Arnold W. Cohen, MD

The authors report no financial relationships relevant to this article.

CASE: Primigravida with ruptured membranes

A 21-year-old patient was admitted to the labor and delivery suite in active labor. After a reassuring fetal tracing was documented, active management with oxytocin was initiated.

Five hours later, the nurse noted a prolonged deceleration.

Resuscitative efforts failed to alleviate the deceleration. The nurse notified the attending OB of the situation. An emergency cesarean section was called because:

1. of a nonreassuring fetal heart rate tracing and
   
2. delivery was not imminent.
   

Now, the attending leaves her home promptly to perform the cesarean section; the anesthesiologist, who is not in the hospital, is notified.

The team is assembled and the patient is moved to the operating room; 34 minutes have elapsed between the time the decision was made to perform the cesarean section and the time the incision is made on the abdomen.

Two minutes later, the baby is delivered. Apgar scores are as follows: 0 at 1 minute; 0 at 5 minutes; 0 at 10 minutes; and 1 at 15 minutes.

Subsequently, the baby is determined to be severely brain-damaged. The parents file a claim of malpractice.

ObGyns have come to depend on ACOG’s Committee Opinions, Educational Bulletins, Practice Bulletins, Policy Statements, and Technology Assessments to help us take the best care of our patients. To quote the College, each of these documents “is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued appropriateness to practice.”¹

Sometimes, however, an ACOG bulletin, statement, or assessment may be misinterpreted and can actually contribute to some of the medicolegal problems that we face. The actual clinical situation just described, relating to ACOG’s statement on the so-called decision-to-incision gold standard, is a case in point.

The parties in the case go to trial

During the subsequent trial, the plaintiff alleges negligence by claiming that the defendant:

• did not anticipate or recognize developing fetal problems
  
• failed to perform a C-section within 30 minutes after the decision was made to do so.
  

The defendant counters:

• There was no fetal indication of hypoxia or cause for concern until the fetal bradycardia was noted
  
• Brain damage was caused by an unanticipated event that occurred more than 30 minutes before delivery
  
• The team responded as rapidly as it could given the circumstances of the hospital and staffing patterns.
  

No verdict was reached; instead, the parties agreed to a multimillion-dollar settlement that is based on 1) more than 30 minutes having elapsed from “decision to incision” and 2) the assertion that a 30-minute decision-to-incision time is the standard of care for an emergency C-section.

Are we held to a standard that can’t be met and has no basis in evidence?

To repeat, as reported in hospital records admitted into evidence at trial, the baby was delivered, with a low Apgar score, 34 minutes after the decision was called. The fact that the incision commenced after more than 30 minutes was a major factor contributing to the multimillion-dollar settlement.

That 30-minute mark is taken directly from the fifth edition of ACOG’s Guideline for Perinatal Care:

Any hospital providing obstetric service should have the capability of responding to an obstetric emergency. No data correlate the timing of intervention with outcome, and there is little likelihood that any will be obtained. However, in general, the consensus has been that hospitals should have the capability of beginning a cesarean section within 30 minutes of the decision to operate.²

The interpretation that all C-sections must be performed within 30 minutes of a decision is challenged by a recent study sponsored by The National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network.³ The design of that study was observational, because no ethical means exist to randomize women to less than or more than 30 minutes from the time of a decision to perform a C-section to the time of the incision.

The data collected came only from primagravid women in active labor who had an infant that had a birth weight of more than 2,500 g. Indications for C-section included: nonreassuring fetal heart rate, umbilical cord prolapse, placental abruption, placenta previa with hemorrhage, and uterine rupture. A total of 11,481 cases were analyzed over a 2-year period, with 2,808 C-sections performed for those indications (a 24.5% rate of C-section). Ninety-four per cent of the C-sections were undertaken because of a nonreassuring fetal heart rate.

 

In a university setting, where one would expect in-house OB coverage and anesthesia to be available, only 65% of emergency C-sections commenced within 30 minutes of a decision (17% in less than 10 minutes; 27% in less than 20 minutes). Investigators also found that, in cases in which a C-section was performed for a nonreassuring fetal heart rate, only 62% were performed in fewer than 30 minutes.

The data are clear: More than one third of all C-sections for these indications did not comply with the “30-minute rule.”

Notably, the study also found that:

• when the decision-to-incision time was less than 30 minutes, the rates of fetal acidemia and intubation in the delivery room were higher
  
• 95% of infants delivered in more than 31 minutes did not experience any of the adverse outcomes listed in the accompanying TABLE
  
• only one of eight neonatal deaths occurred in the group of infants delivered after 31 minutes (at 33 minutes).
  

The investigators also found that decision-to-incision time had no impact on maternal complications.

TABLE

Outcomes are no better when the decision-to-incision time is less than 30 minutes³

OUTCOME	INCIDENCE AT	INCIDENCE AT >30 MIN
Urine pH,	4.8%	1.6%*
Intubation in delivery	3.1%	1.3%*
Hypoxic–ischemic encephalopathy	0.7%	0.5%
Fetal death	0.2%	0%
Neonatal death	0.4%	0.2%
Apgar score at 5 min,	1.0%	0.9%
None of the above	92.6%	95.4%*
*P <.05>

30 minutes? It’s not a mandate

The study supported by NICHD shows that:

• the decision-to-incision interval appears to have no impact on maternal complications
  
• an infant delivered within 30 minutes for an emergency indication was more likely to be acidemic and to require intubation than an infant delivered in longer than 30 minutes for an emergency indication
  
• delivery within 30 minutes does not guarantee that there will be no adverse outcome
  
• 95% of infants delivered in more than 30 minutes did not have compromise.
  

Where did it originate? These facts make us wonder: How did the controversial, seemingly random time of 30 minutes crawl into the courtroom and become a benchmark? Why have attorneys and expert witnesses for the plaintiff taken this 30-minute rule to be fact?

The ACOG guideline is, as stated, clearly not a requirement. It does not mandate that all C-sections commence within 30 minutes from the time of the decision to perform one. Rather, the guideline clearly states that the hospital should be capable of performing the procedure within 30 minutes.

To be clear, we are not advocating a guideline or policy of waiting to perform a C-section! We believe rapid delivery is proper. But the optimal time, or even minimal time, to delivery has not been defined by data—and may never be.

What should it really mean? Thirty minutes, therefore, should be a goal, not a finite time. Data published by NICHD should now be used to temper notions that exceeding the so-called 30-minute rule necessarily 1) is an indicator of substandard care and 2) has adverse effects on outcome for the newborn.

Perhaps it’s time for ACOG to review these recent data and then reaffirm, replace, or withdraw the statement from the perinatal guidelines proposing that 30 minutes be the maximum time from decision to incision.¹

Here’s what you should do until the matter is clarified

If you must defend yourself against an accusation of not having performed a C-section in a timely fashion, data from the NICHD Perinatal Collaborative may offer a helpful defense. Because 38% of C-sections for a nonreassuring fetal heart rate tracing are not performed within 30 minutes of a decision to proceed, even in a university setting, this cannot be considered a standard and not meeting this arbitrary time should be looked on as a frequent occurrence.

Based on current data, therefore, any medicolegal case in which the plaintiff’s attorney implies that failure to conform to this putative standard resulted in a bad outcome should be defended vigorously—and should not be settled.

The authors report no financial relationships relevant to this article.

CASE: Primigravida with ruptured membranes

A 21-year-old patient was admitted to the labor and delivery suite in active labor. After a reassuring fetal tracing was documented, active management with oxytocin was initiated.

Five hours later, the nurse noted a prolonged deceleration.

Resuscitative efforts failed to alleviate the deceleration. The nurse notified the attending OB of the situation. An emergency cesarean section was called because:

1. of a nonreassuring fetal heart rate tracing and
   
2. delivery was not imminent.
   

Now, the attending leaves her home promptly to perform the cesarean section; the anesthesiologist, who is not in the hospital, is notified.

The team is assembled and the patient is moved to the operating room; 34 minutes have elapsed between the time the decision was made to perform the cesarean section and the time the incision is made on the abdomen.

Two minutes later, the baby is delivered. Apgar scores are as follows: 0 at 1 minute; 0 at 5 minutes; 0 at 10 minutes; and 1 at 15 minutes.

Subsequently, the baby is determined to be severely brain-damaged. The parents file a claim of malpractice.

ObGyns have come to depend on ACOG’s Committee Opinions, Educational Bulletins, Practice Bulletins, Policy Statements, and Technology Assessments to help us take the best care of our patients. To quote the College, each of these documents “is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued appropriateness to practice.”¹

Sometimes, however, an ACOG bulletin, statement, or assessment may be misinterpreted and can actually contribute to some of the medicolegal problems that we face. The actual clinical situation just described, relating to ACOG’s statement on the so-called decision-to-incision gold standard, is a case in point.

The parties in the case go to trial

During the subsequent trial, the plaintiff alleges negligence by claiming that the defendant:

• did not anticipate or recognize developing fetal problems
  
• failed to perform a C-section within 30 minutes after the decision was made to do so.
  

The defendant counters:

• There was no fetal indication of hypoxia or cause for concern until the fetal bradycardia was noted
  
• Brain damage was caused by an unanticipated event that occurred more than 30 minutes before delivery
  
• The team responded as rapidly as it could given the circumstances of the hospital and staffing patterns.
  

No verdict was reached; instead, the parties agreed to a multimillion-dollar settlement that is based on 1) more than 30 minutes having elapsed from “decision to incision” and 2) the assertion that a 30-minute decision-to-incision time is the standard of care for an emergency C-section.

Are we held to a standard that can’t be met and has no basis in evidence?

To repeat, as reported in hospital records admitted into evidence at trial, the baby was delivered, with a low Apgar score, 34 minutes after the decision was called. The fact that the incision commenced after more than 30 minutes was a major factor contributing to the multimillion-dollar settlement.

That 30-minute mark is taken directly from the fifth edition of ACOG’s Guideline for Perinatal Care:

Any hospital providing obstetric service should have the capability of responding to an obstetric emergency. No data correlate the timing of intervention with outcome, and there is little likelihood that any will be obtained. However, in general, the consensus has been that hospitals should have the capability of beginning a cesarean section within 30 minutes of the decision to operate.²

The interpretation that all C-sections must be performed within 30 minutes of a decision is challenged by a recent study sponsored by The National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network.³ The design of that study was observational, because no ethical means exist to randomize women to less than or more than 30 minutes from the time of a decision to perform a C-section to the time of the incision.

The data collected came only from primagravid women in active labor who had an infant that had a birth weight of more than 2,500 g. Indications for C-section included: nonreassuring fetal heart rate, umbilical cord prolapse, placental abruption, placenta previa with hemorrhage, and uterine rupture. A total of 11,481 cases were analyzed over a 2-year period, with 2,808 C-sections performed for those indications (a 24.5% rate of C-section). Ninety-four per cent of the C-sections were undertaken because of a nonreassuring fetal heart rate.

 

In a university setting, where one would expect in-house OB coverage and anesthesia to be available, only 65% of emergency C-sections commenced within 30 minutes of a decision (17% in less than 10 minutes; 27% in less than 20 minutes). Investigators also found that, in cases in which a C-section was performed for a nonreassuring fetal heart rate, only 62% were performed in fewer than 30 minutes.

The data are clear: More than one third of all C-sections for these indications did not comply with the “30-minute rule.”

Notably, the study also found that:

• when the decision-to-incision time was less than 30 minutes, the rates of fetal acidemia and intubation in the delivery room were higher
  
• 95% of infants delivered in more than 31 minutes did not experience any of the adverse outcomes listed in the accompanying TABLE
  
• only one of eight neonatal deaths occurred in the group of infants delivered after 31 minutes (at 33 minutes).
  

The investigators also found that decision-to-incision time had no impact on maternal complications.

TABLE

Outcomes are no better when the decision-to-incision time is less than 30 minutes³

OUTCOME	INCIDENCE AT	INCIDENCE AT >30 MIN
Urine pH,	4.8%	1.6%*
Intubation in delivery	3.1%	1.3%*
Hypoxic–ischemic encephalopathy	0.7%	0.5%
Fetal death	0.2%	0%
Neonatal death	0.4%	0.2%
Apgar score at 5 min,	1.0%	0.9%
None of the above	92.6%	95.4%*
*P <.05>

30 minutes? It’s not a mandate

The study supported by NICHD shows that:

• the decision-to-incision interval appears to have no impact on maternal complications
  
• an infant delivered within 30 minutes for an emergency indication was more likely to be acidemic and to require intubation than an infant delivered in longer than 30 minutes for an emergency indication
  
• delivery within 30 minutes does not guarantee that there will be no adverse outcome
  
• 95% of infants delivered in more than 30 minutes did not have compromise.
  

Where did it originate? These facts make us wonder: How did the controversial, seemingly random time of 30 minutes crawl into the courtroom and become a benchmark? Why have attorneys and expert witnesses for the plaintiff taken this 30-minute rule to be fact?

The ACOG guideline is, as stated, clearly not a requirement. It does not mandate that all C-sections commence within 30 minutes from the time of the decision to perform one. Rather, the guideline clearly states that the hospital should be capable of performing the procedure within 30 minutes.

To be clear, we are not advocating a guideline or policy of waiting to perform a C-section! We believe rapid delivery is proper. But the optimal time, or even minimal time, to delivery has not been defined by data—and may never be.

What should it really mean? Thirty minutes, therefore, should be a goal, not a finite time. Data published by NICHD should now be used to temper notions that exceeding the so-called 30-minute rule necessarily 1) is an indicator of substandard care and 2) has adverse effects on outcome for the newborn.

Perhaps it’s time for ACOG to review these recent data and then reaffirm, replace, or withdraw the statement from the perinatal guidelines proposing that 30 minutes be the maximum time from decision to incision.¹

Here’s what you should do until the matter is clarified

If you must defend yourself against an accusation of not having performed a C-section in a timely fashion, data from the NICHD Perinatal Collaborative may offer a helpful defense. Because 38% of C-sections for a nonreassuring fetal heart rate tracing are not performed within 30 minutes of a decision to proceed, even in a university setting, this cannot be considered a standard and not meeting this arbitrary time should be looked on as a frequent occurrence.

Based on current data, therefore, any medicolegal case in which the plaintiff’s attorney implies that failure to conform to this putative standard resulted in a bad outcome should be defended vigorously—and should not be settled.

The authors report no financial relationships relevant to this article.

CASE: Primigravida with ruptured membranes

A 21-year-old patient was admitted to the labor and delivery suite in active labor. After a reassuring fetal tracing was documented, active management with oxytocin was initiated.

Five hours later, the nurse noted a prolonged deceleration.

Resuscitative efforts failed to alleviate the deceleration. The nurse notified the attending OB of the situation. An emergency cesarean section was called because:

1. of a nonreassuring fetal heart rate tracing and
   
2. delivery was not imminent.
   

Now, the attending leaves her home promptly to perform the cesarean section; the anesthesiologist, who is not in the hospital, is notified.

The team is assembled and the patient is moved to the operating room; 34 minutes have elapsed between the time the decision was made to perform the cesarean section and the time the incision is made on the abdomen.

Two minutes later, the baby is delivered. Apgar scores are as follows: 0 at 1 minute; 0 at 5 minutes; 0 at 10 minutes; and 1 at 15 minutes.

Subsequently, the baby is determined to be severely brain-damaged. The parents file a claim of malpractice.

ObGyns have come to depend on ACOG’s Committee Opinions, Educational Bulletins, Practice Bulletins, Policy Statements, and Technology Assessments to help us take the best care of our patients. To quote the College, each of these documents “is reviewed periodically and either reaffirmed, replaced, or withdrawn to ensure its continued appropriateness to practice.”¹

Sometimes, however, an ACOG bulletin, statement, or assessment may be misinterpreted and can actually contribute to some of the medicolegal problems that we face. The actual clinical situation just described, relating to ACOG’s statement on the so-called decision-to-incision gold standard, is a case in point.

The parties in the case go to trial

During the subsequent trial, the plaintiff alleges negligence by claiming that the defendant:

• did not anticipate or recognize developing fetal problems
  
• failed to perform a C-section within 30 minutes after the decision was made to do so.
  

The defendant counters:

• There was no fetal indication of hypoxia or cause for concern until the fetal bradycardia was noted
  
• Brain damage was caused by an unanticipated event that occurred more than 30 minutes before delivery
  
• The team responded as rapidly as it could given the circumstances of the hospital and staffing patterns.
  

No verdict was reached; instead, the parties agreed to a multimillion-dollar settlement that is based on 1) more than 30 minutes having elapsed from “decision to incision” and 2) the assertion that a 30-minute decision-to-incision time is the standard of care for an emergency C-section.

Are we held to a standard that can’t be met and has no basis in evidence?

To repeat, as reported in hospital records admitted into evidence at trial, the baby was delivered, with a low Apgar score, 34 minutes after the decision was called. The fact that the incision commenced after more than 30 minutes was a major factor contributing to the multimillion-dollar settlement.

That 30-minute mark is taken directly from the fifth edition of ACOG’s Guideline for Perinatal Care:

Any hospital providing obstetric service should have the capability of responding to an obstetric emergency. No data correlate the timing of intervention with outcome, and there is little likelihood that any will be obtained. However, in general, the consensus has been that hospitals should have the capability of beginning a cesarean section within 30 minutes of the decision to operate.²

The interpretation that all C-sections must be performed within 30 minutes of a decision is challenged by a recent study sponsored by The National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network.³ The design of that study was observational, because no ethical means exist to randomize women to less than or more than 30 minutes from the time of a decision to perform a C-section to the time of the incision.

The data collected came only from primagravid women in active labor who had an infant that had a birth weight of more than 2,500 g. Indications for C-section included: nonreassuring fetal heart rate, umbilical cord prolapse, placental abruption, placenta previa with hemorrhage, and uterine rupture. A total of 11,481 cases were analyzed over a 2-year period, with 2,808 C-sections performed for those indications (a 24.5% rate of C-section). Ninety-four per cent of the C-sections were undertaken because of a nonreassuring fetal heart rate.

 

In a university setting, where one would expect in-house OB coverage and anesthesia to be available, only 65% of emergency C-sections commenced within 30 minutes of a decision (17% in less than 10 minutes; 27% in less than 20 minutes). Investigators also found that, in cases in which a C-section was performed for a nonreassuring fetal heart rate, only 62% were performed in fewer than 30 minutes.

The data are clear: More than one third of all C-sections for these indications did not comply with the “30-minute rule.”

Notably, the study also found that:

• when the decision-to-incision time was less than 30 minutes, the rates of fetal acidemia and intubation in the delivery room were higher
  
• 95% of infants delivered in more than 31 minutes did not experience any of the adverse outcomes listed in the accompanying TABLE
  
• only one of eight neonatal deaths occurred in the group of infants delivered after 31 minutes (at 33 minutes).
  

The investigators also found that decision-to-incision time had no impact on maternal complications.

TABLE

Outcomes are no better when the decision-to-incision time is less than 30 minutes³

OUTCOME	INCIDENCE AT	INCIDENCE AT >30 MIN
Urine pH,	4.8%	1.6%*
Intubation in delivery	3.1%	1.3%*
Hypoxic–ischemic encephalopathy	0.7%	0.5%
Fetal death	0.2%	0%
Neonatal death	0.4%	0.2%
Apgar score at 5 min,	1.0%	0.9%
None of the above	92.6%	95.4%*
*P <.05>

30 minutes? It’s not a mandate

The study supported by NICHD shows that:

• the decision-to-incision interval appears to have no impact on maternal complications
  
• an infant delivered within 30 minutes for an emergency indication was more likely to be acidemic and to require intubation than an infant delivered in longer than 30 minutes for an emergency indication
  
• delivery within 30 minutes does not guarantee that there will be no adverse outcome
  
• 95% of infants delivered in more than 30 minutes did not have compromise.
  

Where did it originate? These facts make us wonder: How did the controversial, seemingly random time of 30 minutes crawl into the courtroom and become a benchmark? Why have attorneys and expert witnesses for the plaintiff taken this 30-minute rule to be fact?

The ACOG guideline is, as stated, clearly not a requirement. It does not mandate that all C-sections commence within 30 minutes from the time of the decision to perform one. Rather, the guideline clearly states that the hospital should be capable of performing the procedure within 30 minutes.

To be clear, we are not advocating a guideline or policy of waiting to perform a C-section! We believe rapid delivery is proper. But the optimal time, or even minimal time, to delivery has not been defined by data—and may never be.

What should it really mean? Thirty minutes, therefore, should be a goal, not a finite time. Data published by NICHD should now be used to temper notions that exceeding the so-called 30-minute rule necessarily 1) is an indicator of substandard care and 2) has adverse effects on outcome for the newborn.

Perhaps it’s time for ACOG to review these recent data and then reaffirm, replace, or withdraw the statement from the perinatal guidelines proposing that 30 minutes be the maximum time from decision to incision.¹

Here’s what you should do until the matter is clarified

If you must defend yourself against an accusation of not having performed a C-section in a timely fashion, data from the NICHD Perinatal Collaborative may offer a helpful defense. Because 38% of C-sections for a nonreassuring fetal heart rate tracing are not performed within 30 minutes of a decision to proceed, even in a university setting, this cannot be considered a standard and not meeting this arbitrary time should be looked on as a frequent occurrence.

Based on current data, therefore, any medicolegal case in which the plaintiff’s attorney implies that failure to conform to this putative standard resulted in a bad outcome should be defended vigorously—and should not be settled.

We’ve all done it. Stripping the membranes is an old, familiar method of separating the fetal membranes from the lower uterine segment, which is thought to trigger the local production of prostaglandins and hasten the start of contractions.¹

Membrane stripping is a focus of controversy when it comes to the issue of group B streptococcus (GBS). This article looks at the literature on the subject and presents a recent legal case in which a woman colonized with GBS claimed membrane stripping was the proximate cause of her infant’s death. In the case, experts for the plaintiff testified that membrane sweeping in a women colonized with GBS is below the standard of care, despite evidence to the contrary. The case, which involved a 2-week jury trial, resulted in a defense verdict.

The legal case

A 22-year-old primigravida presented at just over 39 weeks’ gestation, reporting spontaneous rupture of membranes 1 hour earlier.

IUGR and Group B strep

Her antenatal course had been complicated by intrauterine growth restriction (IUGR), detected by ultrasound at 34 weeks’ gestation. Because of the IUGR, the fetus was being evaluated twice weekly with nonstress tests and amniotic fluid measurements. At 35 weeks, testing for GBS colonization was positive. At 37 weeks, the membranes were stripped to facilitate cervical ripening because of the diagnosed IUGR.

On admission, she was noted to be afebrile with stable vital signs. She was given antibiotics for the GBS and examined. The membranes were grossly ruptured, with clear fluid pooling in the vagina; the cervix was dilated 3 cm with 80% effacement; and the fetus was at –1 to –2 station.

Although the woman was noted to be contracting every 2 minutes, she was barely aware of the contractions. The fetal heart tracing was initially reassuring, with good variability and no decelerations. She was allowed to walk around for 30 minutes.

Sudden fetal bradycardia

Shortly after the patient was placed back on the fetal heart rate monitor, 52 minutes after her initial presentation and approximately 2 hours after rupture of membranes, a marked and sudden fetal bradycardia was noted.

Emergent cesarean section was performed with a low transverse incision. Eighteen minutes after the onset of the bradycardia, a male infant weighing 3,510 g was delivered, with Apgar scores of 0, 2, and 0, at 1, 5, and 10 minutes, respectively. The umbilical cord arterial pH was 6.97. Pediatricians tried to resuscitate the baby, but intubation revealed immediate return of bright red blood. Despite aggressive intervention, including CPR, respiratory support, antibiotics, and inotropic agents, the infant died at 1 hour of life.

Cause of death: GBS pneumonia

An autopsy revealed bilateral massive consolidation of the lungs due to hemorrhagic bronchopneumonia. Tissue and blood cultures of the spleen, lung, and placenta all grew GBS, as did umbilical cord blood cultures. The cause of death: respiratory failure due to overwhelming GBS pneumonia.

The mother’s postpartum course was complicated by a fever of 100.8°F on the second postoperative day, for which she was treated with intravenous ampicillin, gentamicin, and clindamycin. She was discharged home on the 4th postoperative day.

“Data insufficient” for or against

Many practitioners strip the membranes at term to keep patients from passing their due dates. When the membranes are stripped at 40 weeks’ gestation, two thirds of women enter spontaneous labor within 72 hours; without membrane stripping, only one third of women do.² The strategy also decreases the chance that pregnancies will go past 42 weeks’ gestation.³

Even more important, studies have found membrane stripping to be safe.^3-5 The risk of maternal and neonatal infections does not increase with the procedure, according to a Cochrane Review of 2,797 women in 22 different studies.⁵

The latest statement on the subject from the American College of Obstetricians and Gynecologists (ACOG) is a Committee Opinion published in December 2002—which came after the neonatal death in this case. It says the risks of membrane stripping in women colonized with GBS “have not been investigated in well-designed prospective studies. Therefore, data are insufficient to encourage or discourage this practice in women known to be GBS-colonized.”⁶

Expert testimony

Plaintiff

The main witnesses for the plaintiff were a perinatologist and an obstetrician who specializes in infectious diseases. They opined that the infant’s death was caused by the membrane stripping, given that the mother was known to be colonized with GBS.

 

The perinatologist said his opinion was based on the statements of the infectious disease specialist, who in turn cited a poster presentation at the Infectious Diseases Society for Obstetrics and Gynecology meeting in 2001⁷—which occurred a year after the neonatal death. The poster presentation was a series of 8 cases of perinatal sepsis following membrane stripping; the cases occurred between 1993 and 2000 and were provided by a parents’ group with affected children, “The Jesse Cause.”

Only the perinatologist appeared at trial. When asked to identify a single piece of published, peer-reviewed literature documenting an increased risk of neonatal GBS with membrane stripping, he was unable to do so.

Defense

An expert testified that, although GBS colonization occurs in 20% of all pregnancies, there are no data—prospective, retrospective, or controlled—to suggest that membrane sweeping in GBS-positive patients is associated with GBS sepsis of the newborn, and that membrane sweeping was appropriate in a woman with a fetus affected by unexplained IUGR.

The jury returned a defense verdict after less than 1 day of deliberation. It was not appealed.

Medicolegal lessons

As this case demonstrates, expert witnesses sometimes testify on a plaintiff’s behalf despite clear data refuting their statements. ObGyns should be aware that even a practice with a long history, such as membrane stripping, may be proclaimed outside the standard of care by such witnesses. We consider this kind of testimony unethical.

Until we have more data confirming or refuting the association between membrane sweeping (in cases of GBS colonization) and neonatal sepsis, or the medicolegal system changes, obstetricians should proceed with caution. We counsel our patients thoroughly and document the discussion.

 

The authors report no financial relationships relevant to this article.

We’ve all done it. Stripping the membranes is an old, familiar method of separating the fetal membranes from the lower uterine segment, which is thought to trigger the local production of prostaglandins and hasten the start of contractions.¹

Membrane stripping is a focus of controversy when it comes to the issue of group B streptococcus (GBS). This article looks at the literature on the subject and presents a recent legal case in which a woman colonized with GBS claimed membrane stripping was the proximate cause of her infant’s death. In the case, experts for the plaintiff testified that membrane sweeping in a women colonized with GBS is below the standard of care, despite evidence to the contrary. The case, which involved a 2-week jury trial, resulted in a defense verdict.

The legal case

A 22-year-old primigravida presented at just over 39 weeks’ gestation, reporting spontaneous rupture of membranes 1 hour earlier.

IUGR and Group B strep

Her antenatal course had been complicated by intrauterine growth restriction (IUGR), detected by ultrasound at 34 weeks’ gestation. Because of the IUGR, the fetus was being evaluated twice weekly with nonstress tests and amniotic fluid measurements. At 35 weeks, testing for GBS colonization was positive. At 37 weeks, the membranes were stripped to facilitate cervical ripening because of the diagnosed IUGR.

On admission, she was noted to be afebrile with stable vital signs. She was given antibiotics for the GBS and examined. The membranes were grossly ruptured, with clear fluid pooling in the vagina; the cervix was dilated 3 cm with 80% effacement; and the fetus was at –1 to –2 station.

Although the woman was noted to be contracting every 2 minutes, she was barely aware of the contractions. The fetal heart tracing was initially reassuring, with good variability and no decelerations. She was allowed to walk around for 30 minutes.

Sudden fetal bradycardia

Shortly after the patient was placed back on the fetal heart rate monitor, 52 minutes after her initial presentation and approximately 2 hours after rupture of membranes, a marked and sudden fetal bradycardia was noted.

Emergent cesarean section was performed with a low transverse incision. Eighteen minutes after the onset of the bradycardia, a male infant weighing 3,510 g was delivered, with Apgar scores of 0, 2, and 0, at 1, 5, and 10 minutes, respectively. The umbilical cord arterial pH was 6.97. Pediatricians tried to resuscitate the baby, but intubation revealed immediate return of bright red blood. Despite aggressive intervention, including CPR, respiratory support, antibiotics, and inotropic agents, the infant died at 1 hour of life.

Cause of death: GBS pneumonia

An autopsy revealed bilateral massive consolidation of the lungs due to hemorrhagic bronchopneumonia. Tissue and blood cultures of the spleen, lung, and placenta all grew GBS, as did umbilical cord blood cultures. The cause of death: respiratory failure due to overwhelming GBS pneumonia.

The mother’s postpartum course was complicated by a fever of 100.8°F on the second postoperative day, for which she was treated with intravenous ampicillin, gentamicin, and clindamycin. She was discharged home on the 4th postoperative day.

“Data insufficient” for or against

Many practitioners strip the membranes at term to keep patients from passing their due dates. When the membranes are stripped at 40 weeks’ gestation, two thirds of women enter spontaneous labor within 72 hours; without membrane stripping, only one third of women do.² The strategy also decreases the chance that pregnancies will go past 42 weeks’ gestation.³

Even more important, studies have found membrane stripping to be safe.^3-5 The risk of maternal and neonatal infections does not increase with the procedure, according to a Cochrane Review of 2,797 women in 22 different studies.⁵

The latest statement on the subject from the American College of Obstetricians and Gynecologists (ACOG) is a Committee Opinion published in December 2002—which came after the neonatal death in this case. It says the risks of membrane stripping in women colonized with GBS “have not been investigated in well-designed prospective studies. Therefore, data are insufficient to encourage or discourage this practice in women known to be GBS-colonized.”⁶

Expert testimony

Plaintiff

The main witnesses for the plaintiff were a perinatologist and an obstetrician who specializes in infectious diseases. They opined that the infant’s death was caused by the membrane stripping, given that the mother was known to be colonized with GBS.

 

The perinatologist said his opinion was based on the statements of the infectious disease specialist, who in turn cited a poster presentation at the Infectious Diseases Society for Obstetrics and Gynecology meeting in 2001⁷—which occurred a year after the neonatal death. The poster presentation was a series of 8 cases of perinatal sepsis following membrane stripping; the cases occurred between 1993 and 2000 and were provided by a parents’ group with affected children, “The Jesse Cause.”

Only the perinatologist appeared at trial. When asked to identify a single piece of published, peer-reviewed literature documenting an increased risk of neonatal GBS with membrane stripping, he was unable to do so.

Defense

An expert testified that, although GBS colonization occurs in 20% of all pregnancies, there are no data—prospective, retrospective, or controlled—to suggest that membrane sweeping in GBS-positive patients is associated with GBS sepsis of the newborn, and that membrane sweeping was appropriate in a woman with a fetus affected by unexplained IUGR.

The jury returned a defense verdict after less than 1 day of deliberation. It was not appealed.

Medicolegal lessons

As this case demonstrates, expert witnesses sometimes testify on a plaintiff’s behalf despite clear data refuting their statements. ObGyns should be aware that even a practice with a long history, such as membrane stripping, may be proclaimed outside the standard of care by such witnesses. We consider this kind of testimony unethical.

Until we have more data confirming or refuting the association between membrane sweeping (in cases of GBS colonization) and neonatal sepsis, or the medicolegal system changes, obstetricians should proceed with caution. We counsel our patients thoroughly and document the discussion.

 

The authors report no financial relationships relevant to this article.

We’ve all done it. Stripping the membranes is an old, familiar method of separating the fetal membranes from the lower uterine segment, which is thought to trigger the local production of prostaglandins and hasten the start of contractions.¹

Membrane stripping is a focus of controversy when it comes to the issue of group B streptococcus (GBS). This article looks at the literature on the subject and presents a recent legal case in which a woman colonized with GBS claimed membrane stripping was the proximate cause of her infant’s death. In the case, experts for the plaintiff testified that membrane sweeping in a women colonized with GBS is below the standard of care, despite evidence to the contrary. The case, which involved a 2-week jury trial, resulted in a defense verdict.

The legal case

A 22-year-old primigravida presented at just over 39 weeks’ gestation, reporting spontaneous rupture of membranes 1 hour earlier.

IUGR and Group B strep

Her antenatal course had been complicated by intrauterine growth restriction (IUGR), detected by ultrasound at 34 weeks’ gestation. Because of the IUGR, the fetus was being evaluated twice weekly with nonstress tests and amniotic fluid measurements. At 35 weeks, testing for GBS colonization was positive. At 37 weeks, the membranes were stripped to facilitate cervical ripening because of the diagnosed IUGR.

On admission, she was noted to be afebrile with stable vital signs. She was given antibiotics for the GBS and examined. The membranes were grossly ruptured, with clear fluid pooling in the vagina; the cervix was dilated 3 cm with 80% effacement; and the fetus was at –1 to –2 station.

Although the woman was noted to be contracting every 2 minutes, she was barely aware of the contractions. The fetal heart tracing was initially reassuring, with good variability and no decelerations. She was allowed to walk around for 30 minutes.

Sudden fetal bradycardia

Shortly after the patient was placed back on the fetal heart rate monitor, 52 minutes after her initial presentation and approximately 2 hours after rupture of membranes, a marked and sudden fetal bradycardia was noted.

Emergent cesarean section was performed with a low transverse incision. Eighteen minutes after the onset of the bradycardia, a male infant weighing 3,510 g was delivered, with Apgar scores of 0, 2, and 0, at 1, 5, and 10 minutes, respectively. The umbilical cord arterial pH was 6.97. Pediatricians tried to resuscitate the baby, but intubation revealed immediate return of bright red blood. Despite aggressive intervention, including CPR, respiratory support, antibiotics, and inotropic agents, the infant died at 1 hour of life.

Cause of death: GBS pneumonia

An autopsy revealed bilateral massive consolidation of the lungs due to hemorrhagic bronchopneumonia. Tissue and blood cultures of the spleen, lung, and placenta all grew GBS, as did umbilical cord blood cultures. The cause of death: respiratory failure due to overwhelming GBS pneumonia.

The mother’s postpartum course was complicated by a fever of 100.8°F on the second postoperative day, for which she was treated with intravenous ampicillin, gentamicin, and clindamycin. She was discharged home on the 4th postoperative day.

“Data insufficient” for or against

Many practitioners strip the membranes at term to keep patients from passing their due dates. When the membranes are stripped at 40 weeks’ gestation, two thirds of women enter spontaneous labor within 72 hours; without membrane stripping, only one third of women do.² The strategy also decreases the chance that pregnancies will go past 42 weeks’ gestation.³

Even more important, studies have found membrane stripping to be safe.^3-5 The risk of maternal and neonatal infections does not increase with the procedure, according to a Cochrane Review of 2,797 women in 22 different studies.⁵

The latest statement on the subject from the American College of Obstetricians and Gynecologists (ACOG) is a Committee Opinion published in December 2002—which came after the neonatal death in this case. It says the risks of membrane stripping in women colonized with GBS “have not been investigated in well-designed prospective studies. Therefore, data are insufficient to encourage or discourage this practice in women known to be GBS-colonized.”⁶

Expert testimony

Plaintiff

The main witnesses for the plaintiff were a perinatologist and an obstetrician who specializes in infectious diseases. They opined that the infant’s death was caused by the membrane stripping, given that the mother was known to be colonized with GBS.

 

The perinatologist said his opinion was based on the statements of the infectious disease specialist, who in turn cited a poster presentation at the Infectious Diseases Society for Obstetrics and Gynecology meeting in 2001⁷—which occurred a year after the neonatal death. The poster presentation was a series of 8 cases of perinatal sepsis following membrane stripping; the cases occurred between 1993 and 2000 and were provided by a parents’ group with affected children, “The Jesse Cause.”

Only the perinatologist appeared at trial. When asked to identify a single piece of published, peer-reviewed literature documenting an increased risk of neonatal GBS with membrane stripping, he was unable to do so.

Defense

An expert testified that, although GBS colonization occurs in 20% of all pregnancies, there are no data—prospective, retrospective, or controlled—to suggest that membrane sweeping in GBS-positive patients is associated with GBS sepsis of the newborn, and that membrane sweeping was appropriate in a woman with a fetus affected by unexplained IUGR.

The jury returned a defense verdict after less than 1 day of deliberation. It was not appealed.

Medicolegal lessons

As this case demonstrates, expert witnesses sometimes testify on a plaintiff’s behalf despite clear data refuting their statements. ObGyns should be aware that even a practice with a long history, such as membrane stripping, may be proclaimed outside the standard of care by such witnesses. We consider this kind of testimony unethical.

Until we have more data confirming or refuting the association between membrane sweeping (in cases of GBS colonization) and neonatal sepsis, or the medicolegal system changes, obstetricians should proceed with caution. We counsel our patients thoroughly and document the discussion.

 

The authors report no financial relationships relevant to this article.