Vaginal Birth After Cesarean Risks for Patient And Doctor

As surgical methods improved, anesthesia became safer and new-generation antibiotics greatly reduced the risk of infection, rates of cesarean section began to increase dramatically. Cesarean deliveries are more expensive than vaginal births and require longer hospital stays, thereby driving up the cost. As a result, health care officials began looking for ways to reduce the rate of cesarean deliveries. They observed that approximately one-third of all cesareans were repeats for women who had delivered previously by cesarean. This led to a tremendous interest in the use of VBAC as a way to reduce the rate of cesarean deliveries.

It would seem to be an obvious question to ask whether promoting the use of VBAC was safe before embarking on this course of action. At the very least, it would be reasonable to attempt to learn the real risks and benefits of VBAC, the relative and absolute contraindications and whether labor needed to be managed differently so that women could be properly counseled and able to give informed consent. Instead, the health care community decided to “shoot first and ask questions later.” As recently as July 2004, the American College of Obstetricians and Gynecologists (ACOG) noted that, even today, “there are currently no randomized trials comparing maternal or neonatal outcomes for both repeat cesarean delivery and VBAC”. “Vaginal Birth After Previous Cesarean Delivery,” ACOG Practice Bulletin No. 54, July 2004.

Faulty Information Leads to Rash Decisions

The limited scientific evidence that was relied upon when promoting VBAC suffered from several serious flaws. First, the studies that were available were scientifically flawed and used inconsistent parameters and definitions. Landon, MB et al.: Maternal and Perinatal Outcomes Associated with a Trial of Labor After Prior Cesarean Delivery. N Engl J Med 2004; 351: 2581-2589. Second, the endpoint of these clinical series was maternal mortality following successful VBAC. The statistical risk of maternal death from a successful VBAC is extraordinarily small. However, the real risk of maternal mortality and morbidity occurs when a trial of labor fails and repeat cesarean section is necessitated. These risks far exceed those associated with a planned repeat cesarean delivery prior to the onset of active labor. Third, the available data failed to address perinatal morbidity and mortality associated with an unsuccessful attempt at VBAC. Finally, and still relevant to the debate today, is that the studies were done almost exclusively at major university centers where fully staffed operating rooms, anesthesia personnel and obstetrical services were available 24 hours a day, every day of the year. These data have little relevance to the risk of VBAC in a small community hospital that cannot immediately address the surgical emergency created by a uterine rupture.

In this scientific vacuum, women were encouraged to attempt a trial of labor instead of a planned repeat cesarean section. In fact, the cost savings led to pressure on doctors and hospitals by third-party payers to offer VBAC to patients with contraindications to the procedure. Some insurers even went so far as to require a trial of labor as a condition of reimbursement for services. The result was that the incidence of VBAC rose from 3% in 1981 to 31% in 1998.

A Second Look

In 1999, ACOG, noting the absence of safety data, reported an increased incidence of uterine rupture and associated maternal and fetal morbidity and mortality. “Increasingly, these adverse events during a trial of labor have led to malpractice suits,” said an article in the ACOG Practice Bulletin, and ACOG decided it was finally time to reassess its VBAC recommendations. “Vaginal Birth After Previous Cesarean Delivery,” ACOG Practice Bulletin No. 5, July 1999. Questions were posed as to the safety of VBAC for certain types of patients, such as those with more than one previous cesarean section or those that required medical cervical ripening or labor augmentation, but the data still was not available to make any definitive recommendations on these matters.

It has long been known that the major risk of VBAC is uterine rupture, and that when a rupture occurs the blood supply to the fetus may be compromised leading very quickly — in a matter of minutes — to fetal death or permanent brain damage. Now, for the first time, ACOG advised clinicians that VBAC should only be offered in circumstances where the physician is “immediately available throughout active labor, capable of monitoring labor and performing an emergency cesarean delivery.”

In July 2004, ACOG updated its analysis, discouraging the use of prostaglandins or oxytocin and recommending against offering VBAC to a woman who had more than one previous cesarean delivery if she did not also have a history of at least one successful vaginal delivery. “Vaginal Birth After Previous Cesarean Delivery,” ACOG Practice Bulletin No. 54, July 2004. Some 30 years after VBAC began to be encouraged and 15 years since it became popular, obstetricians and patients were being told of the real dangers.

A recent study published in the New England Journal of Medicine confirms the serious maternal and fetal risks of VBAC. Id.: 2581-2589. The authors note at the outset that the incidence of VBAC had declined by 2002 to only 12.7% of patients with previous cesarean deliveries. The authors of this study attribute this decline, in part, to “medicolegal pressures.” Doctors are getting sued for bad outcomes associated with a trial of labor and, as a result, are reluctant to offer the procedure. The study then sets out the data that underlie these lawsuits. Women who undergo a trial of labor are twice as likely to have complications as those who elect a repeat cesarean section. Their babies are almost twice as likely to die and, if they survive, they face a significantly increased risk of permanent brain damage.

But that only tells part of the story, because 26.6% of patients who have a trial of labor will be unable to deliver vaginally. When that occurs, the risks of maternal and fetal complications rises dramatically. Uterine rupture is 22 times more likely to occur with a failed attempt at vaginal delivery than with successful vaginal delivery. Uterine dehiscence (separation along the previous scar) is almost 15 times more likely. Other complications include hysterectomy (3.21 times increased risk), thromboembolic disease (3.69 times increased risk), endometritis (7.10 times increased risk) and maternal death (5.52 times increased risk). Other maternal adverse events, defined as including broad-ligament hematoma, cystotomy, bowel injury and ureteral injury, is increased 176.24 times when vaginal delivery fails compared with when it is successful. Patients considering VBAC need to be made aware of these risks, along with the acknowledgement by ACOG that “[t]here is no completely reliable way to predict whether a trial of labor will be successful in an individual patient”. Id.: 2581-2589.

The New England Journal of Medicine study concludes that although the absolute risks are small, they are important for counseling women so that they can make a truly informed decision. It is also critical to note that this study was performed at 19 large educational institutions. The data cannot be applied to small community hospital settings where the availability of personnel to respond to an emergency is uncertain. If a uterine rupture occurs and is not promptly detected and a cesarean section performed emergently, the risks are enormous.

A Well-Equipped Facility Is a Must

Recently, there have been articles in the popular press and interviews on news programs concerning the lack of availability of VBAC in certain areas. See Grady: Trying to Avoid 2nd Caesarean, Many Find Choice Isn't Theirs. New York Times, Nov. 29, 2004. The focus in some of these reports is that patients are being denied the right to choose a VBAC in some community hospitals because those hospitals are not equipped to handle the potential complications. This is similar to the policy that only hospitals that are equipped to perform open-heart surgery are permitted to perform angioplasties because of the potential need to convert the procedure. It simply makes common sense that hospitals should not offer procedures to patients if they cannot respond properly to the known risks of the procedure.

Nevertheless, hospital officials and obstetricians have been quoted as saying that one of the reasons for the lack of availability of VBAC is the risk of being sued when things go wrong. In other words, they are suggesting that it is the risk to the healthcare provider, not the patient, which is controlling their decision-making. If that is what it takes to limit the use of VBAC to hospitals that are properly staffed and equipped to respond to uterine ruptures, it demonstrates the essential nature of our civil justice system in promoting safe practices.

Health care providers will only be exposed to liability for complications of VBAC in one or more of the following circumstances: 1) They fail to properly monitor the patient for the possible occurrence of a known dangerous complication; 2) They are not prepared to deal with a foreseeable complication when it occurs; 3) They contribute to the occurrence of the complication such as by performing an unsafe induction of labor with Misoprostol, or augmenting labor in the face of uterine hyperstimulation; 4) They offer a trial of labor to an unsuitable patient, such as one who has had a prior classical incision; or 5) They fail to obtain proper informed consent by fully advising the patient of the material risks, benefits and alternatives.

Conclusion

These requirements of the standard of care are essential to the health and safety of the pregnant woman and her unborn child and should be followed regardless of the risk of a lawsuit. If proper research had been performed before the policy of promoting VBAC became widespread, it would not have taken malpractice lawsuits to determine that VBAC is only safe under very limited circumstances

Major shifts in clinical practice rarely evolve as quickly or dramatically as has occurred with the practice of offering a trial of labor to patients who have had a previous cesarean section. Vaginal birth after cesarean (VBAC) has become a relatively rare event in recent years. The popular press has addressed the issue as a matter of patient choice, while the obstetrical community has focused on safety – both for the patient and for the health care providers. Medical malpractice liability has been cited as a reason for the decision by a number of hospitals in the United States to stop offering VBAC to its patients. If that is, in fact, one of the reasons for this move, it demonstrates the essential nature of our legal system as a check on the use of dangerous and unsupported clinical practices by our health care community.

VBAC in Recent History

Prior to the 1970s, after a woman had a cesarean delivery, she had no choice but to deliver all subsequent babies by the same method. The maxim of “Once a cesarean, always a cesarean” dictated the course of treatment because of the concern, albeit untested in clinical trials, that the presence of a scarred uterus created an unacceptable risk of uterine rupture when it was subjected to the contractive forces of labor.

As surgical methods improved, anesthesia became safer and new-generation antibiotics greatly reduced the risk of infection, rates of cesarean section began to increase dramatically. Cesarean deliveries are more expensive than vaginal births and require longer hospital stays, thereby driving up the cost. As a result, health care officials began looking for ways to reduce the rate of cesarean deliveries. They observed that approximately one-third of all cesareans were repeats for women who had delivered previously by cesarean. This led to a tremendous interest in the use of VBAC as a way to reduce the rate of cesarean deliveries.

It would seem to be an obvious question to ask whether promoting the use of VBAC was safe before embarking on this course of action. At the very least, it would be reasonable to attempt to learn the real risks and benefits of VBAC, the relative and absolute contraindications and whether labor needed to be managed differently so that women could be properly counseled and able to give informed consent. Instead, the health care community decided to “shoot first and ask questions later.” As recently as July 2004, the American College of Obstetricians and Gynecologists (ACOG) noted that, even today, “there are currently no randomized trials comparing maternal or neonatal outcomes for both repeat cesarean delivery and VBAC”. “Vaginal Birth After Previous Cesarean Delivery,” ACOG Practice Bulletin No. 54, July 2004.

Faulty Information Leads to Rash Decisions

The limited scientific evidence that was relied upon when promoting VBAC suffered from several serious flaws. First, the studies that were available were scientifically flawed and used inconsistent parameters and definitions. Landon, MB et al.: Maternal and Perinatal Outcomes Associated with a Trial of Labor After Prior Cesarean Delivery. N Engl J Med 2004; 351: 2581-2589. Second, the endpoint of these clinical series was maternal mortality following successful VBAC. The statistical risk of maternal death from a successful VBAC is extraordinarily small. However, the real risk of maternal mortality and morbidity occurs when a trial of labor fails and repeat cesarean section is necessitated. These risks far exceed those associated with a planned repeat cesarean delivery prior to the onset of active labor. Third, the available data failed to address perinatal morbidity and mortality associated with an unsuccessful attempt at VBAC. Finally, and still relevant to the debate today, is that the studies were done almost exclusively at major university centers where fully staffed operating rooms, anesthesia personnel and obstetrical services were available 24 hours a day, every day of the year. These data have little relevance to the risk of VBAC in a small community hospital that cannot immediately address the surgical emergency created by a uterine rupture.

In this scientific vacuum, women were encouraged to attempt a trial of labor instead of a planned repeat cesarean section. In fact, the cost savings led to pressure on doctors and hospitals by third-party payers to offer VBAC to patients with contraindications to the procedure. Some insurers even went so far as to require a trial of labor as a condition of reimbursement for services. The result was that the incidence of VBAC rose from 3% in 1981 to 31% in 1998.

A Second Look

In 1999, ACOG, noting the absence of safety data, reported an increased incidence of uterine rupture and associated maternal and fetal morbidity and mortality. “Increasingly, these adverse events during a trial of labor have led to malpractice suits,” said an article in the ACOG Practice Bulletin, and ACOG decided it was finally time to reassess its VBAC recommendations. “Vaginal Birth After Previous Cesarean Delivery,” ACOG Practice Bulletin No. 5, July 1999. Questions were posed as to the safety of VBAC for certain types of patients, such as those with more than one previous cesarean section or those that required medical cervical ripening or labor augmentation, but the data still was not available to make any definitive recommendations on these matters.

It has long been known that the major risk of VBAC is uterine rupture, and that when a rupture occurs the blood supply to the fetus may be compromised leading very quickly — in a matter of minutes — to fetal death or permanent brain damage. Now, for the first time, ACOG advised clinicians that VBAC should only be offered in circumstances where the physician is “immediately available throughout active labor, capable of monitoring labor and performing an emergency cesarean delivery.”

In July 2004, ACOG updated its analysis, discouraging the use of prostaglandins or oxytocin and recommending against offering VBAC to a woman who had more than one previous cesarean delivery if she did not also have a history of at least one successful vaginal delivery. “Vaginal Birth After Previous Cesarean Delivery,” ACOG Practice Bulletin No. 54, July 2004. Some 30 years after VBAC began to be encouraged and 15 years since it became popular, obstetricians and patients were being told of the real dangers.

A recent study published in the New England Journal of Medicine confirms the serious maternal and fetal risks of VBAC. Id.: 2581-2589. The authors note at the outset that the incidence of VBAC had declined by 2002 to only 12.7% of patients with previous cesarean deliveries. The authors of this study attribute this decline, in part, to “medicolegal pressures.” Doctors are getting sued for bad outcomes associated with a trial of labor and, as a result, are reluctant to offer the procedure. The study then sets out the data that underlie these lawsuits. Women who undergo a trial of labor are twice as likely to have complications as those who elect a repeat cesarean section. Their babies are almost twice as likely to die and, if they survive, they face a significantly increased risk of permanent brain damage.

But that only tells part of the story, because 26.6% of patients who have a trial of labor will be unable to deliver vaginally. When that occurs, the risks of maternal and fetal complications rises dramatically. Uterine rupture is 22 times more likely to occur with a failed attempt at vaginal delivery than with successful vaginal delivery. Uterine dehiscence (separation along the previous scar) is almost 15 times more likely. Other complications include hysterectomy (3.21 times increased risk), thromboembolic disease (3.69 times increased risk), endometritis (7.10 times increased risk) and maternal death (5.52 times increased risk). Other maternal adverse events, defined as including broad-ligament hematoma, cystotomy, bowel injury and ureteral injury, is increased 176.24 times when vaginal delivery fails compared with when it is successful. Patients considering VBAC need to be made aware of these risks, along with the acknowledgement by ACOG that “[t]here is no completely reliable way to predict whether a trial of labor will be successful in an individual patient”. Id.: 2581-2589.

The New England Journal of Medicine study concludes that although the absolute risks are small, they are important for counseling women so that they can make a truly informed decision. It is also critical to note that this study was performed at 19 large educational institutions. The data cannot be applied to small community hospital settings where the availability of personnel to respond to an emergency is uncertain. If a uterine rupture occurs and is not promptly detected and a cesarean section performed emergently, the risks are enormous.

A Well-Equipped Facility Is a Must

Recently, there have been articles in the popular press and interviews on news programs concerning the lack of availability of VBAC in certain areas. See Grady: Trying to Avoid 2nd Caesarean, Many Find Choice Isn't Theirs. New York Times, Nov. 29, 2004. The focus in some of these reports is that patients are being denied the right to choose a VBAC in some community hospitals because those hospitals are not equipped to handle the potential complications. This is similar to the policy that only hospitals that are equipped to perform open-heart surgery are permitted to perform angioplasties because of the potential need to convert the procedure. It simply makes common sense that hospitals should not offer procedures to patients if they cannot respond properly to the known risks of the procedure.

Nevertheless, hospital officials and obstetricians have been quoted as saying that one of the reasons for the lack of availability of VBAC is the risk of being sued when things go wrong. In other words, they are suggesting that it is the risk to the healthcare provider, not the patient, which is controlling their decision-making. If that is what it takes to limit the use of VBAC to hospitals that are properly staffed and equipped to respond to uterine ruptures, it demonstrates the essential nature of our civil justice system in promoting safe practices.

Health care providers will only be exposed to liability for complications of VBAC in one or more of the following circumstances: 1) They fail to properly monitor the patient for the possible occurrence of a known dangerous complication; 2) They are not prepared to deal with a foreseeable complication when it occurs; 3) They contribute to the occurrence of the complication such as by performing an unsafe induction of labor with Misoprostol, or augmenting labor in the face of uterine hyperstimulation; 4) They offer a trial of labor to an unsuitable patient, such as one who has had a prior classical incision; or 5) They fail to obtain proper informed consent by fully advising the patient of the material risks, benefits and alternatives.

Conclusion

These requirements of the standard of care are essential to the health and safety of the pregnant woman and her unborn child and should be followed regardless of the risk of a lawsuit. If proper research had been performed before the policy of promoting VBAC became widespread, it would not have taken malpractice lawsuits to determine that VBAC is only safe under very limited circumstances