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COMMENT & CONTROVERSY
OBSTETRIC ANAL SPHINCTER INJURY: PREVENTION AND REPAIR
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2021)
Experience with warm perineal compresses and massage
I have been a midwife for 45 years. I have used warm compresses on the perineum my whole career. I don't need data to tell me it provides comfort. My patients do.
I don't do much massage of the perineum, only slightly while applying K-Y or another water-soluble gel.
A slow, controlled extension of the vertex and healthy tissue is the best way to prevent tears.
Karen Parker, MN, CNM
Ashland, Oregon
Dr. Barbieri responds
I thank Ms. Parker for her clinical recommendation: "Yes to warm compresses" and "Massage of the perineum?" Not so much.
Continue to: CESAREAN MYOMECTOMY...
CESAREAN MYOMECTOMY: SAFE OPERATION OR SURGICAL FOLLY?
ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2021)
Timely comments on cesarean myomectomy
Dr. Barbieri's editorial on cesarean myomectomy is very timely, especially the quote from Dr. K.S.J. Olah: "The berating I received was severe and disproportionate to the crime. The rule was that myomectomy performed at cesarean section was not just frowned upon but expressly forbidden."
I had a very similar experience with panniculectomy and "tummy tuck" as a part of cesarean delivery (CD). Traditionally, a combination of a CD with any other surgical procedures (myomectomy, abdominoplasty, and so on) has not been accepted in the obstetric community. The main reason for such an opinion has been the unfounded fear of complications of combined procedures, including but not limited to infection, hematomas, and poor wound healing. None of these concerns have been supported by studies. Obvious advantages of combining a CD with other surgical procedures, including abdominoplasty, are obvious: the elimination of a second anesthesia, increased patient satisfaction, and no need for a second surgery.
We reviewed the outcomes in 52 patients who underwent a combination of CD with other procedures (such as panniculectomy, abdominoplasty, hernia repairs, myomectomies, and ovarian biopsies). The postsurgical outcomes included in the analysis were postsurgical fever and the presence of seromas, hematomas, and wound dehiscence.1 Twelve of our own patients had a panniculectomy during CD performed by a plastic surgeon. While the preoperative complications of panniculectomy may have been well described, there is a paucity of data in women who underwent the cosmetic procedure at the time of CD. We concluded that the performance of a panniculectomy and tummy tuck as part of a CD does not appear to increase surgical complications in patients with a high body mass index. Our preliminary results and call for further studies were received at the American College of Surgeons 2017 meeting in San Diego.2
Boris Petrikovsky, MD, PhD
Sunny Island Beach, Florida
References
1. Petrikovsky BM, Swancoat S, Zharov EV. Safety of panniculectomy during cesarean section: a prospective, non-randomized study. J Reprod Med. 2019;64:197-200.
2. Petrikovsky BM. Is the combination of panniculectomy and cesarean section safe? Scientific Poster Presentation-Obstetrics and Gynecology. J Am Coll Surg. 2017;225(4 suppl 2):E130.
Dr. Barbieri responds
I agree with Dr. Petrikovsky that advances in the field of obstetrical surgery have been inhibited by a tendency to criticize innovation. Less than 40 years ago, leaders in gynecology did not initially accept the application of minimally invasive gynecology surgical techniques to common gyn procedures including hysterectomy. Every surgical field is rapidly innovating. Obstetrical surgeons should be encouraged to pursue new approaches, as you are doing. We wish you success in your pioneering work.
Continue to: A CASE OF BV...
A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH
CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021)
Secnidazole for treatment of BV
The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients.
Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.1 There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy.
Steven E. Chavoustie, MD
North Miami, Florida
Reference
1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S.
Drs. Reeder and Duff respond
We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.1 Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16.
Reference
1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386.
Continue to: OPTIMIZING THE USE OF...
OPTIMIZING THE USE OF OXYTOCIN ON LABOR AND DELIVERY
ROBERT L. BARBIERI, MD (EDITORIAL; JANUARY 2021)
Vigilant labor progress aids in oxytocin optimization
I read with particular interest Dr. Barbieri's editorial on optimizing oxytocin infusion. This topic is relevant for my practice as I am the kind of physician described and I usually get upset when the oxytocin is not managed as I ordered.
In my opinion, several things need clarification. On our unit, the most significant point of controversy is the definition of tachysystole, mainly when we are using a tocodynamometer and not an internal transducer.
I contend that it is quite challenging to ascertain the effectiveness of any given labor pattern based only on the number of contractions. Although we joke about "pit to distress," the truth is that contractions need to be "effective," which to me means strong enough to induce cervical changes.
In my clinical practice, with a tocodynamometer, having 5 contractions that do not produce cervical changes (unless associated with abnormalities of the fetal heart rate tracing) is not a clinically relevant finding as we do not have a way to gauge the strength of such contractions.
I usually employ a mid-range oxytocin protocol, starting at 4 mU per minute and increasing by 4 mU every 20 minutes. Through 30 years of practicing obstetrics, I have found that this protocol renders excellent results in achieving an efficient labor pattern without jeopardizing fetal well-being.
On learning about oxytocin's pharmacokinetics, I still support Dr. Rhonda L. Perry and her colleagues' conclusion that, until we learn better about this aspect of oxytocin pharmacology, each woman is her own bioassay.1 Furthermore, we see this in our daily practice: some patients go into full efficient labor with oxytocin at 4 mU per minute while others at 30 mU per minute do zilch.
Based on the above, I think that optimization requires close vigilance of the labor and the fetal status at any given time, not determining an oxytocin rate of infusion or dosage.
We should be observant on evaluating labor progress, and we should not hesitate to use internal pressure catheters when needed to obtain a more accurate evaluation of the labor pattern.
By examining the patient's labor progress at regular intervals, we also optimize the oxytocin infusion by determining if the infusion is producing the expected cervical changes.
Tomas Hernandez-Mejia, MD
Pasco, Washington
Reference
1. Perry RL, Satin AJ, Barth WH, et al. The pharmacokinetics of oxytocin as they apply to labor induction. Am J Obstet Gynecol. 1996;174:1590-1593.
Dr. Barbieri responds
I thank Dr. Tomas Hernandez-Mejia for sharing his expertise in utilizing a higher dose of oxytocin to optimize labor and birth. Dr. Hernandez-Mejia's view is supported by the recent publication of a high-quality clinical trial showing that a high-dose oxytocin protocol (initial and incremental rate of 6 mIU/min) did not cause an increase in adverse perinatal outcomes compared with a standard-dose protocol (initial and incremental rate of 2 mIU/min) but slightly shortened the duration of labor.1 Based on this clinical trial, my conclusion is that the high-dose protocol, if appropriately monitored for excess uterine contractions and fetal heart rate pattern, is safe.
Reference
1. Son M, Roy A, Stetson BT, et al. High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2021;137:991-998.
Continue to: PREGNANCY OF UNKNOWN...
PREGNANCY OF UNKNOWN LOCATION: EVIDENCE-BASED EVALUATION AND MANAGEMENT
IRIS G. INSOGNA, MD, AND PAULA C. BRADY, MD (AUGUST 2020)
I would like to thank Dr. Iris Insogna and Dr. Paula Brady for their very informative article on pregnancy of unknown location. However, please allow me to make a suggestion that will clarify terminology for all practicing ObGyns.
The medical literature uses the terms cornual pregnancy and interstitial pregnancy interchangeably, although they are actually very different conditions and have significant different implications. Clinicians are often confused about which is an intrauterine pregnancy and which is a true ectopic pregnancy. This confusion was addressed in a 2006 article in Fertility and Sterility, which explains that a cornual pregnancy refers to the implantation and development of a gestation in one of the upper and lateral portions of the uterus.1 This may occur in a rudimentary horn or in one horn of a septate or bicornuate uterus. Conversely, an interstitial pregnancy is a gestation that implants within the proximal, intramural portion of the fallopian tube that is enveloped by myometrium. Therefore, a cornual pregnancy is actually an intrauterine pregnancy, whereas an interstitial pregnancy is a true ectopic pregnancy.
I hope that all clinicians will read the article in Fertility and Sterility and adopt this terminology to avoid future confusion and misunderstandings.
Alan D. Rosen, MD
Houston, Texas
Reference
1. Malinowski A, Bates SK. Semantics and pitfalls in the diagnosis of cornual/interstitial pregnancy. Fertil Steril. 2006;86:1764.e11-1764.e14.
OBSTETRIC ANAL SPHINCTER INJURY: PREVENTION AND REPAIR
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2021)
Experience with warm perineal compresses and massage
I have been a midwife for 45 years. I have used warm compresses on the perineum my whole career. I don't need data to tell me it provides comfort. My patients do.
I don't do much massage of the perineum, only slightly while applying K-Y or another water-soluble gel.
A slow, controlled extension of the vertex and healthy tissue is the best way to prevent tears.
Karen Parker, MN, CNM
Ashland, Oregon
Dr. Barbieri responds
I thank Ms. Parker for her clinical recommendation: "Yes to warm compresses" and "Massage of the perineum?" Not so much.
Continue to: CESAREAN MYOMECTOMY...
CESAREAN MYOMECTOMY: SAFE OPERATION OR SURGICAL FOLLY?
ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2021)
Timely comments on cesarean myomectomy
Dr. Barbieri's editorial on cesarean myomectomy is very timely, especially the quote from Dr. K.S.J. Olah: "The berating I received was severe and disproportionate to the crime. The rule was that myomectomy performed at cesarean section was not just frowned upon but expressly forbidden."
I had a very similar experience with panniculectomy and "tummy tuck" as a part of cesarean delivery (CD). Traditionally, a combination of a CD with any other surgical procedures (myomectomy, abdominoplasty, and so on) has not been accepted in the obstetric community. The main reason for such an opinion has been the unfounded fear of complications of combined procedures, including but not limited to infection, hematomas, and poor wound healing. None of these concerns have been supported by studies. Obvious advantages of combining a CD with other surgical procedures, including abdominoplasty, are obvious: the elimination of a second anesthesia, increased patient satisfaction, and no need for a second surgery.
We reviewed the outcomes in 52 patients who underwent a combination of CD with other procedures (such as panniculectomy, abdominoplasty, hernia repairs, myomectomies, and ovarian biopsies). The postsurgical outcomes included in the analysis were postsurgical fever and the presence of seromas, hematomas, and wound dehiscence.1 Twelve of our own patients had a panniculectomy during CD performed by a plastic surgeon. While the preoperative complications of panniculectomy may have been well described, there is a paucity of data in women who underwent the cosmetic procedure at the time of CD. We concluded that the performance of a panniculectomy and tummy tuck as part of a CD does not appear to increase surgical complications in patients with a high body mass index. Our preliminary results and call for further studies were received at the American College of Surgeons 2017 meeting in San Diego.2
Boris Petrikovsky, MD, PhD
Sunny Island Beach, Florida
References
1. Petrikovsky BM, Swancoat S, Zharov EV. Safety of panniculectomy during cesarean section: a prospective, non-randomized study. J Reprod Med. 2019;64:197-200.
2. Petrikovsky BM. Is the combination of panniculectomy and cesarean section safe? Scientific Poster Presentation-Obstetrics and Gynecology. J Am Coll Surg. 2017;225(4 suppl 2):E130.
Dr. Barbieri responds
I agree with Dr. Petrikovsky that advances in the field of obstetrical surgery have been inhibited by a tendency to criticize innovation. Less than 40 years ago, leaders in gynecology did not initially accept the application of minimally invasive gynecology surgical techniques to common gyn procedures including hysterectomy. Every surgical field is rapidly innovating. Obstetrical surgeons should be encouraged to pursue new approaches, as you are doing. We wish you success in your pioneering work.
Continue to: A CASE OF BV...
A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH
CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021)
Secnidazole for treatment of BV
The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients.
Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.1 There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy.
Steven E. Chavoustie, MD
North Miami, Florida
Reference
1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S.
Drs. Reeder and Duff respond
We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.1 Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16.
Reference
1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386.
Continue to: OPTIMIZING THE USE OF...
OPTIMIZING THE USE OF OXYTOCIN ON LABOR AND DELIVERY
ROBERT L. BARBIERI, MD (EDITORIAL; JANUARY 2021)
Vigilant labor progress aids in oxytocin optimization
I read with particular interest Dr. Barbieri's editorial on optimizing oxytocin infusion. This topic is relevant for my practice as I am the kind of physician described and I usually get upset when the oxytocin is not managed as I ordered.
In my opinion, several things need clarification. On our unit, the most significant point of controversy is the definition of tachysystole, mainly when we are using a tocodynamometer and not an internal transducer.
I contend that it is quite challenging to ascertain the effectiveness of any given labor pattern based only on the number of contractions. Although we joke about "pit to distress," the truth is that contractions need to be "effective," which to me means strong enough to induce cervical changes.
In my clinical practice, with a tocodynamometer, having 5 contractions that do not produce cervical changes (unless associated with abnormalities of the fetal heart rate tracing) is not a clinically relevant finding as we do not have a way to gauge the strength of such contractions.
I usually employ a mid-range oxytocin protocol, starting at 4 mU per minute and increasing by 4 mU every 20 minutes. Through 30 years of practicing obstetrics, I have found that this protocol renders excellent results in achieving an efficient labor pattern without jeopardizing fetal well-being.
On learning about oxytocin's pharmacokinetics, I still support Dr. Rhonda L. Perry and her colleagues' conclusion that, until we learn better about this aspect of oxytocin pharmacology, each woman is her own bioassay.1 Furthermore, we see this in our daily practice: some patients go into full efficient labor with oxytocin at 4 mU per minute while others at 30 mU per minute do zilch.
Based on the above, I think that optimization requires close vigilance of the labor and the fetal status at any given time, not determining an oxytocin rate of infusion or dosage.
We should be observant on evaluating labor progress, and we should not hesitate to use internal pressure catheters when needed to obtain a more accurate evaluation of the labor pattern.
By examining the patient's labor progress at regular intervals, we also optimize the oxytocin infusion by determining if the infusion is producing the expected cervical changes.
Tomas Hernandez-Mejia, MD
Pasco, Washington
Reference
1. Perry RL, Satin AJ, Barth WH, et al. The pharmacokinetics of oxytocin as they apply to labor induction. Am J Obstet Gynecol. 1996;174:1590-1593.
Dr. Barbieri responds
I thank Dr. Tomas Hernandez-Mejia for sharing his expertise in utilizing a higher dose of oxytocin to optimize labor and birth. Dr. Hernandez-Mejia's view is supported by the recent publication of a high-quality clinical trial showing that a high-dose oxytocin protocol (initial and incremental rate of 6 mIU/min) did not cause an increase in adverse perinatal outcomes compared with a standard-dose protocol (initial and incremental rate of 2 mIU/min) but slightly shortened the duration of labor.1 Based on this clinical trial, my conclusion is that the high-dose protocol, if appropriately monitored for excess uterine contractions and fetal heart rate pattern, is safe.
Reference
1. Son M, Roy A, Stetson BT, et al. High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2021;137:991-998.
Continue to: PREGNANCY OF UNKNOWN...
PREGNANCY OF UNKNOWN LOCATION: EVIDENCE-BASED EVALUATION AND MANAGEMENT
IRIS G. INSOGNA, MD, AND PAULA C. BRADY, MD (AUGUST 2020)
I would like to thank Dr. Iris Insogna and Dr. Paula Brady for their very informative article on pregnancy of unknown location. However, please allow me to make a suggestion that will clarify terminology for all practicing ObGyns.
The medical literature uses the terms cornual pregnancy and interstitial pregnancy interchangeably, although they are actually very different conditions and have significant different implications. Clinicians are often confused about which is an intrauterine pregnancy and which is a true ectopic pregnancy. This confusion was addressed in a 2006 article in Fertility and Sterility, which explains that a cornual pregnancy refers to the implantation and development of a gestation in one of the upper and lateral portions of the uterus.1 This may occur in a rudimentary horn or in one horn of a septate or bicornuate uterus. Conversely, an interstitial pregnancy is a gestation that implants within the proximal, intramural portion of the fallopian tube that is enveloped by myometrium. Therefore, a cornual pregnancy is actually an intrauterine pregnancy, whereas an interstitial pregnancy is a true ectopic pregnancy.
I hope that all clinicians will read the article in Fertility and Sterility and adopt this terminology to avoid future confusion and misunderstandings.
Alan D. Rosen, MD
Houston, Texas
Reference
1. Malinowski A, Bates SK. Semantics and pitfalls in the diagnosis of cornual/interstitial pregnancy. Fertil Steril. 2006;86:1764.e11-1764.e14.
OBSTETRIC ANAL SPHINCTER INJURY: PREVENTION AND REPAIR
ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2021)
Experience with warm perineal compresses and massage
I have been a midwife for 45 years. I have used warm compresses on the perineum my whole career. I don't need data to tell me it provides comfort. My patients do.
I don't do much massage of the perineum, only slightly while applying K-Y or another water-soluble gel.
A slow, controlled extension of the vertex and healthy tissue is the best way to prevent tears.
Karen Parker, MN, CNM
Ashland, Oregon
Dr. Barbieri responds
I thank Ms. Parker for her clinical recommendation: "Yes to warm compresses" and "Massage of the perineum?" Not so much.
Continue to: CESAREAN MYOMECTOMY...
CESAREAN MYOMECTOMY: SAFE OPERATION OR SURGICAL FOLLY?
ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2021)
Timely comments on cesarean myomectomy
Dr. Barbieri's editorial on cesarean myomectomy is very timely, especially the quote from Dr. K.S.J. Olah: "The berating I received was severe and disproportionate to the crime. The rule was that myomectomy performed at cesarean section was not just frowned upon but expressly forbidden."
I had a very similar experience with panniculectomy and "tummy tuck" as a part of cesarean delivery (CD). Traditionally, a combination of a CD with any other surgical procedures (myomectomy, abdominoplasty, and so on) has not been accepted in the obstetric community. The main reason for such an opinion has been the unfounded fear of complications of combined procedures, including but not limited to infection, hematomas, and poor wound healing. None of these concerns have been supported by studies. Obvious advantages of combining a CD with other surgical procedures, including abdominoplasty, are obvious: the elimination of a second anesthesia, increased patient satisfaction, and no need for a second surgery.
We reviewed the outcomes in 52 patients who underwent a combination of CD with other procedures (such as panniculectomy, abdominoplasty, hernia repairs, myomectomies, and ovarian biopsies). The postsurgical outcomes included in the analysis were postsurgical fever and the presence of seromas, hematomas, and wound dehiscence.1 Twelve of our own patients had a panniculectomy during CD performed by a plastic surgeon. While the preoperative complications of panniculectomy may have been well described, there is a paucity of data in women who underwent the cosmetic procedure at the time of CD. We concluded that the performance of a panniculectomy and tummy tuck as part of a CD does not appear to increase surgical complications in patients with a high body mass index. Our preliminary results and call for further studies were received at the American College of Surgeons 2017 meeting in San Diego.2
Boris Petrikovsky, MD, PhD
Sunny Island Beach, Florida
References
1. Petrikovsky BM, Swancoat S, Zharov EV. Safety of panniculectomy during cesarean section: a prospective, non-randomized study. J Reprod Med. 2019;64:197-200.
2. Petrikovsky BM. Is the combination of panniculectomy and cesarean section safe? Scientific Poster Presentation-Obstetrics and Gynecology. J Am Coll Surg. 2017;225(4 suppl 2):E130.
Dr. Barbieri responds
I agree with Dr. Petrikovsky that advances in the field of obstetrical surgery have been inhibited by a tendency to criticize innovation. Less than 40 years ago, leaders in gynecology did not initially accept the application of minimally invasive gynecology surgical techniques to common gyn procedures including hysterectomy. Every surgical field is rapidly innovating. Obstetrical surgeons should be encouraged to pursue new approaches, as you are doing. We wish you success in your pioneering work.
Continue to: A CASE OF BV...
A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH
CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021)
Secnidazole for treatment of BV
The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients.
Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.1 There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy.
Steven E. Chavoustie, MD
North Miami, Florida
Reference
1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S.
Drs. Reeder and Duff respond
We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.1 Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16.
Reference
1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386.
Continue to: OPTIMIZING THE USE OF...
OPTIMIZING THE USE OF OXYTOCIN ON LABOR AND DELIVERY
ROBERT L. BARBIERI, MD (EDITORIAL; JANUARY 2021)
Vigilant labor progress aids in oxytocin optimization
I read with particular interest Dr. Barbieri's editorial on optimizing oxytocin infusion. This topic is relevant for my practice as I am the kind of physician described and I usually get upset when the oxytocin is not managed as I ordered.
In my opinion, several things need clarification. On our unit, the most significant point of controversy is the definition of tachysystole, mainly when we are using a tocodynamometer and not an internal transducer.
I contend that it is quite challenging to ascertain the effectiveness of any given labor pattern based only on the number of contractions. Although we joke about "pit to distress," the truth is that contractions need to be "effective," which to me means strong enough to induce cervical changes.
In my clinical practice, with a tocodynamometer, having 5 contractions that do not produce cervical changes (unless associated with abnormalities of the fetal heart rate tracing) is not a clinically relevant finding as we do not have a way to gauge the strength of such contractions.
I usually employ a mid-range oxytocin protocol, starting at 4 mU per minute and increasing by 4 mU every 20 minutes. Through 30 years of practicing obstetrics, I have found that this protocol renders excellent results in achieving an efficient labor pattern without jeopardizing fetal well-being.
On learning about oxytocin's pharmacokinetics, I still support Dr. Rhonda L. Perry and her colleagues' conclusion that, until we learn better about this aspect of oxytocin pharmacology, each woman is her own bioassay.1 Furthermore, we see this in our daily practice: some patients go into full efficient labor with oxytocin at 4 mU per minute while others at 30 mU per minute do zilch.
Based on the above, I think that optimization requires close vigilance of the labor and the fetal status at any given time, not determining an oxytocin rate of infusion or dosage.
We should be observant on evaluating labor progress, and we should not hesitate to use internal pressure catheters when needed to obtain a more accurate evaluation of the labor pattern.
By examining the patient's labor progress at regular intervals, we also optimize the oxytocin infusion by determining if the infusion is producing the expected cervical changes.
Tomas Hernandez-Mejia, MD
Pasco, Washington
Reference
1. Perry RL, Satin AJ, Barth WH, et al. The pharmacokinetics of oxytocin as they apply to labor induction. Am J Obstet Gynecol. 1996;174:1590-1593.
Dr. Barbieri responds
I thank Dr. Tomas Hernandez-Mejia for sharing his expertise in utilizing a higher dose of oxytocin to optimize labor and birth. Dr. Hernandez-Mejia's view is supported by the recent publication of a high-quality clinical trial showing that a high-dose oxytocin protocol (initial and incremental rate of 6 mIU/min) did not cause an increase in adverse perinatal outcomes compared with a standard-dose protocol (initial and incremental rate of 2 mIU/min) but slightly shortened the duration of labor.1 Based on this clinical trial, my conclusion is that the high-dose protocol, if appropriately monitored for excess uterine contractions and fetal heart rate pattern, is safe.
Reference
1. Son M, Roy A, Stetson BT, et al. High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2021;137:991-998.
Continue to: PREGNANCY OF UNKNOWN...
PREGNANCY OF UNKNOWN LOCATION: EVIDENCE-BASED EVALUATION AND MANAGEMENT
IRIS G. INSOGNA, MD, AND PAULA C. BRADY, MD (AUGUST 2020)
I would like to thank Dr. Iris Insogna and Dr. Paula Brady for their very informative article on pregnancy of unknown location. However, please allow me to make a suggestion that will clarify terminology for all practicing ObGyns.
The medical literature uses the terms cornual pregnancy and interstitial pregnancy interchangeably, although they are actually very different conditions and have significant different implications. Clinicians are often confused about which is an intrauterine pregnancy and which is a true ectopic pregnancy. This confusion was addressed in a 2006 article in Fertility and Sterility, which explains that a cornual pregnancy refers to the implantation and development of a gestation in one of the upper and lateral portions of the uterus.1 This may occur in a rudimentary horn or in one horn of a septate or bicornuate uterus. Conversely, an interstitial pregnancy is a gestation that implants within the proximal, intramural portion of the fallopian tube that is enveloped by myometrium. Therefore, a cornual pregnancy is actually an intrauterine pregnancy, whereas an interstitial pregnancy is a true ectopic pregnancy.
I hope that all clinicians will read the article in Fertility and Sterility and adopt this terminology to avoid future confusion and misunderstandings.
Alan D. Rosen, MD
Houston, Texas
Reference
1. Malinowski A, Bates SK. Semantics and pitfalls in the diagnosis of cornual/interstitial pregnancy. Fertil Steril. 2006;86:1764.e11-1764.e14.