allis clamps and mobilize the “rectovaginal septum” off the posterior vaginal wall.
Prolonged delayed absorbable sutures are used to plicate the fibromuscularis tissue in the midline in a side-to-side fashion. I generally use a 2-0 polydioxanone (PDS) absorbable suture on a CT-2 needle, oplaced in interrupted horizontal mattress stitches to the level of the hymen. I try to create a ridge of tissue that is directed posterior toward the rectum.
If the rectal ampulla is enlarged, it will often invert as the dense connective tissue is plicated, thus reducing the size of the rectum. Depending on the size of the rectocele and how high I have gone with the rectocele repair, I place two to eight stitches.
Generally, before placing those sutures, I will place a stitch using a 3-0 Vicryl suture at the apex of the incision so that once I finish the deep layer I can easily run a 3-0 Vicryl suture interlocking with about every third stitch to the level of the hymen. I have found interlocking every few stitches prevents shortening of the wall.
When applicable, the perineal body must be addressed next. With the extent of the deficiency taken into account, I mobilize and dissect the mucosa with Metzenbaum scissors so that I can identify or at least attempt to palpate the ends of the retracted bulbocavernosus muscles.
I will grasp these muscles with an Allis clamp and place a horizontal mattress of stitch using a 2-0 PDS suture on a CT-2 needle. The assistant frequently will assist by grabbing the needle with a tonsil clamp. A finger in the rectum can also help stabilize the needle.
Depending on the tissue, I will place one or two layers at this point. I will then close with the 3-0 Vicryl suture that I'd placed above and held, with a deep layer down and a subcuticular layer back up, with the knot just inside of the hymenal ring, similar to an episiotomy closure.
Although not glamorous, repair of a posterior wall defect can often be life changing for a patient. The ability to have bowel movements without manual manipulation, wear a tampon, or just regain confidence as a consequence of improved body image is invaluable.
Often, at the end of a long reconstructive case, the relative importance of a good colpoperineorrhaphy can be hard to appreciate. Yet, for the completion of pelvic floor function and anatomical outcomes, it is often a necessity.
Seventy-five to 95% of women will have good anatomical outcomes with this type of repair with similar improvements in splinting for defecation.
Allis clamps are placed on the hymen at approximately the 5 o'clock and 7 o'clock positions. Clamps are adjusted to desired introital size. Figure 2: Mobilize the “rectovaginal septum” off the posterior vaginal wall. Figure 3: Plicate the fibromuscularis tissue in the midline in a side-to-side fashion. Figure 4: A tonsil clamp is used to invert the enlarged rectal ampulla as the dense connective tissue is plicated. Figure 5: Mobilize and dissect the mucosa of the perineal body to identify or at least attempt to palpate the ends of the retracted bulbocavernosus muscles. Figure 6: Grasp the retracted bulbocavernosus muscles, and place a horizontal mattress stitch. Figure 7: Close the repair with Vicryl suture that was placed above and held, with a deep layer down and a subcuticular layer back up, with the knot just inside of the hymenal ring.
Source Photos courtesy Dr. Dee E. Fenner
Revisiting Symptomatic Rectocele Repair
Concerns have been raised about the use of mesh and subsequent erosion in rectocele repair via posterior colporrhaphy, although many still advocate the use of mesh. Furthermore, it has been noted in several studies that vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy. Given this issue, it is pertinent to revisit posterior colporrhaphy and perineorrhaphy for rectocele repair without mesh augmentation.
Approximately 200,000 women undergo surgery for pelvic prolapse each year in the United States. According to the Department of Health and Human Services' Administration on Aging, three-quarters of women with prolapse have a rectocele. It has now been nearly a century since approaches to the posterior compartment to treat symptomatic rectoceles were first described. Through much of this time period, posterior colporrhaphy and perineorrhaphy have proven to be the gold standard. By plicating the posterior vaginal muscularis or medial aspect of the levator ani muscles in the midline, and when prudent performing a perineorrhaphy, cure rates of 76%-96% have been noted.
In this Master Class in Gynecologic Surgery, I have asked Dr. Dee E. Fenner, Harold A. Furlong Professor of Women's Health and director of gynecology at the University of Michigan, Ann Arbor, to discuss the technique of posterior colporrhaphy and perineorrhaphy. Dr. Fenner's current research includes mechanisms of vaginal wall support failure; she is a nationally known expert in urogynecology and travels throughout the country as an invited lecturer. It is an honor to have Dr. Fenner's recommendations on this very pertinent topic.
Simulation Training Is Key to Patient Safety
Following publication a decade ago of the Institute of Medicine's landmark report, “To Err Is Human,” the medical world turned a critical eye upon itself to identify sources of the tens of thousands of preventable deaths found to occur annually during hospital stays.
These deaths represented only a fraction of the injuries sustained by patients in our health care system as a result of medical error.
One of the surprising findings was that many of these errors were happening in the hands of highly skilled professionals. Studies that used closed-claims analysis found that system failures, and failures in communication and teamwork, are implicated in a significant proportion of medical errors that result in patient harm.
With a new appreciation for the impact of system breakdowns and communication failures—and the importance of teamwork skills in addition to individual skills—the next question in the medical world became how organizations can revamp systems and integrate tools that will reliably minimize adverse events.
Other high-stakes industries—most notably the military and aviation—have offered lessons. Both recognize the importance of teamwork and communication in minimizing the occurrence of errors and mitigating their adverse effects, regardless of the source.
In both commercial and military aviation, flight teams undergo rigorous training that teaches them to prevent, recognize, and mitigate errors including “human factor” errors—those due not to aircraft failure but to human fallibility. Aviation professionals are trained to prevent errors through crew resource management.
In recent years, medicine has created a variety of training programs that apply resource management principles. Our program, for one, is based on the understanding that health care professionals not only must have knowledge and skills, but must work together because teams perform better than individuals, especially in crisis situations.
Certainly this is the case in obstetrics, where unexpected events are common, situations happen rapidly, and conditions deteriorate quickly.
Our program and other efforts elsewhere incorporate an additional hallmark of training programs in the airline industry: the use of simulation—in our case, to teach the combination of technical, clinical management, and teamwork/communication skills that help maximize patient safety.
Simulation and other types of immersive training allow individuals to learn and practice these skills in an environment where patient safety is not compromised, and in a way that can be standardized and replicated.
The Research on Simulation Training
The use of simulation in graduate and undergraduate medical education and in team training has been demonstrated to improve trainee satisfaction. Multiple studies also have shown improvements in measures of provider self-efficacy and confidence.
The impact of any training, including simulation-based training, on clinical team performance, however, can be difficult to measure. This difficulty is partly due to difficulty in finding appropriate measures of team performance. In as much as improvement in clinical outcomes can be viewed as the best measure of the value of any training, however, our colleagues in England have provided the best evidence in support of simulation-based training.
A team of British investigators instituted multidisciplinary simulation training for all providers of obstetric care in multiple hospitals. After several years of training, these providers have achieved a statistically significant and sustained impact of simulation training on perinatal outcomes, including a decrease in the rates of brachial plexus injuries related to shoulder dystocia (Obstet. Gynecol. 2008;112:14–20), improvements in Apgar scores, and a reduction in hypoxic-ischemic encephalopathy following training on other obstetric emergencies (BJOG 2006;113:177-82).
It will take time before American researchers are able to produce similar proof of the efficacy of simulation training. This is due to a combination of factors, including the fact that we have been slower than our European colleagues to integrate simulation training into obstetric training, and because the number of cases that is needed to demonstrate a significant change in clinical outcomes will require long-term studies across multiple institutions. The funding and collaborations required for this type of study are in their fledgling stages.
It is worth noting, however, that other high-stakes industries have not awaited nor demanded proof of the effectiveness of simulation before embracing it. Dr. David M. Gaba, an anesthesiologist and one of the earliest adopters and biggest proponents of simulation training in medicine, aptly stated once that “no industry in which human lives depend on the skilled performance of responsible operators has waited for unequivocal proof of the benefits of simulation before embracing it. Why should health care be any different?”
A relevant example of this point is that prior to the successful landing of U.S. Airways Flight 1549 on the Hudson by Captain Chesley Sullenbergerand his crew following an extraordinarily rare double-engine failure, a water landing had not been successfully carried out. The aviation industry, however, has done simulation training involving double-engine failures despite their rarity and water landings despite the fact that they had not ever been successfully executed.
The internal validity of such training has always been the aviation industry's impetus to conduct extensive team and simulation training.
The citation on the award given to the crew following this event read: “The reactions of all members of the crew, the split-second decision making, and the handling of this emergency and evacuation was 'textbook' and an example to us all.”
Captain Sullenberger, who himself runs a safety consulting business on the side, has publicly credited the training that he and his crew have received for years for allowing them to successfully land and evacuate the plane without any casualties.
Getting Started
The following tips are based on our experience and that of others:
▸ Simulation is a technique—not a technology. Purchasing a simulator does not mean you have a ready simulation program. The simulators and mannequins are technologies used for simulation. We have heard many stories of people with expensive simulators still sitting unused.
Similarly, owning a particular simulator is not a prerequisite to initiating simulation training.
Before undertaking what can be a significant monetary investment in an expensive simulator, first outline the type of training that will be conducted and then determine what type of simulator and other equipment will be necessary for the type of training that is planned.
There are some relatively affordable low-tech mannequins that can be used in combination with a standardized patient/actor to create a hybrid simulator and very realistic scenarios. For certain scenarios it is possible to use an actor or standardized patient instead of a mannequin.
Some sites have started conducting training using very low-tech solutions and have incorporated both higher-tech simulators and more complex scenarios as both their expertise and their programs have grown.
▸ Plan big but start small. It is critical to identify your target audience(s) and program goals early. It is also important, however, to not try to meet all goals and serve all audiences from the start.
Some sites have very specific training goals that will involve relatively few participants. For example, a site may decide to use simulation to train their nurses and hospitalist ob.gyns. on a couple of basic obstetric emergencies in a “drill” sort of format.
Even a site with a small audience and well-defined objectives will benefit from starting slowly. In this case, for example, it would be best to start by picking one of the “simpler” emergencies such as shoulder dystocia and run that scenario repeatedly until the people responsible for running the simulations feel comfortable and confident in the process of running simulations and debriefing trainees.
Waiting until there is a basic comfort before moving onto more complex scenarios (such as a maternal code) will prevent much frustration among both the trainers and the trainees.
▸ A program does not run itself. Probably one of the most important steps when beginning a simulation initiative is to identify the individual(s) who will organize and run the simulation program and who will take care of such things as scheduling, securing equipment and supplies, setting up and cleaning up, testing scenarios, and managing video recordings.
Although some sites choose to have providers serve in this role, the individuals who run the program do not have to be the medical experts on the topics that will be trained. It is crucial, however, that these individuals be allotted enough time to run the simulation training.
If these individuals are not already well versed in simulation, it may be worth allowing them some time to become familiar with the subject and possibly allowing them to attend some training on running a simulation program.
▸ Simulation takes time. Conducting simulation training is like running a theater where each training session is a play. Writing and rehearsing a scenario take time, as does mounting the stage and conducting the performance.
Although the time it takes to develop a training session will decrease with experience, it is nonetheless a time-consuming effort and not something that is easily added to someone's already full schedule.
▸ Decide up front what you want to accomplish. You have to know what you want to do before you set out to accomplish it. Define a goal before writing a scenario, and then write the scenario to achieve that goal.
“To train teams to have better team communication during obstetric emergencies” is a good goal for a simulation program, but is not a good, clearly defined goal for a scenario, for instance.
“The learner will practice using callbacks or closed-loop communications during obstetric emergencies” is an example of a clearly defined goal appropriate for a scenario.
To meet this goal, one would need to create a scenario in which providers need to make multiple requests of multiple people (for example, for labs, blood, and medication) in a short time succession.
A hemorrhage and a code are examples of clinical situations in which there is a need for many closed-loop communications in a short time. The specific medical condition, however, becomes somewhat secondary in this case because the training and the debriefing will focus on closed-loop communication.
It is possible to meet multiple training goals during one training session, but it is important to not overwhelm the trainees (or the trainers). As trainees and trainers become more experienced, it becomes easier to incorporate more objectives into a single training session, but it is still crucial to focus the training on the objectives and to limit the number of such objectives.
▸ Keep it simple. A long complicated scenario is not necessarily what is needed to achieve training goals. It is worth considering that for certain teaching/training goals, multiple short scenarios may be a better way to get multiple training points across or to reinforce concepts that have already been taught.
Although there are some training goals that may require longer, more complex scenarios, it is worth remembering that when the scenario is longer and more complicated for the learner, it is also longer and more complicated for the trainer.
One should “save” such scenarios for specific training points for which they are needed.
We like to try to create scenarios that run in 10 minutes or less. We also like running a scenario, debriefing the trainees, and then immediately running it again to reinforce the learning points reviewed during the debriefing.
▸ Do not reinvent the wheel. One scenario can often be modified in simple ways to meet different teaching objectives. We added high blood pressure and headache to our simulated patient with precipitous delivery in triage, for instance.
In doing so, we easily added teaching points on the management of severe preeclampsia to our teaching points on managing a precipitous delivery.
Through this process, we also incorporated a teaching point that we try to reinforce through multiple scenarios—the idea that being focused on the task at hand is not the same as putting on blinders because the most obvious or pressing problem is not necessarily your only or biggest problem.
▸ No simulation is better than bad simulation. Do not reinforce bad habits or bad medicine. It is important that teaching points be evidence based, and that during training we reinforce management that is within the standard of care.
Similarly, one should not allow inappropriate behavior to be reinforced during debriefings. It defeats the purpose of simulation training to allow, during debriefings, the very behaviors we are trying to eliminate.
The belligerent, bullying nurse or physician cannot be allowed to dominate or commandeer the debriefing session.
The ability of the trainers to avoid this situation or to manage it in a manner that is going to be productive to the goals of teamwork and communication will be much greater if they have had an opportunity to train and practice their debriefing skills.
▸ Debriefing is key. A debriefing is the time after a scenario when participants are led in a discussion of what happened during the scenario.
The participants identify ways in which things went well and why, and ways in which things did not go well and why.
It is sometimes said that simulation is an excuse for a debriefing; this is because much of the teaching that happens during simulation training occurs during the debriefing.
A debriefing may be very straightforward such as when a scenario is designed to meet very technical or process-oriented goals.
For example, if the goal of the scenario is to practice the steps of the neonatal resuscitation program, then the debriefing may be as simple as identifying those moments when any of the team members did not follow the steps.
Debriefings have the potential, however, to become emotionally charged. This is most likely during debriefings that are meant to train providers on team interactions and communication.
We recommend that if a group is going to institute any team training using simulation, they invest in having their trainers participate in some sort of train-the-trainer programs that will teach them and let them practice their debriefing techniques.
▸ “What happens in 'sim' stays in 'sim.'” For learning to occur, it is important to keep simulation training friendly and safe for the participants.
This means that individuals should not be humiliated, mocked, demeaned, or chastised for things they did or failed to do during a simulated scenario.
The whole point of simulation training is that we are all prone to errors, and that simulation is a way to help train providers and teams of providers to avoid these errors through increased technical skill, communication, and team support.
The incorporation of simulation into training in obstetrics and gynecology in the United States is relatively new, but shows great promise as a tool to improve providers' technical skills, teamwork and communication, and, most importantly, patient safety.
Source Graphics courtesy Dr. Hugh Mighty
Improving Our Safety Profile
Quality is a buzzword in industry, and safety has become one in medicine in recent years.
Safety is not an issue that is new to medicine. Health care professionals have always embraced the idea of safety as a fundamental part of the practice of good medicine, and everyone would agree that their practice is safe, and they've made every effort to execute safe and effective principles as they care for patients. Safety has, however, taken on added urgency since 1999, when the Institute of Medicine released shocking statistics, estimating that as many as 98,000 people die in any given year as a result of medical errors that occur in hospitals.
The findings were an eye-opener for the nation as a whole and for us as physicians. Despite our having embraced a safety mantra, the numbers of deaths due to medical errors were unexpectedly high.
This led to a wave of purposeful efforts to ensure the highest level of effectiveness and the lowest level of adverse consequences. In obstetrics, patient safety takes on added significance because of the potential long-term consequences of adverse outcomes and the associated litigious environment. Initiatives are especially important for the prevention and reduction of adverse events, thus increasing the safety profile to the highest possible level.
Several initiatives have been introduced in recent years to improve our safety profile. We're in an early phase of a significant evolution toward “systemwide” changes in obstetrics safety programs. There are a large number of safety initiatives being tested, but thus far the outcomes and effectiveness of various approaches are unclear. Inherently, we may always have fewer absolute results than we do in other fields.
Despite the limitations of a large body of data, it is worthwhile to review and share various approaches in labor and delivery safety programs, to monitor success as best as we can, and to see if we can identify some evolving best practices.
In this light, we have invited Dr. Hugh Mighty, associate professor and chair, department of obstetrics and gynecology at the University of Maryland, Baltimore, to be our guest professor.
Dr. Mighty has played a key role in establishing patient safety initiatives in labor and delivery at the University of Maryland Medical Center. He is a proponent of the use of simulation as a key safety program initiative and will describe its importance and detail what his experience and the experience of others have shown about how simulation can be meaningfully and successfully integrated into the practice of obstetrics.
Following publication a decade ago of the Institute of Medicine's landmark report, “To Err Is Human,” the medical world turned a critical eye upon itself to identify sources of the tens of thousands of preventable deaths found to occur annually during hospital stays.
These deaths represented only a fraction of the injuries sustained by patients in our health care system as a result of medical error.
One of the surprising findings was that many of these errors were happening in the hands of highly skilled professionals. Studies that used closed-claims analysis found that system failures, and failures in communication and teamwork, are implicated in a significant proportion of medical errors that result in patient harm.
With a new appreciation for the impact of system breakdowns and communication failures—and the importance of teamwork skills in addition to individual skills—the next question in the medical world became how organizations can revamp systems and integrate tools that will reliably minimize adverse events.
Other high-stakes industries—most notably the military and aviation—have offered lessons. Both recognize the importance of teamwork and communication in minimizing the occurrence of errors and mitigating their adverse effects, regardless of the source.
In both commercial and military aviation, flight teams undergo rigorous training that teaches them to prevent, recognize, and mitigate errors including “human factor” errors—those due not to aircraft failure but to human fallibility. Aviation professionals are trained to prevent errors through crew resource management.
In recent years, medicine has created a variety of training programs that apply resource management principles. Our program, for one, is based on the understanding that health care professionals not only must have knowledge and skills, but must work together because teams perform better than individuals, especially in crisis situations.
Certainly this is the case in obstetrics, where unexpected events are common, situations happen rapidly, and conditions deteriorate quickly.
Our program and other efforts elsewhere incorporate an additional hallmark of training programs in the airline industry: the use of simulation—in our case, to teach the combination of technical, clinical management, and teamwork/communication skills that help maximize patient safety.
Simulation and other types of immersive training allow individuals to learn and practice these skills in an environment where patient safety is not compromised, and in a way that can be standardized and replicated.
The Research on Simulation Training
The use of simulation in graduate and undergraduate medical education and in team training has been demonstrated to improve trainee satisfaction. Multiple studies also have shown improvements in measures of provider self-efficacy and confidence.
The impact of any training, including simulation-based training, on clinical team performance, however, can be difficult to measure. This difficulty is partly due to difficulty in finding appropriate measures of team performance. In as much as improvement in clinical outcomes can be viewed as the best measure of the value of any training, however, our colleagues in England have provided the best evidence in support of simulation-based training.
A team of British investigators instituted multidisciplinary simulation training for all providers of obstetric care in multiple hospitals. After several years of training, these providers have achieved a statistically significant and sustained impact of simulation training on perinatal outcomes, including a decrease in the rates of brachial plexus injuries related to shoulder dystocia (Obstet. Gynecol. 2008;112:14–20), improvements in Apgar scores, and a reduction in hypoxic-ischemic encephalopathy following training on other obstetric emergencies (BJOG 2006;113:177-82).
It will take time before American researchers are able to produce similar proof of the efficacy of simulation training. This is due to a combination of factors, including the fact that we have been slower than our European colleagues to integrate simulation training into obstetric training, and because the number of cases that is needed to demonstrate a significant change in clinical outcomes will require long-term studies across multiple institutions. The funding and collaborations required for this type of study are in their fledgling stages.
It is worth noting, however, that other high-stakes industries have not awaited nor demanded proof of the effectiveness of simulation before embracing it. Dr. David M. Gaba, an anesthesiologist and one of the earliest adopters and biggest proponents of simulation training in medicine, aptly stated once that “no industry in which human lives depend on the skilled performance of responsible operators has waited for unequivocal proof of the benefits of simulation before embracing it. Why should health care be any different?”
A relevant example of this point is that prior to the successful landing of U.S. Airways Flight 1549 on the Hudson by Captain Chesley Sullenbergerand his crew following an extraordinarily rare double-engine failure, a water landing had not been successfully carried out. The aviation industry, however, has done simulation training involving double-engine failures despite their rarity and water landings despite the fact that they had not ever been successfully executed.
The internal validity of such training has always been the aviation industry's impetus to conduct extensive team and simulation training.
The citation on the award given to the crew following this event read: “The reactions of all members of the crew, the split-second decision making, and the handling of this emergency and evacuation was 'textbook' and an example to us all.”
Captain Sullenberger, who himself runs a safety consulting business on the side, has publicly credited the training that he and his crew have received for years for allowing them to successfully land and evacuate the plane without any casualties.
Getting Started
The following tips are based on our experience and that of others:
▸ Simulation is a technique—not a technology. Purchasing a simulator does not mean you have a ready simulation program. The simulators and mannequins are technologies used for simulation. We have heard many stories of people with expensive simulators still sitting unused.
Similarly, owning a particular simulator is not a prerequisite to initiating simulation training.
Before undertaking what can be a significant monetary investment in an expensive simulator, first outline the type of training that will be conducted and then determine what type of simulator and other equipment will be necessary for the type of training that is planned.
There are some relatively affordable low-tech mannequins that can be used in combination with a standardized patient/actor to create a hybrid simulator and very realistic scenarios. For certain scenarios it is possible to use an actor or standardized patient instead of a mannequin.
Some sites have started conducting training using very low-tech solutions and have incorporated both higher-tech simulators and more complex scenarios as both their expertise and their programs have grown.
▸ Plan big but start small. It is critical to identify your target audience(s) and program goals early. It is also important, however, to not try to meet all goals and serve all audiences from the start.
Some sites have very specific training goals that will involve relatively few participants. For example, a site may decide to use simulation to train their nurses and hospitalist ob.gyns. on a couple of basic obstetric emergencies in a “drill” sort of format.
Even a site with a small audience and well-defined objectives will benefit from starting slowly. In this case, for example, it would be best to start by picking one of the “simpler” emergencies such as shoulder dystocia and run that scenario repeatedly until the people responsible for running the simulations feel comfortable and confident in the process of running simulations and debriefing trainees.
Waiting until there is a basic comfort before moving onto more complex scenarios (such as a maternal code) will prevent much frustration among both the trainers and the trainees.
▸ A program does not run itself. Probably one of the most important steps when beginning a simulation initiative is to identify the individual(s) who will organize and run the simulation program and who will take care of such things as scheduling, securing equipment and supplies, setting up and cleaning up, testing scenarios, and managing video recordings.
Although some sites choose to have providers serve in this role, the individuals who run the program do not have to be the medical experts on the topics that will be trained. It is crucial, however, that these individuals be allotted enough time to run the simulation training.
If these individuals are not already well versed in simulation, it may be worth allowing them some time to become familiar with the subject and possibly allowing them to attend some training on running a simulation program.
▸ Simulation takes time. Conducting simulation training is like running a theater where each training session is a play. Writing and rehearsing a scenario take time, as does mounting the stage and conducting the performance.
Although the time it takes to develop a training session will decrease with experience, it is nonetheless a time-consuming effort and not something that is easily added to someone's already full schedule.
▸ Decide up front what you want to accomplish. You have to know what you want to do before you set out to accomplish it. Define a goal before writing a scenario, and then write the scenario to achieve that goal.
“To train teams to have better team communication during obstetric emergencies” is a good goal for a simulation program, but is not a good, clearly defined goal for a scenario, for instance.
“The learner will practice using callbacks or closed-loop communications during obstetric emergencies” is an example of a clearly defined goal appropriate for a scenario.
To meet this goal, one would need to create a scenario in which providers need to make multiple requests of multiple people (for example, for labs, blood, and medication) in a short time succession.
A hemorrhage and a code are examples of clinical situations in which there is a need for many closed-loop communications in a short time. The specific medical condition, however, becomes somewhat secondary in this case because the training and the debriefing will focus on closed-loop communication.
It is possible to meet multiple training goals during one training session, but it is important to not overwhelm the trainees (or the trainers). As trainees and trainers become more experienced, it becomes easier to incorporate more objectives into a single training session, but it is still crucial to focus the training on the objectives and to limit the number of such objectives.
▸ Keep it simple. A long complicated scenario is not necessarily what is needed to achieve training goals. It is worth considering that for certain teaching/training goals, multiple short scenarios may be a better way to get multiple training points across or to reinforce concepts that have already been taught.
Although there are some training goals that may require longer, more complex scenarios, it is worth remembering that when the scenario is longer and more complicated for the learner, it is also longer and more complicated for the trainer.
One should “save” such scenarios for specific training points for which they are needed.
We like to try to create scenarios that run in 10 minutes or less. We also like running a scenario, debriefing the trainees, and then immediately running it again to reinforce the learning points reviewed during the debriefing.
▸ Do not reinvent the wheel. One scenario can often be modified in simple ways to meet different teaching objectives. We added high blood pressure and headache to our simulated patient with precipitous delivery in triage, for instance.
In doing so, we easily added teaching points on the management of severe preeclampsia to our teaching points on managing a precipitous delivery.
Through this process, we also incorporated a teaching point that we try to reinforce through multiple scenarios—the idea that being focused on the task at hand is not the same as putting on blinders because the most obvious or pressing problem is not necessarily your only or biggest problem.
▸ No simulation is better than bad simulation. Do not reinforce bad habits or bad medicine. It is important that teaching points be evidence based, and that during training we reinforce management that is within the standard of care.
Similarly, one should not allow inappropriate behavior to be reinforced during debriefings. It defeats the purpose of simulation training to allow, during debriefings, the very behaviors we are trying to eliminate.
The belligerent, bullying nurse or physician cannot be allowed to dominate or commandeer the debriefing session.
The ability of the trainers to avoid this situation or to manage it in a manner that is going to be productive to the goals of teamwork and communication will be much greater if they have had an opportunity to train and practice their debriefing skills.
▸ Debriefing is key. A debriefing is the time after a scenario when participants are led in a discussion of what happened during the scenario.
The participants identify ways in which things went well and why, and ways in which things did not go well and why.
It is sometimes said that simulation is an excuse for a debriefing; this is because much of the teaching that happens during simulation training occurs during the debriefing.
A debriefing may be very straightforward such as when a scenario is designed to meet very technical or process-oriented goals.
For example, if the goal of the scenario is to practice the steps of the neonatal resuscitation program, then the debriefing may be as simple as identifying those moments when any of the team members did not follow the steps.
Debriefings have the potential, however, to become emotionally charged. This is most likely during debriefings that are meant to train providers on team interactions and communication.
We recommend that if a group is going to institute any team training using simulation, they invest in having their trainers participate in some sort of train-the-trainer programs that will teach them and let them practice their debriefing techniques.
▸ “What happens in 'sim' stays in 'sim.'” For learning to occur, it is important to keep simulation training friendly and safe for the participants.
This means that individuals should not be humiliated, mocked, demeaned, or chastised for things they did or failed to do during a simulated scenario.
The whole point of simulation training is that we are all prone to errors, and that simulation is a way to help train providers and teams of providers to avoid these errors through increased technical skill, communication, and team support.
The incorporation of simulation into training in obstetrics and gynecology in the United States is relatively new, but shows great promise as a tool to improve providers' technical skills, teamwork and communication, and, most importantly, patient safety.
Source Graphics courtesy Dr. Hugh Mighty
Improving Our Safety Profile
Quality is a buzzword in industry, and safety has become one in medicine in recent years.
Safety is not an issue that is new to medicine. Health care professionals have always embraced the idea of safety as a fundamental part of the practice of good medicine, and everyone would agree that their practice is safe, and they've made every effort to execute safe and effective principles as they care for patients. Safety has, however, taken on added urgency since 1999, when the Institute of Medicine released shocking statistics, estimating that as many as 98,000 people die in any given year as a result of medical errors that occur in hospitals.
The findings were an eye-opener for the nation as a whole and for us as physicians. Despite our having embraced a safety mantra, the numbers of deaths due to medical errors were unexpectedly high.
This led to a wave of purposeful efforts to ensure the highest level of effectiveness and the lowest level of adverse consequences. In obstetrics, patient safety takes on added significance because of the potential long-term consequences of adverse outcomes and the associated litigious environment. Initiatives are especially important for the prevention and reduction of adverse events, thus increasing the safety profile to the highest possible level.
Several initiatives have been introduced in recent years to improve our safety profile. We're in an early phase of a significant evolution toward “systemwide” changes in obstetrics safety programs. There are a large number of safety initiatives being tested, but thus far the outcomes and effectiveness of various approaches are unclear. Inherently, we may always have fewer absolute results than we do in other fields.
Despite the limitations of a large body of data, it is worthwhile to review and share various approaches in labor and delivery safety programs, to monitor success as best as we can, and to see if we can identify some evolving best practices.
In this light, we have invited Dr. Hugh Mighty, associate professor and chair, department of obstetrics and gynecology at the University of Maryland, Baltimore, to be our guest professor.
Dr. Mighty has played a key role in establishing patient safety initiatives in labor and delivery at the University of Maryland Medical Center. He is a proponent of the use of simulation as a key safety program initiative and will describe its importance and detail what his experience and the experience of others have shown about how simulation can be meaningfully and successfully integrated into the practice of obstetrics.
Following publication a decade ago of the Institute of Medicine's landmark report, “To Err Is Human,” the medical world turned a critical eye upon itself to identify sources of the tens of thousands of preventable deaths found to occur annually during hospital stays.
These deaths represented only a fraction of the injuries sustained by patients in our health care system as a result of medical error.
One of the surprising findings was that many of these errors were happening in the hands of highly skilled professionals. Studies that used closed-claims analysis found that system failures, and failures in communication and teamwork, are implicated in a significant proportion of medical errors that result in patient harm.
With a new appreciation for the impact of system breakdowns and communication failures—and the importance of teamwork skills in addition to individual skills—the next question in the medical world became how organizations can revamp systems and integrate tools that will reliably minimize adverse events.
Other high-stakes industries—most notably the military and aviation—have offered lessons. Both recognize the importance of teamwork and communication in minimizing the occurrence of errors and mitigating their adverse effects, regardless of the source.
In both commercial and military aviation, flight teams undergo rigorous training that teaches them to prevent, recognize, and mitigate errors including “human factor” errors—those due not to aircraft failure but to human fallibility. Aviation professionals are trained to prevent errors through crew resource management.
In recent years, medicine has created a variety of training programs that apply resource management principles. Our program, for one, is based on the understanding that health care professionals not only must have knowledge and skills, but must work together because teams perform better than individuals, especially in crisis situations.
Certainly this is the case in obstetrics, where unexpected events are common, situations happen rapidly, and conditions deteriorate quickly.
Our program and other efforts elsewhere incorporate an additional hallmark of training programs in the airline industry: the use of simulation—in our case, to teach the combination of technical, clinical management, and teamwork/communication skills that help maximize patient safety.
Simulation and other types of immersive training allow individuals to learn and practice these skills in an environment where patient safety is not compromised, and in a way that can be standardized and replicated.
The Research on Simulation Training
The use of simulation in graduate and undergraduate medical education and in team training has been demonstrated to improve trainee satisfaction. Multiple studies also have shown improvements in measures of provider self-efficacy and confidence.
The impact of any training, including simulation-based training, on clinical team performance, however, can be difficult to measure. This difficulty is partly due to difficulty in finding appropriate measures of team performance. In as much as improvement in clinical outcomes can be viewed as the best measure of the value of any training, however, our colleagues in England have provided the best evidence in support of simulation-based training.
A team of British investigators instituted multidisciplinary simulation training for all providers of obstetric care in multiple hospitals. After several years of training, these providers have achieved a statistically significant and sustained impact of simulation training on perinatal outcomes, including a decrease in the rates of brachial plexus injuries related to shoulder dystocia (Obstet. Gynecol. 2008;112:14–20), improvements in Apgar scores, and a reduction in hypoxic-ischemic encephalopathy following training on other obstetric emergencies (BJOG 2006;113:177-82).
It will take time before American researchers are able to produce similar proof of the efficacy of simulation training. This is due to a combination of factors, including the fact that we have been slower than our European colleagues to integrate simulation training into obstetric training, and because the number of cases that is needed to demonstrate a significant change in clinical outcomes will require long-term studies across multiple institutions. The funding and collaborations required for this type of study are in their fledgling stages.
It is worth noting, however, that other high-stakes industries have not awaited nor demanded proof of the effectiveness of simulation before embracing it. Dr. David M. Gaba, an anesthesiologist and one of the earliest adopters and biggest proponents of simulation training in medicine, aptly stated once that “no industry in which human lives depend on the skilled performance of responsible operators has waited for unequivocal proof of the benefits of simulation before embracing it. Why should health care be any different?”
A relevant example of this point is that prior to the successful landing of U.S. Airways Flight 1549 on the Hudson by Captain Chesley Sullenbergerand his crew following an extraordinarily rare double-engine failure, a water landing had not been successfully carried out. The aviation industry, however, has done simulation training involving double-engine failures despite their rarity and water landings despite the fact that they had not ever been successfully executed.
The internal validity of such training has always been the aviation industry's impetus to conduct extensive team and simulation training.
The citation on the award given to the crew following this event read: “The reactions of all members of the crew, the split-second decision making, and the handling of this emergency and evacuation was 'textbook' and an example to us all.”
Captain Sullenberger, who himself runs a safety consulting business on the side, has publicly credited the training that he and his crew have received for years for allowing them to successfully land and evacuate the plane without any casualties.
Getting Started
The following tips are based on our experience and that of others:
▸ Simulation is a technique—not a technology. Purchasing a simulator does not mean you have a ready simulation program. The simulators and mannequins are technologies used for simulation. We have heard many stories of people with expensive simulators still sitting unused.
Similarly, owning a particular simulator is not a prerequisite to initiating simulation training.
Before undertaking what can be a significant monetary investment in an expensive simulator, first outline the type of training that will be conducted and then determine what type of simulator and other equipment will be necessary for the type of training that is planned.
There are some relatively affordable low-tech mannequins that can be used in combination with a standardized patient/actor to create a hybrid simulator and very realistic scenarios. For certain scenarios it is possible to use an actor or standardized patient instead of a mannequin.
Some sites have started conducting training using very low-tech solutions and have incorporated both higher-tech simulators and more complex scenarios as both their expertise and their programs have grown.
▸ Plan big but start small. It is critical to identify your target audience(s) and program goals early. It is also important, however, to not try to meet all goals and serve all audiences from the start.
Some sites have very specific training goals that will involve relatively few participants. For example, a site may decide to use simulation to train their nurses and hospitalist ob.gyns. on a couple of basic obstetric emergencies in a “drill” sort of format.
Even a site with a small audience and well-defined objectives will benefit from starting slowly. In this case, for example, it would be best to start by picking one of the “simpler” emergencies such as shoulder dystocia and run that scenario repeatedly until the people responsible for running the simulations feel comfortable and confident in the process of running simulations and debriefing trainees.
Waiting until there is a basic comfort before moving onto more complex scenarios (such as a maternal code) will prevent much frustration among both the trainers and the trainees.
▸ A program does not run itself. Probably one of the most important steps when beginning a simulation initiative is to identify the individual(s) who will organize and run the simulation program and who will take care of such things as scheduling, securing equipment and supplies, setting up and cleaning up, testing scenarios, and managing video recordings.
Although some sites choose to have providers serve in this role, the individuals who run the program do not have to be the medical experts on the topics that will be trained. It is crucial, however, that these individuals be allotted enough time to run the simulation training.
If these individuals are not already well versed in simulation, it may be worth allowing them some time to become familiar with the subject and possibly allowing them to attend some training on running a simulation program.
▸ Simulation takes time. Conducting simulation training is like running a theater where each training session is a play. Writing and rehearsing a scenario take time, as does mounting the stage and conducting the performance.
Although the time it takes to develop a training session will decrease with experience, it is nonetheless a time-consuming effort and not something that is easily added to someone's already full schedule.
▸ Decide up front what you want to accomplish. You have to know what you want to do before you set out to accomplish it. Define a goal before writing a scenario, and then write the scenario to achieve that goal.
“To train teams to have better team communication during obstetric emergencies” is a good goal for a simulation program, but is not a good, clearly defined goal for a scenario, for instance.
“The learner will practice using callbacks or closed-loop communications during obstetric emergencies” is an example of a clearly defined goal appropriate for a scenario.
To meet this goal, one would need to create a scenario in which providers need to make multiple requests of multiple people (for example, for labs, blood, and medication) in a short time succession.
A hemorrhage and a code are examples of clinical situations in which there is a need for many closed-loop communications in a short time. The specific medical condition, however, becomes somewhat secondary in this case because the training and the debriefing will focus on closed-loop communication.
It is possible to meet multiple training goals during one training session, but it is important to not overwhelm the trainees (or the trainers). As trainees and trainers become more experienced, it becomes easier to incorporate more objectives into a single training session, but it is still crucial to focus the training on the objectives and to limit the number of such objectives.
▸ Keep it simple. A long complicated scenario is not necessarily what is needed to achieve training goals. It is worth considering that for certain teaching/training goals, multiple short scenarios may be a better way to get multiple training points across or to reinforce concepts that have already been taught.
Although there are some training goals that may require longer, more complex scenarios, it is worth remembering that when the scenario is longer and more complicated for the learner, it is also longer and more complicated for the trainer.
One should “save” such scenarios for specific training points for which they are needed.
We like to try to create scenarios that run in 10 minutes or less. We also like running a scenario, debriefing the trainees, and then immediately running it again to reinforce the learning points reviewed during the debriefing.
▸ Do not reinvent the wheel. One scenario can often be modified in simple ways to meet different teaching objectives. We added high blood pressure and headache to our simulated patient with precipitous delivery in triage, for instance.
In doing so, we easily added teaching points on the management of severe preeclampsia to our teaching points on managing a precipitous delivery.
Through this process, we also incorporated a teaching point that we try to reinforce through multiple scenarios—the idea that being focused on the task at hand is not the same as putting on blinders because the most obvious or pressing problem is not necessarily your only or biggest problem.
▸ No simulation is better than bad simulation. Do not reinforce bad habits or bad medicine. It is important that teaching points be evidence based, and that during training we reinforce management that is within the standard of care.
Similarly, one should not allow inappropriate behavior to be reinforced during debriefings. It defeats the purpose of simulation training to allow, during debriefings, the very behaviors we are trying to eliminate.
The belligerent, bullying nurse or physician cannot be allowed to dominate or commandeer the debriefing session.
The ability of the trainers to avoid this situation or to manage it in a manner that is going to be productive to the goals of teamwork and communication will be much greater if they have had an opportunity to train and practice their debriefing skills.
▸ Debriefing is key. A debriefing is the time after a scenario when participants are led in a discussion of what happened during the scenario.
The participants identify ways in which things went well and why, and ways in which things did not go well and why.
It is sometimes said that simulation is an excuse for a debriefing; this is because much of the teaching that happens during simulation training occurs during the debriefing.
A debriefing may be very straightforward such as when a scenario is designed to meet very technical or process-oriented goals.
For example, if the goal of the scenario is to practice the steps of the neonatal resuscitation program, then the debriefing may be as simple as identifying those moments when any of the team members did not follow the steps.
Debriefings have the potential, however, to become emotionally charged. This is most likely during debriefings that are meant to train providers on team interactions and communication.
We recommend that if a group is going to institute any team training using simulation, they invest in having their trainers participate in some sort of train-the-trainer programs that will teach them and let them practice their debriefing techniques.
▸ “What happens in 'sim' stays in 'sim.'” For learning to occur, it is important to keep simulation training friendly and safe for the participants.
This means that individuals should not be humiliated, mocked, demeaned, or chastised for things they did or failed to do during a simulated scenario.
The whole point of simulation training is that we are all prone to errors, and that simulation is a way to help train providers and teams of providers to avoid these errors through increased technical skill, communication, and team support.
The incorporation of simulation into training in obstetrics and gynecology in the United States is relatively new, but shows great promise as a tool to improve providers' technical skills, teamwork and communication, and, most importantly, patient safety.
Source Graphics courtesy Dr. Hugh Mighty
Improving Our Safety Profile
Quality is a buzzword in industry, and safety has become one in medicine in recent years.
Safety is not an issue that is new to medicine. Health care professionals have always embraced the idea of safety as a fundamental part of the practice of good medicine, and everyone would agree that their practice is safe, and they've made every effort to execute safe and effective principles as they care for patients. Safety has, however, taken on added urgency since 1999, when the Institute of Medicine released shocking statistics, estimating that as many as 98,000 people die in any given year as a result of medical errors that occur in hospitals.
The findings were an eye-opener for the nation as a whole and for us as physicians. Despite our having embraced a safety mantra, the numbers of deaths due to medical errors were unexpectedly high.
This led to a wave of purposeful efforts to ensure the highest level of effectiveness and the lowest level of adverse consequences. In obstetrics, patient safety takes on added significance because of the potential long-term consequences of adverse outcomes and the associated litigious environment. Initiatives are especially important for the prevention and reduction of adverse events, thus increasing the safety profile to the highest possible level.
Several initiatives have been introduced in recent years to improve our safety profile. We're in an early phase of a significant evolution toward “systemwide” changes in obstetrics safety programs. There are a large number of safety initiatives being tested, but thus far the outcomes and effectiveness of various approaches are unclear. Inherently, we may always have fewer absolute results than we do in other fields.
Despite the limitations of a large body of data, it is worthwhile to review and share various approaches in labor and delivery safety programs, to monitor success as best as we can, and to see if we can identify some evolving best practices.
In this light, we have invited Dr. Hugh Mighty, associate professor and chair, department of obstetrics and gynecology at the University of Maryland, Baltimore, to be our guest professor.
Dr. Mighty has played a key role in establishing patient safety initiatives in labor and delivery at the University of Maryland Medical Center. He is a proponent of the use of simulation as a key safety program initiative and will describe its importance and detail what his experience and the experience of others have shown about how simulation can be meaningfully and successfully integrated into the practice of obstetrics.
Laparoscopic Single-Site Hysterectomies
For more than 20 years now, surgeons have been exploring minimally invasive techniques to decrease the complications of traditional abdominal hysterectomy.
Although two-thirds of all hysterectomies in the United States still are performed through a large abdominal incision, we know that minimally invasive hysterectomy provides women with a faster recovery, less pain, a quicker return to normal activities, and fewer complications.
Gynecologic surgeons who have embraced laparoscopy for patients who are not candidates for a vaginal hysterectomy have improved their laparoscopic skills notably over the last 10-15 years. The laparoscopic techniques themselves, however, have remained relatively unchanged since laparoscopic hysterectomy became an option.
From my standpoint as a minimally invasive gynecologic surgeon, I view conventional laparoscopic hysterectomy as a wonderful option for women who do not qualify for a vaginal approach. But on the flip side, I see further progress to be made since the surgery still requires several small incisions and ports, each of which increases the potential morbidity from bleeding, nerve injuries, or port-site hernias and hematomas, and each of which diminishes the cosmetic outcome that many women desire.
This next frontier for women needing hysterectomy—the next logical step in the development of minimally invasive surgery—may have recently arrived. It is a new laparoscopic approach, most commonly called single-incision laparoscopy or laparoendoscopic single-site surgery (LESS), that involves a single umbilical incision and the use of one special port through which three to four traditional or slightly modified hand instruments can be passed.
Numerous terms have been used over the years to describe single-incision laparoscopic surgery, from keyhole surgery to transumbilical endoscopic surgery to embryonic natural orifice transluminal endoscopic surgery. Just recently, a multispecialty, industry-sponsored consortium published a white paper/consensus statement saying that the term laparoendoscopic single-site surgery “most accurately conveys the broad philosophical and practical aspects of the field” (Surg. Endosc. 2009 Dec. 9;doi:10.1007/s00464-009-0688-8).
While LESS will likely be the term used most often in print, I still often use the term “single-incision laparoscopic surgery” in my discussions with patients.
Urologists are among the specialists who have reported a significant increase in the use of LESS in the past several years; successes for partial nephrectomy, pyeloplasty, renal biopsy, and numerous other procedures have been described.
In gynecologic surgery, we are building on this experience. We have a unique advantage, though, in that we have access to the uterus through the vagina. Using a uterine manipulator gives us an extra hand, in essence making a single-incision approach much easier for us than it is for other specialists.
My initial experience and that of other gynecologic surgeons suggests that single-incision laparoscopy is feasible and well tolerated and leaves no visible physical scar. Depending on the specific anatomy of each patient's umbilicus, we can often hide the incision completely in its natural creases. And just as—if not more—importantly, we may further reduce the potential morbidity associated with the use of multiple laparoscopic trocars.
History and Instrumentation
Laparoscopic hysterectomy using a single umbilical puncture was first reported by Dr. Marco A. Pelosi and Dr. Marco A. Pelosi III in 1991 (N.J. Med. 1991;88:721-6).hThe instrumentation they used for their laparoscopic-assisted vaginal hysterectomies was primitive, compared with the currently available ports, instruments, and optics, however, and the technique did not catch on. Single-incision total laparoscopic hysterectomy as we know it today really came about in 2007, when Dr. Homero Rivas, a general surgeon who was performing single-incision laparoscopic cholecystectomy at the University of Texas Southwestern Medical Center at Dallas, traveled to Mexico where his brother is a gynecologist. There, with his brother's guidance, Dr. Rivas successfully performed a hysterectomy using single-incision laparoscopy.
Single-incision laparoscopy was really taking off in general surgery and urology at about this time. Many minimally invasive surgeons saw it as a bridge to an experimental approach called natural orifice transluminal endoscopic surgery (NOTES), which uses natural orifices for access to the abdominal viscera and which might, they believed, represent the ultimate approach to minimally invasive surgery.
Single-incision laparoscopy rapidly became more than a bridge to NOTES, however. It came into its own, surpassing NOTES as a technique with lasting and broad acceptance—and one without the limitations or surgical difficulties of NOTES. Nephrectomies, splenectomies, appendectomies, and a host of other procedures were performed using single-incision laparoscopy.
Like Dr. Rivas and other general and gynecologic surgeons who began using the technique several years ago, I began my experience with single-incision total laparoscopic hysterectomy utilizing articulating surgical equipment that had been around for years. (I started using the technique in 2008.) In the past few years, laparoscopic equipment has been modified and refined in ways that have made the technique even easier and achievable by more surgeons. Articulating laparoscopic graspers, endoshears, and graspers all are commercially available.
I believe that single-incision laparoscopic hysterectomy is easiest when articulating instruments and a flexible-tip scope are used, although some surgeons are using higher-angled scopes (30 or 45 degrees) and prototype instruments that are angled rather than having the capability to articulate. (An array of bent laparoscopic instrumentation should be commercially available early this year.)
The goal, of course, is to avoid the crowding or clashing of instruments—commonly called “sword fighting”—that can come with inserting several instruments through a single port and at a single trajectory. As with any laparoscopic surgery, one needs appropriate triangulation in order to have enough intracorporeal working space with access to the tissue.
I have used a specialized 5-mm Olympus flexible scope with a reticulating camera tip. With its hysteroscopelike controls, the instrument can flex to angles greater than 90 degrees in any direction. By flexing the camera tip, I can increase my working space and deflect the camera out of the operative field to prevent my hands and instruments from clashing.
To effectively use an articulating instrument such as a grasper, I find it is best to work “across” the patient. For work on the right side, this means inserting the articulating instrument through the left cannula on the port. The instrument will cross the pelvis and articulate back toward the midline. The straight vessel-sealing device is then placed through the remaining cannula.
A wider array of articulating laparoscopes and instruments should soon be available. Most, if not all, major manufacturers of laparoscopic equipment now have divisions on single-incision laparoscopy. (In December, the Millennium Research Group, a medical technology market research group, predicted that more than 20% of all laparoscopic procedures will be done through a single-port approach by 2014.)
Four companies currently market multichannel ports that can be inserted into the base of the umbilicus. The differences in the ports are subtle, and one's choice is a matter of personal preference.
The two Food and Drug Administration–approved multichannel ports that are most commonly used today are the SILS port by Covidien, and the TriPort now distributed by Olympus. Each consists of a retractor component that is placed through the fascia and individual valves or ports where laparoscopic instruments and scopes can be inserted simultaneously. Each of these multichannel ports has three inlet ports—one that holds a 12-mm instrument and two for 5-mm instruments.
Like the other instrumentation available for single-incision laparoscopy, the multichannel ports are in their infancy. All are in their first generation and are being revised by their manufacturers. The first of the second-generation ports should become available early this year.
Technique and Surgical Pearls
Overall, there is not much difference between the LESS approach and conventional laparoscopy, and the new approach should be performed in a manner that is similar to the conventional laparoscopic technique with which one is most familiar.
Entering the abdomen is performed in the traditional open laparoscopy technique described by Hassan. Although standard single-channel ports generally require a 5- to 10-mm incision (or a 15-mmincision for the Hassan entry technique), the multichannel ports used for single-incision laparoscopy require a slightly larger incision. I generally recommend a 20- to 25-mm incision.
In patients with a deeper umbilicus, I make a midline incision through the base of the umbilicus. In thinner patients with a flat umbilicus, I use a semicircular incision around the base of the umbilicus. In either case, making the incision in keeping with the natural folds of the umbilicus enables one to minimize or eliminate any visible scar in the abdomen.
With the TriPort, the inner ring is loaded into the transducer, and inserted into the fascial incision by advancing a lever with one's thumb. The plastic is repeatedly pulled up and the ring is advanced until it is firmly in place against the patient's abdomen. The port is then clamped into place so that it sits snugly against the inner abdominal peritoneum.
In obese patients, I recommend suturing the peritoneum to the fascia to prevent the inner ring from slipping into the preperitoneal space as the case progresses.
In patients for whom I use a semicircular incision, the fascial opening can be extended bilaterally to facilitate easy placement of either the SILS port or the TriPort by using S hooks to expand the incision.
To insert the SILS port, the port is grasped with a Kelly clamp and placed into the fascia so that it sits flat on the abdominal surface with the inner ring inside the peritoneal cavity. Individual cannulas are then placed in the holes of the SILS port.
The camera (a flexible-tip camera in this case) is inserted into the port, and the tip flexed, to assess the abdomen and pelvis. One can achieve the best, unobstructed views of the pelvis—and avoid instrument clashing—when the camera tip is placed toward the anterior abdominal wall and deviated downward toward the pelvis. As the surgery proceeds, one can obtain excellent views by simply adjusting the flexible-tip camera.
In a total laparoscopic hysterectomy, I have found that it is easier to begin with the primary surgeon standing near the patient's left shoulder to address the left side first. The uterine manipulator will deflect the uterus cephalad and toward the operator, placing the right utero-ovarian ligaments under tension.
With use of the reticulating grasper, the utero-ovarian ligament is elevated, which provides easy access for a straight vessel-sealing device. At this point the camera is best positioned providing views from the right lower quadrant looking anteriorly. (This is accomplished by lowering the camera toward the patient's chest and deflecting the camera tip inferiorly and medially.)
A vessel-sealing device of your choice can then be used to cross-clamp, seal, and transect the utero-ovarian, round, and broad ligaments. The bladder flap can be developed with either a hook cautery, scissors, or a vessel-sealing device. Often, the small vaginal branches of the uterine vessels will become compressed across the top of the manipulator cuff—be sure to use the vessel-sealing device to control this.
For the colpotomy, I generally use the monopolar hook with 40- to 50-W pure cutting. The disposable hook electrode is advantageous for LESS because it can be bent. By moving the flexible-tip camera, one can adequately visualize the entire colpotomy. I also use the uterine manipulator to advantage—applying upward pressure usually provides adequate views of all the cervical-vaginal attachments.
Once the uterus is detached, it generally can be delivered vaginally. When necessary, morcellation can be accomplished either vaginally (with or without a mechanical morcellator) or with a morcellator placed through the port in the umbilicus.
Suturing presents the biggest challenges. Even those who have mastered suturing in conventional laparoscopy will face a learning curve. The vaginal cuff can be closed intracorporeally using one conventional needle driver and one reticulating grasper, but it can also be facilitated with a commercial suturing device and extracorporeal knot tying. (This latter option may be advisable during the learning curve.)
When extracorporeal knot tying is used, be careful to prevent the suture from getting wrapped around the other instruments, especially if using the TriPort.
A few more tips to shorten the learning curve with single-incision laparoscopic hysterectomy:
▸ Don't hesitate to “pexy” the ovaries, epiploica, uterus, etc., when necessary.
▸ Lubricate instruments frequently.
▸ Complete one side before moving on to the other side. Anything you can do to minimize instrument changes will improve efficiency and eliminate the need to reposition the camera and instruments. When switching sides, maintain the same instrument configuration.
▸ The camera in the vertical position with upward flexion at the tip provides an excellent view of the posterior uterus and cul de sac.
▸ The camera in the horizontal position with downward flexion at the tip provides excellent views of the anterior uterus and bladder flap, and is preferable for viewing the broad ligaments.
Experience and Outcomes
Since June 2008, I have done more than 90 hysterectomies and 20 other surgeries using the LESS technique. Data from a 5-month period in 2008, involving 22 patients who had LESS surgery (19 of whom had a hysterectomy), show that patients used narcotic pain medications for an average of 2.5 days and any analgesic medication for an average of 5 days. Their length of stay averaged approximately 11.5 hours, and they returned to work after an average of 3.5 days. The average uterine weight was 324 g, and weight was as high as 1,600 g.
Blood loss averaged 50 mL, and the median operative time was 171 minutes. Surgical time was directly related to body mass index and uterine weight, and estimated blood loss increased with increasing uterine weight. Prior laparotomy and the presence of severe adhesions did not affect the length of surgery.
I encountered no intraoperative complications or conversions, although in one patient, morcellation of the 1,600-g uterus was carried out through an additional 15-mm suprapubic incision.
The complications I encountered in this initial group of 22 patients were vaginal bleeding on day 6 in one patient and a suture granuloma 3 weeks postop in another. A third patient had a tubo-ovarian abscess 11 days after surgery; she had a history of sexually transmitted diseases and substance abuse.
These outcomes may be a little better than those of standard laparoscopic surgery—they are at least comparable—and the cosmetic results are certainly superior. It may be difficult to demonstrate statistically significant differences in pain and recovery, at least in smaller populations of patients. I am in the process of doing a comparative study of conventional laparoscopy and LESS, but a larger series will be needed to quantify many of the intraoperative and postoperative benefits.
Laparoscopic surgeons have been driven to learn and offer the technique to reduce the minimal but not insignificant risk of complications associated with each incision. Why would I put four incisions in my patient when I can complete the procedure through just one?
For work on the right side, the articulating instrument is placed through the left cannula on the multichannel port.
Source Courtesy Dr. Kevin J. Stepp
Surgical pearl: The gynecologic surgeon can achieve unobstructed views of the pelvis by adjusting the tip of the flexible-tip camera.
A reticulating grasper (left) can be used to elevate the utero-ovarian ligament in order to provide access for a straight vessel-sealing device (right).
Source Images courtesy Dr. Kevin J. Stepp
'Minimal' Minimally Invasive Surgery
So, is it time for an old dog to learn a new trick? That's exactly what I thought to myself as I attended a program on laparoscopic single-site surgery during the annual meeting of the AAGL.
After performing operative laparoscopy for more than a quarter of a century, I questioned whether I was truly ready to convert my midumbilical “closed” technique to a larger infraumbilical “open” technique. At the end of the day, I pondered, are 5-mm lateral incisions really not cosmetic? Once in the abdominal cavity, could I really retrain myself to use articulating instrumentation? Does single-port surgery offer the same triangulation of instrumentation as conventional laparoscopic surgery, or for that matter, robotic-assisted surgery?
As you read this latest edition of the Master Class in Gynecologic Surgery, authored by an excellent young physician, Dr. Kevin J. Stepp, I am sure you will contemplate issues similar to these. Nevertheless, this truly is exciting, thought-provoking technology that is “all the buzz” in minimally invasive surgery.
Dr. Stepp is assistant professor of reproductive biology at Case Western Reserve University, Cleveland. He is the program director for the new urogynecology and minimally invasive surgery fellowship at MetroHealth Medical Center in Cleveland. Dr. Stepp also serves as the director of gynecologic surgical education for the MetroHealth/Cleveland Clinic obstetrics and gynecology residency program. In 2009, he performed the world's first single-surgeon, single-incision robotic-assisted laparoscopic hysterectomy.
For more than 20 years now, surgeons have been exploring minimally invasive techniques to decrease the complications of traditional abdominal hysterectomy.
Although two-thirds of all hysterectomies in the United States still are performed through a large abdominal incision, we know that minimally invasive hysterectomy provides women with a faster recovery, less pain, a quicker return to normal activities, and fewer complications.
Gynecologic surgeons who have embraced laparoscopy for patients who are not candidates for a vaginal hysterectomy have improved their laparoscopic skills notably over the last 10-15 years. The laparoscopic techniques themselves, however, have remained relatively unchanged since laparoscopic hysterectomy became an option.
From my standpoint as a minimally invasive gynecologic surgeon, I view conventional laparoscopic hysterectomy as a wonderful option for women who do not qualify for a vaginal approach. But on the flip side, I see further progress to be made since the surgery still requires several small incisions and ports, each of which increases the potential morbidity from bleeding, nerve injuries, or port-site hernias and hematomas, and each of which diminishes the cosmetic outcome that many women desire.
This next frontier for women needing hysterectomy—the next logical step in the development of minimally invasive surgery—may have recently arrived. It is a new laparoscopic approach, most commonly called single-incision laparoscopy or laparoendoscopic single-site surgery (LESS), that involves a single umbilical incision and the use of one special port through which three to four traditional or slightly modified hand instruments can be passed.
Numerous terms have been used over the years to describe single-incision laparoscopic surgery, from keyhole surgery to transumbilical endoscopic surgery to embryonic natural orifice transluminal endoscopic surgery. Just recently, a multispecialty, industry-sponsored consortium published a white paper/consensus statement saying that the term laparoendoscopic single-site surgery “most accurately conveys the broad philosophical and practical aspects of the field” (Surg. Endosc. 2009 Dec. 9;doi:10.1007/s00464-009-0688-8).
While LESS will likely be the term used most often in print, I still often use the term “single-incision laparoscopic surgery” in my discussions with patients.
Urologists are among the specialists who have reported a significant increase in the use of LESS in the past several years; successes for partial nephrectomy, pyeloplasty, renal biopsy, and numerous other procedures have been described.
In gynecologic surgery, we are building on this experience. We have a unique advantage, though, in that we have access to the uterus through the vagina. Using a uterine manipulator gives us an extra hand, in essence making a single-incision approach much easier for us than it is for other specialists.
My initial experience and that of other gynecologic surgeons suggests that single-incision laparoscopy is feasible and well tolerated and leaves no visible physical scar. Depending on the specific anatomy of each patient's umbilicus, we can often hide the incision completely in its natural creases. And just as—if not more—importantly, we may further reduce the potential morbidity associated with the use of multiple laparoscopic trocars.
History and Instrumentation
Laparoscopic hysterectomy using a single umbilical puncture was first reported by Dr. Marco A. Pelosi and Dr. Marco A. Pelosi III in 1991 (N.J. Med. 1991;88:721-6).hThe instrumentation they used for their laparoscopic-assisted vaginal hysterectomies was primitive, compared with the currently available ports, instruments, and optics, however, and the technique did not catch on. Single-incision total laparoscopic hysterectomy as we know it today really came about in 2007, when Dr. Homero Rivas, a general surgeon who was performing single-incision laparoscopic cholecystectomy at the University of Texas Southwestern Medical Center at Dallas, traveled to Mexico where his brother is a gynecologist. There, with his brother's guidance, Dr. Rivas successfully performed a hysterectomy using single-incision laparoscopy.
Single-incision laparoscopy was really taking off in general surgery and urology at about this time. Many minimally invasive surgeons saw it as a bridge to an experimental approach called natural orifice transluminal endoscopic surgery (NOTES), which uses natural orifices for access to the abdominal viscera and which might, they believed, represent the ultimate approach to minimally invasive surgery.
Single-incision laparoscopy rapidly became more than a bridge to NOTES, however. It came into its own, surpassing NOTES as a technique with lasting and broad acceptance—and one without the limitations or surgical difficulties of NOTES. Nephrectomies, splenectomies, appendectomies, and a host of other procedures were performed using single-incision laparoscopy.
Like Dr. Rivas and other general and gynecologic surgeons who began using the technique several years ago, I began my experience with single-incision total laparoscopic hysterectomy utilizing articulating surgical equipment that had been around for years. (I started using the technique in 2008.) In the past few years, laparoscopic equipment has been modified and refined in ways that have made the technique even easier and achievable by more surgeons. Articulating laparoscopic graspers, endoshears, and graspers all are commercially available.
I believe that single-incision laparoscopic hysterectomy is easiest when articulating instruments and a flexible-tip scope are used, although some surgeons are using higher-angled scopes (30 or 45 degrees) and prototype instruments that are angled rather than having the capability to articulate. (An array of bent laparoscopic instrumentation should be commercially available early this year.)
The goal, of course, is to avoid the crowding or clashing of instruments—commonly called “sword fighting”—that can come with inserting several instruments through a single port and at a single trajectory. As with any laparoscopic surgery, one needs appropriate triangulation in order to have enough intracorporeal working space with access to the tissue.
I have used a specialized 5-mm Olympus flexible scope with a reticulating camera tip. With its hysteroscopelike controls, the instrument can flex to angles greater than 90 degrees in any direction. By flexing the camera tip, I can increase my working space and deflect the camera out of the operative field to prevent my hands and instruments from clashing.
To effectively use an articulating instrument such as a grasper, I find it is best to work “across” the patient. For work on the right side, this means inserting the articulating instrument through the left cannula on the port. The instrument will cross the pelvis and articulate back toward the midline. The straight vessel-sealing device is then placed through the remaining cannula.
A wider array of articulating laparoscopes and instruments should soon be available. Most, if not all, major manufacturers of laparoscopic equipment now have divisions on single-incision laparoscopy. (In December, the Millennium Research Group, a medical technology market research group, predicted that more than 20% of all laparoscopic procedures will be done through a single-port approach by 2014.)
Four companies currently market multichannel ports that can be inserted into the base of the umbilicus. The differences in the ports are subtle, and one's choice is a matter of personal preference.
The two Food and Drug Administration–approved multichannel ports that are most commonly used today are the SILS port by Covidien, and the TriPort now distributed by Olympus. Each consists of a retractor component that is placed through the fascia and individual valves or ports where laparoscopic instruments and scopes can be inserted simultaneously. Each of these multichannel ports has three inlet ports—one that holds a 12-mm instrument and two for 5-mm instruments.
Like the other instrumentation available for single-incision laparoscopy, the multichannel ports are in their infancy. All are in their first generation and are being revised by their manufacturers. The first of the second-generation ports should become available early this year.
Technique and Surgical Pearls
Overall, there is not much difference between the LESS approach and conventional laparoscopy, and the new approach should be performed in a manner that is similar to the conventional laparoscopic technique with which one is most familiar.
Entering the abdomen is performed in the traditional open laparoscopy technique described by Hassan. Although standard single-channel ports generally require a 5- to 10-mm incision (or a 15-mmincision for the Hassan entry technique), the multichannel ports used for single-incision laparoscopy require a slightly larger incision. I generally recommend a 20- to 25-mm incision.
In patients with a deeper umbilicus, I make a midline incision through the base of the umbilicus. In thinner patients with a flat umbilicus, I use a semicircular incision around the base of the umbilicus. In either case, making the incision in keeping with the natural folds of the umbilicus enables one to minimize or eliminate any visible scar in the abdomen.
With the TriPort, the inner ring is loaded into the transducer, and inserted into the fascial incision by advancing a lever with one's thumb. The plastic is repeatedly pulled up and the ring is advanced until it is firmly in place against the patient's abdomen. The port is then clamped into place so that it sits snugly against the inner abdominal peritoneum.
In obese patients, I recommend suturing the peritoneum to the fascia to prevent the inner ring from slipping into the preperitoneal space as the case progresses.
In patients for whom I use a semicircular incision, the fascial opening can be extended bilaterally to facilitate easy placement of either the SILS port or the TriPort by using S hooks to expand the incision.
To insert the SILS port, the port is grasped with a Kelly clamp and placed into the fascia so that it sits flat on the abdominal surface with the inner ring inside the peritoneal cavity. Individual cannulas are then placed in the holes of the SILS port.
The camera (a flexible-tip camera in this case) is inserted into the port, and the tip flexed, to assess the abdomen and pelvis. One can achieve the best, unobstructed views of the pelvis—and avoid instrument clashing—when the camera tip is placed toward the anterior abdominal wall and deviated downward toward the pelvis. As the surgery proceeds, one can obtain excellent views by simply adjusting the flexible-tip camera.
In a total laparoscopic hysterectomy, I have found that it is easier to begin with the primary surgeon standing near the patient's left shoulder to address the left side first. The uterine manipulator will deflect the uterus cephalad and toward the operator, placing the right utero-ovarian ligaments under tension.
With use of the reticulating grasper, the utero-ovarian ligament is elevated, which provides easy access for a straight vessel-sealing device. At this point the camera is best positioned providing views from the right lower quadrant looking anteriorly. (This is accomplished by lowering the camera toward the patient's chest and deflecting the camera tip inferiorly and medially.)
A vessel-sealing device of your choice can then be used to cross-clamp, seal, and transect the utero-ovarian, round, and broad ligaments. The bladder flap can be developed with either a hook cautery, scissors, or a vessel-sealing device. Often, the small vaginal branches of the uterine vessels will become compressed across the top of the manipulator cuff—be sure to use the vessel-sealing device to control this.
For the colpotomy, I generally use the monopolar hook with 40- to 50-W pure cutting. The disposable hook electrode is advantageous for LESS because it can be bent. By moving the flexible-tip camera, one can adequately visualize the entire colpotomy. I also use the uterine manipulator to advantage—applying upward pressure usually provides adequate views of all the cervical-vaginal attachments.
Once the uterus is detached, it generally can be delivered vaginally. When necessary, morcellation can be accomplished either vaginally (with or without a mechanical morcellator) or with a morcellator placed through the port in the umbilicus.
Suturing presents the biggest challenges. Even those who have mastered suturing in conventional laparoscopy will face a learning curve. The vaginal cuff can be closed intracorporeally using one conventional needle driver and one reticulating grasper, but it can also be facilitated with a commercial suturing device and extracorporeal knot tying. (This latter option may be advisable during the learning curve.)
When extracorporeal knot tying is used, be careful to prevent the suture from getting wrapped around the other instruments, especially if using the TriPort.
A few more tips to shorten the learning curve with single-incision laparoscopic hysterectomy:
▸ Don't hesitate to “pexy” the ovaries, epiploica, uterus, etc., when necessary.
▸ Lubricate instruments frequently.
▸ Complete one side before moving on to the other side. Anything you can do to minimize instrument changes will improve efficiency and eliminate the need to reposition the camera and instruments. When switching sides, maintain the same instrument configuration.
▸ The camera in the vertical position with upward flexion at the tip provides an excellent view of the posterior uterus and cul de sac.
▸ The camera in the horizontal position with downward flexion at the tip provides excellent views of the anterior uterus and bladder flap, and is preferable for viewing the broad ligaments.
Experience and Outcomes
Since June 2008, I have done more than 90 hysterectomies and 20 other surgeries using the LESS technique. Data from a 5-month period in 2008, involving 22 patients who had LESS surgery (19 of whom had a hysterectomy), show that patients used narcotic pain medications for an average of 2.5 days and any analgesic medication for an average of 5 days. Their length of stay averaged approximately 11.5 hours, and they returned to work after an average of 3.5 days. The average uterine weight was 324 g, and weight was as high as 1,600 g.
Blood loss averaged 50 mL, and the median operative time was 171 minutes. Surgical time was directly related to body mass index and uterine weight, and estimated blood loss increased with increasing uterine weight. Prior laparotomy and the presence of severe adhesions did not affect the length of surgery.
I encountered no intraoperative complications or conversions, although in one patient, morcellation of the 1,600-g uterus was carried out through an additional 15-mm suprapubic incision.
The complications I encountered in this initial group of 22 patients were vaginal bleeding on day 6 in one patient and a suture granuloma 3 weeks postop in another. A third patient had a tubo-ovarian abscess 11 days after surgery; she had a history of sexually transmitted diseases and substance abuse.
These outcomes may be a little better than those of standard laparoscopic surgery—they are at least comparable—and the cosmetic results are certainly superior. It may be difficult to demonstrate statistically significant differences in pain and recovery, at least in smaller populations of patients. I am in the process of doing a comparative study of conventional laparoscopy and LESS, but a larger series will be needed to quantify many of the intraoperative and postoperative benefits.
Laparoscopic surgeons have been driven to learn and offer the technique to reduce the minimal but not insignificant risk of complications associated with each incision. Why would I put four incisions in my patient when I can complete the procedure through just one?
For work on the right side, the articulating instrument is placed through the left cannula on the multichannel port.
Source Courtesy Dr. Kevin J. Stepp
Surgical pearl: The gynecologic surgeon can achieve unobstructed views of the pelvis by adjusting the tip of the flexible-tip camera.
A reticulating grasper (left) can be used to elevate the utero-ovarian ligament in order to provide access for a straight vessel-sealing device (right).
Source Images courtesy Dr. Kevin J. Stepp
'Minimal' Minimally Invasive Surgery
So, is it time for an old dog to learn a new trick? That's exactly what I thought to myself as I attended a program on laparoscopic single-site surgery during the annual meeting of the AAGL.
After performing operative laparoscopy for more than a quarter of a century, I questioned whether I was truly ready to convert my midumbilical “closed” technique to a larger infraumbilical “open” technique. At the end of the day, I pondered, are 5-mm lateral incisions really not cosmetic? Once in the abdominal cavity, could I really retrain myself to use articulating instrumentation? Does single-port surgery offer the same triangulation of instrumentation as conventional laparoscopic surgery, or for that matter, robotic-assisted surgery?
As you read this latest edition of the Master Class in Gynecologic Surgery, authored by an excellent young physician, Dr. Kevin J. Stepp, I am sure you will contemplate issues similar to these. Nevertheless, this truly is exciting, thought-provoking technology that is “all the buzz” in minimally invasive surgery.
Dr. Stepp is assistant professor of reproductive biology at Case Western Reserve University, Cleveland. He is the program director for the new urogynecology and minimally invasive surgery fellowship at MetroHealth Medical Center in Cleveland. Dr. Stepp also serves as the director of gynecologic surgical education for the MetroHealth/Cleveland Clinic obstetrics and gynecology residency program. In 2009, he performed the world's first single-surgeon, single-incision robotic-assisted laparoscopic hysterectomy.
For more than 20 years now, surgeons have been exploring minimally invasive techniques to decrease the complications of traditional abdominal hysterectomy.
Although two-thirds of all hysterectomies in the United States still are performed through a large abdominal incision, we know that minimally invasive hysterectomy provides women with a faster recovery, less pain, a quicker return to normal activities, and fewer complications.
Gynecologic surgeons who have embraced laparoscopy for patients who are not candidates for a vaginal hysterectomy have improved their laparoscopic skills notably over the last 10-15 years. The laparoscopic techniques themselves, however, have remained relatively unchanged since laparoscopic hysterectomy became an option.
From my standpoint as a minimally invasive gynecologic surgeon, I view conventional laparoscopic hysterectomy as a wonderful option for women who do not qualify for a vaginal approach. But on the flip side, I see further progress to be made since the surgery still requires several small incisions and ports, each of which increases the potential morbidity from bleeding, nerve injuries, or port-site hernias and hematomas, and each of which diminishes the cosmetic outcome that many women desire.
This next frontier for women needing hysterectomy—the next logical step in the development of minimally invasive surgery—may have recently arrived. It is a new laparoscopic approach, most commonly called single-incision laparoscopy or laparoendoscopic single-site surgery (LESS), that involves a single umbilical incision and the use of one special port through which three to four traditional or slightly modified hand instruments can be passed.
Numerous terms have been used over the years to describe single-incision laparoscopic surgery, from keyhole surgery to transumbilical endoscopic surgery to embryonic natural orifice transluminal endoscopic surgery. Just recently, a multispecialty, industry-sponsored consortium published a white paper/consensus statement saying that the term laparoendoscopic single-site surgery “most accurately conveys the broad philosophical and practical aspects of the field” (Surg. Endosc. 2009 Dec. 9;doi:10.1007/s00464-009-0688-8).
While LESS will likely be the term used most often in print, I still often use the term “single-incision laparoscopic surgery” in my discussions with patients.
Urologists are among the specialists who have reported a significant increase in the use of LESS in the past several years; successes for partial nephrectomy, pyeloplasty, renal biopsy, and numerous other procedures have been described.
In gynecologic surgery, we are building on this experience. We have a unique advantage, though, in that we have access to the uterus through the vagina. Using a uterine manipulator gives us an extra hand, in essence making a single-incision approach much easier for us than it is for other specialists.
My initial experience and that of other gynecologic surgeons suggests that single-incision laparoscopy is feasible and well tolerated and leaves no visible physical scar. Depending on the specific anatomy of each patient's umbilicus, we can often hide the incision completely in its natural creases. And just as—if not more—importantly, we may further reduce the potential morbidity associated with the use of multiple laparoscopic trocars.
History and Instrumentation
Laparoscopic hysterectomy using a single umbilical puncture was first reported by Dr. Marco A. Pelosi and Dr. Marco A. Pelosi III in 1991 (N.J. Med. 1991;88:721-6).hThe instrumentation they used for their laparoscopic-assisted vaginal hysterectomies was primitive, compared with the currently available ports, instruments, and optics, however, and the technique did not catch on. Single-incision total laparoscopic hysterectomy as we know it today really came about in 2007, when Dr. Homero Rivas, a general surgeon who was performing single-incision laparoscopic cholecystectomy at the University of Texas Southwestern Medical Center at Dallas, traveled to Mexico where his brother is a gynecologist. There, with his brother's guidance, Dr. Rivas successfully performed a hysterectomy using single-incision laparoscopy.
Single-incision laparoscopy was really taking off in general surgery and urology at about this time. Many minimally invasive surgeons saw it as a bridge to an experimental approach called natural orifice transluminal endoscopic surgery (NOTES), which uses natural orifices for access to the abdominal viscera and which might, they believed, represent the ultimate approach to minimally invasive surgery.
Single-incision laparoscopy rapidly became more than a bridge to NOTES, however. It came into its own, surpassing NOTES as a technique with lasting and broad acceptance—and one without the limitations or surgical difficulties of NOTES. Nephrectomies, splenectomies, appendectomies, and a host of other procedures were performed using single-incision laparoscopy.
Like Dr. Rivas and other general and gynecologic surgeons who began using the technique several years ago, I began my experience with single-incision total laparoscopic hysterectomy utilizing articulating surgical equipment that had been around for years. (I started using the technique in 2008.) In the past few years, laparoscopic equipment has been modified and refined in ways that have made the technique even easier and achievable by more surgeons. Articulating laparoscopic graspers, endoshears, and graspers all are commercially available.
I believe that single-incision laparoscopic hysterectomy is easiest when articulating instruments and a flexible-tip scope are used, although some surgeons are using higher-angled scopes (30 or 45 degrees) and prototype instruments that are angled rather than having the capability to articulate. (An array of bent laparoscopic instrumentation should be commercially available early this year.)
The goal, of course, is to avoid the crowding or clashing of instruments—commonly called “sword fighting”—that can come with inserting several instruments through a single port and at a single trajectory. As with any laparoscopic surgery, one needs appropriate triangulation in order to have enough intracorporeal working space with access to the tissue.
I have used a specialized 5-mm Olympus flexible scope with a reticulating camera tip. With its hysteroscopelike controls, the instrument can flex to angles greater than 90 degrees in any direction. By flexing the camera tip, I can increase my working space and deflect the camera out of the operative field to prevent my hands and instruments from clashing.
To effectively use an articulating instrument such as a grasper, I find it is best to work “across” the patient. For work on the right side, this means inserting the articulating instrument through the left cannula on the port. The instrument will cross the pelvis and articulate back toward the midline. The straight vessel-sealing device is then placed through the remaining cannula.
A wider array of articulating laparoscopes and instruments should soon be available. Most, if not all, major manufacturers of laparoscopic equipment now have divisions on single-incision laparoscopy. (In December, the Millennium Research Group, a medical technology market research group, predicted that more than 20% of all laparoscopic procedures will be done through a single-port approach by 2014.)
Four companies currently market multichannel ports that can be inserted into the base of the umbilicus. The differences in the ports are subtle, and one's choice is a matter of personal preference.
The two Food and Drug Administration–approved multichannel ports that are most commonly used today are the SILS port by Covidien, and the TriPort now distributed by Olympus. Each consists of a retractor component that is placed through the fascia and individual valves or ports where laparoscopic instruments and scopes can be inserted simultaneously. Each of these multichannel ports has three inlet ports—one that holds a 12-mm instrument and two for 5-mm instruments.
Like the other instrumentation available for single-incision laparoscopy, the multichannel ports are in their infancy. All are in their first generation and are being revised by their manufacturers. The first of the second-generation ports should become available early this year.
Technique and Surgical Pearls
Overall, there is not much difference between the LESS approach and conventional laparoscopy, and the new approach should be performed in a manner that is similar to the conventional laparoscopic technique with which one is most familiar.
Entering the abdomen is performed in the traditional open laparoscopy technique described by Hassan. Although standard single-channel ports generally require a 5- to 10-mm incision (or a 15-mmincision for the Hassan entry technique), the multichannel ports used for single-incision laparoscopy require a slightly larger incision. I generally recommend a 20- to 25-mm incision.
In patients with a deeper umbilicus, I make a midline incision through the base of the umbilicus. In thinner patients with a flat umbilicus, I use a semicircular incision around the base of the umbilicus. In either case, making the incision in keeping with the natural folds of the umbilicus enables one to minimize or eliminate any visible scar in the abdomen.
With the TriPort, the inner ring is loaded into the transducer, and inserted into the fascial incision by advancing a lever with one's thumb. The plastic is repeatedly pulled up and the ring is advanced until it is firmly in place against the patient's abdomen. The port is then clamped into place so that it sits snugly against the inner abdominal peritoneum.
In obese patients, I recommend suturing the peritoneum to the fascia to prevent the inner ring from slipping into the preperitoneal space as the case progresses.
In patients for whom I use a semicircular incision, the fascial opening can be extended bilaterally to facilitate easy placement of either the SILS port or the TriPort by using S hooks to expand the incision.
To insert the SILS port, the port is grasped with a Kelly clamp and placed into the fascia so that it sits flat on the abdominal surface with the inner ring inside the peritoneal cavity. Individual cannulas are then placed in the holes of the SILS port.
The camera (a flexible-tip camera in this case) is inserted into the port, and the tip flexed, to assess the abdomen and pelvis. One can achieve the best, unobstructed views of the pelvis—and avoid instrument clashing—when the camera tip is placed toward the anterior abdominal wall and deviated downward toward the pelvis. As the surgery proceeds, one can obtain excellent views by simply adjusting the flexible-tip camera.
In a total laparoscopic hysterectomy, I have found that it is easier to begin with the primary surgeon standing near the patient's left shoulder to address the left side first. The uterine manipulator will deflect the uterus cephalad and toward the operator, placing the right utero-ovarian ligaments under tension.
With use of the reticulating grasper, the utero-ovarian ligament is elevated, which provides easy access for a straight vessel-sealing device. At this point the camera is best positioned providing views from the right lower quadrant looking anteriorly. (This is accomplished by lowering the camera toward the patient's chest and deflecting the camera tip inferiorly and medially.)
A vessel-sealing device of your choice can then be used to cross-clamp, seal, and transect the utero-ovarian, round, and broad ligaments. The bladder flap can be developed with either a hook cautery, scissors, or a vessel-sealing device. Often, the small vaginal branches of the uterine vessels will become compressed across the top of the manipulator cuff—be sure to use the vessel-sealing device to control this.
For the colpotomy, I generally use the monopolar hook with 40- to 50-W pure cutting. The disposable hook electrode is advantageous for LESS because it can be bent. By moving the flexible-tip camera, one can adequately visualize the entire colpotomy. I also use the uterine manipulator to advantage—applying upward pressure usually provides adequate views of all the cervical-vaginal attachments.
Once the uterus is detached, it generally can be delivered vaginally. When necessary, morcellation can be accomplished either vaginally (with or without a mechanical morcellator) or with a morcellator placed through the port in the umbilicus.
Suturing presents the biggest challenges. Even those who have mastered suturing in conventional laparoscopy will face a learning curve. The vaginal cuff can be closed intracorporeally using one conventional needle driver and one reticulating grasper, but it can also be facilitated with a commercial suturing device and extracorporeal knot tying. (This latter option may be advisable during the learning curve.)
When extracorporeal knot tying is used, be careful to prevent the suture from getting wrapped around the other instruments, especially if using the TriPort.
A few more tips to shorten the learning curve with single-incision laparoscopic hysterectomy:
▸ Don't hesitate to “pexy” the ovaries, epiploica, uterus, etc., when necessary.
▸ Lubricate instruments frequently.
▸ Complete one side before moving on to the other side. Anything you can do to minimize instrument changes will improve efficiency and eliminate the need to reposition the camera and instruments. When switching sides, maintain the same instrument configuration.
▸ The camera in the vertical position with upward flexion at the tip provides an excellent view of the posterior uterus and cul de sac.
▸ The camera in the horizontal position with downward flexion at the tip provides excellent views of the anterior uterus and bladder flap, and is preferable for viewing the broad ligaments.
Experience and Outcomes
Since June 2008, I have done more than 90 hysterectomies and 20 other surgeries using the LESS technique. Data from a 5-month period in 2008, involving 22 patients who had LESS surgery (19 of whom had a hysterectomy), show that patients used narcotic pain medications for an average of 2.5 days and any analgesic medication for an average of 5 days. Their length of stay averaged approximately 11.5 hours, and they returned to work after an average of 3.5 days. The average uterine weight was 324 g, and weight was as high as 1,600 g.
Blood loss averaged 50 mL, and the median operative time was 171 minutes. Surgical time was directly related to body mass index and uterine weight, and estimated blood loss increased with increasing uterine weight. Prior laparotomy and the presence of severe adhesions did not affect the length of surgery.
I encountered no intraoperative complications or conversions, although in one patient, morcellation of the 1,600-g uterus was carried out through an additional 15-mm suprapubic incision.
The complications I encountered in this initial group of 22 patients were vaginal bleeding on day 6 in one patient and a suture granuloma 3 weeks postop in another. A third patient had a tubo-ovarian abscess 11 days after surgery; she had a history of sexually transmitted diseases and substance abuse.
These outcomes may be a little better than those of standard laparoscopic surgery—they are at least comparable—and the cosmetic results are certainly superior. It may be difficult to demonstrate statistically significant differences in pain and recovery, at least in smaller populations of patients. I am in the process of doing a comparative study of conventional laparoscopy and LESS, but a larger series will be needed to quantify many of the intraoperative and postoperative benefits.
Laparoscopic surgeons have been driven to learn and offer the technique to reduce the minimal but not insignificant risk of complications associated with each incision. Why would I put four incisions in my patient when I can complete the procedure through just one?
For work on the right side, the articulating instrument is placed through the left cannula on the multichannel port.
Source Courtesy Dr. Kevin J. Stepp
Surgical pearl: The gynecologic surgeon can achieve unobstructed views of the pelvis by adjusting the tip of the flexible-tip camera.
A reticulating grasper (left) can be used to elevate the utero-ovarian ligament in order to provide access for a straight vessel-sealing device (right).
Source Images courtesy Dr. Kevin J. Stepp
'Minimal' Minimally Invasive Surgery
So, is it time for an old dog to learn a new trick? That's exactly what I thought to myself as I attended a program on laparoscopic single-site surgery during the annual meeting of the AAGL.
After performing operative laparoscopy for more than a quarter of a century, I questioned whether I was truly ready to convert my midumbilical “closed” technique to a larger infraumbilical “open” technique. At the end of the day, I pondered, are 5-mm lateral incisions really not cosmetic? Once in the abdominal cavity, could I really retrain myself to use articulating instrumentation? Does single-port surgery offer the same triangulation of instrumentation as conventional laparoscopic surgery, or for that matter, robotic-assisted surgery?
As you read this latest edition of the Master Class in Gynecologic Surgery, authored by an excellent young physician, Dr. Kevin J. Stepp, I am sure you will contemplate issues similar to these. Nevertheless, this truly is exciting, thought-provoking technology that is “all the buzz” in minimally invasive surgery.
Dr. Stepp is assistant professor of reproductive biology at Case Western Reserve University, Cleveland. He is the program director for the new urogynecology and minimally invasive surgery fellowship at MetroHealth Medical Center in Cleveland. Dr. Stepp also serves as the director of gynecologic surgical education for the MetroHealth/Cleveland Clinic obstetrics and gynecology residency program. In 2009, he performed the world's first single-surgeon, single-incision robotic-assisted laparoscopic hysterectomy.
Oral Antihyperglycemic Agents and Diabetes in Pregnancy
It is well recognized that the complications and adverse perinatal outcomes associated with gestational diabetes and type 2 diabetes in pregnancy are glucose dependent. The main question in medical management, therefore, is how to maximize glycemic control.
The choice of medication should be determined by the ability of the drug to achieve the targeted level of glycemic control. For some patients, oral antihyperglycemic agents will be the drug of choice while in others combination therapy and/or insulin should be used.
For years, pharmacologic therapy for diabetes in pregnancy was limited to insulin. Obstetricians feared that oral antihyperglycemic agents, as an alternative to insulin therapy, could cause adverse pregnancy outcomes, particularly congenital anomalies and metabolic complications. Because of these concerns, sulfonylurea drugs were contraindicated in pregnancy.
These recommendations were founded, however, on anecdotal reports and poorly designed retrospective studies that were performed prior to the availability of second-generation sulfonylureas such as glyburide.
Today, there is clear evidence from in vivo and in vitro studies that glyburide does not cross the placenta in any appreciable quantity while metformin, another oral glucose-lowering agent, crosses the placenta freely.
Several randomized studies (five glyburide and two metformin studies), as well as other well-designed studies published over the last decade, also have demonstrated that glyburide is as effective and safe as insulin therapy for glycemic control during pregnancy.
Research has shown, moreover, that it's the blood glucose levels—not the drugs themselves—that cause adverse outcomes.
This is good news, because the use of oral antihyperglycemic agents enhances drug compliance for the patient.
Taking a tablet once in the morning and once in the evening is easier, more convenient, and less expensive than giving oneself insulin injections several times a day. Given the choice of insulin injections versus tablets, almost all women will opt for the latter.
Offering glyburide as a safe and effective alternative to insulin has been recommended by several editorials and professional organizations. Indeed, the use of glyburide has become the standard of care in the management of gestational diabetes mellitus (GDM) in many centers and private practices throughout the United States.
It is important to appreciate, however, that in general, as disease severity increases, there is diminishing success in achieving the desired levels of glycemic control.
Although the majority of women with gestational diabetes will benefit from the use of these drugs (approximately 80%), fewer women with type 2 diabetes will be able to achieve optimal glycemic control.
The emphasis overall in diabetes management must therefore be on the level of glycemic control achieved by the patient, with the failure of a drug signaling the need to change the drug algorithm.
Safety, Efficacy of Glyburide
Oral antihyperglycemic drugs—most commonly glyburide and metformin—are the first-line drugs for treating nonpregnant women with type 2 diabetes. These patients are typically older and suffer from greater disease severity (higher fasting and postprandial blood glucose levels and a decreased pancreatic reserve of 50%-80%). They therefore are not comparable to patients with gestational diabetes who are relatively younger and have greater pancreatic reserve.
This begs the following question: If the oral antihyperglycemic drugs are in fact safe for the fetus and can potentially optimize glycemic control—enabling patients to reach targeted levels of glucose control in pregnancy with the same efficacy as insulin—why should GDM patients who represent the milder form of intolerance on the glucose continuum not be treated with these drugs?
In the early 1990s, my colleagues and I evaluated the potential of first-generation and second-generation sulfonylureas to cross the placenta. Using the single-cotyledon placental model—a model that is widely used to characterize the transport and metabolism of drugs and nutrients—we found only minimal transport of glyburide in either the maternal-fetal or the fetal-maternal direction (Am. J. Obstet. Gynecol. 1991;165:807-12).
The transfer of glyburide remained negligible even when we varied the albumin concentration and increased maternal glyburide levels to 100 times the therapeutic level. In no case was there any appreciable metabolism of the agent. First-generation sulfonylureas, on the other hand, crossed the placenta in this model. Metformin did as well, almost freely.
Thereafter, several studies from different centers confirmed that glyburide does not cross the placenta significantly. The studies demonstrated, for instance, that 99.8% of the glyburide is bound to albumin, that the agent has a short elimination half-life, and that effluxes are affected from the fetal-maternal direction. Research also confirmed that metformin does cross the placenta.
In a later prospective, randomized trial comparing glyburide and insulin in 404 women with GDM, my colleagues and I found no significant differences in either the degree of glycemic control or perinatal outcomes (N. Engl. J. Med. 2000;343:1134-8). Target levels of glycemic control were achieved in 82% of the patients receiving glyburide and 88% of those receiving insulin.
There were no significant differences between the groups in the rate of infants who were large for gestational age or who had macrosomia, a ponderal index greater than 2.85, lung complications, hypoglycemia, or fetal anomalies.
We also tested the cord serum at delivery and found similar cord-serum insulin concentrations in the two groups. Glyburide was not detected in the cord serum above the level of 10 ng/mL.
Since 2000, more than 20 studies (4 of them randomized) have been published that show similar success rates with glyburide and insulin in achieving good glycemic control in gestational diabetes as well as similar perinatal outcomes. Most of the studies have been small and not randomized. Oftentimes, however, well-designed retrospective or case-control studies can be just as reliable. In this case, the studies collectively provide a solid basis for evaluation.
In a meta-analysis published last year, investigators concluded that the studies suggest there are no increased perinatal risks with glyburide compared with insulin for the treatment of GDM (Ann. Pharmacotherapy 2008;42:483-90).
Nine studies met the inclusion criteria for the analysis, which totaled 745 glyburide-exposed pregnancies and 637 insulin-exposed pregnancies. Women were typically treated starting at 24 weeks of gestation.
The use of glyburide was not associated, the investigators said, with risk of macrosomia, differences in birth weight, rate of large-for-gestational-age births, differences in gestational age at birth, ICU admission, or risk of neonatal hypoglycemia.
Metformin as an Option
Glyburide and metformin have different mechanisms of action. Glyburide works on the pancreas to stimulate insulin secretion. Metformin, which belongs to the class of oral antihyperglycemic agents known as the biguanides, lowers glucose levels by decreasing hepatic glucose production and decreasing peripheral insulin resistance.
Some have suggested that because metformin does not stimulate insulin secretion, it is less likely than glyburide to cause hypoglycemia and may be the preferable choice for treating diabetes in pregnancy.
While we have not directly compared metformin and glyburide in this regard, our data and data from other studies demonstrate that the rate of maternal hypoglycemia is significantly higher with insulin than with glyburide therapy. In one study using continuous blood glucose measurements, we showed that the maternal rate of hypoglycemic episodes was five times higher in insulin-treated patients than in glyburide-treated patients (Obstet. Gynecol. 2004;104:88-93).
Earlier findings suggesting the opposite—that glyburide is more likely to cause hypoglycemia than is insulin therapy—were from studies in much older, nonpregnant women. Diabetes in patients who are in their 50s through their 80s cannot be compared, in general, to the less severe disease in younger women of reproductive age.
Metformin, like glyburide, has been shown in numerous studies to have no adverse effect in pregnancy in terms of anomalies. The first large randomized, controlled trial to assess the safety and efficacy of metformin versus insulin—published last year—found similar efficacy in achieving target levels of glucose control and no difference in perinatal outcomes among 751 women randomized to one of the two groups (N. Engl. J. Med. 2008;358:2003-15).
Like glyburide, metformin is a class B drug. Because metformin crosses the placenta, physicians must take this into consideration when deciding which oral antihyperglycemic agent to choose. Even if a drug crosses the placenta, however, it should not automatically be considered contraindicated for use in pregnancy because the majority of drugs used in pregnancy cross the placenta without adverse effect to the fetus.
Also of possible concern is the fact that the rate of large-for-gestational-age infants in the New England Journal of Medicine (NEJM) metformin-versus-insulin study was twice the rate of large-for-gestational-age infants in our NEJM study comparing glyburide with insulin. This suggests that the rate of success in achieving glycemic control in pregnancy may be lower with metformin than with glyburide.
We need other studies, however, that directly compare glyburide with metformin (rather than comparing each with insulin), and the resultant perinatal outcomes and glycemic control, in order to address this issue.
Metformin is a popular drug for the treatment of polycystic ovary syndrome (PCOS), which presents the question of whether patients on metformin for PCOS should conceive while on the drug, or halt the drug if they unexpectedly conceive.
The answers in these cases call for individual judgment. In my opinion, metformin is a drug that can be used in pregnancy, as long as one keeps in the back of one's mind the fact that it does cross the placenta. One must also consider that although recent retrospective and prospective trials have shown no adverse effects of metformin in terms of anomalies, no published randomized study has evaluated pregnancy outcomes when patients were treated with the drug from preconception throughout gestation.
With respect to continuing either metformin or glyburide throughout pregnancy for those patients who are treated with these drugs during the preconception stage, the main concern in my opinion is whether the drugs can achieve the levels of glycemic control desired in pregnant women with type 2 diabetes. Because current data have shown that the level of glycemia—and not the drug—is associated with any increased rate of anomalies, I believe patients can remain on these drugs as long as the targeted level of glycemic control is maintained.
Overall, considering that we have a more extensive, more conclusive body of evidence for glyburide than metformin—and considering that glyburide does not cross the placenta—metformin is generally a second choice for me.
Pearls of Management
GDM and type 2 diabetes are essentially the same disease. They are similar in risk factors and in metabolic and endocrine abnormalities. Both are characterized by peripheral insulin resistance, decreased insulin secretion (reflecting declining beta-cell function), and impaired regulation of hepatic glucose.
GDM represents an early stage of the deterioration continuum toward type 2 diabetes. It is characterized by a milder glycemic profile. As I alluded to in a previous Master Class installment (“How Type 2 Diabetes Complicates Pregnancy,” September 2009, p. 28), though, it is increasingly believed that many of the women who are diagnosed with gestational diabetes actually meet the criteria for type 2 diabetes.
Because oral antihyperglycemic agents are the gold standard for therapy in type 2 in the general population—the landmark U.K. Prospective Diabetes Study (UKPDS) of type 2 diabetes showed that 70% of patients achieved desirable levels of glucose control with the use of glyburide—it is sensible to assume that women with GDM or early type 2 diabetes will respond to oral therapy with even greater success.
In general, oral glucose-lowering agents will decrease HbA1c levels by 1%-2% (insulin, by 1%-2.5%). This roughly corresponds to a drop in fasting blood glucose levels of 30-60 mg/dL.
Oral therapy should be initiated when women cannot achieve fasting blood glucose levels of 95 mg/dL or less, or postprandial levels of 120 mg/dL or less after 2 hours. Diet and exercise can be recommended first for many of our patients, of course, but we must do so with careful consideration of the time that we have to meet target levels of control and prevent macrosomia and other adverse outcomes. Research has shown that at least 60% of patients with GDM eventually will require pharmacologic therapy.
Any pharmacologic therapy necessitates frequent dose adjustment to obtain the desired effect of the drug. Oral antihyperglycemic drugs should be increased only to the maximum dose allowed (20 mg daily in the case of glyburide).
The maximal dose of a drug and steady state are different in nonpregnant and pregnant patients, of course, because drug clearance is higher during pregnancy. However, in order to minimize any potential for complications like maternal hypoglycemia, our aim in diabetes management is to provide the minimal dose that will result in a desirable level of glycemic control.
Different oral antihyperglycemic agents act through diverse mechanisms, and the drugs' characteristics provide a physiological approach to the treatment of type 2 diabetes and GDM. Combination therapies will enhance the effect of these drugs on glucose metabolism, and “whole” patient care (including glucose monitoring, education, and diet adherence) will determine overall success in managing this disease and maximizing the quality of perinatal outcomes.
When insulin is added for the patient treated with oral agents, a single dose at bedtime can be sufficient in many cases. One of the benefits of this combination is the need for a lower dose of insulin. Insulin therapy alone should be used when other combinations have failed and is not limited by a maximum dose.
In obstetrics, we've lagged at least 2 decades behind the field of diabetes management in the general population. Now, however, we should be embracing the use of oral antihyperglycemic agents as the standard of care. We may find with further research that other drugs may have a greater therapeutic effect, but for now glyburide is the best front-line choice for glycemic control.
Glyburide Management
1. Start with 2.5 mg in the morning. If needed, drug titration should occur every 3-7 days.
2. Increase the morning dose by 2.5 mg.
3. Add the evening dose of 5 mg.
4. Increase the morning dose by 5 mg to 10 mg.
5. Increase the evening dose by 5 mg to 10 mg.
Note: The maximal dose is 20 mg daily.
Source: Dr. Langer
Key Points
▸ The level of glycemic control achieved—not the mode of therapy—is the key to improving outcomes in GDM and type 2 diabetes in pregnancy.
▸ Medical therapy with oral agents should be reserved for patients whose fasting plasma glucose levels remain above 95 mg/dL (or whose postprandial levels remain above 120 mg/dL) despite diet therapy and for those who are not appropriate candidates for diet therapy alone.
▸ The aim of therapy is to provide the minimal dose that will result in a desirable level of glycemic control and the least amount of complications for the mother.
▸ Well-designed studies have shown no association between oral antihyperglycemic agents and congenital malformations.
▸ Glyburide, metformin, and insulin are equally effective for GDM treatment at all disease severity levels.
▸ Glyburide is as effective as insulin for the treatment of obese GDM patients.
▸ Combination therapy or insulin therapy should be initiated if desired levels of glucose control are not achieved with one oral agent.
▸ Medication is just one component of intensive therapy. “Whole” patient care is also important.
Source: Dr. Langer
Treating Gestational Diabetes
Within our society there are several conditions that are currently demanding a significant amount of our attention. Among them are obesity and diabetes.
In certain populations—in ethnic minority groups and among Native Americans in particular—there has clearly been a rise in gestational diabetes. There is also an association between the increased incidence of diabetes in pregnancy and an increasingly obese population. The two problems, we are learning, are truly entwined.
In the Master Class published in September, we addressed the diabetes pandemic, which some refer to as “diabesity” because of its association with obesity, and how diabetes complicates pregnancy for the mother and threatens fetal development and outcome.
Sometimes diabetes during pregnancy is of the type 2 variety. Gestational diabetes and type 2 diabetes are sometimes confused in their presentation and hence their diagnosis, however. Admittedly, a precise diagnosis of type 2 diabetes is often made in retrospect following the conclusion of the pregnancy. The diagnostic distinction is important, however, as a diagnosis of type 2 diabetes often drives a more serious approach to glycemic control.
In light of the increasing incidence of diabetes in pregnancy, the age-old problem of optimum treatment takes on even more significance.
Diet is still a mainstay. Insulin therapy remains difficult for patients to accept because it requires injections on a daily basis. Oral agents have been avoided for years because of concerns about safety and the lack of well-controlled data to establish whether such agents cross the placenta and may be potentially harmful to the fetus.
We are now at a juncture in our therapeutic maturity, however, where an increasing amount of information and data are available on the use of therapeutic options such as oral antidiabetic agents.
In light of this crossroads—the convergence of significantly more knowledge and a significantly higher prevalence of diabetes—we thought it high time to review the subject of gestational diabetes, and particularly the contemporary therapeutic options that are now available and can be applied in pregnancy.
I have again invited Oded Langer, M.D., Ph.D., who in September discussed why diabetes must be detected early and treated seriously, to discuss the latest research on oral antidiabetic agents in pregnancy and provide some useful perspective on diabetes management in our patient population.
Dr. Langer is an internationally recognized expert on diabetes in pregnancy who has written and lectured extensively on this subject. He is the Babcock Professor and chairman of the department of obstetrics and gynecology at St. Luke's–Roosevelt Hospital Center, a hospital affiliated with Columbia University in New York.
It is well recognized that the complications and adverse perinatal outcomes associated with gestational diabetes and type 2 diabetes in pregnancy are glucose dependent. The main question in medical management, therefore, is how to maximize glycemic control.
The choice of medication should be determined by the ability of the drug to achieve the targeted level of glycemic control. For some patients, oral antihyperglycemic agents will be the drug of choice while in others combination therapy and/or insulin should be used.
For years, pharmacologic therapy for diabetes in pregnancy was limited to insulin. Obstetricians feared that oral antihyperglycemic agents, as an alternative to insulin therapy, could cause adverse pregnancy outcomes, particularly congenital anomalies and metabolic complications. Because of these concerns, sulfonylurea drugs were contraindicated in pregnancy.
These recommendations were founded, however, on anecdotal reports and poorly designed retrospective studies that were performed prior to the availability of second-generation sulfonylureas such as glyburide.
Today, there is clear evidence from in vivo and in vitro studies that glyburide does not cross the placenta in any appreciable quantity while metformin, another oral glucose-lowering agent, crosses the placenta freely.
Several randomized studies (five glyburide and two metformin studies), as well as other well-designed studies published over the last decade, also have demonstrated that glyburide is as effective and safe as insulin therapy for glycemic control during pregnancy.
Research has shown, moreover, that it's the blood glucose levels—not the drugs themselves—that cause adverse outcomes.
This is good news, because the use of oral antihyperglycemic agents enhances drug compliance for the patient.
Taking a tablet once in the morning and once in the evening is easier, more convenient, and less expensive than giving oneself insulin injections several times a day. Given the choice of insulin injections versus tablets, almost all women will opt for the latter.
Offering glyburide as a safe and effective alternative to insulin has been recommended by several editorials and professional organizations. Indeed, the use of glyburide has become the standard of care in the management of gestational diabetes mellitus (GDM) in many centers and private practices throughout the United States.
It is important to appreciate, however, that in general, as disease severity increases, there is diminishing success in achieving the desired levels of glycemic control.
Although the majority of women with gestational diabetes will benefit from the use of these drugs (approximately 80%), fewer women with type 2 diabetes will be able to achieve optimal glycemic control.
The emphasis overall in diabetes management must therefore be on the level of glycemic control achieved by the patient, with the failure of a drug signaling the need to change the drug algorithm.
Safety, Efficacy of Glyburide
Oral antihyperglycemic drugs—most commonly glyburide and metformin—are the first-line drugs for treating nonpregnant women with type 2 diabetes. These patients are typically older and suffer from greater disease severity (higher fasting and postprandial blood glucose levels and a decreased pancreatic reserve of 50%-80%). They therefore are not comparable to patients with gestational diabetes who are relatively younger and have greater pancreatic reserve.
This begs the following question: If the oral antihyperglycemic drugs are in fact safe for the fetus and can potentially optimize glycemic control—enabling patients to reach targeted levels of glucose control in pregnancy with the same efficacy as insulin—why should GDM patients who represent the milder form of intolerance on the glucose continuum not be treated with these drugs?
In the early 1990s, my colleagues and I evaluated the potential of first-generation and second-generation sulfonylureas to cross the placenta. Using the single-cotyledon placental model—a model that is widely used to characterize the transport and metabolism of drugs and nutrients—we found only minimal transport of glyburide in either the maternal-fetal or the fetal-maternal direction (Am. J. Obstet. Gynecol. 1991;165:807-12).
The transfer of glyburide remained negligible even when we varied the albumin concentration and increased maternal glyburide levels to 100 times the therapeutic level. In no case was there any appreciable metabolism of the agent. First-generation sulfonylureas, on the other hand, crossed the placenta in this model. Metformin did as well, almost freely.
Thereafter, several studies from different centers confirmed that glyburide does not cross the placenta significantly. The studies demonstrated, for instance, that 99.8% of the glyburide is bound to albumin, that the agent has a short elimination half-life, and that effluxes are affected from the fetal-maternal direction. Research also confirmed that metformin does cross the placenta.
In a later prospective, randomized trial comparing glyburide and insulin in 404 women with GDM, my colleagues and I found no significant differences in either the degree of glycemic control or perinatal outcomes (N. Engl. J. Med. 2000;343:1134-8). Target levels of glycemic control were achieved in 82% of the patients receiving glyburide and 88% of those receiving insulin.
There were no significant differences between the groups in the rate of infants who were large for gestational age or who had macrosomia, a ponderal index greater than 2.85, lung complications, hypoglycemia, or fetal anomalies.
We also tested the cord serum at delivery and found similar cord-serum insulin concentrations in the two groups. Glyburide was not detected in the cord serum above the level of 10 ng/mL.
Since 2000, more than 20 studies (4 of them randomized) have been published that show similar success rates with glyburide and insulin in achieving good glycemic control in gestational diabetes as well as similar perinatal outcomes. Most of the studies have been small and not randomized. Oftentimes, however, well-designed retrospective or case-control studies can be just as reliable. In this case, the studies collectively provide a solid basis for evaluation.
In a meta-analysis published last year, investigators concluded that the studies suggest there are no increased perinatal risks with glyburide compared with insulin for the treatment of GDM (Ann. Pharmacotherapy 2008;42:483-90).
Nine studies met the inclusion criteria for the analysis, which totaled 745 glyburide-exposed pregnancies and 637 insulin-exposed pregnancies. Women were typically treated starting at 24 weeks of gestation.
The use of glyburide was not associated, the investigators said, with risk of macrosomia, differences in birth weight, rate of large-for-gestational-age births, differences in gestational age at birth, ICU admission, or risk of neonatal hypoglycemia.
Metformin as an Option
Glyburide and metformin have different mechanisms of action. Glyburide works on the pancreas to stimulate insulin secretion. Metformin, which belongs to the class of oral antihyperglycemic agents known as the biguanides, lowers glucose levels by decreasing hepatic glucose production and decreasing peripheral insulin resistance.
Some have suggested that because metformin does not stimulate insulin secretion, it is less likely than glyburide to cause hypoglycemia and may be the preferable choice for treating diabetes in pregnancy.
While we have not directly compared metformin and glyburide in this regard, our data and data from other studies demonstrate that the rate of maternal hypoglycemia is significantly higher with insulin than with glyburide therapy. In one study using continuous blood glucose measurements, we showed that the maternal rate of hypoglycemic episodes was five times higher in insulin-treated patients than in glyburide-treated patients (Obstet. Gynecol. 2004;104:88-93).
Earlier findings suggesting the opposite—that glyburide is more likely to cause hypoglycemia than is insulin therapy—were from studies in much older, nonpregnant women. Diabetes in patients who are in their 50s through their 80s cannot be compared, in general, to the less severe disease in younger women of reproductive age.
Metformin, like glyburide, has been shown in numerous studies to have no adverse effect in pregnancy in terms of anomalies. The first large randomized, controlled trial to assess the safety and efficacy of metformin versus insulin—published last year—found similar efficacy in achieving target levels of glucose control and no difference in perinatal outcomes among 751 women randomized to one of the two groups (N. Engl. J. Med. 2008;358:2003-15).
Like glyburide, metformin is a class B drug. Because metformin crosses the placenta, physicians must take this into consideration when deciding which oral antihyperglycemic agent to choose. Even if a drug crosses the placenta, however, it should not automatically be considered contraindicated for use in pregnancy because the majority of drugs used in pregnancy cross the placenta without adverse effect to the fetus.
Also of possible concern is the fact that the rate of large-for-gestational-age infants in the New England Journal of Medicine (NEJM) metformin-versus-insulin study was twice the rate of large-for-gestational-age infants in our NEJM study comparing glyburide with insulin. This suggests that the rate of success in achieving glycemic control in pregnancy may be lower with metformin than with glyburide.
We need other studies, however, that directly compare glyburide with metformin (rather than comparing each with insulin), and the resultant perinatal outcomes and glycemic control, in order to address this issue.
Metformin is a popular drug for the treatment of polycystic ovary syndrome (PCOS), which presents the question of whether patients on metformin for PCOS should conceive while on the drug, or halt the drug if they unexpectedly conceive.
The answers in these cases call for individual judgment. In my opinion, metformin is a drug that can be used in pregnancy, as long as one keeps in the back of one's mind the fact that it does cross the placenta. One must also consider that although recent retrospective and prospective trials have shown no adverse effects of metformin in terms of anomalies, no published randomized study has evaluated pregnancy outcomes when patients were treated with the drug from preconception throughout gestation.
With respect to continuing either metformin or glyburide throughout pregnancy for those patients who are treated with these drugs during the preconception stage, the main concern in my opinion is whether the drugs can achieve the levels of glycemic control desired in pregnant women with type 2 diabetes. Because current data have shown that the level of glycemia—and not the drug—is associated with any increased rate of anomalies, I believe patients can remain on these drugs as long as the targeted level of glycemic control is maintained.
Overall, considering that we have a more extensive, more conclusive body of evidence for glyburide than metformin—and considering that glyburide does not cross the placenta—metformin is generally a second choice for me.
Pearls of Management
GDM and type 2 diabetes are essentially the same disease. They are similar in risk factors and in metabolic and endocrine abnormalities. Both are characterized by peripheral insulin resistance, decreased insulin secretion (reflecting declining beta-cell function), and impaired regulation of hepatic glucose.
GDM represents an early stage of the deterioration continuum toward type 2 diabetes. It is characterized by a milder glycemic profile. As I alluded to in a previous Master Class installment (“How Type 2 Diabetes Complicates Pregnancy,” September 2009, p. 28), though, it is increasingly believed that many of the women who are diagnosed with gestational diabetes actually meet the criteria for type 2 diabetes.
Because oral antihyperglycemic agents are the gold standard for therapy in type 2 in the general population—the landmark U.K. Prospective Diabetes Study (UKPDS) of type 2 diabetes showed that 70% of patients achieved desirable levels of glucose control with the use of glyburide—it is sensible to assume that women with GDM or early type 2 diabetes will respond to oral therapy with even greater success.
In general, oral glucose-lowering agents will decrease HbA1c levels by 1%-2% (insulin, by 1%-2.5%). This roughly corresponds to a drop in fasting blood glucose levels of 30-60 mg/dL.
Oral therapy should be initiated when women cannot achieve fasting blood glucose levels of 95 mg/dL or less, or postprandial levels of 120 mg/dL or less after 2 hours. Diet and exercise can be recommended first for many of our patients, of course, but we must do so with careful consideration of the time that we have to meet target levels of control and prevent macrosomia and other adverse outcomes. Research has shown that at least 60% of patients with GDM eventually will require pharmacologic therapy.
Any pharmacologic therapy necessitates frequent dose adjustment to obtain the desired effect of the drug. Oral antihyperglycemic drugs should be increased only to the maximum dose allowed (20 mg daily in the case of glyburide).
The maximal dose of a drug and steady state are different in nonpregnant and pregnant patients, of course, because drug clearance is higher during pregnancy. However, in order to minimize any potential for complications like maternal hypoglycemia, our aim in diabetes management is to provide the minimal dose that will result in a desirable level of glycemic control.
Different oral antihyperglycemic agents act through diverse mechanisms, and the drugs' characteristics provide a physiological approach to the treatment of type 2 diabetes and GDM. Combination therapies will enhance the effect of these drugs on glucose metabolism, and “whole” patient care (including glucose monitoring, education, and diet adherence) will determine overall success in managing this disease and maximizing the quality of perinatal outcomes.
When insulin is added for the patient treated with oral agents, a single dose at bedtime can be sufficient in many cases. One of the benefits of this combination is the need for a lower dose of insulin. Insulin therapy alone should be used when other combinations have failed and is not limited by a maximum dose.
In obstetrics, we've lagged at least 2 decades behind the field of diabetes management in the general population. Now, however, we should be embracing the use of oral antihyperglycemic agents as the standard of care. We may find with further research that other drugs may have a greater therapeutic effect, but for now glyburide is the best front-line choice for glycemic control.
Glyburide Management
1. Start with 2.5 mg in the morning. If needed, drug titration should occur every 3-7 days.
2. Increase the morning dose by 2.5 mg.
3. Add the evening dose of 5 mg.
4. Increase the morning dose by 5 mg to 10 mg.
5. Increase the evening dose by 5 mg to 10 mg.
Note: The maximal dose is 20 mg daily.
Source: Dr. Langer
Key Points
▸ The level of glycemic control achieved—not the mode of therapy—is the key to improving outcomes in GDM and type 2 diabetes in pregnancy.
▸ Medical therapy with oral agents should be reserved for patients whose fasting plasma glucose levels remain above 95 mg/dL (or whose postprandial levels remain above 120 mg/dL) despite diet therapy and for those who are not appropriate candidates for diet therapy alone.
▸ The aim of therapy is to provide the minimal dose that will result in a desirable level of glycemic control and the least amount of complications for the mother.
▸ Well-designed studies have shown no association between oral antihyperglycemic agents and congenital malformations.
▸ Glyburide, metformin, and insulin are equally effective for GDM treatment at all disease severity levels.
▸ Glyburide is as effective as insulin for the treatment of obese GDM patients.
▸ Combination therapy or insulin therapy should be initiated if desired levels of glucose control are not achieved with one oral agent.
▸ Medication is just one component of intensive therapy. “Whole” patient care is also important.
Source: Dr. Langer
Treating Gestational Diabetes
Within our society there are several conditions that are currently demanding a significant amount of our attention. Among them are obesity and diabetes.
In certain populations—in ethnic minority groups and among Native Americans in particular—there has clearly been a rise in gestational diabetes. There is also an association between the increased incidence of diabetes in pregnancy and an increasingly obese population. The two problems, we are learning, are truly entwined.
In the Master Class published in September, we addressed the diabetes pandemic, which some refer to as “diabesity” because of its association with obesity, and how diabetes complicates pregnancy for the mother and threatens fetal development and outcome.
Sometimes diabetes during pregnancy is of the type 2 variety. Gestational diabetes and type 2 diabetes are sometimes confused in their presentation and hence their diagnosis, however. Admittedly, a precise diagnosis of type 2 diabetes is often made in retrospect following the conclusion of the pregnancy. The diagnostic distinction is important, however, as a diagnosis of type 2 diabetes often drives a more serious approach to glycemic control.
In light of the increasing incidence of diabetes in pregnancy, the age-old problem of optimum treatment takes on even more significance.
Diet is still a mainstay. Insulin therapy remains difficult for patients to accept because it requires injections on a daily basis. Oral agents have been avoided for years because of concerns about safety and the lack of well-controlled data to establish whether such agents cross the placenta and may be potentially harmful to the fetus.
We are now at a juncture in our therapeutic maturity, however, where an increasing amount of information and data are available on the use of therapeutic options such as oral antidiabetic agents.
In light of this crossroads—the convergence of significantly more knowledge and a significantly higher prevalence of diabetes—we thought it high time to review the subject of gestational diabetes, and particularly the contemporary therapeutic options that are now available and can be applied in pregnancy.
I have again invited Oded Langer, M.D., Ph.D., who in September discussed why diabetes must be detected early and treated seriously, to discuss the latest research on oral antidiabetic agents in pregnancy and provide some useful perspective on diabetes management in our patient population.
Dr. Langer is an internationally recognized expert on diabetes in pregnancy who has written and lectured extensively on this subject. He is the Babcock Professor and chairman of the department of obstetrics and gynecology at St. Luke's–Roosevelt Hospital Center, a hospital affiliated with Columbia University in New York.
It is well recognized that the complications and adverse perinatal outcomes associated with gestational diabetes and type 2 diabetes in pregnancy are glucose dependent. The main question in medical management, therefore, is how to maximize glycemic control.
The choice of medication should be determined by the ability of the drug to achieve the targeted level of glycemic control. For some patients, oral antihyperglycemic agents will be the drug of choice while in others combination therapy and/or insulin should be used.
For years, pharmacologic therapy for diabetes in pregnancy was limited to insulin. Obstetricians feared that oral antihyperglycemic agents, as an alternative to insulin therapy, could cause adverse pregnancy outcomes, particularly congenital anomalies and metabolic complications. Because of these concerns, sulfonylurea drugs were contraindicated in pregnancy.
These recommendations were founded, however, on anecdotal reports and poorly designed retrospective studies that were performed prior to the availability of second-generation sulfonylureas such as glyburide.
Today, there is clear evidence from in vivo and in vitro studies that glyburide does not cross the placenta in any appreciable quantity while metformin, another oral glucose-lowering agent, crosses the placenta freely.
Several randomized studies (five glyburide and two metformin studies), as well as other well-designed studies published over the last decade, also have demonstrated that glyburide is as effective and safe as insulin therapy for glycemic control during pregnancy.
Research has shown, moreover, that it's the blood glucose levels—not the drugs themselves—that cause adverse outcomes.
This is good news, because the use of oral antihyperglycemic agents enhances drug compliance for the patient.
Taking a tablet once in the morning and once in the evening is easier, more convenient, and less expensive than giving oneself insulin injections several times a day. Given the choice of insulin injections versus tablets, almost all women will opt for the latter.
Offering glyburide as a safe and effective alternative to insulin has been recommended by several editorials and professional organizations. Indeed, the use of glyburide has become the standard of care in the management of gestational diabetes mellitus (GDM) in many centers and private practices throughout the United States.
It is important to appreciate, however, that in general, as disease severity increases, there is diminishing success in achieving the desired levels of glycemic control.
Although the majority of women with gestational diabetes will benefit from the use of these drugs (approximately 80%), fewer women with type 2 diabetes will be able to achieve optimal glycemic control.
The emphasis overall in diabetes management must therefore be on the level of glycemic control achieved by the patient, with the failure of a drug signaling the need to change the drug algorithm.
Safety, Efficacy of Glyburide
Oral antihyperglycemic drugs—most commonly glyburide and metformin—are the first-line drugs for treating nonpregnant women with type 2 diabetes. These patients are typically older and suffer from greater disease severity (higher fasting and postprandial blood glucose levels and a decreased pancreatic reserve of 50%-80%). They therefore are not comparable to patients with gestational diabetes who are relatively younger and have greater pancreatic reserve.
This begs the following question: If the oral antihyperglycemic drugs are in fact safe for the fetus and can potentially optimize glycemic control—enabling patients to reach targeted levels of glucose control in pregnancy with the same efficacy as insulin—why should GDM patients who represent the milder form of intolerance on the glucose continuum not be treated with these drugs?
In the early 1990s, my colleagues and I evaluated the potential of first-generation and second-generation sulfonylureas to cross the placenta. Using the single-cotyledon placental model—a model that is widely used to characterize the transport and metabolism of drugs and nutrients—we found only minimal transport of glyburide in either the maternal-fetal or the fetal-maternal direction (Am. J. Obstet. Gynecol. 1991;165:807-12).
The transfer of glyburide remained negligible even when we varied the albumin concentration and increased maternal glyburide levels to 100 times the therapeutic level. In no case was there any appreciable metabolism of the agent. First-generation sulfonylureas, on the other hand, crossed the placenta in this model. Metformin did as well, almost freely.
Thereafter, several studies from different centers confirmed that glyburide does not cross the placenta significantly. The studies demonstrated, for instance, that 99.8% of the glyburide is bound to albumin, that the agent has a short elimination half-life, and that effluxes are affected from the fetal-maternal direction. Research also confirmed that metformin does cross the placenta.
In a later prospective, randomized trial comparing glyburide and insulin in 404 women with GDM, my colleagues and I found no significant differences in either the degree of glycemic control or perinatal outcomes (N. Engl. J. Med. 2000;343:1134-8). Target levels of glycemic control were achieved in 82% of the patients receiving glyburide and 88% of those receiving insulin.
There were no significant differences between the groups in the rate of infants who were large for gestational age or who had macrosomia, a ponderal index greater than 2.85, lung complications, hypoglycemia, or fetal anomalies.
We also tested the cord serum at delivery and found similar cord-serum insulin concentrations in the two groups. Glyburide was not detected in the cord serum above the level of 10 ng/mL.
Since 2000, more than 20 studies (4 of them randomized) have been published that show similar success rates with glyburide and insulin in achieving good glycemic control in gestational diabetes as well as similar perinatal outcomes. Most of the studies have been small and not randomized. Oftentimes, however, well-designed retrospective or case-control studies can be just as reliable. In this case, the studies collectively provide a solid basis for evaluation.
In a meta-analysis published last year, investigators concluded that the studies suggest there are no increased perinatal risks with glyburide compared with insulin for the treatment of GDM (Ann. Pharmacotherapy 2008;42:483-90).
Nine studies met the inclusion criteria for the analysis, which totaled 745 glyburide-exposed pregnancies and 637 insulin-exposed pregnancies. Women were typically treated starting at 24 weeks of gestation.
The use of glyburide was not associated, the investigators said, with risk of macrosomia, differences in birth weight, rate of large-for-gestational-age births, differences in gestational age at birth, ICU admission, or risk of neonatal hypoglycemia.
Metformin as an Option
Glyburide and metformin have different mechanisms of action. Glyburide works on the pancreas to stimulate insulin secretion. Metformin, which belongs to the class of oral antihyperglycemic agents known as the biguanides, lowers glucose levels by decreasing hepatic glucose production and decreasing peripheral insulin resistance.
Some have suggested that because metformin does not stimulate insulin secretion, it is less likely than glyburide to cause hypoglycemia and may be the preferable choice for treating diabetes in pregnancy.
While we have not directly compared metformin and glyburide in this regard, our data and data from other studies demonstrate that the rate of maternal hypoglycemia is significantly higher with insulin than with glyburide therapy. In one study using continuous blood glucose measurements, we showed that the maternal rate of hypoglycemic episodes was five times higher in insulin-treated patients than in glyburide-treated patients (Obstet. Gynecol. 2004;104:88-93).
Earlier findings suggesting the opposite—that glyburide is more likely to cause hypoglycemia than is insulin therapy—were from studies in much older, nonpregnant women. Diabetes in patients who are in their 50s through their 80s cannot be compared, in general, to the less severe disease in younger women of reproductive age.
Metformin, like glyburide, has been shown in numerous studies to have no adverse effect in pregnancy in terms of anomalies. The first large randomized, controlled trial to assess the safety and efficacy of metformin versus insulin—published last year—found similar efficacy in achieving target levels of glucose control and no difference in perinatal outcomes among 751 women randomized to one of the two groups (N. Engl. J. Med. 2008;358:2003-15).
Like glyburide, metformin is a class B drug. Because metformin crosses the placenta, physicians must take this into consideration when deciding which oral antihyperglycemic agent to choose. Even if a drug crosses the placenta, however, it should not automatically be considered contraindicated for use in pregnancy because the majority of drugs used in pregnancy cross the placenta without adverse effect to the fetus.
Also of possible concern is the fact that the rate of large-for-gestational-age infants in the New England Journal of Medicine (NEJM) metformin-versus-insulin study was twice the rate of large-for-gestational-age infants in our NEJM study comparing glyburide with insulin. This suggests that the rate of success in achieving glycemic control in pregnancy may be lower with metformin than with glyburide.
We need other studies, however, that directly compare glyburide with metformin (rather than comparing each with insulin), and the resultant perinatal outcomes and glycemic control, in order to address this issue.
Metformin is a popular drug for the treatment of polycystic ovary syndrome (PCOS), which presents the question of whether patients on metformin for PCOS should conceive while on the drug, or halt the drug if they unexpectedly conceive.
The answers in these cases call for individual judgment. In my opinion, metformin is a drug that can be used in pregnancy, as long as one keeps in the back of one's mind the fact that it does cross the placenta. One must also consider that although recent retrospective and prospective trials have shown no adverse effects of metformin in terms of anomalies, no published randomized study has evaluated pregnancy outcomes when patients were treated with the drug from preconception throughout gestation.
With respect to continuing either metformin or glyburide throughout pregnancy for those patients who are treated with these drugs during the preconception stage, the main concern in my opinion is whether the drugs can achieve the levels of glycemic control desired in pregnant women with type 2 diabetes. Because current data have shown that the level of glycemia—and not the drug—is associated with any increased rate of anomalies, I believe patients can remain on these drugs as long as the targeted level of glycemic control is maintained.
Overall, considering that we have a more extensive, more conclusive body of evidence for glyburide than metformin—and considering that glyburide does not cross the placenta—metformin is generally a second choice for me.
Pearls of Management
GDM and type 2 diabetes are essentially the same disease. They are similar in risk factors and in metabolic and endocrine abnormalities. Both are characterized by peripheral insulin resistance, decreased insulin secretion (reflecting declining beta-cell function), and impaired regulation of hepatic glucose.
GDM represents an early stage of the deterioration continuum toward type 2 diabetes. It is characterized by a milder glycemic profile. As I alluded to in a previous Master Class installment (“How Type 2 Diabetes Complicates Pregnancy,” September 2009, p. 28), though, it is increasingly believed that many of the women who are diagnosed with gestational diabetes actually meet the criteria for type 2 diabetes.
Because oral antihyperglycemic agents are the gold standard for therapy in type 2 in the general population—the landmark U.K. Prospective Diabetes Study (UKPDS) of type 2 diabetes showed that 70% of patients achieved desirable levels of glucose control with the use of glyburide—it is sensible to assume that women with GDM or early type 2 diabetes will respond to oral therapy with even greater success.
In general, oral glucose-lowering agents will decrease HbA1c levels by 1%-2% (insulin, by 1%-2.5%). This roughly corresponds to a drop in fasting blood glucose levels of 30-60 mg/dL.
Oral therapy should be initiated when women cannot achieve fasting blood glucose levels of 95 mg/dL or less, or postprandial levels of 120 mg/dL or less after 2 hours. Diet and exercise can be recommended first for many of our patients, of course, but we must do so with careful consideration of the time that we have to meet target levels of control and prevent macrosomia and other adverse outcomes. Research has shown that at least 60% of patients with GDM eventually will require pharmacologic therapy.
Any pharmacologic therapy necessitates frequent dose adjustment to obtain the desired effect of the drug. Oral antihyperglycemic drugs should be increased only to the maximum dose allowed (20 mg daily in the case of glyburide).
The maximal dose of a drug and steady state are different in nonpregnant and pregnant patients, of course, because drug clearance is higher during pregnancy. However, in order to minimize any potential for complications like maternal hypoglycemia, our aim in diabetes management is to provide the minimal dose that will result in a desirable level of glycemic control.
Different oral antihyperglycemic agents act through diverse mechanisms, and the drugs' characteristics provide a physiological approach to the treatment of type 2 diabetes and GDM. Combination therapies will enhance the effect of these drugs on glucose metabolism, and “whole” patient care (including glucose monitoring, education, and diet adherence) will determine overall success in managing this disease and maximizing the quality of perinatal outcomes.
When insulin is added for the patient treated with oral agents, a single dose at bedtime can be sufficient in many cases. One of the benefits of this combination is the need for a lower dose of insulin. Insulin therapy alone should be used when other combinations have failed and is not limited by a maximum dose.
In obstetrics, we've lagged at least 2 decades behind the field of diabetes management in the general population. Now, however, we should be embracing the use of oral antihyperglycemic agents as the standard of care. We may find with further research that other drugs may have a greater therapeutic effect, but for now glyburide is the best front-line choice for glycemic control.
Glyburide Management
1. Start with 2.5 mg in the morning. If needed, drug titration should occur every 3-7 days.
2. Increase the morning dose by 2.5 mg.
3. Add the evening dose of 5 mg.
4. Increase the morning dose by 5 mg to 10 mg.
5. Increase the evening dose by 5 mg to 10 mg.
Note: The maximal dose is 20 mg daily.
Source: Dr. Langer
Key Points
▸ The level of glycemic control achieved—not the mode of therapy—is the key to improving outcomes in GDM and type 2 diabetes in pregnancy.
▸ Medical therapy with oral agents should be reserved for patients whose fasting plasma glucose levels remain above 95 mg/dL (or whose postprandial levels remain above 120 mg/dL) despite diet therapy and for those who are not appropriate candidates for diet therapy alone.
▸ The aim of therapy is to provide the minimal dose that will result in a desirable level of glycemic control and the least amount of complications for the mother.
▸ Well-designed studies have shown no association between oral antihyperglycemic agents and congenital malformations.
▸ Glyburide, metformin, and insulin are equally effective for GDM treatment at all disease severity levels.
▸ Glyburide is as effective as insulin for the treatment of obese GDM patients.
▸ Combination therapy or insulin therapy should be initiated if desired levels of glucose control are not achieved with one oral agent.
▸ Medication is just one component of intensive therapy. “Whole” patient care is also important.
Source: Dr. Langer
Treating Gestational Diabetes
Within our society there are several conditions that are currently demanding a significant amount of our attention. Among them are obesity and diabetes.
In certain populations—in ethnic minority groups and among Native Americans in particular—there has clearly been a rise in gestational diabetes. There is also an association between the increased incidence of diabetes in pregnancy and an increasingly obese population. The two problems, we are learning, are truly entwined.
In the Master Class published in September, we addressed the diabetes pandemic, which some refer to as “diabesity” because of its association with obesity, and how diabetes complicates pregnancy for the mother and threatens fetal development and outcome.
Sometimes diabetes during pregnancy is of the type 2 variety. Gestational diabetes and type 2 diabetes are sometimes confused in their presentation and hence their diagnosis, however. Admittedly, a precise diagnosis of type 2 diabetes is often made in retrospect following the conclusion of the pregnancy. The diagnostic distinction is important, however, as a diagnosis of type 2 diabetes often drives a more serious approach to glycemic control.
In light of the increasing incidence of diabetes in pregnancy, the age-old problem of optimum treatment takes on even more significance.
Diet is still a mainstay. Insulin therapy remains difficult for patients to accept because it requires injections on a daily basis. Oral agents have been avoided for years because of concerns about safety and the lack of well-controlled data to establish whether such agents cross the placenta and may be potentially harmful to the fetus.
We are now at a juncture in our therapeutic maturity, however, where an increasing amount of information and data are available on the use of therapeutic options such as oral antidiabetic agents.
In light of this crossroads—the convergence of significantly more knowledge and a significantly higher prevalence of diabetes—we thought it high time to review the subject of gestational diabetes, and particularly the contemporary therapeutic options that are now available and can be applied in pregnancy.
I have again invited Oded Langer, M.D., Ph.D., who in September discussed why diabetes must be detected early and treated seriously, to discuss the latest research on oral antidiabetic agents in pregnancy and provide some useful perspective on diabetes management in our patient population.
Dr. Langer is an internationally recognized expert on diabetes in pregnancy who has written and lectured extensively on this subject. He is the Babcock Professor and chairman of the department of obstetrics and gynecology at St. Luke's–Roosevelt Hospital Center, a hospital affiliated with Columbia University in New York.
Vaginoscopy in Practice
Gynecologic surgeons are getting good reimbursement rates for office hysteroscopy, and patients appreciate the convenience of having hysteroscopic evaluations done more quickly and comfortably in an office with which they are familiar.
As commitments to office-based surgery expand, it seems logical and important for physicians to become familiar with—and consider adopting—a less-invasive approach to hysteroscopy. The vaginoscopic technique for hysteroscopy—sometimes referred to as a no-touch approach—avoids the use of a vaginal speculum and cervical tenaculum. It is an easier and quicker procedure for the surgeon, provides equally good visualization, and most importantly is even more tolerable for patients than the traditional approach that utilizes instrumentation.
Without placing a speculum in the vagina, grasping the cervix with a tenaculum, or injecting a paracervical block, I have seen a significant decrease in discomfort among my patients. I use minimal premedication and rarely use any local anesthetic. In addition to diagnosing and evaluating the uterine cavity, I can perform minor therapeutic and operative procedures such as removing polyps, lysing adhesions, obtaining biopsies, removing lost intrauterine devices, and occluding the tubes using the Essure sterilization system.
With patients tolerating the procedure even more than they would a traditional hysteroscopy, we have the opportunity to increase the possible applications of hysteroscopy, to do more during the procedure, and to advance hysteroscopy even further as a successful in-office procedure that is part and parcel of our diagnostic and therapeutic armamentarium.
Key Studies
Vaginoscopy has been described in the literature as far back as the 1950s and continues to be used for diagnosing vaginal endometriosis, pelvic floor mesh erosions, vaginal fistulas, and cervical pathology, for example, as well as excising vaginal lesions or longitudinal vaginal septums. It has also been utilized in the pediatric/adolescent population for visualizing and removing foreign bodies, and for evaluating pelvic trauma, abnormal bleeding, and infection.
Dr. Stefano Bettocchi and Dr. Luigi Selvaggi in Italy were the first, however, to describe the utilization of a vaginoscopic approach to office hysteroscopy for evaluating the endocervical canal and uterine cavity in addition to the vagina and external cervical os. In a paper published in 1997 in the Journal of the American Association of Gynecologic Laparoscopists (4:255–8), they described various approaches they took to improve patient tolerance during the 1,200 diagnostic hysteroscopies they performed between 1992 and 1996.
The first 49 procedures were done using the speculum and tenaculum but without local anesthesia. The investigators saw high rates of discomfort (53%), moderate pain (25%), and severe pain (20%), as well as two cases of serious vagal reactions.
They then began using local anesthetic (mepivacaine 2%) but found that, while it helped some of the women, many of them continued to have discomfort or pain. In the next 169 cases, 69% had discomfort or mild pain, 11% had moderate pain, and 8% had severe pain resulting in suspension of the procedure (again, including two women who had vagal reactions requiring medical assistance).
Dr. Bettocchi and Dr. Selvaggi then decided to use the speculum to visualize the cervix but not place the tenaculum. They did not use any anesthesia with this group of 308 women. Their patients' pain levels started decreasing quite a bit, with 66% of these patients reporting no complaints. Cases of severe pain disappeared completely.
They then took it a step further to deal with the remaining causes of pain (32% had reported mild pain and 2% had reported moderate pain) and utilized the vaginoscopic approach. In these last 680 procedures—in unselected patients, both multiparas and nulliparas—the patients had a 96% no-discomfort rate. By not using the speculum and tenaculum to expose and grasp the cervix, the investigators nearly eliminated patient discomfort while still performing effective hysteroscopy.
Since this landmark report, several teams that have adopted a vaginoscopic approach to hysteroscopy have reported good results, and at least two teams among those I reviewed in the literature have conducted randomized prospective studies.
Dr. M. Sharma and his team in London randomized 120 women to undergo either traditional hysteroscopy or vaginoscopic hysteroscopy (60 women in each group)—with a further breakdown into the use of a 2.9-mm and a 4-mm hysteroscope. The investigators reported an overall success rate of 99%. They used the need for local anesthesia as a primary outcome measure. Although they reported lower requirements with the vaginoscopic approach using the narrower hysteroscope, they found that overall, there was no significant difference in the use of local anesthesia among the groups. There also were no statistically significant differences in pain scores between the two techniques.
The main difference for this team lay in the length of the procedure. Hysteroscopy and biopsy times were significantly shorter (more than 25% faster) with the vaginoscopic technique—a difference that Dr. Sharma and his colleagues said is important for patients who are anxious about the procedure (BJOG 2005;112:963–7).
In the other randomized study, in contrast, Dr. O. Garbin and his colleagues in France found that patients had significantly less pain with the vaginoscopic approach. Their randomization of 200 patients to conventional and 200 patients to vaginoscopic hysteroscopy—with no use of either anesthesia or premedication in either group—showed no differences in the quality, success, or duration of the exam but significant differences in patients' ratings of pain on a visual analog scale. Two cases of vasovagal syncope occurred in the group with traditional hysteroscopy.
Cervical passage was easier overall with vaginoscopic hysteroscopy, Dr. Garbin and his team reported, though the differences were not significant (Hum. Reprod. 2006;21:2996–3000). All of their procedures were performed using rigid single-flow hysteroscopes with an external sheath diameter of 3.5 mm.
The two randomized studies were quite different, and it's possible that Dr. Sharma's study lacked sufficient power. Certainly, it was more complicated with its use of two different hysteroscopes and the frequent use of anesthesia. Interestingly, Dr. Garbin and his colleagues addressed the issue of pelvic infection and pointed out that their procedures began with disinfection—something that was not mentioned in either Dr. Bettocchi's or Dr. Sharma's reports but is a practice that we do routinely.
All told, what I've taken away from the literature thus far is that the vaginoscopic approach to hysteroscopy is superior in terms of patient tolerance and can be quicker—without any impairment in cervical passage or visual quality.
In Practice
I first prep the vagina and the cervix with a small-diameter swab dipped in Betadine (povidone-iodine), or an alternative if the patient has an allergy to iodine. I use normal saline as a distention medium, so each patient is positioned on an under-buttocks drape to catch fluid. A 1,000-cc normal saline bag inserted in a pressure bag is hung on a tall IV pole with standard IV tubing.
I tell patients in preprocedure counseling that the use of saline and distention of the uterine walls usually causes some cramping but that ibuprofen or Celebrex (celecoxib) can minimize this cramping. I show them the diameter of the hysteroscope, which often helps alleviate any anxiety. In rare cases, if a patient is very anxious and worried about her tolerance for the procedure, or if the procedure is expected to be unusually long, I will prescribe Valium (diazepam). Usually such patients are young and have never experienced a gynecologic procedure before. In practice, however, I have almost never needed to use any local anesthetic.
I do premedicate patients—especially nulliparous patients and postmenopausal patients with stenotic cervices—with Cytotec (misoprostol) to facilitate an easier entry of the hysteroscope into the cervix.
I use a 3-mm single-flow rigid hysteroscope for diagnostic purposes and can quickly add the operative sheath, making the hysteroscope a 5-mm operative rigid hysteroscope, when I need to perform a minor procedure. If I anticipate performing a procedure, I will directly enter with the 5-mm hysteroscope. I prefer using the Bettocchi hysteroscope system (Karl Storz Endoscopy-America Inc.) because of its oblong shape that, when rotated horizontally with the light cord, easily slips into the slit-shaped external cervical os.
Rigid hysteroscopes have a camera lens angle of 0–30 degrees. I most often use scopes with a 30-degree angle to optimize visualization with minimal manipulation. With this angle, the hysteroscope can be brought to the midline of the uterine cavity and simply rotated about 90 degrees to the left or right with the light cord without much movement of the hysteroscope to visualize the cornu.
In contrast, visualizing the cornu with a 0-degree scope would require manipulation of the entire hysteroscope, potentially increasing patient discomfort. A 12-degree scope offers similar advantages to the 30-degree scope, and either one can be chosen based on physician familiarity and preference.
After placing the hysteroscope into the lower vagina, I guide it into the posterior fornix of the vagina so that I know I'm at the end of the vaginal canal. Then, I slowly pull back while observing anteriorly and visualizing the external cervical os. I then introduce the hysteroscope through the cervical os, and based on an understanding of the anatomy and the scope's angled view, I guide the hysteroscope through the endocervical canal and into the uterus. If I am not getting good distention of the vaginal walls, I will gently pinch the labia together to minimize fluid leakage.
Insertion of the hysteroscope without a tenaculum requires a great deal of dexterity and comfort with the instrument. The surgeon needs to understand the correlation between what is seen on the screen and the exact position of the hysteroscope so that the instrument does not rub against the cervix or the uterine tissue and cause trauma and pain.
With an angled hysteroscope, the image displayed on the screen reflects what is actually above the tip of the instrument. If the opening to the cervical os looks like it's straight ahead, for instance, it is actually above the direction in which the scope is being guided, and the scope must therefore be angled to enter the canal. Understanding the correlation and being comfortable with this 12- or 30-degree fore-oblique view takes some practice, as does visualizing the cervix correctly when pulling back from the posterior fornix. For most gynecologic surgeons, the necessary skills and comfort levels fall into place after just a few vaginoscopic procedures.
I have not found any difference in difficulty based on the axis of the uterus. I fact, I have found that utilizing a vaginal speculum in conjunction with a cervical tenaculum to straighten the uterine axis has limited my hysteroscope manipulation for extreme ante- or retroversion, increasing patient discomfort.
Just as with traditional hysteroscopy, operative hysteroscopy is possible right after or even at the same time as a diagnostic hysteroscopy performed with a vaginoscopic approach. The gynecologic surgeon can remove polyps that are visualized during a diagnostic procedure, for instance; perform adhesiolysis for Asherman's syndrome and tubular cannulation for blocked proximal tubal obstruction; retrieve lost IUDs; and perform tubal occlusion using the Essure system. My most recent tubal occlusion procedure took less than 5 minutes from start to finish, and the patient drove herself home within 15 minutes after completion of the procedure.
I do nothing differently when performing an operative hysteroscopy utilizing the vaginoscopic approach than I would using the traditional approach, except for not using the speculum and tenaculum.
I recommend fluid monitoring when performing operative hysteroscopy especially. I generally monitor fluid outflow in my practice, with a nurse checking fluid levels and monitoring the deficit while I explain to the patient what I am doing and visualizing. Because diagnostic procedures are fairly short, the likelihood of fluid intravasation at high volumes is low, however.
Vaginoscopy can be extremely helpful for evaluating patients who are morbidly obese and for whom standard office instruments are not adequately sized for visualization of the cervix. I recently tried to obtain a Pap smear and do an endometrial biopsy in a patient who was morbidly obese and had a large fibroid uterus, but with conventional methods I was unable to do so using our instruments. I brought the patient to the operating room to use larger instruments, but even these were insufficient. I finally performed the Pap smear successfully by palpating the cervix and os, and used vaginoscopy to visualize the entire cervix. I then continued with the hysteroscopy and endometrial biopsy.
After the diagnostic—and sometimes operative—procedure, our nurses will check patients' vital signs and ensure that they are feeling well and are ambulatory. Most of the time, patients leave the office within 15 minutes or so, happy to have had their procedure done in the office as opposed to the hospital.
Vaginoscopy also has been shown to be effective, fast, and easy for managing gynecologic problems in pediatric and adolescent patients. In a report published in 2000, Dr. Abraham Golan and his colleagues in Israel reported that they were able to complete the procedure successfully in 22 patients aged 3–16 years who were evaluated for vulvovaginitis, vaginal trauma, bleeding, or genital malformation (J. Am. Assoc. Gynecol. Laparosc. 2000;7:526–8). Gynecologic surgeons who build skills and experience with the vaginoscopic approach to hysteroscopy could also serve the pediatric/adolescent community well.
The hysteroscope is guided into the posterior vaginal fornix.
Source IMAGES COURTESY DR. AARATHI CHOLKERI-SINGH
Then it is pulled back while the external cervical os is visualized anteriorly.
Then the scope is guided through the endocervical canal.
Vaginoscopy's Approach to Hysteroscopy
Over the past several years, the number of office-based gynecologic surgical procedures has skyrocketed. Factors cited in this trend toward in-office surgery are better reimbursement, greater efficiency for both patient and physician, as well as the ability to provide a familiar environment for the patient. Both diagnostic as well as operative hysteroscopy are two such procedures that easily can be converted to the office setting.
A common concern from the inception of in-office surgery is patient comfort. With the use of anesthetic agents, convalescence both in the office setting as well as at home may be extended. Furthermore, the cost of the procedure will be increased, thus affecting overall reimbursement. Finally, most gynecologists are uncomfortable providing even conscious sedation for their patient in the office. Thus, the key to successful transition to surgery in an office setting would be to modify the procedures to minimize pain. Vaginoscopy allows such an approach to both diagnostic and operative hysteroscopy.
I am especially pleased that my associate, Dr. Aarathi Cholkeri-Singh, has agreed to write this edition of the Master Class in Gynecologic Surgery on vaginoscopy. After completing her residency at Advocate Lutheran General Hospital, a large teaching hospital in a Northern suburb of Chicago, Dr. Cholkeri-Singh went on to complete an AAGL/American Society for Reproductive Medicine Fellowship in minimally invasive gynecologic surgery at Harvard Medical School and Brown University hospital affiliates. It was during her training that Dr. Cholkeri-Singh gained experience with in-office vaginoscopy under the watchful eye of noted hysteroscopic guru Dr. Keith Isaacson.
Now the associate director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Dr. Cholkeri-Singh's practice is concentrated on minimally invasive gynecologic surgery and office gynecology. She will be a featured speaker at the AAGL's 38th Global Congress of Minimally Invasive Gynecology this month in Orlando.
Gynecologic surgeons are getting good reimbursement rates for office hysteroscopy, and patients appreciate the convenience of having hysteroscopic evaluations done more quickly and comfortably in an office with which they are familiar.
As commitments to office-based surgery expand, it seems logical and important for physicians to become familiar with—and consider adopting—a less-invasive approach to hysteroscopy. The vaginoscopic technique for hysteroscopy—sometimes referred to as a no-touch approach—avoids the use of a vaginal speculum and cervical tenaculum. It is an easier and quicker procedure for the surgeon, provides equally good visualization, and most importantly is even more tolerable for patients than the traditional approach that utilizes instrumentation.
Without placing a speculum in the vagina, grasping the cervix with a tenaculum, or injecting a paracervical block, I have seen a significant decrease in discomfort among my patients. I use minimal premedication and rarely use any local anesthetic. In addition to diagnosing and evaluating the uterine cavity, I can perform minor therapeutic and operative procedures such as removing polyps, lysing adhesions, obtaining biopsies, removing lost intrauterine devices, and occluding the tubes using the Essure sterilization system.
With patients tolerating the procedure even more than they would a traditional hysteroscopy, we have the opportunity to increase the possible applications of hysteroscopy, to do more during the procedure, and to advance hysteroscopy even further as a successful in-office procedure that is part and parcel of our diagnostic and therapeutic armamentarium.
Key Studies
Vaginoscopy has been described in the literature as far back as the 1950s and continues to be used for diagnosing vaginal endometriosis, pelvic floor mesh erosions, vaginal fistulas, and cervical pathology, for example, as well as excising vaginal lesions or longitudinal vaginal septums. It has also been utilized in the pediatric/adolescent population for visualizing and removing foreign bodies, and for evaluating pelvic trauma, abnormal bleeding, and infection.
Dr. Stefano Bettocchi and Dr. Luigi Selvaggi in Italy were the first, however, to describe the utilization of a vaginoscopic approach to office hysteroscopy for evaluating the endocervical canal and uterine cavity in addition to the vagina and external cervical os. In a paper published in 1997 in the Journal of the American Association of Gynecologic Laparoscopists (4:255–8), they described various approaches they took to improve patient tolerance during the 1,200 diagnostic hysteroscopies they performed between 1992 and 1996.
The first 49 procedures were done using the speculum and tenaculum but without local anesthesia. The investigators saw high rates of discomfort (53%), moderate pain (25%), and severe pain (20%), as well as two cases of serious vagal reactions.
They then began using local anesthetic (mepivacaine 2%) but found that, while it helped some of the women, many of them continued to have discomfort or pain. In the next 169 cases, 69% had discomfort or mild pain, 11% had moderate pain, and 8% had severe pain resulting in suspension of the procedure (again, including two women who had vagal reactions requiring medical assistance).
Dr. Bettocchi and Dr. Selvaggi then decided to use the speculum to visualize the cervix but not place the tenaculum. They did not use any anesthesia with this group of 308 women. Their patients' pain levels started decreasing quite a bit, with 66% of these patients reporting no complaints. Cases of severe pain disappeared completely.
They then took it a step further to deal with the remaining causes of pain (32% had reported mild pain and 2% had reported moderate pain) and utilized the vaginoscopic approach. In these last 680 procedures—in unselected patients, both multiparas and nulliparas—the patients had a 96% no-discomfort rate. By not using the speculum and tenaculum to expose and grasp the cervix, the investigators nearly eliminated patient discomfort while still performing effective hysteroscopy.
Since this landmark report, several teams that have adopted a vaginoscopic approach to hysteroscopy have reported good results, and at least two teams among those I reviewed in the literature have conducted randomized prospective studies.
Dr. M. Sharma and his team in London randomized 120 women to undergo either traditional hysteroscopy or vaginoscopic hysteroscopy (60 women in each group)—with a further breakdown into the use of a 2.9-mm and a 4-mm hysteroscope. The investigators reported an overall success rate of 99%. They used the need for local anesthesia as a primary outcome measure. Although they reported lower requirements with the vaginoscopic approach using the narrower hysteroscope, they found that overall, there was no significant difference in the use of local anesthesia among the groups. There also were no statistically significant differences in pain scores between the two techniques.
The main difference for this team lay in the length of the procedure. Hysteroscopy and biopsy times were significantly shorter (more than 25% faster) with the vaginoscopic technique—a difference that Dr. Sharma and his colleagues said is important for patients who are anxious about the procedure (BJOG 2005;112:963–7).
In the other randomized study, in contrast, Dr. O. Garbin and his colleagues in France found that patients had significantly less pain with the vaginoscopic approach. Their randomization of 200 patients to conventional and 200 patients to vaginoscopic hysteroscopy—with no use of either anesthesia or premedication in either group—showed no differences in the quality, success, or duration of the exam but significant differences in patients' ratings of pain on a visual analog scale. Two cases of vasovagal syncope occurred in the group with traditional hysteroscopy.
Cervical passage was easier overall with vaginoscopic hysteroscopy, Dr. Garbin and his team reported, though the differences were not significant (Hum. Reprod. 2006;21:2996–3000). All of their procedures were performed using rigid single-flow hysteroscopes with an external sheath diameter of 3.5 mm.
The two randomized studies were quite different, and it's possible that Dr. Sharma's study lacked sufficient power. Certainly, it was more complicated with its use of two different hysteroscopes and the frequent use of anesthesia. Interestingly, Dr. Garbin and his colleagues addressed the issue of pelvic infection and pointed out that their procedures began with disinfection—something that was not mentioned in either Dr. Bettocchi's or Dr. Sharma's reports but is a practice that we do routinely.
All told, what I've taken away from the literature thus far is that the vaginoscopic approach to hysteroscopy is superior in terms of patient tolerance and can be quicker—without any impairment in cervical passage or visual quality.
In Practice
I first prep the vagina and the cervix with a small-diameter swab dipped in Betadine (povidone-iodine), or an alternative if the patient has an allergy to iodine. I use normal saline as a distention medium, so each patient is positioned on an under-buttocks drape to catch fluid. A 1,000-cc normal saline bag inserted in a pressure bag is hung on a tall IV pole with standard IV tubing.
I tell patients in preprocedure counseling that the use of saline and distention of the uterine walls usually causes some cramping but that ibuprofen or Celebrex (celecoxib) can minimize this cramping. I show them the diameter of the hysteroscope, which often helps alleviate any anxiety. In rare cases, if a patient is very anxious and worried about her tolerance for the procedure, or if the procedure is expected to be unusually long, I will prescribe Valium (diazepam). Usually such patients are young and have never experienced a gynecologic procedure before. In practice, however, I have almost never needed to use any local anesthetic.
I do premedicate patients—especially nulliparous patients and postmenopausal patients with stenotic cervices—with Cytotec (misoprostol) to facilitate an easier entry of the hysteroscope into the cervix.
I use a 3-mm single-flow rigid hysteroscope for diagnostic purposes and can quickly add the operative sheath, making the hysteroscope a 5-mm operative rigid hysteroscope, when I need to perform a minor procedure. If I anticipate performing a procedure, I will directly enter with the 5-mm hysteroscope. I prefer using the Bettocchi hysteroscope system (Karl Storz Endoscopy-America Inc.) because of its oblong shape that, when rotated horizontally with the light cord, easily slips into the slit-shaped external cervical os.
Rigid hysteroscopes have a camera lens angle of 0–30 degrees. I most often use scopes with a 30-degree angle to optimize visualization with minimal manipulation. With this angle, the hysteroscope can be brought to the midline of the uterine cavity and simply rotated about 90 degrees to the left or right with the light cord without much movement of the hysteroscope to visualize the cornu.
In contrast, visualizing the cornu with a 0-degree scope would require manipulation of the entire hysteroscope, potentially increasing patient discomfort. A 12-degree scope offers similar advantages to the 30-degree scope, and either one can be chosen based on physician familiarity and preference.
After placing the hysteroscope into the lower vagina, I guide it into the posterior fornix of the vagina so that I know I'm at the end of the vaginal canal. Then, I slowly pull back while observing anteriorly and visualizing the external cervical os. I then introduce the hysteroscope through the cervical os, and based on an understanding of the anatomy and the scope's angled view, I guide the hysteroscope through the endocervical canal and into the uterus. If I am not getting good distention of the vaginal walls, I will gently pinch the labia together to minimize fluid leakage.
Insertion of the hysteroscope without a tenaculum requires a great deal of dexterity and comfort with the instrument. The surgeon needs to understand the correlation between what is seen on the screen and the exact position of the hysteroscope so that the instrument does not rub against the cervix or the uterine tissue and cause trauma and pain.
With an angled hysteroscope, the image displayed on the screen reflects what is actually above the tip of the instrument. If the opening to the cervical os looks like it's straight ahead, for instance, it is actually above the direction in which the scope is being guided, and the scope must therefore be angled to enter the canal. Understanding the correlation and being comfortable with this 12- or 30-degree fore-oblique view takes some practice, as does visualizing the cervix correctly when pulling back from the posterior fornix. For most gynecologic surgeons, the necessary skills and comfort levels fall into place after just a few vaginoscopic procedures.
I have not found any difference in difficulty based on the axis of the uterus. I fact, I have found that utilizing a vaginal speculum in conjunction with a cervical tenaculum to straighten the uterine axis has limited my hysteroscope manipulation for extreme ante- or retroversion, increasing patient discomfort.
Just as with traditional hysteroscopy, operative hysteroscopy is possible right after or even at the same time as a diagnostic hysteroscopy performed with a vaginoscopic approach. The gynecologic surgeon can remove polyps that are visualized during a diagnostic procedure, for instance; perform adhesiolysis for Asherman's syndrome and tubular cannulation for blocked proximal tubal obstruction; retrieve lost IUDs; and perform tubal occlusion using the Essure system. My most recent tubal occlusion procedure took less than 5 minutes from start to finish, and the patient drove herself home within 15 minutes after completion of the procedure.
I do nothing differently when performing an operative hysteroscopy utilizing the vaginoscopic approach than I would using the traditional approach, except for not using the speculum and tenaculum.
I recommend fluid monitoring when performing operative hysteroscopy especially. I generally monitor fluid outflow in my practice, with a nurse checking fluid levels and monitoring the deficit while I explain to the patient what I am doing and visualizing. Because diagnostic procedures are fairly short, the likelihood of fluid intravasation at high volumes is low, however.
Vaginoscopy can be extremely helpful for evaluating patients who are morbidly obese and for whom standard office instruments are not adequately sized for visualization of the cervix. I recently tried to obtain a Pap smear and do an endometrial biopsy in a patient who was morbidly obese and had a large fibroid uterus, but with conventional methods I was unable to do so using our instruments. I brought the patient to the operating room to use larger instruments, but even these were insufficient. I finally performed the Pap smear successfully by palpating the cervix and os, and used vaginoscopy to visualize the entire cervix. I then continued with the hysteroscopy and endometrial biopsy.
After the diagnostic—and sometimes operative—procedure, our nurses will check patients' vital signs and ensure that they are feeling well and are ambulatory. Most of the time, patients leave the office within 15 minutes or so, happy to have had their procedure done in the office as opposed to the hospital.
Vaginoscopy also has been shown to be effective, fast, and easy for managing gynecologic problems in pediatric and adolescent patients. In a report published in 2000, Dr. Abraham Golan and his colleagues in Israel reported that they were able to complete the procedure successfully in 22 patients aged 3–16 years who were evaluated for vulvovaginitis, vaginal trauma, bleeding, or genital malformation (J. Am. Assoc. Gynecol. Laparosc. 2000;7:526–8). Gynecologic surgeons who build skills and experience with the vaginoscopic approach to hysteroscopy could also serve the pediatric/adolescent community well.
The hysteroscope is guided into the posterior vaginal fornix.
Source IMAGES COURTESY DR. AARATHI CHOLKERI-SINGH
Then it is pulled back while the external cervical os is visualized anteriorly.
Then the scope is guided through the endocervical canal.
Vaginoscopy's Approach to Hysteroscopy
Over the past several years, the number of office-based gynecologic surgical procedures has skyrocketed. Factors cited in this trend toward in-office surgery are better reimbursement, greater efficiency for both patient and physician, as well as the ability to provide a familiar environment for the patient. Both diagnostic as well as operative hysteroscopy are two such procedures that easily can be converted to the office setting.
A common concern from the inception of in-office surgery is patient comfort. With the use of anesthetic agents, convalescence both in the office setting as well as at home may be extended. Furthermore, the cost of the procedure will be increased, thus affecting overall reimbursement. Finally, most gynecologists are uncomfortable providing even conscious sedation for their patient in the office. Thus, the key to successful transition to surgery in an office setting would be to modify the procedures to minimize pain. Vaginoscopy allows such an approach to both diagnostic and operative hysteroscopy.
I am especially pleased that my associate, Dr. Aarathi Cholkeri-Singh, has agreed to write this edition of the Master Class in Gynecologic Surgery on vaginoscopy. After completing her residency at Advocate Lutheran General Hospital, a large teaching hospital in a Northern suburb of Chicago, Dr. Cholkeri-Singh went on to complete an AAGL/American Society for Reproductive Medicine Fellowship in minimally invasive gynecologic surgery at Harvard Medical School and Brown University hospital affiliates. It was during her training that Dr. Cholkeri-Singh gained experience with in-office vaginoscopy under the watchful eye of noted hysteroscopic guru Dr. Keith Isaacson.
Now the associate director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Dr. Cholkeri-Singh's practice is concentrated on minimally invasive gynecologic surgery and office gynecology. She will be a featured speaker at the AAGL's 38th Global Congress of Minimally Invasive Gynecology this month in Orlando.
Gynecologic surgeons are getting good reimbursement rates for office hysteroscopy, and patients appreciate the convenience of having hysteroscopic evaluations done more quickly and comfortably in an office with which they are familiar.
As commitments to office-based surgery expand, it seems logical and important for physicians to become familiar with—and consider adopting—a less-invasive approach to hysteroscopy. The vaginoscopic technique for hysteroscopy—sometimes referred to as a no-touch approach—avoids the use of a vaginal speculum and cervical tenaculum. It is an easier and quicker procedure for the surgeon, provides equally good visualization, and most importantly is even more tolerable for patients than the traditional approach that utilizes instrumentation.
Without placing a speculum in the vagina, grasping the cervix with a tenaculum, or injecting a paracervical block, I have seen a significant decrease in discomfort among my patients. I use minimal premedication and rarely use any local anesthetic. In addition to diagnosing and evaluating the uterine cavity, I can perform minor therapeutic and operative procedures such as removing polyps, lysing adhesions, obtaining biopsies, removing lost intrauterine devices, and occluding the tubes using the Essure sterilization system.
With patients tolerating the procedure even more than they would a traditional hysteroscopy, we have the opportunity to increase the possible applications of hysteroscopy, to do more during the procedure, and to advance hysteroscopy even further as a successful in-office procedure that is part and parcel of our diagnostic and therapeutic armamentarium.
Key Studies
Vaginoscopy has been described in the literature as far back as the 1950s and continues to be used for diagnosing vaginal endometriosis, pelvic floor mesh erosions, vaginal fistulas, and cervical pathology, for example, as well as excising vaginal lesions or longitudinal vaginal septums. It has also been utilized in the pediatric/adolescent population for visualizing and removing foreign bodies, and for evaluating pelvic trauma, abnormal bleeding, and infection.
Dr. Stefano Bettocchi and Dr. Luigi Selvaggi in Italy were the first, however, to describe the utilization of a vaginoscopic approach to office hysteroscopy for evaluating the endocervical canal and uterine cavity in addition to the vagina and external cervical os. In a paper published in 1997 in the Journal of the American Association of Gynecologic Laparoscopists (4:255–8), they described various approaches they took to improve patient tolerance during the 1,200 diagnostic hysteroscopies they performed between 1992 and 1996.
The first 49 procedures were done using the speculum and tenaculum but without local anesthesia. The investigators saw high rates of discomfort (53%), moderate pain (25%), and severe pain (20%), as well as two cases of serious vagal reactions.
They then began using local anesthetic (mepivacaine 2%) but found that, while it helped some of the women, many of them continued to have discomfort or pain. In the next 169 cases, 69% had discomfort or mild pain, 11% had moderate pain, and 8% had severe pain resulting in suspension of the procedure (again, including two women who had vagal reactions requiring medical assistance).
Dr. Bettocchi and Dr. Selvaggi then decided to use the speculum to visualize the cervix but not place the tenaculum. They did not use any anesthesia with this group of 308 women. Their patients' pain levels started decreasing quite a bit, with 66% of these patients reporting no complaints. Cases of severe pain disappeared completely.
They then took it a step further to deal with the remaining causes of pain (32% had reported mild pain and 2% had reported moderate pain) and utilized the vaginoscopic approach. In these last 680 procedures—in unselected patients, both multiparas and nulliparas—the patients had a 96% no-discomfort rate. By not using the speculum and tenaculum to expose and grasp the cervix, the investigators nearly eliminated patient discomfort while still performing effective hysteroscopy.
Since this landmark report, several teams that have adopted a vaginoscopic approach to hysteroscopy have reported good results, and at least two teams among those I reviewed in the literature have conducted randomized prospective studies.
Dr. M. Sharma and his team in London randomized 120 women to undergo either traditional hysteroscopy or vaginoscopic hysteroscopy (60 women in each group)—with a further breakdown into the use of a 2.9-mm and a 4-mm hysteroscope. The investigators reported an overall success rate of 99%. They used the need for local anesthesia as a primary outcome measure. Although they reported lower requirements with the vaginoscopic approach using the narrower hysteroscope, they found that overall, there was no significant difference in the use of local anesthesia among the groups. There also were no statistically significant differences in pain scores between the two techniques.
The main difference for this team lay in the length of the procedure. Hysteroscopy and biopsy times were significantly shorter (more than 25% faster) with the vaginoscopic technique—a difference that Dr. Sharma and his colleagues said is important for patients who are anxious about the procedure (BJOG 2005;112:963–7).
In the other randomized study, in contrast, Dr. O. Garbin and his colleagues in France found that patients had significantly less pain with the vaginoscopic approach. Their randomization of 200 patients to conventional and 200 patients to vaginoscopic hysteroscopy—with no use of either anesthesia or premedication in either group—showed no differences in the quality, success, or duration of the exam but significant differences in patients' ratings of pain on a visual analog scale. Two cases of vasovagal syncope occurred in the group with traditional hysteroscopy.
Cervical passage was easier overall with vaginoscopic hysteroscopy, Dr. Garbin and his team reported, though the differences were not significant (Hum. Reprod. 2006;21:2996–3000). All of their procedures were performed using rigid single-flow hysteroscopes with an external sheath diameter of 3.5 mm.
The two randomized studies were quite different, and it's possible that Dr. Sharma's study lacked sufficient power. Certainly, it was more complicated with its use of two different hysteroscopes and the frequent use of anesthesia. Interestingly, Dr. Garbin and his colleagues addressed the issue of pelvic infection and pointed out that their procedures began with disinfection—something that was not mentioned in either Dr. Bettocchi's or Dr. Sharma's reports but is a practice that we do routinely.
All told, what I've taken away from the literature thus far is that the vaginoscopic approach to hysteroscopy is superior in terms of patient tolerance and can be quicker—without any impairment in cervical passage or visual quality.
In Practice
I first prep the vagina and the cervix with a small-diameter swab dipped in Betadine (povidone-iodine), or an alternative if the patient has an allergy to iodine. I use normal saline as a distention medium, so each patient is positioned on an under-buttocks drape to catch fluid. A 1,000-cc normal saline bag inserted in a pressure bag is hung on a tall IV pole with standard IV tubing.
I tell patients in preprocedure counseling that the use of saline and distention of the uterine walls usually causes some cramping but that ibuprofen or Celebrex (celecoxib) can minimize this cramping. I show them the diameter of the hysteroscope, which often helps alleviate any anxiety. In rare cases, if a patient is very anxious and worried about her tolerance for the procedure, or if the procedure is expected to be unusually long, I will prescribe Valium (diazepam). Usually such patients are young and have never experienced a gynecologic procedure before. In practice, however, I have almost never needed to use any local anesthetic.
I do premedicate patients—especially nulliparous patients and postmenopausal patients with stenotic cervices—with Cytotec (misoprostol) to facilitate an easier entry of the hysteroscope into the cervix.
I use a 3-mm single-flow rigid hysteroscope for diagnostic purposes and can quickly add the operative sheath, making the hysteroscope a 5-mm operative rigid hysteroscope, when I need to perform a minor procedure. If I anticipate performing a procedure, I will directly enter with the 5-mm hysteroscope. I prefer using the Bettocchi hysteroscope system (Karl Storz Endoscopy-America Inc.) because of its oblong shape that, when rotated horizontally with the light cord, easily slips into the slit-shaped external cervical os.
Rigid hysteroscopes have a camera lens angle of 0–30 degrees. I most often use scopes with a 30-degree angle to optimize visualization with minimal manipulation. With this angle, the hysteroscope can be brought to the midline of the uterine cavity and simply rotated about 90 degrees to the left or right with the light cord without much movement of the hysteroscope to visualize the cornu.
In contrast, visualizing the cornu with a 0-degree scope would require manipulation of the entire hysteroscope, potentially increasing patient discomfort. A 12-degree scope offers similar advantages to the 30-degree scope, and either one can be chosen based on physician familiarity and preference.
After placing the hysteroscope into the lower vagina, I guide it into the posterior fornix of the vagina so that I know I'm at the end of the vaginal canal. Then, I slowly pull back while observing anteriorly and visualizing the external cervical os. I then introduce the hysteroscope through the cervical os, and based on an understanding of the anatomy and the scope's angled view, I guide the hysteroscope through the endocervical canal and into the uterus. If I am not getting good distention of the vaginal walls, I will gently pinch the labia together to minimize fluid leakage.
Insertion of the hysteroscope without a tenaculum requires a great deal of dexterity and comfort with the instrument. The surgeon needs to understand the correlation between what is seen on the screen and the exact position of the hysteroscope so that the instrument does not rub against the cervix or the uterine tissue and cause trauma and pain.
With an angled hysteroscope, the image displayed on the screen reflects what is actually above the tip of the instrument. If the opening to the cervical os looks like it's straight ahead, for instance, it is actually above the direction in which the scope is being guided, and the scope must therefore be angled to enter the canal. Understanding the correlation and being comfortable with this 12- or 30-degree fore-oblique view takes some practice, as does visualizing the cervix correctly when pulling back from the posterior fornix. For most gynecologic surgeons, the necessary skills and comfort levels fall into place after just a few vaginoscopic procedures.
I have not found any difference in difficulty based on the axis of the uterus. I fact, I have found that utilizing a vaginal speculum in conjunction with a cervical tenaculum to straighten the uterine axis has limited my hysteroscope manipulation for extreme ante- or retroversion, increasing patient discomfort.
Just as with traditional hysteroscopy, operative hysteroscopy is possible right after or even at the same time as a diagnostic hysteroscopy performed with a vaginoscopic approach. The gynecologic surgeon can remove polyps that are visualized during a diagnostic procedure, for instance; perform adhesiolysis for Asherman's syndrome and tubular cannulation for blocked proximal tubal obstruction; retrieve lost IUDs; and perform tubal occlusion using the Essure system. My most recent tubal occlusion procedure took less than 5 minutes from start to finish, and the patient drove herself home within 15 minutes after completion of the procedure.
I do nothing differently when performing an operative hysteroscopy utilizing the vaginoscopic approach than I would using the traditional approach, except for not using the speculum and tenaculum.
I recommend fluid monitoring when performing operative hysteroscopy especially. I generally monitor fluid outflow in my practice, with a nurse checking fluid levels and monitoring the deficit while I explain to the patient what I am doing and visualizing. Because diagnostic procedures are fairly short, the likelihood of fluid intravasation at high volumes is low, however.
Vaginoscopy can be extremely helpful for evaluating patients who are morbidly obese and for whom standard office instruments are not adequately sized for visualization of the cervix. I recently tried to obtain a Pap smear and do an endometrial biopsy in a patient who was morbidly obese and had a large fibroid uterus, but with conventional methods I was unable to do so using our instruments. I brought the patient to the operating room to use larger instruments, but even these were insufficient. I finally performed the Pap smear successfully by palpating the cervix and os, and used vaginoscopy to visualize the entire cervix. I then continued with the hysteroscopy and endometrial biopsy.
After the diagnostic—and sometimes operative—procedure, our nurses will check patients' vital signs and ensure that they are feeling well and are ambulatory. Most of the time, patients leave the office within 15 minutes or so, happy to have had their procedure done in the office as opposed to the hospital.
Vaginoscopy also has been shown to be effective, fast, and easy for managing gynecologic problems in pediatric and adolescent patients. In a report published in 2000, Dr. Abraham Golan and his colleagues in Israel reported that they were able to complete the procedure successfully in 22 patients aged 3–16 years who were evaluated for vulvovaginitis, vaginal trauma, bleeding, or genital malformation (J. Am. Assoc. Gynecol. Laparosc. 2000;7:526–8). Gynecologic surgeons who build skills and experience with the vaginoscopic approach to hysteroscopy could also serve the pediatric/adolescent community well.
The hysteroscope is guided into the posterior vaginal fornix.
Source IMAGES COURTESY DR. AARATHI CHOLKERI-SINGH
Then it is pulled back while the external cervical os is visualized anteriorly.
Then the scope is guided through the endocervical canal.
Vaginoscopy's Approach to Hysteroscopy
Over the past several years, the number of office-based gynecologic surgical procedures has skyrocketed. Factors cited in this trend toward in-office surgery are better reimbursement, greater efficiency for both patient and physician, as well as the ability to provide a familiar environment for the patient. Both diagnostic as well as operative hysteroscopy are two such procedures that easily can be converted to the office setting.
A common concern from the inception of in-office surgery is patient comfort. With the use of anesthetic agents, convalescence both in the office setting as well as at home may be extended. Furthermore, the cost of the procedure will be increased, thus affecting overall reimbursement. Finally, most gynecologists are uncomfortable providing even conscious sedation for their patient in the office. Thus, the key to successful transition to surgery in an office setting would be to modify the procedures to minimize pain. Vaginoscopy allows such an approach to both diagnostic and operative hysteroscopy.
I am especially pleased that my associate, Dr. Aarathi Cholkeri-Singh, has agreed to write this edition of the Master Class in Gynecologic Surgery on vaginoscopy. After completing her residency at Advocate Lutheran General Hospital, a large teaching hospital in a Northern suburb of Chicago, Dr. Cholkeri-Singh went on to complete an AAGL/American Society for Reproductive Medicine Fellowship in minimally invasive gynecologic surgery at Harvard Medical School and Brown University hospital affiliates. It was during her training that Dr. Cholkeri-Singh gained experience with in-office vaginoscopy under the watchful eye of noted hysteroscopic guru Dr. Keith Isaacson.
Now the associate director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Dr. Cholkeri-Singh's practice is concentrated on minimally invasive gynecologic surgery and office gynecology. She will be a featured speaker at the AAGL's 38th Global Congress of Minimally Invasive Gynecology this month in Orlando.
Ob.Gyns. on the Front Line in the H1N1 Flu Pandemic
As obstetricians we stand at the front line of preventing and treating pandemic influenza A(H1N1). Our pregnant patients who become infected with the H1N1 virus will potentially be more likely than the general population to develop severe disease, to be hospitalized, and to die from complications of the infection. They also will be at high risk of having preterm birth and fetal loss.
All this means that we must take an aggressive approach to therapy, treating women at the time they present with symptoms and being honest with them about their risks. Moreover, we must plan and execute infection control protocols and other nonpharmacologic interventions that traditionally have not been part of our armamentarium.
To be prepared, it is important that we understand influenza—why and how seasonal and pandemic influenza occur, how pregnant women have fared in previous pandemics, and what their outcomes have been thus far in the current pandemic. Most of us know little about influenza, but as we now practice on the front line with patients who are highly vulnerable, we must know more.
Understanding Pandemic Influenza
Influenza viruses are RNA viruses composed of eight separate negative-strand RNA segments that code for 11 viral proteins. These viruses regularly mutate while replicating themselves, altering their genome and shuffling their genes enough each year that our immune systems do not recognize them.
These ongoing genetic alterations are what drive annual epidemics of seasonal flu and are what make the influenza virus so different from the varicella-zoster virus (chickenpox) and other familiar viruses that are not RNA viruses. While infection with the varicella-zoster virus, or vaccination against it, gives most of us immunity for life, we are all susceptible to annual occurrences of seasonal influenza, regardless of how healthy we are.
There are three influenza virus types: influenza A, B, and C. Only types A and B cause infection in humans. Influenza A, which has been associated with most major pandemics and causes about two-thirds of seasonal influenza, is subtyped according to two surface proteins/antigens: hemagglutinin (H) and neuraminidase (N). Viruses with three different hemagglutinin subtypes H1, H2, and H3, as well as neuraminidase subtypes N1 and N2, have been previously associated with infections in humans.
The major natural reservoir for influenza A virus subtypes is the intestinal track of birds, particularly ducks, geese, and other water fowl. A significant number of different flu virus variations are normal flora in the intestinal tract of these birds.
While most viral infections that humans occasionally acquire from the birds are self-limited, some infections can be dangerous. If one is unlucky enough to be simultaneously infected with an avian influenza virus and a human influenza virus, the genes in each of these two viruses can randomly reassort, or rearrange themselves, to form a new virus.
This phenomenon, called reassortment, is one of two possible phenomena that lead to “antigen shift,” which results in immunologically unique viruses that produce pandemic influenza strains.
The other phenomenon that produces intermittent pandemic strains is called adaptation. In this scenario, an avian virus mutates enough over time—particularly with respect to its hemagglutinin molecule—that it becomes able to infect humans and to be easily transmissible from person to person.
The 1918 “Spanish” influenza pandemic produced by an H1N1 influenza virus—the most lethal pandemic in recorded history that was responsible for an estimated 50-100 million deaths worldwide—is believed to have resulted from genomic adaptation. An avian virus mutated enough that it spread from birds to humans and was then transmissible from person to person by common methods of viral spread. An attenuated version of this H1N1 virus then recurred annually for almost the next 30 years.
The 1957 “Asian flu” pandemic, on the other hand, emerged as a result of reassortment. A person infected with the then seasonally recurring H1N1 human virus was simultaneously infected with an H2N2 avian virus, and the genes reassorted to produce a new immunologically unique H2N2 virus. Fortunately, this virus did not contain many of the virulence factors that influenza viruses need to be highly lethal, so the 1957 pandemic was far milder than the 1918 pandemic.
A similar reassortment process led to the “Hong Kong flu” pandemic in 1968. It is believed that a person infected with the then seasonal H2N2 virus became infected with an H3 avian virus as well, generating a new H3N2 virus. Again, this virus was not as lethal as the 1918 virus, and after the pandemic subsided, an attenuated version became the annual seasonal influenza strain.
Interestingly, the H1N1 virus suddenly reappeared in the 1970s. Since then, seasonal influenza has been produced by a combination of the H3N2 virus and the H1N1 virus. Thus, annual influenza vaccines target both the seasonal H1N1 virus and the virus derived from the 1969 pandemic, along with the influenza B virus.
Epidemiological data going back over a hundred years show that influenza pandemics occur about every 30 years. Although the reasons for this recurring time interval are not understood, the data are strong enough that, especially since the late 1990s, experts have anticipated the development of the next pandemic.
The H5N1 avian influenza that emerged in Hong Kong in 1997 fortunately has not mutated enough to be easily transmissible among humans. Experts have been concerned, however, that this virus will undergo either adaptation or reassortment and lead to a severe pandemic. Thus far, human infections with the H5N1 avian influenza virus have been associated with an overall mortality of approximately 60%. Of the 433 cases reported to the World Health Organization through June of this year, 262 people had died.
A novel H1N1 influenza A virus containing genes from human, avian, and swine viruses was first identified in pigs in the United States in 1998. Although less significant than birds, pigs play an important role in the spread of influenza because they are susceptible to influenza virus from both birds and humans. Between 2005 and 2009, 11 cases of human infection with this triple-reassortment virus were described in the United States. In March and April of this year, further reassortment of this novel influenza A(H1N1) virus—one with uniquely different hemagglutinin and neuraminidase surface proteins—was identified in patients in Mexico. Transmissibility of the new H1N1 flu virus is high. Since initial cases of the novel H1N1 influenza virus were identified in Mexico, and then in Southern California, the virus has spread rapidly. In June, the WHO declared a pandemic. As of early September, tens of thousands of cases had been reported in the United States, and hundreds of thousands of cases had been reported worldwide.
It is important to appreciate the fact that pandemic influenza can occur in waves, with alternating periods of high infectivity and weeks or months of fewer infections; this pattern was particularly apparent in the 1918 pandemic.
In the 1918 pandemic, the second wave (lasting 8-10 weeks) occurred in the fall and was associated with a much higher mortality (up to 2%) than the first wave that had occurred in the spring. A third wave occurring in the spring of 1919 was similar to the first wave in terms of its high morbidity and relatively lower mortality.
Pandemics and Pregnancy
For reasons that are unclear, pregnant women have been observed to have higher morbidity and mortality compared with nonpregnant patients during influenza infections—seasonal or pandemic.
Observational reports of the 1918 pandemic paint a grim picture. One report published in the Journal of the American Medical Association in 1918, for instance, showed that 52 of 101 pregnant women who were admitted to Cook County Hospital in Chicago during a 2-month period with severe influenza succumbed to the illness. This mortality of 51% in pregnant patients was significantly higher than the observed 33% mortality rate in nonpregnant patients admitted to the hospital (719 of 2,154 nonpregnant patients who were admitted during the same time period died).
Additionally, among the 49 pregnant survivors in this sample, 43% either aborted or delivered prematurely (J. Am. Med. Assoc. 1918:71;1898-99). These are remarkable numbers.
Milder pandemics have had lower mortality overall, but reports have clearly shown that disproportionate numbers of pregnant women—particularly in the third trimester—have succumbed during influenza pandemics compared with the general population. An observational report from the milder 1968 pandemic, for instance, shows that pregnant women still were disproportionately represented among those dying during the pandemic.
Thus far in the current pandemic, the Centers for Disease Control and Prevention has reported similar trends—that pregnant women who contract the virus are significantly more likely to require hospitalization and are disproportionately represented among those who have died from it.
Of 34 cases of confirmed or probable H1N1 influenza in pregnant women that were reported to the CDC during the first month of the pandemic (mid-April to mid-May), 11 (32%) were admitted to the hospital. Dr. Denise Jamieson and her coinvestigators at the CDC noted that this hospitalization rate was four times higher than the hospitalization rate in the nonpregnant population due to influenza infection (Lancet 2009 Aug. 8;
doi:10.1016/S0140-6736[09]61304-0
This report by Dr. Jamieson also noted that the mortality is disproportionately elevated among pregnant women, especially in the third trimester. Four of six relatively healthy pregnant women who died during the first 2 months of the pandemic (mid-April to mid-June) were in the third trimester.
Each of the six women who succumbed developed acute viral pneumonia and subsequent acute respiratory distress syndrome requiring mechanical ventilation. (There were 45 total deaths reported during this period.)
Overall, just as it was in the 1918 pandemic, the highest mortality in the current pandemic appears to be occurring in the healthiest segments of the population—those in their late teens to late 40s—rather than in the very young and elderly (in addition to the chronically ill) as is typical for seasonal influenza. There is some evidence that suggests this increased mortality among the young, healthy population is due to a phenomenon called “cytokine storm,” or cytokine dysregulation. The body launches such a robust, overly exuberant immune response that it becomes self-destructive.
How this relates to pregnant women is unclear, as is their overall higher risk for more severe disease, complications, and death. There is speculation that their higher morbidity and mortality risk with influenza relates to immunologic changes in pregnancy, alterations in their respiratory physiology, and/or the overall greater metabolic demands of pregnancy. At this point, however, the testing of these hypotheses with the necessary animal studies has not been done.
In Practice Today
Therapeutic recommendations are driven by this history of pandemic influenza and the outcomes for pregnant women, as well as experience thus far with the current H1N1 influenza pandemic. Because pregnant women tend to have such a rapid onset and progression of disease, it is important to treat women at the time they present with symptoms, rather than waiting until these patients get worse or until culture results have been obtained.
The CDC has recommended that symptomatic pregnant women be treated with oseltamivir (Tamiflu), an antiviral neuraminidase inhibitor, as soon as possible after the onset of symptoms, and that pregnant women with significant exposure receive a prophylactic course of oseltamivir or zanamivir (Relenza). The benefit is expected to be greatest when treatment is initiated within 48 hours.
(In the CDC's Lancet-published report on H1N1 in pregnancy, the earliest initiation of oseltamivir in the pregnant women who died was 6 days after symptom onset.)
The vast majority of patients who have influenza—at least 80%—will present with a fever. Cough, sore throat, and muscle aches are other common symptoms. Occasionally, patients will have nausea or vomiting. During an active influenza pandemic, if a pregnant patient presents with signs and symptoms consistent with an influenzalike illness, we should err on the side of caution and begin empiric treatment.
In cases in which the diagnosis is unclear—in a patient with new nausea and vomiting but no fever or other symptoms suggestive of influenza, for instance—it is critical that we caution patients to call right away if they develop respiratory symptoms and/or a fever.
Because of concerns regarding the potential side effects of the antiviral medications, pregnant women can be expected to be hesitant about initiating treatment. However, given the increased risks of significant morbidity and mortality associated with untreated influenza infection, the risk-benefit ratio strongly favors the early initiation of effective antiviral medication.
Pregnant women are in the CDC's high-risk category for early vaccination, and certainly this is the best way to prevent their risk of significant morbidity and mortality. It is important that we educate our support staff to encourage patients to receive the vaccine; studies have shown that flu vaccination rates were low when nurses and front office staff were not committed to and invested in the idea.
There is only a small chance that individuals will acquire the seasonal influenza strain, but because pregnant women face increased risks with seasonal influenza as well, the CDC has recommended that they should still receive the seasonal influenza vaccine.
Vaccination also will protect pregnant women against the potential dangers of sequential influenza infections; being compromised with an infection of seasonal flu would potentially further increase a pregnant woman's risk of becoming severely ill with a subsequent pandemic H1N1 infection.
Public health measures call for “social distancing” as a nonpharmacologic method of influenza prevention—that is, these measures recommend limiting the number of people one is surrounded by or exposed to. Such measures have special meaning for us as obstetricians. It is imperative that we see infected and noninfected patients at separate time periods and/or in separate locations, and that we limit the numbers of pregnant women coming into our offices for prenatal care in the midst of a pandemic.
The use of masks and other standard infection control procedures also is imperative, and will help decrease viral transmission. But we must do more. We don't want one infected patient sitting in our waiting room with 10 other noninfected patients. Given what we know about the transmissibility of the virus, at least three or four of them would become infected in such a scenario.
In the middle of an active influenza pandemic, the benefit of having an otherwise healthy woman at midgestation keep her routinely scheduled prenatal visit as opposed to deferring her visit and staying at home (possibly calling in to talk with a triage nurse) will need to be considered.
The alternatives are not perfect, but we certainly do not want to expose healthy pregnant women to a potentially lethal infection in our waiting room or even in the bus or elevator of our office building.
Our other challenge will involve hospital care. As obstetricians we will need to facilitate and lead the development of labor and delivery triage systems aimed at separating infected and noninfected laboring patients.
ELSEVIER GLOBAL MEDICAL NEWS
Pandemic H1N1 Flu and Pregnancy
Our nation is facing an influenza pandemic this fall and winter, adding to the difficulties of dealing with a struggling economy, two foreign wars, and attempts to reform our health care.
Indeed, on June 11, 2009, the World Health Organization announced that a pandemic of influenza A(H1N1) was underway. The U.S. count includes thousands of hospitalizations and more than 350 deaths to date.
Although most people who have become ill with this new virus have recovered without requiring medical treatment, there is great concern regarding the effects of this novel flu virus on vulnerable populations.
Seasonal influenza typically poses the greatest risk to the very young and the very old, but this influenza pandemic poses the greatest risk to young people and to pregnant women, in particular. High rates of severe illnesses and even deaths have been reported among pregnant women during this current outbreak. Thus, this pandemic has to be taken very seriously in obstetrics, and we need to employ all preventive measures possible. If we can do this effectively, we can head off the most significant and severe adverse consequences in our pregnant patients.
In an effort to provide the greatest education for the obstetrical community, and to create the greatest preparedness for managing the H1N1 pandemic, we have chosen to do a comprehensive Master Class on this subject. We have invited Mark Phillippe, M.D., M.H.C.M., to tell us how previous influenza pandemics have affected pregnant women and to discuss what impact the current pandemic is already having. We also have asked him to provide in detail his preparedness plan for practicing obstetricians.
Dr. Phillippe is John Van Sicklen Maeck Professor and Chairman of the department of obstetrics, gynecology, and reproductive sciences at the University of Vermont, Burlington. He is a nationally recognized maternal-fetal medicine expert, and has a research interest in influenza and how and why it impacts maternal mortality and the risk of pregnancy loss.
Key Points
The newly emerged pandemic influenza A(H1N1) virus is expected to present significant challenges to the entire health care system.
The challenges will be especially great for pregnant women and those who provide medical care for them.
Previous influenza pandemics have been notable for increased morbidity and mortality among pregnant women, especially during the third trimester.
In the past, all that could be offered to pregnant women was supportive care. We now have antiviral medications and will soon have a vaccine for the pandemic H1N1 virus.
We need to educate ourselves and our patients about how to use these therapeutic interventions effectively.
Source: Dr. Phillippe
As obstetricians we stand at the front line of preventing and treating pandemic influenza A(H1N1). Our pregnant patients who become infected with the H1N1 virus will potentially be more likely than the general population to develop severe disease, to be hospitalized, and to die from complications of the infection. They also will be at high risk of having preterm birth and fetal loss.
All this means that we must take an aggressive approach to therapy, treating women at the time they present with symptoms and being honest with them about their risks. Moreover, we must plan and execute infection control protocols and other nonpharmacologic interventions that traditionally have not been part of our armamentarium.
To be prepared, it is important that we understand influenza—why and how seasonal and pandemic influenza occur, how pregnant women have fared in previous pandemics, and what their outcomes have been thus far in the current pandemic. Most of us know little about influenza, but as we now practice on the front line with patients who are highly vulnerable, we must know more.
Understanding Pandemic Influenza
Influenza viruses are RNA viruses composed of eight separate negative-strand RNA segments that code for 11 viral proteins. These viruses regularly mutate while replicating themselves, altering their genome and shuffling their genes enough each year that our immune systems do not recognize them.
These ongoing genetic alterations are what drive annual epidemics of seasonal flu and are what make the influenza virus so different from the varicella-zoster virus (chickenpox) and other familiar viruses that are not RNA viruses. While infection with the varicella-zoster virus, or vaccination against it, gives most of us immunity for life, we are all susceptible to annual occurrences of seasonal influenza, regardless of how healthy we are.
There are three influenza virus types: influenza A, B, and C. Only types A and B cause infection in humans. Influenza A, which has been associated with most major pandemics and causes about two-thirds of seasonal influenza, is subtyped according to two surface proteins/antigens: hemagglutinin (H) and neuraminidase (N). Viruses with three different hemagglutinin subtypes H1, H2, and H3, as well as neuraminidase subtypes N1 and N2, have been previously associated with infections in humans.
The major natural reservoir for influenza A virus subtypes is the intestinal track of birds, particularly ducks, geese, and other water fowl. A significant number of different flu virus variations are normal flora in the intestinal tract of these birds.
While most viral infections that humans occasionally acquire from the birds are self-limited, some infections can be dangerous. If one is unlucky enough to be simultaneously infected with an avian influenza virus and a human influenza virus, the genes in each of these two viruses can randomly reassort, or rearrange themselves, to form a new virus.
This phenomenon, called reassortment, is one of two possible phenomena that lead to “antigen shift,” which results in immunologically unique viruses that produce pandemic influenza strains.
The other phenomenon that produces intermittent pandemic strains is called adaptation. In this scenario, an avian virus mutates enough over time—particularly with respect to its hemagglutinin molecule—that it becomes able to infect humans and to be easily transmissible from person to person.
The 1918 “Spanish” influenza pandemic produced by an H1N1 influenza virus—the most lethal pandemic in recorded history that was responsible for an estimated 50-100 million deaths worldwide—is believed to have resulted from genomic adaptation. An avian virus mutated enough that it spread from birds to humans and was then transmissible from person to person by common methods of viral spread. An attenuated version of this H1N1 virus then recurred annually for almost the next 30 years.
The 1957 “Asian flu” pandemic, on the other hand, emerged as a result of reassortment. A person infected with the then seasonally recurring H1N1 human virus was simultaneously infected with an H2N2 avian virus, and the genes reassorted to produce a new immunologically unique H2N2 virus. Fortunately, this virus did not contain many of the virulence factors that influenza viruses need to be highly lethal, so the 1957 pandemic was far milder than the 1918 pandemic.
A similar reassortment process led to the “Hong Kong flu” pandemic in 1968. It is believed that a person infected with the then seasonal H2N2 virus became infected with an H3 avian virus as well, generating a new H3N2 virus. Again, this virus was not as lethal as the 1918 virus, and after the pandemic subsided, an attenuated version became the annual seasonal influenza strain.
Interestingly, the H1N1 virus suddenly reappeared in the 1970s. Since then, seasonal influenza has been produced by a combination of the H3N2 virus and the H1N1 virus. Thus, annual influenza vaccines target both the seasonal H1N1 virus and the virus derived from the 1969 pandemic, along with the influenza B virus.
Epidemiological data going back over a hundred years show that influenza pandemics occur about every 30 years. Although the reasons for this recurring time interval are not understood, the data are strong enough that, especially since the late 1990s, experts have anticipated the development of the next pandemic.
The H5N1 avian influenza that emerged in Hong Kong in 1997 fortunately has not mutated enough to be easily transmissible among humans. Experts have been concerned, however, that this virus will undergo either adaptation or reassortment and lead to a severe pandemic. Thus far, human infections with the H5N1 avian influenza virus have been associated with an overall mortality of approximately 60%. Of the 433 cases reported to the World Health Organization through June of this year, 262 people had died.
A novel H1N1 influenza A virus containing genes from human, avian, and swine viruses was first identified in pigs in the United States in 1998. Although less significant than birds, pigs play an important role in the spread of influenza because they are susceptible to influenza virus from both birds and humans. Between 2005 and 2009, 11 cases of human infection with this triple-reassortment virus were described in the United States. In March and April of this year, further reassortment of this novel influenza A(H1N1) virus—one with uniquely different hemagglutinin and neuraminidase surface proteins—was identified in patients in Mexico. Transmissibility of the new H1N1 flu virus is high. Since initial cases of the novel H1N1 influenza virus were identified in Mexico, and then in Southern California, the virus has spread rapidly. In June, the WHO declared a pandemic. As of early September, tens of thousands of cases had been reported in the United States, and hundreds of thousands of cases had been reported worldwide.
It is important to appreciate the fact that pandemic influenza can occur in waves, with alternating periods of high infectivity and weeks or months of fewer infections; this pattern was particularly apparent in the 1918 pandemic.
In the 1918 pandemic, the second wave (lasting 8-10 weeks) occurred in the fall and was associated with a much higher mortality (up to 2%) than the first wave that had occurred in the spring. A third wave occurring in the spring of 1919 was similar to the first wave in terms of its high morbidity and relatively lower mortality.
Pandemics and Pregnancy
For reasons that are unclear, pregnant women have been observed to have higher morbidity and mortality compared with nonpregnant patients during influenza infections—seasonal or pandemic.
Observational reports of the 1918 pandemic paint a grim picture. One report published in the Journal of the American Medical Association in 1918, for instance, showed that 52 of 101 pregnant women who were admitted to Cook County Hospital in Chicago during a 2-month period with severe influenza succumbed to the illness. This mortality of 51% in pregnant patients was significantly higher than the observed 33% mortality rate in nonpregnant patients admitted to the hospital (719 of 2,154 nonpregnant patients who were admitted during the same time period died).
Additionally, among the 49 pregnant survivors in this sample, 43% either aborted or delivered prematurely (J. Am. Med. Assoc. 1918:71;1898-99). These are remarkable numbers.
Milder pandemics have had lower mortality overall, but reports have clearly shown that disproportionate numbers of pregnant women—particularly in the third trimester—have succumbed during influenza pandemics compared with the general population. An observational report from the milder 1968 pandemic, for instance, shows that pregnant women still were disproportionately represented among those dying during the pandemic.
Thus far in the current pandemic, the Centers for Disease Control and Prevention has reported similar trends—that pregnant women who contract the virus are significantly more likely to require hospitalization and are disproportionately represented among those who have died from it.
Of 34 cases of confirmed or probable H1N1 influenza in pregnant women that were reported to the CDC during the first month of the pandemic (mid-April to mid-May), 11 (32%) were admitted to the hospital. Dr. Denise Jamieson and her coinvestigators at the CDC noted that this hospitalization rate was four times higher than the hospitalization rate in the nonpregnant population due to influenza infection (Lancet 2009 Aug. 8;
doi:10.1016/S0140-6736[09]61304-0
This report by Dr. Jamieson also noted that the mortality is disproportionately elevated among pregnant women, especially in the third trimester. Four of six relatively healthy pregnant women who died during the first 2 months of the pandemic (mid-April to mid-June) were in the third trimester.
Each of the six women who succumbed developed acute viral pneumonia and subsequent acute respiratory distress syndrome requiring mechanical ventilation. (There were 45 total deaths reported during this period.)
Overall, just as it was in the 1918 pandemic, the highest mortality in the current pandemic appears to be occurring in the healthiest segments of the population—those in their late teens to late 40s—rather than in the very young and elderly (in addition to the chronically ill) as is typical for seasonal influenza. There is some evidence that suggests this increased mortality among the young, healthy population is due to a phenomenon called “cytokine storm,” or cytokine dysregulation. The body launches such a robust, overly exuberant immune response that it becomes self-destructive.
How this relates to pregnant women is unclear, as is their overall higher risk for more severe disease, complications, and death. There is speculation that their higher morbidity and mortality risk with influenza relates to immunologic changes in pregnancy, alterations in their respiratory physiology, and/or the overall greater metabolic demands of pregnancy. At this point, however, the testing of these hypotheses with the necessary animal studies has not been done.
In Practice Today
Therapeutic recommendations are driven by this history of pandemic influenza and the outcomes for pregnant women, as well as experience thus far with the current H1N1 influenza pandemic. Because pregnant women tend to have such a rapid onset and progression of disease, it is important to treat women at the time they present with symptoms, rather than waiting until these patients get worse or until culture results have been obtained.
The CDC has recommended that symptomatic pregnant women be treated with oseltamivir (Tamiflu), an antiviral neuraminidase inhibitor, as soon as possible after the onset of symptoms, and that pregnant women with significant exposure receive a prophylactic course of oseltamivir or zanamivir (Relenza). The benefit is expected to be greatest when treatment is initiated within 48 hours.
(In the CDC's Lancet-published report on H1N1 in pregnancy, the earliest initiation of oseltamivir in the pregnant women who died was 6 days after symptom onset.)
The vast majority of patients who have influenza—at least 80%—will present with a fever. Cough, sore throat, and muscle aches are other common symptoms. Occasionally, patients will have nausea or vomiting. During an active influenza pandemic, if a pregnant patient presents with signs and symptoms consistent with an influenzalike illness, we should err on the side of caution and begin empiric treatment.
In cases in which the diagnosis is unclear—in a patient with new nausea and vomiting but no fever or other symptoms suggestive of influenza, for instance—it is critical that we caution patients to call right away if they develop respiratory symptoms and/or a fever.
Because of concerns regarding the potential side effects of the antiviral medications, pregnant women can be expected to be hesitant about initiating treatment. However, given the increased risks of significant morbidity and mortality associated with untreated influenza infection, the risk-benefit ratio strongly favors the early initiation of effective antiviral medication.
Pregnant women are in the CDC's high-risk category for early vaccination, and certainly this is the best way to prevent their risk of significant morbidity and mortality. It is important that we educate our support staff to encourage patients to receive the vaccine; studies have shown that flu vaccination rates were low when nurses and front office staff were not committed to and invested in the idea.
There is only a small chance that individuals will acquire the seasonal influenza strain, but because pregnant women face increased risks with seasonal influenza as well, the CDC has recommended that they should still receive the seasonal influenza vaccine.
Vaccination also will protect pregnant women against the potential dangers of sequential influenza infections; being compromised with an infection of seasonal flu would potentially further increase a pregnant woman's risk of becoming severely ill with a subsequent pandemic H1N1 infection.
Public health measures call for “social distancing” as a nonpharmacologic method of influenza prevention—that is, these measures recommend limiting the number of people one is surrounded by or exposed to. Such measures have special meaning for us as obstetricians. It is imperative that we see infected and noninfected patients at separate time periods and/or in separate locations, and that we limit the numbers of pregnant women coming into our offices for prenatal care in the midst of a pandemic.
The use of masks and other standard infection control procedures also is imperative, and will help decrease viral transmission. But we must do more. We don't want one infected patient sitting in our waiting room with 10 other noninfected patients. Given what we know about the transmissibility of the virus, at least three or four of them would become infected in such a scenario.
In the middle of an active influenza pandemic, the benefit of having an otherwise healthy woman at midgestation keep her routinely scheduled prenatal visit as opposed to deferring her visit and staying at home (possibly calling in to talk with a triage nurse) will need to be considered.
The alternatives are not perfect, but we certainly do not want to expose healthy pregnant women to a potentially lethal infection in our waiting room or even in the bus or elevator of our office building.
Our other challenge will involve hospital care. As obstetricians we will need to facilitate and lead the development of labor and delivery triage systems aimed at separating infected and noninfected laboring patients.
ELSEVIER GLOBAL MEDICAL NEWS
Pandemic H1N1 Flu and Pregnancy
Our nation is facing an influenza pandemic this fall and winter, adding to the difficulties of dealing with a struggling economy, two foreign wars, and attempts to reform our health care.
Indeed, on June 11, 2009, the World Health Organization announced that a pandemic of influenza A(H1N1) was underway. The U.S. count includes thousands of hospitalizations and more than 350 deaths to date.
Although most people who have become ill with this new virus have recovered without requiring medical treatment, there is great concern regarding the effects of this novel flu virus on vulnerable populations.
Seasonal influenza typically poses the greatest risk to the very young and the very old, but this influenza pandemic poses the greatest risk to young people and to pregnant women, in particular. High rates of severe illnesses and even deaths have been reported among pregnant women during this current outbreak. Thus, this pandemic has to be taken very seriously in obstetrics, and we need to employ all preventive measures possible. If we can do this effectively, we can head off the most significant and severe adverse consequences in our pregnant patients.
In an effort to provide the greatest education for the obstetrical community, and to create the greatest preparedness for managing the H1N1 pandemic, we have chosen to do a comprehensive Master Class on this subject. We have invited Mark Phillippe, M.D., M.H.C.M., to tell us how previous influenza pandemics have affected pregnant women and to discuss what impact the current pandemic is already having. We also have asked him to provide in detail his preparedness plan for practicing obstetricians.
Dr. Phillippe is John Van Sicklen Maeck Professor and Chairman of the department of obstetrics, gynecology, and reproductive sciences at the University of Vermont, Burlington. He is a nationally recognized maternal-fetal medicine expert, and has a research interest in influenza and how and why it impacts maternal mortality and the risk of pregnancy loss.
Key Points
The newly emerged pandemic influenza A(H1N1) virus is expected to present significant challenges to the entire health care system.
The challenges will be especially great for pregnant women and those who provide medical care for them.
Previous influenza pandemics have been notable for increased morbidity and mortality among pregnant women, especially during the third trimester.
In the past, all that could be offered to pregnant women was supportive care. We now have antiviral medications and will soon have a vaccine for the pandemic H1N1 virus.
We need to educate ourselves and our patients about how to use these therapeutic interventions effectively.
Source: Dr. Phillippe
As obstetricians we stand at the front line of preventing and treating pandemic influenza A(H1N1). Our pregnant patients who become infected with the H1N1 virus will potentially be more likely than the general population to develop severe disease, to be hospitalized, and to die from complications of the infection. They also will be at high risk of having preterm birth and fetal loss.
All this means that we must take an aggressive approach to therapy, treating women at the time they present with symptoms and being honest with them about their risks. Moreover, we must plan and execute infection control protocols and other nonpharmacologic interventions that traditionally have not been part of our armamentarium.
To be prepared, it is important that we understand influenza—why and how seasonal and pandemic influenza occur, how pregnant women have fared in previous pandemics, and what their outcomes have been thus far in the current pandemic. Most of us know little about influenza, but as we now practice on the front line with patients who are highly vulnerable, we must know more.
Understanding Pandemic Influenza
Influenza viruses are RNA viruses composed of eight separate negative-strand RNA segments that code for 11 viral proteins. These viruses regularly mutate while replicating themselves, altering their genome and shuffling their genes enough each year that our immune systems do not recognize them.
These ongoing genetic alterations are what drive annual epidemics of seasonal flu and are what make the influenza virus so different from the varicella-zoster virus (chickenpox) and other familiar viruses that are not RNA viruses. While infection with the varicella-zoster virus, or vaccination against it, gives most of us immunity for life, we are all susceptible to annual occurrences of seasonal influenza, regardless of how healthy we are.
There are three influenza virus types: influenza A, B, and C. Only types A and B cause infection in humans. Influenza A, which has been associated with most major pandemics and causes about two-thirds of seasonal influenza, is subtyped according to two surface proteins/antigens: hemagglutinin (H) and neuraminidase (N). Viruses with three different hemagglutinin subtypes H1, H2, and H3, as well as neuraminidase subtypes N1 and N2, have been previously associated with infections in humans.
The major natural reservoir for influenza A virus subtypes is the intestinal track of birds, particularly ducks, geese, and other water fowl. A significant number of different flu virus variations are normal flora in the intestinal tract of these birds.
While most viral infections that humans occasionally acquire from the birds are self-limited, some infections can be dangerous. If one is unlucky enough to be simultaneously infected with an avian influenza virus and a human influenza virus, the genes in each of these two viruses can randomly reassort, or rearrange themselves, to form a new virus.
This phenomenon, called reassortment, is one of two possible phenomena that lead to “antigen shift,” which results in immunologically unique viruses that produce pandemic influenza strains.
The other phenomenon that produces intermittent pandemic strains is called adaptation. In this scenario, an avian virus mutates enough over time—particularly with respect to its hemagglutinin molecule—that it becomes able to infect humans and to be easily transmissible from person to person.
The 1918 “Spanish” influenza pandemic produced by an H1N1 influenza virus—the most lethal pandemic in recorded history that was responsible for an estimated 50-100 million deaths worldwide—is believed to have resulted from genomic adaptation. An avian virus mutated enough that it spread from birds to humans and was then transmissible from person to person by common methods of viral spread. An attenuated version of this H1N1 virus then recurred annually for almost the next 30 years.
The 1957 “Asian flu” pandemic, on the other hand, emerged as a result of reassortment. A person infected with the then seasonally recurring H1N1 human virus was simultaneously infected with an H2N2 avian virus, and the genes reassorted to produce a new immunologically unique H2N2 virus. Fortunately, this virus did not contain many of the virulence factors that influenza viruses need to be highly lethal, so the 1957 pandemic was far milder than the 1918 pandemic.
A similar reassortment process led to the “Hong Kong flu” pandemic in 1968. It is believed that a person infected with the then seasonal H2N2 virus became infected with an H3 avian virus as well, generating a new H3N2 virus. Again, this virus was not as lethal as the 1918 virus, and after the pandemic subsided, an attenuated version became the annual seasonal influenza strain.
Interestingly, the H1N1 virus suddenly reappeared in the 1970s. Since then, seasonal influenza has been produced by a combination of the H3N2 virus and the H1N1 virus. Thus, annual influenza vaccines target both the seasonal H1N1 virus and the virus derived from the 1969 pandemic, along with the influenza B virus.
Epidemiological data going back over a hundred years show that influenza pandemics occur about every 30 years. Although the reasons for this recurring time interval are not understood, the data are strong enough that, especially since the late 1990s, experts have anticipated the development of the next pandemic.
The H5N1 avian influenza that emerged in Hong Kong in 1997 fortunately has not mutated enough to be easily transmissible among humans. Experts have been concerned, however, that this virus will undergo either adaptation or reassortment and lead to a severe pandemic. Thus far, human infections with the H5N1 avian influenza virus have been associated with an overall mortality of approximately 60%. Of the 433 cases reported to the World Health Organization through June of this year, 262 people had died.
A novel H1N1 influenza A virus containing genes from human, avian, and swine viruses was first identified in pigs in the United States in 1998. Although less significant than birds, pigs play an important role in the spread of influenza because they are susceptible to influenza virus from both birds and humans. Between 2005 and 2009, 11 cases of human infection with this triple-reassortment virus were described in the United States. In March and April of this year, further reassortment of this novel influenza A(H1N1) virus—one with uniquely different hemagglutinin and neuraminidase surface proteins—was identified in patients in Mexico. Transmissibility of the new H1N1 flu virus is high. Since initial cases of the novel H1N1 influenza virus were identified in Mexico, and then in Southern California, the virus has spread rapidly. In June, the WHO declared a pandemic. As of early September, tens of thousands of cases had been reported in the United States, and hundreds of thousands of cases had been reported worldwide.
It is important to appreciate the fact that pandemic influenza can occur in waves, with alternating periods of high infectivity and weeks or months of fewer infections; this pattern was particularly apparent in the 1918 pandemic.
In the 1918 pandemic, the second wave (lasting 8-10 weeks) occurred in the fall and was associated with a much higher mortality (up to 2%) than the first wave that had occurred in the spring. A third wave occurring in the spring of 1919 was similar to the first wave in terms of its high morbidity and relatively lower mortality.
Pandemics and Pregnancy
For reasons that are unclear, pregnant women have been observed to have higher morbidity and mortality compared with nonpregnant patients during influenza infections—seasonal or pandemic.
Observational reports of the 1918 pandemic paint a grim picture. One report published in the Journal of the American Medical Association in 1918, for instance, showed that 52 of 101 pregnant women who were admitted to Cook County Hospital in Chicago during a 2-month period with severe influenza succumbed to the illness. This mortality of 51% in pregnant patients was significantly higher than the observed 33% mortality rate in nonpregnant patients admitted to the hospital (719 of 2,154 nonpregnant patients who were admitted during the same time period died).
Additionally, among the 49 pregnant survivors in this sample, 43% either aborted or delivered prematurely (J. Am. Med. Assoc. 1918:71;1898-99). These are remarkable numbers.
Milder pandemics have had lower mortality overall, but reports have clearly shown that disproportionate numbers of pregnant women—particularly in the third trimester—have succumbed during influenza pandemics compared with the general population. An observational report from the milder 1968 pandemic, for instance, shows that pregnant women still were disproportionately represented among those dying during the pandemic.
Thus far in the current pandemic, the Centers for Disease Control and Prevention has reported similar trends—that pregnant women who contract the virus are significantly more likely to require hospitalization and are disproportionately represented among those who have died from it.
Of 34 cases of confirmed or probable H1N1 influenza in pregnant women that were reported to the CDC during the first month of the pandemic (mid-April to mid-May), 11 (32%) were admitted to the hospital. Dr. Denise Jamieson and her coinvestigators at the CDC noted that this hospitalization rate was four times higher than the hospitalization rate in the nonpregnant population due to influenza infection (Lancet 2009 Aug. 8;
doi:10.1016/S0140-6736[09]61304-0
This report by Dr. Jamieson also noted that the mortality is disproportionately elevated among pregnant women, especially in the third trimester. Four of six relatively healthy pregnant women who died during the first 2 months of the pandemic (mid-April to mid-June) were in the third trimester.
Each of the six women who succumbed developed acute viral pneumonia and subsequent acute respiratory distress syndrome requiring mechanical ventilation. (There were 45 total deaths reported during this period.)
Overall, just as it was in the 1918 pandemic, the highest mortality in the current pandemic appears to be occurring in the healthiest segments of the population—those in their late teens to late 40s—rather than in the very young and elderly (in addition to the chronically ill) as is typical for seasonal influenza. There is some evidence that suggests this increased mortality among the young, healthy population is due to a phenomenon called “cytokine storm,” or cytokine dysregulation. The body launches such a robust, overly exuberant immune response that it becomes self-destructive.
How this relates to pregnant women is unclear, as is their overall higher risk for more severe disease, complications, and death. There is speculation that their higher morbidity and mortality risk with influenza relates to immunologic changes in pregnancy, alterations in their respiratory physiology, and/or the overall greater metabolic demands of pregnancy. At this point, however, the testing of these hypotheses with the necessary animal studies has not been done.
In Practice Today
Therapeutic recommendations are driven by this history of pandemic influenza and the outcomes for pregnant women, as well as experience thus far with the current H1N1 influenza pandemic. Because pregnant women tend to have such a rapid onset and progression of disease, it is important to treat women at the time they present with symptoms, rather than waiting until these patients get worse or until culture results have been obtained.
The CDC has recommended that symptomatic pregnant women be treated with oseltamivir (Tamiflu), an antiviral neuraminidase inhibitor, as soon as possible after the onset of symptoms, and that pregnant women with significant exposure receive a prophylactic course of oseltamivir or zanamivir (Relenza). The benefit is expected to be greatest when treatment is initiated within 48 hours.
(In the CDC's Lancet-published report on H1N1 in pregnancy, the earliest initiation of oseltamivir in the pregnant women who died was 6 days after symptom onset.)
The vast majority of patients who have influenza—at least 80%—will present with a fever. Cough, sore throat, and muscle aches are other common symptoms. Occasionally, patients will have nausea or vomiting. During an active influenza pandemic, if a pregnant patient presents with signs and symptoms consistent with an influenzalike illness, we should err on the side of caution and begin empiric treatment.
In cases in which the diagnosis is unclear—in a patient with new nausea and vomiting but no fever or other symptoms suggestive of influenza, for instance—it is critical that we caution patients to call right away if they develop respiratory symptoms and/or a fever.
Because of concerns regarding the potential side effects of the antiviral medications, pregnant women can be expected to be hesitant about initiating treatment. However, given the increased risks of significant morbidity and mortality associated with untreated influenza infection, the risk-benefit ratio strongly favors the early initiation of effective antiviral medication.
Pregnant women are in the CDC's high-risk category for early vaccination, and certainly this is the best way to prevent their risk of significant morbidity and mortality. It is important that we educate our support staff to encourage patients to receive the vaccine; studies have shown that flu vaccination rates were low when nurses and front office staff were not committed to and invested in the idea.
There is only a small chance that individuals will acquire the seasonal influenza strain, but because pregnant women face increased risks with seasonal influenza as well, the CDC has recommended that they should still receive the seasonal influenza vaccine.
Vaccination also will protect pregnant women against the potential dangers of sequential influenza infections; being compromised with an infection of seasonal flu would potentially further increase a pregnant woman's risk of becoming severely ill with a subsequent pandemic H1N1 infection.
Public health measures call for “social distancing” as a nonpharmacologic method of influenza prevention—that is, these measures recommend limiting the number of people one is surrounded by or exposed to. Such measures have special meaning for us as obstetricians. It is imperative that we see infected and noninfected patients at separate time periods and/or in separate locations, and that we limit the numbers of pregnant women coming into our offices for prenatal care in the midst of a pandemic.
The use of masks and other standard infection control procedures also is imperative, and will help decrease viral transmission. But we must do more. We don't want one infected patient sitting in our waiting room with 10 other noninfected patients. Given what we know about the transmissibility of the virus, at least three or four of them would become infected in such a scenario.
In the middle of an active influenza pandemic, the benefit of having an otherwise healthy woman at midgestation keep her routinely scheduled prenatal visit as opposed to deferring her visit and staying at home (possibly calling in to talk with a triage nurse) will need to be considered.
The alternatives are not perfect, but we certainly do not want to expose healthy pregnant women to a potentially lethal infection in our waiting room or even in the bus or elevator of our office building.
Our other challenge will involve hospital care. As obstetricians we will need to facilitate and lead the development of labor and delivery triage systems aimed at separating infected and noninfected laboring patients.
ELSEVIER GLOBAL MEDICAL NEWS
Pandemic H1N1 Flu and Pregnancy
Our nation is facing an influenza pandemic this fall and winter, adding to the difficulties of dealing with a struggling economy, two foreign wars, and attempts to reform our health care.
Indeed, on June 11, 2009, the World Health Organization announced that a pandemic of influenza A(H1N1) was underway. The U.S. count includes thousands of hospitalizations and more than 350 deaths to date.
Although most people who have become ill with this new virus have recovered without requiring medical treatment, there is great concern regarding the effects of this novel flu virus on vulnerable populations.
Seasonal influenza typically poses the greatest risk to the very young and the very old, but this influenza pandemic poses the greatest risk to young people and to pregnant women, in particular. High rates of severe illnesses and even deaths have been reported among pregnant women during this current outbreak. Thus, this pandemic has to be taken very seriously in obstetrics, and we need to employ all preventive measures possible. If we can do this effectively, we can head off the most significant and severe adverse consequences in our pregnant patients.
In an effort to provide the greatest education for the obstetrical community, and to create the greatest preparedness for managing the H1N1 pandemic, we have chosen to do a comprehensive Master Class on this subject. We have invited Mark Phillippe, M.D., M.H.C.M., to tell us how previous influenza pandemics have affected pregnant women and to discuss what impact the current pandemic is already having. We also have asked him to provide in detail his preparedness plan for practicing obstetricians.
Dr. Phillippe is John Van Sicklen Maeck Professor and Chairman of the department of obstetrics, gynecology, and reproductive sciences at the University of Vermont, Burlington. He is a nationally recognized maternal-fetal medicine expert, and has a research interest in influenza and how and why it impacts maternal mortality and the risk of pregnancy loss.
Key Points
The newly emerged pandemic influenza A(H1N1) virus is expected to present significant challenges to the entire health care system.
The challenges will be especially great for pregnant women and those who provide medical care for them.
Previous influenza pandemics have been notable for increased morbidity and mortality among pregnant women, especially during the third trimester.
In the past, all that could be offered to pregnant women was supportive care. We now have antiviral medications and will soon have a vaccine for the pandemic H1N1 virus.
We need to educate ourselves and our patients about how to use these therapeutic interventions effectively.
Source: Dr. Phillippe
How Type 2 Diabetes Complicates Pregnancy
With the incidence of obesity rising in the United States and Europe, the rate of type 2 diabetes is increasing significantly as well. In 2000, investigators reported a 33% increase from 1990 to 1998 in the prevalence of type 2 diabetes, and a 76% prevalence increase in individuals aged 30–39 years (Diab. Care 2000:23:1278–83). Others have estimated that the majority of pregestational pregnant diabetic women (80%–90%) are type 2.
The rates of obesity and type 2 diabetes have risen further since 2000, so much so that the current pandemic—now often referred to “diabesity”—has implications that are more urgent than ever for obstetrics and for our goal of optimizing outcomes for women and their newborns. Today it is estimated that 8%–15% of pregnant women have type 2 diabetes, and if current trends continue, it will soon be higher.
Unless we take a more aggressive and intensive approach to identification and management—unless we aim for primary prevention of hyperglycemia-related complications to the greatest degree possible—a significant number of our pregnant patients will face complications and adverse perinatal outcomes associated with type 2 diabetes.
We have to focus on the care of these women with the same diligence that has been applied to pregnant and nonpregnant women with type 1 diabetes. For one, we must be more proactive in promoting preconception care, and in cases in which that doesn't happen, we must act early to identify potentially harmful levels of glycemia.
We must then strive for as much glycemic control as possible, because various levels of improvement can prevent different anomalies and complications.
Perinatal Outcomes
Compared with type 1 diabetes, there are relatively few data on the effects of type 2 diabetes on pregnancy outcome. Still, evidence is mounting that the abnormal maternal glycemic profiles characterizing type 2 diabetes are associated with adverse perinatal outcome, and that improvement in glycemic control results in better perinatal outcomes.
Investigators have consistently reported significantly higher rates of perinatal morbidity and mortality in women with type 2 diabetes than in the general population, and most studies report a prevalence of congenital anomalies in the offspring of women with type 2 diabetes that is several times higher than the rate found in the general population and similar to the prevalence of congenital anomalies associated with type 1 diabetes. (The rate of congenital abnormalities contributes significantly, of course, to overall perinatal mortality.) Other studies suggest that the rate of congenital anomalies in the children of women with type 2 diabetes is twice as high as the rate reported with type 1 diabetes.
Fetal macrosomia is another major problem. Most studies report fourfold to fivefold higher rates of macrosomia in infants of mothers with type 2 diabetes. Metabolic and respiratory complications also occur. More specifically, the perinatal mortality in women with type 2 diabetes has varied from approximately 3.7% in a study done in New Zealand to 18% in research conducted in Canada, with an overall mean of 7.6% in the 14 studies conducted since 2000.
The rate of major anomalies in type 2 diabetic women has ranged from 3% in South Africa to 12.3% in the United Kingdom with an overall mean of 8% in the 17 studies conducted since 2000. The rate of anomalies in the general population, as reported in only 6 of the 17 studies, has ranged from 1.6% to 3.1%.
The rate of large-for-gestational-age (LGA) infants in studies addressing type 2 diabetes and published between 1970 and 1980 was 33% (a range of 28%–40%). The rate reported since 2000 in published studies is 39% (a range of 30%–45%). The rate of cesarean section since 2000 is 62% (J. Mater. Fetal Med. 2008:21;181–9).
Unfortunately, in the past 4–5 decades, we have not improved the care of pregnant patients with type 2 diabetes. There has been no significant change in perinatal outcomes. Analyses of anomaly rates, for instance, show no real change since the 1970s. We have to ask, therefore, what are we really doing for these patients?
Part of the problem is that patients are diagnosed too late. The majority of women with type 2 diabetes is seen for the first prenatal visit during or after organogenesis occurs. We talk with patients about organogenesis occurring during the first trimester, but most anomalies actually occur in the first 4–5 weeks of pregnancy.
Only a small percentage of type 2 patients (5%–24%) receive preconception care, a shortcoming driven partly by the fact that 50%–60% of pregnancies are unplanned and partly by our own failures in the public health and preventive arena. Moreover, testing for gestational diabetes, which often uncovers type 2 diabetes, does not occur until about midpregnancy.
The other part of the problem could well be that we are not treating these patients intensively enough.
Early Detection, Intensive Treatment
We must intensify efforts to educate patients and physicians about the risks of type 2 diabetes in pregnancy and the need to control glucose levels before pregnancy occurs.
The benefits of preconception care in reducing congenital malformations in the context of diabetes are clear. In a meta-analysis of studies on preconception care in women with diabetes published from 1970 to 2000, the pooled rate for major malformations among a total of approximately 2,600 offspring was 2.1% in the group that received preconception care compared with 6.5% in the group that did not receive the care.
Another look at major and minor anomalies together showed a pooled rate of 2.4% in the preconception care groups compared with 7.7% in the women who did not receive this care. Early first trimester mean glycosylated hemoglobin values also were significantly lower in the women who received preconception care (QJM 2001:94;435–44).
Stepping up our promotion of preconception care is a first step toward primary prevention of diabetes-associated complications, but we also ought to set new criteria in our practices that stipulate that patients who are obese or have a previous history of gestational diabetes will have fasting plasma glucose tests performed in conjunction with the first prenatal office visit or immediately afterward.
A deliberate methodology for identifying patients early on who are at risk for type 2 diabetes and testing them promptly—and not waiting for standard gestational diabetes testing—will enable us to impact pregnancy outcomes.
Neither the American Diabetes Association nor other medical groups have yet issued guidelines on fasting plasma glucose testing in early pregnancy, but this does not mean we shouldn't pursue such testing. Currently, for adults younger than 45 years, the ADA recommends testing to detect prediabetes and type 2 diabetes in individuals who are overweight or obese and who have one more risk factor. Giving birth to a baby weighing more than 9 pounds or being diagnosed with gestational diabetes is considered a risk factor.
Given the stakes for the child as well as the mother, I do not believe, however, that we should require both overweight/obesity and previous macrosomia or gestational diabetes as criteria for testing.
Similarly, I believe that we should lower our diagnostic threshold for type 2 diabetes in patients who are pregnant. More than 60% of patients with gestational diabetes fall into the category of impaired glucose tolerance (fasting plasma glucose of 100–125 mg/dL). Today we are calling these patients gestational diabetics when they really should be called type 2 diabetics.
The recently completed National Institutes of Health-sponsored Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study and the study on gestational diabetes by the Maternal-Fetal Medicine Units Network (MFMU) used fasting plasma glucose levels of 105 mg/dL and 95 mg/dL, respectively, as thresholds for the exclusion of patients from the studies.
The HAPO study linked adverse pregnancy outcomes with glycemia levels that have traditionally been considered normal, and the MFMU study is yielding similar findings. However, given the studies' exclusion thresholds (which were set with ethical considerations in mind), we have disallowed ourselves the opportunity to firmly establish whether patients with impaired glucose tolerance should be considered type 2 diabetics.
Current diagnostic criteria for the population in general—by which a fasting blood glucose level (FBG) of 126 mg/dL indicates diabetes and an FBG of 100–125 mg/dL indicates impaired fasting glucose or prediabetes—were set several years ago when it became apparent that the previous diagnostic threshold of 140 mg/dL was too high. Studies showed clearly that complications relating to hyperglycemia—from retinopathy to nephropathy, neuropathy, and various micro- and macrovascular complications—occur in patients with FBG levels much lower than 140 mg/dL.
Recent research has shown, moreover, that long-term damage to the body may occur even in patients diagnosed with prediabetes. Investigators have reported, for instance, that approximately 10% of these patients have neuropathy and/or retinopathy.
When I see an FBG level of 100–125 mg/dL in a pregnant patient, even though this is by current standards considered “prediabetes” in the nonpregnant state, I consider this to be diabetes. This approach takes into account the fact that fasting plasma glucose levels during pregnancy are lower than actual values post pregnancy. It also takes into consideration something I have found in my discussions with patients: the observation that psychologically, these women are significantly more receptive to a serious approach to glycemic control if we're talking about diabetes rather than prediabetes or gestational diabetes.
With respect to the glucose threshold that will minimize adverse perinatal outcome, studies have shown that glucose levels of pre- and postprandial and fasting blood glucose under 140 mg/dL will be sufficient to achieve rates of congenital anomalies, spontaneous abortion, and perinatal mortality comparable with those seen in nondiabetic populations.
The target glucose threshold for the prevention of macrosomia and its accompanying complications, however, is significantly lower. Studies suggest that we need to achieve mean blood glucose levels of less than 100 mg/dL to prevent macrosomia (J. Matern. Fetal Neonatal Med. 2000:9;35–41). Fortunately, we have a bit more time to impact the rates of macrosomia since this complication develops later in pregnancy, in contrast to the development of congenital anomalies so early.
We still have much to learn about the exact levels of glycemia that are necessary to reduce complications, but our current knowledge that different glucose thresholds exist for different types of complications enables us to keep patients motivated to improve glycemic control.
Even when it's not possible to achieve optimal glycemic control, any improvement should be beneficial because it will reduce the rate of complications for a given glucose threshold.
As obstetricians work together to improve care for pregnant patients with type 2 diabetes, it is also important that we develop criteria for blood glucose measurement and monitoring. Should we all measure fasting blood glucose? Postprandial blood glucose? Right now, our approaches vary. We need consistency and clear definitions if we are to compare outcomes effectively.
I always tell patients that if we work together, we will be able to improve outcomes, and I tell them never to give up. In the preconception phase, we aim for an FBG of less than 140 mg/dL, then we work on continuously lowering this level until, at around 20 weeks' gestation, we tighten glycemic control to prevent stillbirth, macrosomia, and metabolic complications.
We need to remember that diabetes in pregnancy is a chronic disease that is extremely demanding, requiring frequent blood glucose tests throughout the day, insulin injections or ingestion of oral hypoglycemic agents, frequent fetal testing, and adherence to a diet protocol. This all requires patient-physician cooperation.
Compliance in these patients should comprise all the above demands so that if a patient fails to adhere to the diabetic protocol, we can ask whether her failure to comply is based on her needs and expectations, or her physician's needs and expectations. In the end, we as obstetricians treat two patients whose needs sometimes coincide and sometimes collide. Our goal is to develop management protocols that maximize the mutual needs of both.
Source CDC
With the incidence of obesity rising in the United States and Europe, the rate of type 2 diabetes is increasing significantly as well. In 2000, investigators reported a 33% increase from 1990 to 1998 in the prevalence of type 2 diabetes, and a 76% prevalence increase in individuals aged 30–39 years (Diab. Care 2000:23:1278–83). Others have estimated that the majority of pregestational pregnant diabetic women (80%–90%) are type 2.
The rates of obesity and type 2 diabetes have risen further since 2000, so much so that the current pandemic—now often referred to “diabesity”—has implications that are more urgent than ever for obstetrics and for our goal of optimizing outcomes for women and their newborns. Today it is estimated that 8%–15% of pregnant women have type 2 diabetes, and if current trends continue, it will soon be higher.
Unless we take a more aggressive and intensive approach to identification and management—unless we aim for primary prevention of hyperglycemia-related complications to the greatest degree possible—a significant number of our pregnant patients will face complications and adverse perinatal outcomes associated with type 2 diabetes.
We have to focus on the care of these women with the same diligence that has been applied to pregnant and nonpregnant women with type 1 diabetes. For one, we must be more proactive in promoting preconception care, and in cases in which that doesn't happen, we must act early to identify potentially harmful levels of glycemia.
We must then strive for as much glycemic control as possible, because various levels of improvement can prevent different anomalies and complications.
Perinatal Outcomes
Compared with type 1 diabetes, there are relatively few data on the effects of type 2 diabetes on pregnancy outcome. Still, evidence is mounting that the abnormal maternal glycemic profiles characterizing type 2 diabetes are associated with adverse perinatal outcome, and that improvement in glycemic control results in better perinatal outcomes.
Investigators have consistently reported significantly higher rates of perinatal morbidity and mortality in women with type 2 diabetes than in the general population, and most studies report a prevalence of congenital anomalies in the offspring of women with type 2 diabetes that is several times higher than the rate found in the general population and similar to the prevalence of congenital anomalies associated with type 1 diabetes. (The rate of congenital abnormalities contributes significantly, of course, to overall perinatal mortality.) Other studies suggest that the rate of congenital anomalies in the children of women with type 2 diabetes is twice as high as the rate reported with type 1 diabetes.
Fetal macrosomia is another major problem. Most studies report fourfold to fivefold higher rates of macrosomia in infants of mothers with type 2 diabetes. Metabolic and respiratory complications also occur. More specifically, the perinatal mortality in women with type 2 diabetes has varied from approximately 3.7% in a study done in New Zealand to 18% in research conducted in Canada, with an overall mean of 7.6% in the 14 studies conducted since 2000.
The rate of major anomalies in type 2 diabetic women has ranged from 3% in South Africa to 12.3% in the United Kingdom with an overall mean of 8% in the 17 studies conducted since 2000. The rate of anomalies in the general population, as reported in only 6 of the 17 studies, has ranged from 1.6% to 3.1%.
The rate of large-for-gestational-age (LGA) infants in studies addressing type 2 diabetes and published between 1970 and 1980 was 33% (a range of 28%–40%). The rate reported since 2000 in published studies is 39% (a range of 30%–45%). The rate of cesarean section since 2000 is 62% (J. Mater. Fetal Med. 2008:21;181–9).
Unfortunately, in the past 4–5 decades, we have not improved the care of pregnant patients with type 2 diabetes. There has been no significant change in perinatal outcomes. Analyses of anomaly rates, for instance, show no real change since the 1970s. We have to ask, therefore, what are we really doing for these patients?
Part of the problem is that patients are diagnosed too late. The majority of women with type 2 diabetes is seen for the first prenatal visit during or after organogenesis occurs. We talk with patients about organogenesis occurring during the first trimester, but most anomalies actually occur in the first 4–5 weeks of pregnancy.
Only a small percentage of type 2 patients (5%–24%) receive preconception care, a shortcoming driven partly by the fact that 50%–60% of pregnancies are unplanned and partly by our own failures in the public health and preventive arena. Moreover, testing for gestational diabetes, which often uncovers type 2 diabetes, does not occur until about midpregnancy.
The other part of the problem could well be that we are not treating these patients intensively enough.
Early Detection, Intensive Treatment
We must intensify efforts to educate patients and physicians about the risks of type 2 diabetes in pregnancy and the need to control glucose levels before pregnancy occurs.
The benefits of preconception care in reducing congenital malformations in the context of diabetes are clear. In a meta-analysis of studies on preconception care in women with diabetes published from 1970 to 2000, the pooled rate for major malformations among a total of approximately 2,600 offspring was 2.1% in the group that received preconception care compared with 6.5% in the group that did not receive the care.
Another look at major and minor anomalies together showed a pooled rate of 2.4% in the preconception care groups compared with 7.7% in the women who did not receive this care. Early first trimester mean glycosylated hemoglobin values also were significantly lower in the women who received preconception care (QJM 2001:94;435–44).
Stepping up our promotion of preconception care is a first step toward primary prevention of diabetes-associated complications, but we also ought to set new criteria in our practices that stipulate that patients who are obese or have a previous history of gestational diabetes will have fasting plasma glucose tests performed in conjunction with the first prenatal office visit or immediately afterward.
A deliberate methodology for identifying patients early on who are at risk for type 2 diabetes and testing them promptly—and not waiting for standard gestational diabetes testing—will enable us to impact pregnancy outcomes.
Neither the American Diabetes Association nor other medical groups have yet issued guidelines on fasting plasma glucose testing in early pregnancy, but this does not mean we shouldn't pursue such testing. Currently, for adults younger than 45 years, the ADA recommends testing to detect prediabetes and type 2 diabetes in individuals who are overweight or obese and who have one more risk factor. Giving birth to a baby weighing more than 9 pounds or being diagnosed with gestational diabetes is considered a risk factor.
Given the stakes for the child as well as the mother, I do not believe, however, that we should require both overweight/obesity and previous macrosomia or gestational diabetes as criteria for testing.
Similarly, I believe that we should lower our diagnostic threshold for type 2 diabetes in patients who are pregnant. More than 60% of patients with gestational diabetes fall into the category of impaired glucose tolerance (fasting plasma glucose of 100–125 mg/dL). Today we are calling these patients gestational diabetics when they really should be called type 2 diabetics.
The recently completed National Institutes of Health-sponsored Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study and the study on gestational diabetes by the Maternal-Fetal Medicine Units Network (MFMU) used fasting plasma glucose levels of 105 mg/dL and 95 mg/dL, respectively, as thresholds for the exclusion of patients from the studies.
The HAPO study linked adverse pregnancy outcomes with glycemia levels that have traditionally been considered normal, and the MFMU study is yielding similar findings. However, given the studies' exclusion thresholds (which were set with ethical considerations in mind), we have disallowed ourselves the opportunity to firmly establish whether patients with impaired glucose tolerance should be considered type 2 diabetics.
Current diagnostic criteria for the population in general—by which a fasting blood glucose level (FBG) of 126 mg/dL indicates diabetes and an FBG of 100–125 mg/dL indicates impaired fasting glucose or prediabetes—were set several years ago when it became apparent that the previous diagnostic threshold of 140 mg/dL was too high. Studies showed clearly that complications relating to hyperglycemia—from retinopathy to nephropathy, neuropathy, and various micro- and macrovascular complications—occur in patients with FBG levels much lower than 140 mg/dL.
Recent research has shown, moreover, that long-term damage to the body may occur even in patients diagnosed with prediabetes. Investigators have reported, for instance, that approximately 10% of these patients have neuropathy and/or retinopathy.
When I see an FBG level of 100–125 mg/dL in a pregnant patient, even though this is by current standards considered “prediabetes” in the nonpregnant state, I consider this to be diabetes. This approach takes into account the fact that fasting plasma glucose levels during pregnancy are lower than actual values post pregnancy. It also takes into consideration something I have found in my discussions with patients: the observation that psychologically, these women are significantly more receptive to a serious approach to glycemic control if we're talking about diabetes rather than prediabetes or gestational diabetes.
With respect to the glucose threshold that will minimize adverse perinatal outcome, studies have shown that glucose levels of pre- and postprandial and fasting blood glucose under 140 mg/dL will be sufficient to achieve rates of congenital anomalies, spontaneous abortion, and perinatal mortality comparable with those seen in nondiabetic populations.
The target glucose threshold for the prevention of macrosomia and its accompanying complications, however, is significantly lower. Studies suggest that we need to achieve mean blood glucose levels of less than 100 mg/dL to prevent macrosomia (J. Matern. Fetal Neonatal Med. 2000:9;35–41). Fortunately, we have a bit more time to impact the rates of macrosomia since this complication develops later in pregnancy, in contrast to the development of congenital anomalies so early.
We still have much to learn about the exact levels of glycemia that are necessary to reduce complications, but our current knowledge that different glucose thresholds exist for different types of complications enables us to keep patients motivated to improve glycemic control.
Even when it's not possible to achieve optimal glycemic control, any improvement should be beneficial because it will reduce the rate of complications for a given glucose threshold.
As obstetricians work together to improve care for pregnant patients with type 2 diabetes, it is also important that we develop criteria for blood glucose measurement and monitoring. Should we all measure fasting blood glucose? Postprandial blood glucose? Right now, our approaches vary. We need consistency and clear definitions if we are to compare outcomes effectively.
I always tell patients that if we work together, we will be able to improve outcomes, and I tell them never to give up. In the preconception phase, we aim for an FBG of less than 140 mg/dL, then we work on continuously lowering this level until, at around 20 weeks' gestation, we tighten glycemic control to prevent stillbirth, macrosomia, and metabolic complications.
We need to remember that diabetes in pregnancy is a chronic disease that is extremely demanding, requiring frequent blood glucose tests throughout the day, insulin injections or ingestion of oral hypoglycemic agents, frequent fetal testing, and adherence to a diet protocol. This all requires patient-physician cooperation.
Compliance in these patients should comprise all the above demands so that if a patient fails to adhere to the diabetic protocol, we can ask whether her failure to comply is based on her needs and expectations, or her physician's needs and expectations. In the end, we as obstetricians treat two patients whose needs sometimes coincide and sometimes collide. Our goal is to develop management protocols that maximize the mutual needs of both.
Source CDC
With the incidence of obesity rising in the United States and Europe, the rate of type 2 diabetes is increasing significantly as well. In 2000, investigators reported a 33% increase from 1990 to 1998 in the prevalence of type 2 diabetes, and a 76% prevalence increase in individuals aged 30–39 years (Diab. Care 2000:23:1278–83). Others have estimated that the majority of pregestational pregnant diabetic women (80%–90%) are type 2.
The rates of obesity and type 2 diabetes have risen further since 2000, so much so that the current pandemic—now often referred to “diabesity”—has implications that are more urgent than ever for obstetrics and for our goal of optimizing outcomes for women and their newborns. Today it is estimated that 8%–15% of pregnant women have type 2 diabetes, and if current trends continue, it will soon be higher.
Unless we take a more aggressive and intensive approach to identification and management—unless we aim for primary prevention of hyperglycemia-related complications to the greatest degree possible—a significant number of our pregnant patients will face complications and adverse perinatal outcomes associated with type 2 diabetes.
We have to focus on the care of these women with the same diligence that has been applied to pregnant and nonpregnant women with type 1 diabetes. For one, we must be more proactive in promoting preconception care, and in cases in which that doesn't happen, we must act early to identify potentially harmful levels of glycemia.
We must then strive for as much glycemic control as possible, because various levels of improvement can prevent different anomalies and complications.
Perinatal Outcomes
Compared with type 1 diabetes, there are relatively few data on the effects of type 2 diabetes on pregnancy outcome. Still, evidence is mounting that the abnormal maternal glycemic profiles characterizing type 2 diabetes are associated with adverse perinatal outcome, and that improvement in glycemic control results in better perinatal outcomes.
Investigators have consistently reported significantly higher rates of perinatal morbidity and mortality in women with type 2 diabetes than in the general population, and most studies report a prevalence of congenital anomalies in the offspring of women with type 2 diabetes that is several times higher than the rate found in the general population and similar to the prevalence of congenital anomalies associated with type 1 diabetes. (The rate of congenital abnormalities contributes significantly, of course, to overall perinatal mortality.) Other studies suggest that the rate of congenital anomalies in the children of women with type 2 diabetes is twice as high as the rate reported with type 1 diabetes.
Fetal macrosomia is another major problem. Most studies report fourfold to fivefold higher rates of macrosomia in infants of mothers with type 2 diabetes. Metabolic and respiratory complications also occur. More specifically, the perinatal mortality in women with type 2 diabetes has varied from approximately 3.7% in a study done in New Zealand to 18% in research conducted in Canada, with an overall mean of 7.6% in the 14 studies conducted since 2000.
The rate of major anomalies in type 2 diabetic women has ranged from 3% in South Africa to 12.3% in the United Kingdom with an overall mean of 8% in the 17 studies conducted since 2000. The rate of anomalies in the general population, as reported in only 6 of the 17 studies, has ranged from 1.6% to 3.1%.
The rate of large-for-gestational-age (LGA) infants in studies addressing type 2 diabetes and published between 1970 and 1980 was 33% (a range of 28%–40%). The rate reported since 2000 in published studies is 39% (a range of 30%–45%). The rate of cesarean section since 2000 is 62% (J. Mater. Fetal Med. 2008:21;181–9).
Unfortunately, in the past 4–5 decades, we have not improved the care of pregnant patients with type 2 diabetes. There has been no significant change in perinatal outcomes. Analyses of anomaly rates, for instance, show no real change since the 1970s. We have to ask, therefore, what are we really doing for these patients?
Part of the problem is that patients are diagnosed too late. The majority of women with type 2 diabetes is seen for the first prenatal visit during or after organogenesis occurs. We talk with patients about organogenesis occurring during the first trimester, but most anomalies actually occur in the first 4–5 weeks of pregnancy.
Only a small percentage of type 2 patients (5%–24%) receive preconception care, a shortcoming driven partly by the fact that 50%–60% of pregnancies are unplanned and partly by our own failures in the public health and preventive arena. Moreover, testing for gestational diabetes, which often uncovers type 2 diabetes, does not occur until about midpregnancy.
The other part of the problem could well be that we are not treating these patients intensively enough.
Early Detection, Intensive Treatment
We must intensify efforts to educate patients and physicians about the risks of type 2 diabetes in pregnancy and the need to control glucose levels before pregnancy occurs.
The benefits of preconception care in reducing congenital malformations in the context of diabetes are clear. In a meta-analysis of studies on preconception care in women with diabetes published from 1970 to 2000, the pooled rate for major malformations among a total of approximately 2,600 offspring was 2.1% in the group that received preconception care compared with 6.5% in the group that did not receive the care.
Another look at major and minor anomalies together showed a pooled rate of 2.4% in the preconception care groups compared with 7.7% in the women who did not receive this care. Early first trimester mean glycosylated hemoglobin values also were significantly lower in the women who received preconception care (QJM 2001:94;435–44).
Stepping up our promotion of preconception care is a first step toward primary prevention of diabetes-associated complications, but we also ought to set new criteria in our practices that stipulate that patients who are obese or have a previous history of gestational diabetes will have fasting plasma glucose tests performed in conjunction with the first prenatal office visit or immediately afterward.
A deliberate methodology for identifying patients early on who are at risk for type 2 diabetes and testing them promptly—and not waiting for standard gestational diabetes testing—will enable us to impact pregnancy outcomes.
Neither the American Diabetes Association nor other medical groups have yet issued guidelines on fasting plasma glucose testing in early pregnancy, but this does not mean we shouldn't pursue such testing. Currently, for adults younger than 45 years, the ADA recommends testing to detect prediabetes and type 2 diabetes in individuals who are overweight or obese and who have one more risk factor. Giving birth to a baby weighing more than 9 pounds or being diagnosed with gestational diabetes is considered a risk factor.
Given the stakes for the child as well as the mother, I do not believe, however, that we should require both overweight/obesity and previous macrosomia or gestational diabetes as criteria for testing.
Similarly, I believe that we should lower our diagnostic threshold for type 2 diabetes in patients who are pregnant. More than 60% of patients with gestational diabetes fall into the category of impaired glucose tolerance (fasting plasma glucose of 100–125 mg/dL). Today we are calling these patients gestational diabetics when they really should be called type 2 diabetics.
The recently completed National Institutes of Health-sponsored Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study and the study on gestational diabetes by the Maternal-Fetal Medicine Units Network (MFMU) used fasting plasma glucose levels of 105 mg/dL and 95 mg/dL, respectively, as thresholds for the exclusion of patients from the studies.
The HAPO study linked adverse pregnancy outcomes with glycemia levels that have traditionally been considered normal, and the MFMU study is yielding similar findings. However, given the studies' exclusion thresholds (which were set with ethical considerations in mind), we have disallowed ourselves the opportunity to firmly establish whether patients with impaired glucose tolerance should be considered type 2 diabetics.
Current diagnostic criteria for the population in general—by which a fasting blood glucose level (FBG) of 126 mg/dL indicates diabetes and an FBG of 100–125 mg/dL indicates impaired fasting glucose or prediabetes—were set several years ago when it became apparent that the previous diagnostic threshold of 140 mg/dL was too high. Studies showed clearly that complications relating to hyperglycemia—from retinopathy to nephropathy, neuropathy, and various micro- and macrovascular complications—occur in patients with FBG levels much lower than 140 mg/dL.
Recent research has shown, moreover, that long-term damage to the body may occur even in patients diagnosed with prediabetes. Investigators have reported, for instance, that approximately 10% of these patients have neuropathy and/or retinopathy.
When I see an FBG level of 100–125 mg/dL in a pregnant patient, even though this is by current standards considered “prediabetes” in the nonpregnant state, I consider this to be diabetes. This approach takes into account the fact that fasting plasma glucose levels during pregnancy are lower than actual values post pregnancy. It also takes into consideration something I have found in my discussions with patients: the observation that psychologically, these women are significantly more receptive to a serious approach to glycemic control if we're talking about diabetes rather than prediabetes or gestational diabetes.
With respect to the glucose threshold that will minimize adverse perinatal outcome, studies have shown that glucose levels of pre- and postprandial and fasting blood glucose under 140 mg/dL will be sufficient to achieve rates of congenital anomalies, spontaneous abortion, and perinatal mortality comparable with those seen in nondiabetic populations.
The target glucose threshold for the prevention of macrosomia and its accompanying complications, however, is significantly lower. Studies suggest that we need to achieve mean blood glucose levels of less than 100 mg/dL to prevent macrosomia (J. Matern. Fetal Neonatal Med. 2000:9;35–41). Fortunately, we have a bit more time to impact the rates of macrosomia since this complication develops later in pregnancy, in contrast to the development of congenital anomalies so early.
We still have much to learn about the exact levels of glycemia that are necessary to reduce complications, but our current knowledge that different glucose thresholds exist for different types of complications enables us to keep patients motivated to improve glycemic control.
Even when it's not possible to achieve optimal glycemic control, any improvement should be beneficial because it will reduce the rate of complications for a given glucose threshold.
As obstetricians work together to improve care for pregnant patients with type 2 diabetes, it is also important that we develop criteria for blood glucose measurement and monitoring. Should we all measure fasting blood glucose? Postprandial blood glucose? Right now, our approaches vary. We need consistency and clear definitions if we are to compare outcomes effectively.
I always tell patients that if we work together, we will be able to improve outcomes, and I tell them never to give up. In the preconception phase, we aim for an FBG of less than 140 mg/dL, then we work on continuously lowering this level until, at around 20 weeks' gestation, we tighten glycemic control to prevent stillbirth, macrosomia, and metabolic complications.
We need to remember that diabetes in pregnancy is a chronic disease that is extremely demanding, requiring frequent blood glucose tests throughout the day, insulin injections or ingestion of oral hypoglycemic agents, frequent fetal testing, and adherence to a diet protocol. This all requires patient-physician cooperation.
Compliance in these patients should comprise all the above demands so that if a patient fails to adhere to the diabetic protocol, we can ask whether her failure to comply is based on her needs and expectations, or her physician's needs and expectations. In the end, we as obstetricians treat two patients whose needs sometimes coincide and sometimes collide. Our goal is to develop management protocols that maximize the mutual needs of both.
Source CDC
The Diabetes Pandemic
The world is experiencing a diabetes pandemic, with the incidence projected to double worldwide over current levels by 2030. This extraordinary rise in the rate of diabetes worldwide has been paralleled by a similarly rapid rate of increase in the incidence of obesity. Most of the rise in diabetes rate is occurring in the type 2 category.
As a result of this pandemic in the general population, pregnant women also have a high rate of diabetes. Indeed, some clinics report that as many as 20% or more of their pregnant patients have diabetes. This presents an increasing challenge to the practitioner, especially because these patients present not only with diabetes but its associated complications for the mother and for fetal development and fetal outcome.
If there was ever a time when educating practitioners regarding contemporary methods of managing pregnant patients with diabetes is needed, it is now. Thus, we have decided to dedicate two issues of our Master Class series to the management of diabetes in pregnancy. The first installment, below, addresses how diabetes affects perinatal outcomes and how we can work to detect diabetes early and provide intensive treatment. The second installment, scheduled for the December issue, will delve into the use of oral antidiabetic agents in pregnancy.
Between the two parts of this series will be another Master Class that addresses another very challenging public health problem: the novel influenza A(H1N1) pandemic.
Both topics—diabetes in pregnancy, and influenza in pregnancy—are extremely high priority and highly contemporary, and are worthy of significant attention.
For this Master Class, I have invited Oded Langer, M.D, Ph.D., an internationally recognized expert on diabetes in pregnancy who has written and lectured extensively on this subject. Dr. Langer is the Babcock Professor and chairman of the department of obstetrics and gynecology at St. Luke's-Roosevelt Hospital Center, a university hospital of Columbia University in New York.
The world is experiencing a diabetes pandemic, with the incidence projected to double worldwide over current levels by 2030. This extraordinary rise in the rate of diabetes worldwide has been paralleled by a similarly rapid rate of increase in the incidence of obesity. Most of the rise in diabetes rate is occurring in the type 2 category.
As a result of this pandemic in the general population, pregnant women also have a high rate of diabetes. Indeed, some clinics report that as many as 20% or more of their pregnant patients have diabetes. This presents an increasing challenge to the practitioner, especially because these patients present not only with diabetes but its associated complications for the mother and for fetal development and fetal outcome.
If there was ever a time when educating practitioners regarding contemporary methods of managing pregnant patients with diabetes is needed, it is now. Thus, we have decided to dedicate two issues of our Master Class series to the management of diabetes in pregnancy. The first installment, below, addresses how diabetes affects perinatal outcomes and how we can work to detect diabetes early and provide intensive treatment. The second installment, scheduled for the December issue, will delve into the use of oral antidiabetic agents in pregnancy.
Between the two parts of this series will be another Master Class that addresses another very challenging public health problem: the novel influenza A(H1N1) pandemic.
Both topics—diabetes in pregnancy, and influenza in pregnancy—are extremely high priority and highly contemporary, and are worthy of significant attention.
For this Master Class, I have invited Oded Langer, M.D, Ph.D., an internationally recognized expert on diabetes in pregnancy who has written and lectured extensively on this subject. Dr. Langer is the Babcock Professor and chairman of the department of obstetrics and gynecology at St. Luke's-Roosevelt Hospital Center, a university hospital of Columbia University in New York.
The world is experiencing a diabetes pandemic, with the incidence projected to double worldwide over current levels by 2030. This extraordinary rise in the rate of diabetes worldwide has been paralleled by a similarly rapid rate of increase in the incidence of obesity. Most of the rise in diabetes rate is occurring in the type 2 category.
As a result of this pandemic in the general population, pregnant women also have a high rate of diabetes. Indeed, some clinics report that as many as 20% or more of their pregnant patients have diabetes. This presents an increasing challenge to the practitioner, especially because these patients present not only with diabetes but its associated complications for the mother and for fetal development and fetal outcome.
If there was ever a time when educating practitioners regarding contemporary methods of managing pregnant patients with diabetes is needed, it is now. Thus, we have decided to dedicate two issues of our Master Class series to the management of diabetes in pregnancy. The first installment, below, addresses how diabetes affects perinatal outcomes and how we can work to detect diabetes early and provide intensive treatment. The second installment, scheduled for the December issue, will delve into the use of oral antidiabetic agents in pregnancy.
Between the two parts of this series will be another Master Class that addresses another very challenging public health problem: the novel influenza A(H1N1) pandemic.
Both topics—diabetes in pregnancy, and influenza in pregnancy—are extremely high priority and highly contemporary, and are worthy of significant attention.
For this Master Class, I have invited Oded Langer, M.D, Ph.D., an internationally recognized expert on diabetes in pregnancy who has written and lectured extensively on this subject. Dr. Langer is the Babcock Professor and chairman of the department of obstetrics and gynecology at St. Luke's-Roosevelt Hospital Center, a university hospital of Columbia University in New York.
Potential Pitfalls in Pregnant Patients
Operative laparoscopy during pregnancy has been part of the growing field of minimally invasive surgery for more than 2 decades. As efforts during the 1980s to develop laparoscopic techniques unfolded, pregnant women were on the radar screen; one of the first textbooks of minimally invasive surgery, published in the 1980s, for instance, featured a chapter on laparoscopy in pregnancy.
A report on more than 150 patients undergoing laparoscopic appendectomy, including 6 pregnant patients, was published in 1990 (Surg. Endosc. 1990;4:100–2). The first laparoscopic cholecystectomy during pregnancy was reported in 1991 (Obstet. Gynecol. 1991;78[pt. 2]:958–9).
Through the 1990s, as technology improved and laparoscopy assumed a prominent place in gynecologic practice, and as general surgeons acquired more skill in laparoscopy, it became increasingly apparent that pregnant patients with appendicitis, cholecystitis, and other complications—both nonobstetric problems and problems of a more obstetric and gynecologic nature—were among the patients for whom laparoscopic surgery is often the treatment of choice.
Experience with the laparoscopic approach in pregnant patients increased, and anesthesiologists, surgeons, and obstetricians learned more about the effects of excessive intraabdominal pressure, other anesthesia-related problems, and the importance of prophylaxis for deep vein thromboses, among other issues.
Today, we can tell pregnant patients that laparoscopic surgery is a safe option. Data have shown that the second trimester is generally the safest time to intervene, and that most complications—when they do occur—seem to be related to the underlying disorder rather than the surgery per se. Overall, the complication rate for laparoscopic surgery during pregnancy is similar to that in the nonpregnant state.
It is important that we are aware of and knowledgeable about the unique presentation of certain problems during pregnancy, such as acute appendicitis and cholecystitis, and that we are ready to call upon a general surgeon with advanced minimally invasive skills.
Problems Requiring Surgery
Up to 2% of pregnancies are complicated by a surgical problem.
By far the most common surgical condition during pregnancy is acute appendicitis; its incidence is 0.5–1 per 1,000 pregnancies. Other surgical emergencies in pregnancy include acute cholecystitis (with an incidence of 5 per 10,000 pregnancies), intestinal obstruction, persistent ovarian cysts larger than 6 cm, and ovarian torsion and other adnexal problems. (The incidence of adnexal torsion is 1 in 5,000, and the incidence of any adnexal problem complicating pregnancy is 1 per 500–600 pregnancies.)
With the advent of assisted reproductive technologies, the incidence of heterotropic pregnancies is increasing, and growing numbers of successful laparoscopic surgeries for these pregnancies in hemodynamically unstable patients also are being reported. The extrauterine pregnancy can be addressed via salpingostomy or salpingectomy depending on the intraoperative findings. Minimal disturbance of the uterus and intrauterine gestation is the goal of intraoperative management.
The approach to laparoscopic surgery for these patients must take into account the physiological changes of pregnancy, including a 45% increase in plasma volume and a 10%-20% increase in cardiac volume, as well as increased oxygen consumption, decreased functional residual volume, and a theoretical predisposition to thromboembolic complications.
We must also be aware that the Trendelenburg position increases intrathoracic pressure, impairing venous return and accentuating the change in functional residual capacity. We may not, therefore, be able to achieve as steep a Trendelenburg position in pregnancy as in the nonpregnant state.
Because we are dealing with two passengers on these surgical journeys, we also must ensure that we not disturb the uteroplacental blood flow and oxygenation—that is, we must prevent fetal asphyxia and preterm labor—and that we are cognizant of the potential teratogenic effects of analgesics and other medications.
Medications and Assessment
Medications that have been recommended related to surgical intervention during pregnancy include indomethacin supplementation 25–50 mg preoperatively and a second dose 12 hours later. Unfortunately, however, there is a paucity of prospective data to support any one specific recommendation.
Progesterone supplementation—through a vaginal supplement of 25–100 mg postop for up to 7 days—has also been advocated after the procedure. Again, there are no well-designed studies to provide a firm basis for medication support.
Data from studies in ovariectomized rats supports the subcutaneous use of 3 mg of progesterone plus 200 ng of estradiol benzoate for 10–19 days with monitoring of serum progesterone levels (J. Reprod. Fertil. 1990;90:63–70).
Diagnostic procedures utilizing radiation should be limited to 5–10 rad during the first 25 weeks of gestation. Beyond that dosage, chromosomal mutations and neurologic abnormalities become concerns, as does the theoretical increased risk of childhood leukemia and other hematologic cancers.
Assessment CT scans generally are an appropriate test during pregnancy because the amount of radiation is relatively low—from 2 to 4 rad for a single study. MR imaging is appropriate, of course, as it does not involve ionizing radiation. Potentially concerning is the use of a contrast agent with CT or MR imaging. Gadolinium is commonly used in pregnancy; the use of this or other contrast agents should be discussed by the obstetrician and radiologist.
The second trimester is generally the safest time to intervene because there is a higher incidence of preterm labor in the third trimester and spontaneous abortion during the first trimester. The incidence of miscarriage after surgery in the second trimester is 5.6%, compared with 12% in the first trimester.
Ideally, pre-, intra-, and postoperative management should be planned through multispecialty discussion involving anesthesiologists, general surgeons, and gynecologic surgeons.
Preanesthetic medications include benzodiazepines (for example, midazolam) and/or opioids (such as Fentanyl administered intravenously). Intravenous induction agents include propofol, barbiturates, ketamine, and etomidate (Arch. Gynecol. Obstet. 2007;276:201–9). Neuromuscular blocking medications include succinylcholine, vecuronium, or atracurium complemented by the administration of nitrous oxide.
Operative Management
Patient positioning during surgery is critical. The pregnant patient should be placed in the left lateral decubitus position, with her right hip elevated, to minimize interference with venous return. She must also undergo a more gradual, careful change to the Trendelenburg position than a nonpregnant patient would, and even more gradual reverse Trendelenburg positional changes.
Intraoperative monitoring should include measurement of vital signs, oxygen saturation, and end-tidal CO2 level, and observation of uterine activity. Intraabdominal pressure generally should be in the range of 12–15 mm Hg. Ideally, lower-extremity pneumatic compression devices should be utilized.
Careful monitoring for signs of preterm labor is also important. Fetal heart rate monitoring can provide useful data, both preoperatively and postoperatively. The use of tocolytic agents is certainly indicated when there are signs of preterm labor, but there is minimal support among experts for routine prophylactic tocolysis in the second trimester. Depending on the clinical circumstance, at 24 weeks' gestation, tocolysis can be considered.
Experts have debated for years the gestational age at which the uterus limits laparoscopic access to the abdominal cavity, and there still is no consensus.
Controversy continues over the use of the open laparoscopic technique versus the use of the Veress needle traditional technique (closed), especially in the left upper quadrant. Researchers are also investigating the use of gasless laparoscopy during pregnancy.
The vast majority of gynecologic and general surgeons who perform laparoscopic surgery in pregnant patients lean toward an open laparoscopic technique, but the closed and gasless techniques are also acceptable. I favor the primary use of an open approach with the Hasson cannula. This often provides better overall control with regard to entrance into the peritoneal cavity.
Clinicians who opt to use a Veress needle are certainly focused on an acceptable alternative to introduction of CO2 into the peritoneal cavity. The decision-making process is primarily a reflection of the gynecologic surgeon's training and level of comfort.
We should strive to avoid placing any instruments near the cervix. A sponge on a stick can provide an element of uterine manipulation in an atraumatic manner.
Secondary trocar placement must take into account the size of the uterus, with secondary trocar sleeves placed above the umbilicus and away from the uterus. Careful planning of where ports should be placed is a wise idea prior to making the skin incision. Inferior epigastric vessels should be identified to include superficial branches.
Direct visualization of trocar entrance into the abdominal cavity is of paramount importance and should be documented in the record accordingly.
Prompt Diagnosis
Associated morbidity makes a prompt diagnosis of acute appendicitis or cholecystitis critical. As obstetricians we should be well versed in the various symptoms and clinical presentation of these problems in pregnant patients. We must have a high index of suspicion and be ready to engage a general surgeon colleague early on.
A diagnosis of appendicitis can all too easily be delayed because of the displacement of the appendix by the gravid uterus and the normal physiological leukocytosis of pregnancy. The consequences of delay, however, are significant: The incidence of fetal loss is as high as 35% when the appendix ruptures, compared with 1.5% with uncomplicated appendicitis.
The appendix changes location during gestation, rising progressively above the McBurney point. At 8 or 9 months, the appendix can essentially be as high as the top of the uterine fundus. As an inflamed appendix drifts away from the abdominal wall, the signs of peritoneal irritation are often minimized; fewer than half of pregnant patients, in fact, have peritoneal signs.
During the first trimester, the pain is primarily in the area of the McBurney point, and sometimes in the pelvic area. In the second trimester, the pain is associated with the displacement of the appendix, with the point of maximal tenderness frequently above the iliac crest. In the third trimester, pain and tenderness may be localized to the right costal margin. Irrespective of the trimester, patients often have right lateral rectal tenderness.
The pain of appendicitis must be differentiated from the pain of uterine origin. The latter often can be alleviated by providing adequate hydration and placing the patient in the decubitus position. Both Alder's sign (fixed tenderness) and Bryan's sign (tenderness in the right lateral position) can help with this differentiation.
Acute cholecystitis often presents initially with biliary colic associated with nausea and vomiting. When the common bile duct is obstructed by a stone, pain persists and often radiates to the subscapular area, right flank, or shoulder. Patients typically have right subcostal tenderness associated with fever.
Ultrasonography is usually effective for diagnosing the presence of stones or dilatation of the common bile duct. Technetium-99m-iminodiacetic acid scans of the gallbladder can be used in pregnancy with minimal risk of radiation exposure.
Whenever possible, first-trimester patients with cholecystitis should be treated conservatively until the second trimester. Any patient who does not improve with medical management, however, should undergo laparoscopic surgery regardless of the gestational age of the fetus.
With adnexal cysts, it is generally acceptable to provide expectant management if the enlargement is less than 6 cm. There is evidence that 80%-90% of these enlargements will resolve spontaneously.
Again, it is of paramount importance that the obstetrician/gynecologist is cognizant of the anatomic and physiological changes associated with pregnancy. The option of a minimally invasive approach is often appropriate and timely in the management of nonobstetric emergencies during pregnancy.
Source ELSEVIER GLOBAL MEDICAL NEWS
Laparoscopic Surgery During Pregnancy
In a large multisurgeon survey published by the Society of Laparoendoscopic Surgeons, 1.2% of the 16,329 surgeon members said they performed laparoscopic procedures in pregnancy. The most common of the 413 laparoscopic procedures performed in pregnancy by these 192 surgeons appeared to be cholecystectomies, adnexal procedures, and appendectomies (J. Reprod. Med. 1997;42:33–8).
In an excellent review article (Obstet. Gynecol. Surv. 2001;56:50–9), Dr. Mohammad Fatum and Dr. Nathan Rojansky from Hadassah Ein-Kerem Medical Center and the Hebrew University Medical School, Jerusalem, noted the following major advantages of laparoscopic surgery during pregnancy:
▸ Small abdominal incisions resulting in rapid postoperative recovery and early mobilization, thus minimizing the increased risk of thromboembolism associated with pregnancy.
▸ Early return of gastrointestinal activity because of less manipulation of the bowel during surgery, which may result in fewer postoperative adhesions and intestinal obstruction.
▸ Smaller scars.
▸ Fewer incisional hernias.
▸ A reduced rate of fetal depression because of decreased pain and less narcotic use.
▸ Shorter hospitalization time and a prompt return to regular life.
I am pleased that Dr. Joseph S. Sanfilippo agreed to author this edition of the Master Class in Gynecologic Surgery on laparoscopic surgery during pregnancy.
A 1973 Chicago Medical School graduate, Dr. Sanfilippo was honored with a Distinguished Alumnus Award in 1990. He completed his fellowship in reproductive endocrinology and infertility at the University of Louisville (Ky.) School of Medicine and later gained his MBA degree at Chatham College in Pittsburgh.
Currently, Dr. Sanfilippo is professor of obstetrics, gynecology, and reproductive sciences; vice chairman of reproductive sciences; and director of reproductive endocrinology and infertility at Magee-Womens Hospital, Pittsburgh.
He has been a prolific researcher and author, particularly in the areas of surgery, reproductive medicine, and adolescent gynecology.
He also is considered an expert in laparoscopic surgery in pregnancy and has contributed to literature in this area as well.
Laparoscopic Cholecystectomy
▸ The overall complication rate for this procedure has been reported to be 0.75% in the literature.
▸ The highest incidence of fetal loss associated with laparoscopic cholecystectomy is in the first trimester, and the highest incidence of premature labor is in the third trimester.
▸ Elective abortion is not recommended, even with an intraoperative cholangiogram.
▸ Extrahepatic biliary obstruction due to gallstones can be managed laparoscopically.
Source: Dr. Sanfilippo
Operative laparoscopy during pregnancy has been part of the growing field of minimally invasive surgery for more than 2 decades. As efforts during the 1980s to develop laparoscopic techniques unfolded, pregnant women were on the radar screen; one of the first textbooks of minimally invasive surgery, published in the 1980s, for instance, featured a chapter on laparoscopy in pregnancy.
A report on more than 150 patients undergoing laparoscopic appendectomy, including 6 pregnant patients, was published in 1990 (Surg. Endosc. 1990;4:100–2). The first laparoscopic cholecystectomy during pregnancy was reported in 1991 (Obstet. Gynecol. 1991;78[pt. 2]:958–9).
Through the 1990s, as technology improved and laparoscopy assumed a prominent place in gynecologic practice, and as general surgeons acquired more skill in laparoscopy, it became increasingly apparent that pregnant patients with appendicitis, cholecystitis, and other complications—both nonobstetric problems and problems of a more obstetric and gynecologic nature—were among the patients for whom laparoscopic surgery is often the treatment of choice.
Experience with the laparoscopic approach in pregnant patients increased, and anesthesiologists, surgeons, and obstetricians learned more about the effects of excessive intraabdominal pressure, other anesthesia-related problems, and the importance of prophylaxis for deep vein thromboses, among other issues.
Today, we can tell pregnant patients that laparoscopic surgery is a safe option. Data have shown that the second trimester is generally the safest time to intervene, and that most complications—when they do occur—seem to be related to the underlying disorder rather than the surgery per se. Overall, the complication rate for laparoscopic surgery during pregnancy is similar to that in the nonpregnant state.
It is important that we are aware of and knowledgeable about the unique presentation of certain problems during pregnancy, such as acute appendicitis and cholecystitis, and that we are ready to call upon a general surgeon with advanced minimally invasive skills.
Problems Requiring Surgery
Up to 2% of pregnancies are complicated by a surgical problem.
By far the most common surgical condition during pregnancy is acute appendicitis; its incidence is 0.5–1 per 1,000 pregnancies. Other surgical emergencies in pregnancy include acute cholecystitis (with an incidence of 5 per 10,000 pregnancies), intestinal obstruction, persistent ovarian cysts larger than 6 cm, and ovarian torsion and other adnexal problems. (The incidence of adnexal torsion is 1 in 5,000, and the incidence of any adnexal problem complicating pregnancy is 1 per 500–600 pregnancies.)
With the advent of assisted reproductive technologies, the incidence of heterotropic pregnancies is increasing, and growing numbers of successful laparoscopic surgeries for these pregnancies in hemodynamically unstable patients also are being reported. The extrauterine pregnancy can be addressed via salpingostomy or salpingectomy depending on the intraoperative findings. Minimal disturbance of the uterus and intrauterine gestation is the goal of intraoperative management.
The approach to laparoscopic surgery for these patients must take into account the physiological changes of pregnancy, including a 45% increase in plasma volume and a 10%-20% increase in cardiac volume, as well as increased oxygen consumption, decreased functional residual volume, and a theoretical predisposition to thromboembolic complications.
We must also be aware that the Trendelenburg position increases intrathoracic pressure, impairing venous return and accentuating the change in functional residual capacity. We may not, therefore, be able to achieve as steep a Trendelenburg position in pregnancy as in the nonpregnant state.
Because we are dealing with two passengers on these surgical journeys, we also must ensure that we not disturb the uteroplacental blood flow and oxygenation—that is, we must prevent fetal asphyxia and preterm labor—and that we are cognizant of the potential teratogenic effects of analgesics and other medications.
Medications and Assessment
Medications that have been recommended related to surgical intervention during pregnancy include indomethacin supplementation 25–50 mg preoperatively and a second dose 12 hours later. Unfortunately, however, there is a paucity of prospective data to support any one specific recommendation.
Progesterone supplementation—through a vaginal supplement of 25–100 mg postop for up to 7 days—has also been advocated after the procedure. Again, there are no well-designed studies to provide a firm basis for medication support.
Data from studies in ovariectomized rats supports the subcutaneous use of 3 mg of progesterone plus 200 ng of estradiol benzoate for 10–19 days with monitoring of serum progesterone levels (J. Reprod. Fertil. 1990;90:63–70).
Diagnostic procedures utilizing radiation should be limited to 5–10 rad during the first 25 weeks of gestation. Beyond that dosage, chromosomal mutations and neurologic abnormalities become concerns, as does the theoretical increased risk of childhood leukemia and other hematologic cancers.
Assessment CT scans generally are an appropriate test during pregnancy because the amount of radiation is relatively low—from 2 to 4 rad for a single study. MR imaging is appropriate, of course, as it does not involve ionizing radiation. Potentially concerning is the use of a contrast agent with CT or MR imaging. Gadolinium is commonly used in pregnancy; the use of this or other contrast agents should be discussed by the obstetrician and radiologist.
The second trimester is generally the safest time to intervene because there is a higher incidence of preterm labor in the third trimester and spontaneous abortion during the first trimester. The incidence of miscarriage after surgery in the second trimester is 5.6%, compared with 12% in the first trimester.
Ideally, pre-, intra-, and postoperative management should be planned through multispecialty discussion involving anesthesiologists, general surgeons, and gynecologic surgeons.
Preanesthetic medications include benzodiazepines (for example, midazolam) and/or opioids (such as Fentanyl administered intravenously). Intravenous induction agents include propofol, barbiturates, ketamine, and etomidate (Arch. Gynecol. Obstet. 2007;276:201–9). Neuromuscular blocking medications include succinylcholine, vecuronium, or atracurium complemented by the administration of nitrous oxide.
Operative Management
Patient positioning during surgery is critical. The pregnant patient should be placed in the left lateral decubitus position, with her right hip elevated, to minimize interference with venous return. She must also undergo a more gradual, careful change to the Trendelenburg position than a nonpregnant patient would, and even more gradual reverse Trendelenburg positional changes.
Intraoperative monitoring should include measurement of vital signs, oxygen saturation, and end-tidal CO2 level, and observation of uterine activity. Intraabdominal pressure generally should be in the range of 12–15 mm Hg. Ideally, lower-extremity pneumatic compression devices should be utilized.
Careful monitoring for signs of preterm labor is also important. Fetal heart rate monitoring can provide useful data, both preoperatively and postoperatively. The use of tocolytic agents is certainly indicated when there are signs of preterm labor, but there is minimal support among experts for routine prophylactic tocolysis in the second trimester. Depending on the clinical circumstance, at 24 weeks' gestation, tocolysis can be considered.
Experts have debated for years the gestational age at which the uterus limits laparoscopic access to the abdominal cavity, and there still is no consensus.
Controversy continues over the use of the open laparoscopic technique versus the use of the Veress needle traditional technique (closed), especially in the left upper quadrant. Researchers are also investigating the use of gasless laparoscopy during pregnancy.
The vast majority of gynecologic and general surgeons who perform laparoscopic surgery in pregnant patients lean toward an open laparoscopic technique, but the closed and gasless techniques are also acceptable. I favor the primary use of an open approach with the Hasson cannula. This often provides better overall control with regard to entrance into the peritoneal cavity.
Clinicians who opt to use a Veress needle are certainly focused on an acceptable alternative to introduction of CO2 into the peritoneal cavity. The decision-making process is primarily a reflection of the gynecologic surgeon's training and level of comfort.
We should strive to avoid placing any instruments near the cervix. A sponge on a stick can provide an element of uterine manipulation in an atraumatic manner.
Secondary trocar placement must take into account the size of the uterus, with secondary trocar sleeves placed above the umbilicus and away from the uterus. Careful planning of where ports should be placed is a wise idea prior to making the skin incision. Inferior epigastric vessels should be identified to include superficial branches.
Direct visualization of trocar entrance into the abdominal cavity is of paramount importance and should be documented in the record accordingly.
Prompt Diagnosis
Associated morbidity makes a prompt diagnosis of acute appendicitis or cholecystitis critical. As obstetricians we should be well versed in the various symptoms and clinical presentation of these problems in pregnant patients. We must have a high index of suspicion and be ready to engage a general surgeon colleague early on.
A diagnosis of appendicitis can all too easily be delayed because of the displacement of the appendix by the gravid uterus and the normal physiological leukocytosis of pregnancy. The consequences of delay, however, are significant: The incidence of fetal loss is as high as 35% when the appendix ruptures, compared with 1.5% with uncomplicated appendicitis.
The appendix changes location during gestation, rising progressively above the McBurney point. At 8 or 9 months, the appendix can essentially be as high as the top of the uterine fundus. As an inflamed appendix drifts away from the abdominal wall, the signs of peritoneal irritation are often minimized; fewer than half of pregnant patients, in fact, have peritoneal signs.
During the first trimester, the pain is primarily in the area of the McBurney point, and sometimes in the pelvic area. In the second trimester, the pain is associated with the displacement of the appendix, with the point of maximal tenderness frequently above the iliac crest. In the third trimester, pain and tenderness may be localized to the right costal margin. Irrespective of the trimester, patients often have right lateral rectal tenderness.
The pain of appendicitis must be differentiated from the pain of uterine origin. The latter often can be alleviated by providing adequate hydration and placing the patient in the decubitus position. Both Alder's sign (fixed tenderness) and Bryan's sign (tenderness in the right lateral position) can help with this differentiation.
Acute cholecystitis often presents initially with biliary colic associated with nausea and vomiting. When the common bile duct is obstructed by a stone, pain persists and often radiates to the subscapular area, right flank, or shoulder. Patients typically have right subcostal tenderness associated with fever.
Ultrasonography is usually effective for diagnosing the presence of stones or dilatation of the common bile duct. Technetium-99m-iminodiacetic acid scans of the gallbladder can be used in pregnancy with minimal risk of radiation exposure.
Whenever possible, first-trimester patients with cholecystitis should be treated conservatively until the second trimester. Any patient who does not improve with medical management, however, should undergo laparoscopic surgery regardless of the gestational age of the fetus.
With adnexal cysts, it is generally acceptable to provide expectant management if the enlargement is less than 6 cm. There is evidence that 80%-90% of these enlargements will resolve spontaneously.
Again, it is of paramount importance that the obstetrician/gynecologist is cognizant of the anatomic and physiological changes associated with pregnancy. The option of a minimally invasive approach is often appropriate and timely in the management of nonobstetric emergencies during pregnancy.
Source ELSEVIER GLOBAL MEDICAL NEWS
Laparoscopic Surgery During Pregnancy
In a large multisurgeon survey published by the Society of Laparoendoscopic Surgeons, 1.2% of the 16,329 surgeon members said they performed laparoscopic procedures in pregnancy. The most common of the 413 laparoscopic procedures performed in pregnancy by these 192 surgeons appeared to be cholecystectomies, adnexal procedures, and appendectomies (J. Reprod. Med. 1997;42:33–8).
In an excellent review article (Obstet. Gynecol. Surv. 2001;56:50–9), Dr. Mohammad Fatum and Dr. Nathan Rojansky from Hadassah Ein-Kerem Medical Center and the Hebrew University Medical School, Jerusalem, noted the following major advantages of laparoscopic surgery during pregnancy:
▸ Small abdominal incisions resulting in rapid postoperative recovery and early mobilization, thus minimizing the increased risk of thromboembolism associated with pregnancy.
▸ Early return of gastrointestinal activity because of less manipulation of the bowel during surgery, which may result in fewer postoperative adhesions and intestinal obstruction.
▸ Smaller scars.
▸ Fewer incisional hernias.
▸ A reduced rate of fetal depression because of decreased pain and less narcotic use.
▸ Shorter hospitalization time and a prompt return to regular life.
I am pleased that Dr. Joseph S. Sanfilippo agreed to author this edition of the Master Class in Gynecologic Surgery on laparoscopic surgery during pregnancy.
A 1973 Chicago Medical School graduate, Dr. Sanfilippo was honored with a Distinguished Alumnus Award in 1990. He completed his fellowship in reproductive endocrinology and infertility at the University of Louisville (Ky.) School of Medicine and later gained his MBA degree at Chatham College in Pittsburgh.
Currently, Dr. Sanfilippo is professor of obstetrics, gynecology, and reproductive sciences; vice chairman of reproductive sciences; and director of reproductive endocrinology and infertility at Magee-Womens Hospital, Pittsburgh.
He has been a prolific researcher and author, particularly in the areas of surgery, reproductive medicine, and adolescent gynecology.
He also is considered an expert in laparoscopic surgery in pregnancy and has contributed to literature in this area as well.
Laparoscopic Cholecystectomy
▸ The overall complication rate for this procedure has been reported to be 0.75% in the literature.
▸ The highest incidence of fetal loss associated with laparoscopic cholecystectomy is in the first trimester, and the highest incidence of premature labor is in the third trimester.
▸ Elective abortion is not recommended, even with an intraoperative cholangiogram.
▸ Extrahepatic biliary obstruction due to gallstones can be managed laparoscopically.
Source: Dr. Sanfilippo
Operative laparoscopy during pregnancy has been part of the growing field of minimally invasive surgery for more than 2 decades. As efforts during the 1980s to develop laparoscopic techniques unfolded, pregnant women were on the radar screen; one of the first textbooks of minimally invasive surgery, published in the 1980s, for instance, featured a chapter on laparoscopy in pregnancy.
A report on more than 150 patients undergoing laparoscopic appendectomy, including 6 pregnant patients, was published in 1990 (Surg. Endosc. 1990;4:100–2). The first laparoscopic cholecystectomy during pregnancy was reported in 1991 (Obstet. Gynecol. 1991;78[pt. 2]:958–9).
Through the 1990s, as technology improved and laparoscopy assumed a prominent place in gynecologic practice, and as general surgeons acquired more skill in laparoscopy, it became increasingly apparent that pregnant patients with appendicitis, cholecystitis, and other complications—both nonobstetric problems and problems of a more obstetric and gynecologic nature—were among the patients for whom laparoscopic surgery is often the treatment of choice.
Experience with the laparoscopic approach in pregnant patients increased, and anesthesiologists, surgeons, and obstetricians learned more about the effects of excessive intraabdominal pressure, other anesthesia-related problems, and the importance of prophylaxis for deep vein thromboses, among other issues.
Today, we can tell pregnant patients that laparoscopic surgery is a safe option. Data have shown that the second trimester is generally the safest time to intervene, and that most complications—when they do occur—seem to be related to the underlying disorder rather than the surgery per se. Overall, the complication rate for laparoscopic surgery during pregnancy is similar to that in the nonpregnant state.
It is important that we are aware of and knowledgeable about the unique presentation of certain problems during pregnancy, such as acute appendicitis and cholecystitis, and that we are ready to call upon a general surgeon with advanced minimally invasive skills.
Problems Requiring Surgery
Up to 2% of pregnancies are complicated by a surgical problem.
By far the most common surgical condition during pregnancy is acute appendicitis; its incidence is 0.5–1 per 1,000 pregnancies. Other surgical emergencies in pregnancy include acute cholecystitis (with an incidence of 5 per 10,000 pregnancies), intestinal obstruction, persistent ovarian cysts larger than 6 cm, and ovarian torsion and other adnexal problems. (The incidence of adnexal torsion is 1 in 5,000, and the incidence of any adnexal problem complicating pregnancy is 1 per 500–600 pregnancies.)
With the advent of assisted reproductive technologies, the incidence of heterotropic pregnancies is increasing, and growing numbers of successful laparoscopic surgeries for these pregnancies in hemodynamically unstable patients also are being reported. The extrauterine pregnancy can be addressed via salpingostomy or salpingectomy depending on the intraoperative findings. Minimal disturbance of the uterus and intrauterine gestation is the goal of intraoperative management.
The approach to laparoscopic surgery for these patients must take into account the physiological changes of pregnancy, including a 45% increase in plasma volume and a 10%-20% increase in cardiac volume, as well as increased oxygen consumption, decreased functional residual volume, and a theoretical predisposition to thromboembolic complications.
We must also be aware that the Trendelenburg position increases intrathoracic pressure, impairing venous return and accentuating the change in functional residual capacity. We may not, therefore, be able to achieve as steep a Trendelenburg position in pregnancy as in the nonpregnant state.
Because we are dealing with two passengers on these surgical journeys, we also must ensure that we not disturb the uteroplacental blood flow and oxygenation—that is, we must prevent fetal asphyxia and preterm labor—and that we are cognizant of the potential teratogenic effects of analgesics and other medications.
Medications and Assessment
Medications that have been recommended related to surgical intervention during pregnancy include indomethacin supplementation 25–50 mg preoperatively and a second dose 12 hours later. Unfortunately, however, there is a paucity of prospective data to support any one specific recommendation.
Progesterone supplementation—through a vaginal supplement of 25–100 mg postop for up to 7 days—has also been advocated after the procedure. Again, there are no well-designed studies to provide a firm basis for medication support.
Data from studies in ovariectomized rats supports the subcutaneous use of 3 mg of progesterone plus 200 ng of estradiol benzoate for 10–19 days with monitoring of serum progesterone levels (J. Reprod. Fertil. 1990;90:63–70).
Diagnostic procedures utilizing radiation should be limited to 5–10 rad during the first 25 weeks of gestation. Beyond that dosage, chromosomal mutations and neurologic abnormalities become concerns, as does the theoretical increased risk of childhood leukemia and other hematologic cancers.
Assessment CT scans generally are an appropriate test during pregnancy because the amount of radiation is relatively low—from 2 to 4 rad for a single study. MR imaging is appropriate, of course, as it does not involve ionizing radiation. Potentially concerning is the use of a contrast agent with CT or MR imaging. Gadolinium is commonly used in pregnancy; the use of this or other contrast agents should be discussed by the obstetrician and radiologist.
The second trimester is generally the safest time to intervene because there is a higher incidence of preterm labor in the third trimester and spontaneous abortion during the first trimester. The incidence of miscarriage after surgery in the second trimester is 5.6%, compared with 12% in the first trimester.
Ideally, pre-, intra-, and postoperative management should be planned through multispecialty discussion involving anesthesiologists, general surgeons, and gynecologic surgeons.
Preanesthetic medications include benzodiazepines (for example, midazolam) and/or opioids (such as Fentanyl administered intravenously). Intravenous induction agents include propofol, barbiturates, ketamine, and etomidate (Arch. Gynecol. Obstet. 2007;276:201–9). Neuromuscular blocking medications include succinylcholine, vecuronium, or atracurium complemented by the administration of nitrous oxide.
Operative Management
Patient positioning during surgery is critical. The pregnant patient should be placed in the left lateral decubitus position, with her right hip elevated, to minimize interference with venous return. She must also undergo a more gradual, careful change to the Trendelenburg position than a nonpregnant patient would, and even more gradual reverse Trendelenburg positional changes.
Intraoperative monitoring should include measurement of vital signs, oxygen saturation, and end-tidal CO2 level, and observation of uterine activity. Intraabdominal pressure generally should be in the range of 12–15 mm Hg. Ideally, lower-extremity pneumatic compression devices should be utilized.
Careful monitoring for signs of preterm labor is also important. Fetal heart rate monitoring can provide useful data, both preoperatively and postoperatively. The use of tocolytic agents is certainly indicated when there are signs of preterm labor, but there is minimal support among experts for routine prophylactic tocolysis in the second trimester. Depending on the clinical circumstance, at 24 weeks' gestation, tocolysis can be considered.
Experts have debated for years the gestational age at which the uterus limits laparoscopic access to the abdominal cavity, and there still is no consensus.
Controversy continues over the use of the open laparoscopic technique versus the use of the Veress needle traditional technique (closed), especially in the left upper quadrant. Researchers are also investigating the use of gasless laparoscopy during pregnancy.
The vast majority of gynecologic and general surgeons who perform laparoscopic surgery in pregnant patients lean toward an open laparoscopic technique, but the closed and gasless techniques are also acceptable. I favor the primary use of an open approach with the Hasson cannula. This often provides better overall control with regard to entrance into the peritoneal cavity.
Clinicians who opt to use a Veress needle are certainly focused on an acceptable alternative to introduction of CO2 into the peritoneal cavity. The decision-making process is primarily a reflection of the gynecologic surgeon's training and level of comfort.
We should strive to avoid placing any instruments near the cervix. A sponge on a stick can provide an element of uterine manipulation in an atraumatic manner.
Secondary trocar placement must take into account the size of the uterus, with secondary trocar sleeves placed above the umbilicus and away from the uterus. Careful planning of where ports should be placed is a wise idea prior to making the skin incision. Inferior epigastric vessels should be identified to include superficial branches.
Direct visualization of trocar entrance into the abdominal cavity is of paramount importance and should be documented in the record accordingly.
Prompt Diagnosis
Associated morbidity makes a prompt diagnosis of acute appendicitis or cholecystitis critical. As obstetricians we should be well versed in the various symptoms and clinical presentation of these problems in pregnant patients. We must have a high index of suspicion and be ready to engage a general surgeon colleague early on.
A diagnosis of appendicitis can all too easily be delayed because of the displacement of the appendix by the gravid uterus and the normal physiological leukocytosis of pregnancy. The consequences of delay, however, are significant: The incidence of fetal loss is as high as 35% when the appendix ruptures, compared with 1.5% with uncomplicated appendicitis.
The appendix changes location during gestation, rising progressively above the McBurney point. At 8 or 9 months, the appendix can essentially be as high as the top of the uterine fundus. As an inflamed appendix drifts away from the abdominal wall, the signs of peritoneal irritation are often minimized; fewer than half of pregnant patients, in fact, have peritoneal signs.
During the first trimester, the pain is primarily in the area of the McBurney point, and sometimes in the pelvic area. In the second trimester, the pain is associated with the displacement of the appendix, with the point of maximal tenderness frequently above the iliac crest. In the third trimester, pain and tenderness may be localized to the right costal margin. Irrespective of the trimester, patients often have right lateral rectal tenderness.
The pain of appendicitis must be differentiated from the pain of uterine origin. The latter often can be alleviated by providing adequate hydration and placing the patient in the decubitus position. Both Alder's sign (fixed tenderness) and Bryan's sign (tenderness in the right lateral position) can help with this differentiation.
Acute cholecystitis often presents initially with biliary colic associated with nausea and vomiting. When the common bile duct is obstructed by a stone, pain persists and often radiates to the subscapular area, right flank, or shoulder. Patients typically have right subcostal tenderness associated with fever.
Ultrasonography is usually effective for diagnosing the presence of stones or dilatation of the common bile duct. Technetium-99m-iminodiacetic acid scans of the gallbladder can be used in pregnancy with minimal risk of radiation exposure.
Whenever possible, first-trimester patients with cholecystitis should be treated conservatively until the second trimester. Any patient who does not improve with medical management, however, should undergo laparoscopic surgery regardless of the gestational age of the fetus.
With adnexal cysts, it is generally acceptable to provide expectant management if the enlargement is less than 6 cm. There is evidence that 80%-90% of these enlargements will resolve spontaneously.
Again, it is of paramount importance that the obstetrician/gynecologist is cognizant of the anatomic and physiological changes associated with pregnancy. The option of a minimally invasive approach is often appropriate and timely in the management of nonobstetric emergencies during pregnancy.
Source ELSEVIER GLOBAL MEDICAL NEWS
Laparoscopic Surgery During Pregnancy
In a large multisurgeon survey published by the Society of Laparoendoscopic Surgeons, 1.2% of the 16,329 surgeon members said they performed laparoscopic procedures in pregnancy. The most common of the 413 laparoscopic procedures performed in pregnancy by these 192 surgeons appeared to be cholecystectomies, adnexal procedures, and appendectomies (J. Reprod. Med. 1997;42:33–8).
In an excellent review article (Obstet. Gynecol. Surv. 2001;56:50–9), Dr. Mohammad Fatum and Dr. Nathan Rojansky from Hadassah Ein-Kerem Medical Center and the Hebrew University Medical School, Jerusalem, noted the following major advantages of laparoscopic surgery during pregnancy:
▸ Small abdominal incisions resulting in rapid postoperative recovery and early mobilization, thus minimizing the increased risk of thromboembolism associated with pregnancy.
▸ Early return of gastrointestinal activity because of less manipulation of the bowel during surgery, which may result in fewer postoperative adhesions and intestinal obstruction.
▸ Smaller scars.
▸ Fewer incisional hernias.
▸ A reduced rate of fetal depression because of decreased pain and less narcotic use.
▸ Shorter hospitalization time and a prompt return to regular life.
I am pleased that Dr. Joseph S. Sanfilippo agreed to author this edition of the Master Class in Gynecologic Surgery on laparoscopic surgery during pregnancy.
A 1973 Chicago Medical School graduate, Dr. Sanfilippo was honored with a Distinguished Alumnus Award in 1990. He completed his fellowship in reproductive endocrinology and infertility at the University of Louisville (Ky.) School of Medicine and later gained his MBA degree at Chatham College in Pittsburgh.
Currently, Dr. Sanfilippo is professor of obstetrics, gynecology, and reproductive sciences; vice chairman of reproductive sciences; and director of reproductive endocrinology and infertility at Magee-Womens Hospital, Pittsburgh.
He has been a prolific researcher and author, particularly in the areas of surgery, reproductive medicine, and adolescent gynecology.
He also is considered an expert in laparoscopic surgery in pregnancy and has contributed to literature in this area as well.
Laparoscopic Cholecystectomy
▸ The overall complication rate for this procedure has been reported to be 0.75% in the literature.
▸ The highest incidence of fetal loss associated with laparoscopic cholecystectomy is in the first trimester, and the highest incidence of premature labor is in the third trimester.
▸ Elective abortion is not recommended, even with an intraoperative cholangiogram.
▸ Extrahepatic biliary obstruction due to gallstones can be managed laparoscopically.
Source: Dr. Sanfilippo