Janelle Yates

No surprise that the lawyer who wrote Sue the Doctor and Win! has a divergent view of the medical liability “crisis,” compared with the way ObGyns usually see it.

Lewis Laska, JD, PhD, shares ObGyns’ concerns about the effect of malpractice on women and their children. But he doesn’t agree that the number of lawsuits is increasing, or that the dollar value of jury verdicts is rising beyond what might be expected with “normal” inflation, or that most malpractice cases are generated by “greedy” lawyers.

Instead, he asserts that most liability cases arise from poor care, that ObGyns and other physicians often do themselves more harm than good when responding to a poor outcome, and that all doctors could learn a lot by considering the viewpoint of their nemesis, the trial attorney.

OBG Management decided to explore Dr. Laska’s intriguing proposition to view medical malpractice through an alternative lens and take advantage of his considerable experience as an attorney and medical malpractice expert. In a Q&A session, we asked about some of his assertions and inquired specifically about the ways he believes physicians draw avoidable medicolegal trouble.

Dr. Laska is a legal consultant and editor of Medical Malpractice Verdicts, Settlements & Experts, a monthly compendium of malpractice cases from around the country (www.verdictslaska.com) and the sole source of malpractice case summaries in the “Medical Verdicts”

OBG MANAGEMENT: Let’s focus first on the fundamental disagreements between malpractice attorneys and physicians. In your opinion, what are the most common misconceptions among ObGyns about malpractice litigation? That is, what do doctors just not “get” about the reasons they get sued?

LEWIS LASKA: They think that lawyers are always looking for ways to sue doctors; in reality, it’s just the opposite. For every lawsuit filed, as many as 100 are turned down. There are a lot of angry people out there, and trial lawyers do a lot of filtering.

Doctors also have the attitude that malpractice lawsuits are caused by lawyers rather than by anything that the doctor did or failed to do. In other words, physicians seem to think that health-care safety would improve if only there were no lawyers—and they overlook the obvious: that somebody (a nurse or doctor) did something wrong.

The most common misconception among ObGyns is that there is nothing they can do to avoid being sued. In reality, however, there is much that can be done. If ObGyns participated in drills to manage shoulder dystocia and common emergencies, and honed their skills and those of labor and delivery nurses so that their responses to these so-called complications were improved, they wouldn’t get sued so often.

ObGyns also fail to manage gestational diabetes aggressively, a clearly avoidable “complication.” Finally, if ObGyns were more responsive to questions from their patients, and acted more kindly, patients wouldn’t be so eager to sue them.

Is the number of lawsuits rising?

OBG MANAGEMENT: How many malpractice cases are filed each year in the United States?

LASKA: No one except the insurance companies knows how many malpractice cases are filed—and they aren’t telling. There is no central source in this country in which lawsuit filings are tallied, although some years ago the Physician Insurers Association of America cited an estimate of 30,000.

Nor is there clear agreement about what constitutes a malpractice “case.” Does it include a fall from a hospital bed? A fall from an ObGyn’s examining table?

It also is important, in addressing this question, to point out that a lawsuit is not the same thing as a claim. The latter may involve a patient simply complaining about poor treatment, bad office staff, and so on. Although a lawsuit is certainly a claim, a claim is not a lawsuit—and there are many, many more claims than lawsuits.

OBG MANAGEMENT: Is the number of malpractice lawsuits increasing?

LASKA: The most recent data that address this question are from the year 2006 and come from the National Practitioner Data Bank (NPDB). There were 15,843 medical malpractice payment reports received that year. That figure is 8.3% less than the number received in 2005, which showed a 2.2% decrease from 2004.¹

Anecdotal data provide additional evidence that the number of malpractice lawsuits is dropping. For example, Massachusetts Lawyers Weekly reported that 485 lawsuits were filed in 2008, compared with 708 in 2000. And Pennsylvania Lawyers Weekly noted that 1,602 lawsuits were filed in 2008, compared with 1,641 in 2007 and 2,732 in 2002.

As for the number of lawsuits filed each year, I think the 30,000 figure is about right. According to the NPDB, the average delay between an incident that leads to payment and the payment itself is 4.88 years—and that delay actually increased by 80% from 2005 to 2006.¹ If we assume that 30,000 cases are filed each year, and that it takes about 5 years for a case to close, that means about 15,843 payments each year, since it is a cumulative number for about 5 years’ worth of cases.

 

OBG MANAGEMENT: What about the dollar amount of jury verdicts? Has that been increasing in recent years?

LASKA: My impression is that any increase in the amount of dollars awarded simply reflects medical inflation—namely, the increase in the cost of medical care. This is especially true when the lawsuit involves future medical care, as in the case of a baby injured by health-care negligence.

Accurate dollar data are very hard to find. According to the NPDB, obstetrics-related cases generated 8.7% of all payments reported in 2006, and also were responsible for the highest median payment: $333,334.¹

When discussing dollar data, it is important to avoid the use of averages because a few very high outcomes distort this figure—and most of these amounts are lowered on appeal or settled for much less on appeal. The better figure is the median, which I cited above.

Why are so many cases settled?

OBG MANAGEMENT: In your book, you note the following:

In 1994, it was reported by American Medical News, the AMA’s weekly newspaper, that of every 100 birth-injury lawsuits filed, 47 were dropped by the plaintiffs or dismissed by the court prior to trial. Of the remaining 53 cases, 40 (three quarters) were settled by monetary payment. That leaves 13 cases. Of these, the doctor won 78%. In other words, plaintiffs won only three of the 13 that went to trial. This means that only 3% of birth injury cases result in a plaintiff‘s verdict.²

 

Are these figures still relatively accurate?

LASKA: Yes, so far as I can tell.

OBG MANAGEMENT: Why do you think so many cases (40%) are settled by monetary payment? Is there blatant negligence in those cases? Or is the insurance company simply reluctant to bear the burden of cost of seeing the case all the way to trial?

LASKA: Sorry, but this is a false dichotomy. Insurance companies never settle unless there is provable liability. The notion that an insurance company would settle a big injury case with marginal liability is simply a cultural myth of medicine.

Why do patients sue?

OBG MANAGEMENT: In your book, you say many injured patients sue just to find out what really went wrong because the doctor has not been communicative about all the events that transpired. If physicians were more straightforward about adverse outcomes and the reasons for them, do you think fewer patients would sue?

LASKA: Yes, I think there would be fewer suits, lower settlements, and greater trust. Doctors should stop demanding “tort reform” and look more closely at themselves.

If my book seems too toxic for ObGyns, another option is Medical Errors and Medical Narcissism by John D. Banja. He argues that physicians are self-obsessed, wanting to be seen as “perfect.” And when they do wrong, they follow a path driven by narcissism. Shock and concern are followed by rationalization, avoidance, and minimization.

By the way, most people would like doctors to communicate with them the way physicians communicate with patients (and one another) on television. Jurors are sometimes stunned to learn that the doctor being sued did not communicate with nurses about the problem as it arose, and then disappeared without talking to the injured patient.

OBG MANAGEMENT: You say that about one in eight patients who sustain injury in the hospital actually sues. Why do you think that figure is so low?

LASKA: The injuries sustained are not so severe that a lawyer can be convinced to take the case, or the patient simply does not know that she was injured by negligence.

Because it takes so much money to press a health-care liability case, the injury has to be severe to justify it. Here’s an example: The obstetrician cuts the baby’s face during a cesarean delivery. The parents are outraged, but if the baby heals nicely, there really isn’t much of a case that will bring enough money from a jury to justify a lawsuit.

OBG MANAGEMENT: In your book, you claim that juries are moved not by sympathy, but by anger. Could you elaborate?

LASKA: When a physician is sued, and, in response, points the finger at someone else, who points the finger right back, juries conclude that the team simply was not working together. And the refusal of anyone on that team to accept responsibility makes the jury angry. Doctors may call it “system breakdown,” but juries consider it malpractice—or, the term I now use, “health-care liability.”

Another reason juries get angry is the rude and condescending behavior that physicians sometimes exhibit in videotaped testimony. Sometimes doctors make fools of themselves in these videotapes by contradicting themselves, contradicting the medical records, contradicting the testimony of nurses, and so on. This kind of behavior will torpedo a case and lead to a higher verdict than it would have in the days before videotaping, when the deposition was merely read to the jury.

How do lawyers try these cases?

OBG MANAGEMENT: Has the way in which lawyers try cases changed?

LASKA: Most medical liability cases now end up in the hands of legal “specialists,” who have experience in a particular area. In addition, lawyers now share information better than in the past. ObGyns and other doctors don’t understand that health-care victims’ lawyers are working together as never before and learning to overcome the many defenses—some very tenuous—that are raised in a doctor’s defense.

A recent Tennessee case is an example. In Olinger v. University Medical Center, the defendant ObGyn (and his experts) testified that shoulder dystocia is a “sudden emergency” because it occurs in only 3% of deliveries.³ They also asserted that 90% of the time, shoulder dystocia is relieved by initial maneuvers, such as McRoberts’ maneuver.

In this case, because the doctor had delivered 4,000 babies and had encountered shoulder dystocia only 100 times, and because the legal case represented the first time initial maneuvers had failed to resolve the dystocia, the defense argued that the occurrence was a true “sudden emergency,” allowing the jury to be so instructed on that issue.

 

The doctor won his case—fine. But now that it is established in Tennessee law and Tennessee medicine that shoulder dystocia that cannot be resolved with “initial maneuvers” is a medical emergency, you can bet that victims’ lawyers are going to find ways to demonstrate that a particular case is one in which the doctor did not know how to deal with this particular “sudden emergency.” In short, the Olinger case provides a roadmap for how to win (or turn down) a shoulder dystocia case.

OBG MANAGEMENT: What do you think about proposals set forth to resolve the malpractice crisis?

LASKA: In the 1970s, physicians advocated malpractice review panels to end the so-called crisis. These panels fell from favor because they did not work. Now, the idea du jour is the establishment of special “malpractice courts.”

What will be the result? A cadre of superspecialists will develop who handle nothing but malpractice court cases. The typical lawyer will refer cases to one of these superspecialists (as they usually do now), and it will become easier to prove the standard of care nationwide. After all, why should the handling of a case involving shoulder dystocia be different in Phoenix than it is in Nashville?

Doctors, be careful what you wish for. Special malpractice courts are the first step toward national standards of care.

OBG MANAGEMENT: A final question: Who buys your book, Sue the Doctor and Win!, as far as you are able to gauge?

LASKA: The primary buyers have been MD/JDs, probably because they all wanted to write such a book. Nurse consultants have also been buying it, as well as “puppy” lawyers at malpractice firms.

By the way, the book has sold poorly. Everybody thinks they already know all they need to know about malpractice. That includes doctors and victim’s lawyers.

f

No surprise that the lawyer who wrote Sue the Doctor and Win! has a divergent view of the medical liability “crisis,” compared with the way ObGyns usually see it.

Lewis Laska, JD, PhD, shares ObGyns’ concerns about the effect of malpractice on women and their children. But he doesn’t agree that the number of lawsuits is increasing, or that the dollar value of jury verdicts is rising beyond what might be expected with “normal” inflation, or that most malpractice cases are generated by “greedy” lawyers.

Instead, he asserts that most liability cases arise from poor care, that ObGyns and other physicians often do themselves more harm than good when responding to a poor outcome, and that all doctors could learn a lot by considering the viewpoint of their nemesis, the trial attorney.

OBG Management decided to explore Dr. Laska’s intriguing proposition to view medical malpractice through an alternative lens and take advantage of his considerable experience as an attorney and medical malpractice expert. In a Q&A session, we asked about some of his assertions and inquired specifically about the ways he believes physicians draw avoidable medicolegal trouble.

Dr. Laska is a legal consultant and editor of Medical Malpractice Verdicts, Settlements & Experts, a monthly compendium of malpractice cases from around the country (www.verdictslaska.com) and the sole source of malpractice case summaries in the “Medical Verdicts”

OBG MANAGEMENT: Let’s focus first on the fundamental disagreements between malpractice attorneys and physicians. In your opinion, what are the most common misconceptions among ObGyns about malpractice litigation? That is, what do doctors just not “get” about the reasons they get sued?

LEWIS LASKA: They think that lawyers are always looking for ways to sue doctors; in reality, it’s just the opposite. For every lawsuit filed, as many as 100 are turned down. There are a lot of angry people out there, and trial lawyers do a lot of filtering.

Doctors also have the attitude that malpractice lawsuits are caused by lawyers rather than by anything that the doctor did or failed to do. In other words, physicians seem to think that health-care safety would improve if only there were no lawyers—and they overlook the obvious: that somebody (a nurse or doctor) did something wrong.

The most common misconception among ObGyns is that there is nothing they can do to avoid being sued. In reality, however, there is much that can be done. If ObGyns participated in drills to manage shoulder dystocia and common emergencies, and honed their skills and those of labor and delivery nurses so that their responses to these so-called complications were improved, they wouldn’t get sued so often.

ObGyns also fail to manage gestational diabetes aggressively, a clearly avoidable “complication.” Finally, if ObGyns were more responsive to questions from their patients, and acted more kindly, patients wouldn’t be so eager to sue them.

Is the number of lawsuits rising?

OBG MANAGEMENT: How many malpractice cases are filed each year in the United States?

LASKA: No one except the insurance companies knows how many malpractice cases are filed—and they aren’t telling. There is no central source in this country in which lawsuit filings are tallied, although some years ago the Physician Insurers Association of America cited an estimate of 30,000.

Nor is there clear agreement about what constitutes a malpractice “case.” Does it include a fall from a hospital bed? A fall from an ObGyn’s examining table?

It also is important, in addressing this question, to point out that a lawsuit is not the same thing as a claim. The latter may involve a patient simply complaining about poor treatment, bad office staff, and so on. Although a lawsuit is certainly a claim, a claim is not a lawsuit—and there are many, many more claims than lawsuits.

OBG MANAGEMENT: Is the number of malpractice lawsuits increasing?

LASKA: The most recent data that address this question are from the year 2006 and come from the National Practitioner Data Bank (NPDB). There were 15,843 medical malpractice payment reports received that year. That figure is 8.3% less than the number received in 2005, which showed a 2.2% decrease from 2004.¹

Anecdotal data provide additional evidence that the number of malpractice lawsuits is dropping. For example, Massachusetts Lawyers Weekly reported that 485 lawsuits were filed in 2008, compared with 708 in 2000. And Pennsylvania Lawyers Weekly noted that 1,602 lawsuits were filed in 2008, compared with 1,641 in 2007 and 2,732 in 2002.

As for the number of lawsuits filed each year, I think the 30,000 figure is about right. According to the NPDB, the average delay between an incident that leads to payment and the payment itself is 4.88 years—and that delay actually increased by 80% from 2005 to 2006.¹ If we assume that 30,000 cases are filed each year, and that it takes about 5 years for a case to close, that means about 15,843 payments each year, since it is a cumulative number for about 5 years’ worth of cases.

 

OBG MANAGEMENT: What about the dollar amount of jury verdicts? Has that been increasing in recent years?

LASKA: My impression is that any increase in the amount of dollars awarded simply reflects medical inflation—namely, the increase in the cost of medical care. This is especially true when the lawsuit involves future medical care, as in the case of a baby injured by health-care negligence.

Accurate dollar data are very hard to find. According to the NPDB, obstetrics-related cases generated 8.7% of all payments reported in 2006, and also were responsible for the highest median payment: $333,334.¹

When discussing dollar data, it is important to avoid the use of averages because a few very high outcomes distort this figure—and most of these amounts are lowered on appeal or settled for much less on appeal. The better figure is the median, which I cited above.

Why are so many cases settled?

OBG MANAGEMENT: In your book, you note the following:

In 1994, it was reported by American Medical News, the AMA’s weekly newspaper, that of every 100 birth-injury lawsuits filed, 47 were dropped by the plaintiffs or dismissed by the court prior to trial. Of the remaining 53 cases, 40 (three quarters) were settled by monetary payment. That leaves 13 cases. Of these, the doctor won 78%. In other words, plaintiffs won only three of the 13 that went to trial. This means that only 3% of birth injury cases result in a plaintiff‘s verdict.²

 

Are these figures still relatively accurate?

LASKA: Yes, so far as I can tell.

OBG MANAGEMENT: Why do you think so many cases (40%) are settled by monetary payment? Is there blatant negligence in those cases? Or is the insurance company simply reluctant to bear the burden of cost of seeing the case all the way to trial?

LASKA: Sorry, but this is a false dichotomy. Insurance companies never settle unless there is provable liability. The notion that an insurance company would settle a big injury case with marginal liability is simply a cultural myth of medicine.

Why do patients sue?

OBG MANAGEMENT: In your book, you say many injured patients sue just to find out what really went wrong because the doctor has not been communicative about all the events that transpired. If physicians were more straightforward about adverse outcomes and the reasons for them, do you think fewer patients would sue?

LASKA: Yes, I think there would be fewer suits, lower settlements, and greater trust. Doctors should stop demanding “tort reform” and look more closely at themselves.

If my book seems too toxic for ObGyns, another option is Medical Errors and Medical Narcissism by John D. Banja. He argues that physicians are self-obsessed, wanting to be seen as “perfect.” And when they do wrong, they follow a path driven by narcissism. Shock and concern are followed by rationalization, avoidance, and minimization.

By the way, most people would like doctors to communicate with them the way physicians communicate with patients (and one another) on television. Jurors are sometimes stunned to learn that the doctor being sued did not communicate with nurses about the problem as it arose, and then disappeared without talking to the injured patient.

OBG MANAGEMENT: You say that about one in eight patients who sustain injury in the hospital actually sues. Why do you think that figure is so low?

LASKA: The injuries sustained are not so severe that a lawyer can be convinced to take the case, or the patient simply does not know that she was injured by negligence.

Because it takes so much money to press a health-care liability case, the injury has to be severe to justify it. Here’s an example: The obstetrician cuts the baby’s face during a cesarean delivery. The parents are outraged, but if the baby heals nicely, there really isn’t much of a case that will bring enough money from a jury to justify a lawsuit.

OBG MANAGEMENT: In your book, you claim that juries are moved not by sympathy, but by anger. Could you elaborate?

LASKA: When a physician is sued, and, in response, points the finger at someone else, who points the finger right back, juries conclude that the team simply was not working together. And the refusal of anyone on that team to accept responsibility makes the jury angry. Doctors may call it “system breakdown,” but juries consider it malpractice—or, the term I now use, “health-care liability.”

Another reason juries get angry is the rude and condescending behavior that physicians sometimes exhibit in videotaped testimony. Sometimes doctors make fools of themselves in these videotapes by contradicting themselves, contradicting the medical records, contradicting the testimony of nurses, and so on. This kind of behavior will torpedo a case and lead to a higher verdict than it would have in the days before videotaping, when the deposition was merely read to the jury.

How do lawyers try these cases?

OBG MANAGEMENT: Has the way in which lawyers try cases changed?

LASKA: Most medical liability cases now end up in the hands of legal “specialists,” who have experience in a particular area. In addition, lawyers now share information better than in the past. ObGyns and other doctors don’t understand that health-care victims’ lawyers are working together as never before and learning to overcome the many defenses—some very tenuous—that are raised in a doctor’s defense.

A recent Tennessee case is an example. In Olinger v. University Medical Center, the defendant ObGyn (and his experts) testified that shoulder dystocia is a “sudden emergency” because it occurs in only 3% of deliveries.³ They also asserted that 90% of the time, shoulder dystocia is relieved by initial maneuvers, such as McRoberts’ maneuver.

In this case, because the doctor had delivered 4,000 babies and had encountered shoulder dystocia only 100 times, and because the legal case represented the first time initial maneuvers had failed to resolve the dystocia, the defense argued that the occurrence was a true “sudden emergency,” allowing the jury to be so instructed on that issue.

 

The doctor won his case—fine. But now that it is established in Tennessee law and Tennessee medicine that shoulder dystocia that cannot be resolved with “initial maneuvers” is a medical emergency, you can bet that victims’ lawyers are going to find ways to demonstrate that a particular case is one in which the doctor did not know how to deal with this particular “sudden emergency.” In short, the Olinger case provides a roadmap for how to win (or turn down) a shoulder dystocia case.

OBG MANAGEMENT: What do you think about proposals set forth to resolve the malpractice crisis?

LASKA: In the 1970s, physicians advocated malpractice review panels to end the so-called crisis. These panels fell from favor because they did not work. Now, the idea du jour is the establishment of special “malpractice courts.”

What will be the result? A cadre of superspecialists will develop who handle nothing but malpractice court cases. The typical lawyer will refer cases to one of these superspecialists (as they usually do now), and it will become easier to prove the standard of care nationwide. After all, why should the handling of a case involving shoulder dystocia be different in Phoenix than it is in Nashville?

Doctors, be careful what you wish for. Special malpractice courts are the first step toward national standards of care.

OBG MANAGEMENT: A final question: Who buys your book, Sue the Doctor and Win!, as far as you are able to gauge?

LASKA: The primary buyers have been MD/JDs, probably because they all wanted to write such a book. Nurse consultants have also been buying it, as well as “puppy” lawyers at malpractice firms.

By the way, the book has sold poorly. Everybody thinks they already know all they need to know about malpractice. That includes doctors and victim’s lawyers.

f

No surprise that the lawyer who wrote Sue the Doctor and Win! has a divergent view of the medical liability “crisis,” compared with the way ObGyns usually see it.

Lewis Laska, JD, PhD, shares ObGyns’ concerns about the effect of malpractice on women and their children. But he doesn’t agree that the number of lawsuits is increasing, or that the dollar value of jury verdicts is rising beyond what might be expected with “normal” inflation, or that most malpractice cases are generated by “greedy” lawyers.

Instead, he asserts that most liability cases arise from poor care, that ObGyns and other physicians often do themselves more harm than good when responding to a poor outcome, and that all doctors could learn a lot by considering the viewpoint of their nemesis, the trial attorney.

OBG Management decided to explore Dr. Laska’s intriguing proposition to view medical malpractice through an alternative lens and take advantage of his considerable experience as an attorney and medical malpractice expert. In a Q&A session, we asked about some of his assertions and inquired specifically about the ways he believes physicians draw avoidable medicolegal trouble.

Dr. Laska is a legal consultant and editor of Medical Malpractice Verdicts, Settlements & Experts, a monthly compendium of malpractice cases from around the country (www.verdictslaska.com) and the sole source of malpractice case summaries in the “Medical Verdicts”

OBG MANAGEMENT: Let’s focus first on the fundamental disagreements between malpractice attorneys and physicians. In your opinion, what are the most common misconceptions among ObGyns about malpractice litigation? That is, what do doctors just not “get” about the reasons they get sued?

LEWIS LASKA: They think that lawyers are always looking for ways to sue doctors; in reality, it’s just the opposite. For every lawsuit filed, as many as 100 are turned down. There are a lot of angry people out there, and trial lawyers do a lot of filtering.

Doctors also have the attitude that malpractice lawsuits are caused by lawyers rather than by anything that the doctor did or failed to do. In other words, physicians seem to think that health-care safety would improve if only there were no lawyers—and they overlook the obvious: that somebody (a nurse or doctor) did something wrong.

The most common misconception among ObGyns is that there is nothing they can do to avoid being sued. In reality, however, there is much that can be done. If ObGyns participated in drills to manage shoulder dystocia and common emergencies, and honed their skills and those of labor and delivery nurses so that their responses to these so-called complications were improved, they wouldn’t get sued so often.

ObGyns also fail to manage gestational diabetes aggressively, a clearly avoidable “complication.” Finally, if ObGyns were more responsive to questions from their patients, and acted more kindly, patients wouldn’t be so eager to sue them.

Is the number of lawsuits rising?

OBG MANAGEMENT: How many malpractice cases are filed each year in the United States?

LASKA: No one except the insurance companies knows how many malpractice cases are filed—and they aren’t telling. There is no central source in this country in which lawsuit filings are tallied, although some years ago the Physician Insurers Association of America cited an estimate of 30,000.

Nor is there clear agreement about what constitutes a malpractice “case.” Does it include a fall from a hospital bed? A fall from an ObGyn’s examining table?

It also is important, in addressing this question, to point out that a lawsuit is not the same thing as a claim. The latter may involve a patient simply complaining about poor treatment, bad office staff, and so on. Although a lawsuit is certainly a claim, a claim is not a lawsuit—and there are many, many more claims than lawsuits.

OBG MANAGEMENT: Is the number of malpractice lawsuits increasing?

LASKA: The most recent data that address this question are from the year 2006 and come from the National Practitioner Data Bank (NPDB). There were 15,843 medical malpractice payment reports received that year. That figure is 8.3% less than the number received in 2005, which showed a 2.2% decrease from 2004.¹

Anecdotal data provide additional evidence that the number of malpractice lawsuits is dropping. For example, Massachusetts Lawyers Weekly reported that 485 lawsuits were filed in 2008, compared with 708 in 2000. And Pennsylvania Lawyers Weekly noted that 1,602 lawsuits were filed in 2008, compared with 1,641 in 2007 and 2,732 in 2002.

As for the number of lawsuits filed each year, I think the 30,000 figure is about right. According to the NPDB, the average delay between an incident that leads to payment and the payment itself is 4.88 years—and that delay actually increased by 80% from 2005 to 2006.¹ If we assume that 30,000 cases are filed each year, and that it takes about 5 years for a case to close, that means about 15,843 payments each year, since it is a cumulative number for about 5 years’ worth of cases.

 

OBG MANAGEMENT: What about the dollar amount of jury verdicts? Has that been increasing in recent years?

LASKA: My impression is that any increase in the amount of dollars awarded simply reflects medical inflation—namely, the increase in the cost of medical care. This is especially true when the lawsuit involves future medical care, as in the case of a baby injured by health-care negligence.

Accurate dollar data are very hard to find. According to the NPDB, obstetrics-related cases generated 8.7% of all payments reported in 2006, and also were responsible for the highest median payment: $333,334.¹

When discussing dollar data, it is important to avoid the use of averages because a few very high outcomes distort this figure—and most of these amounts are lowered on appeal or settled for much less on appeal. The better figure is the median, which I cited above.

Why are so many cases settled?

OBG MANAGEMENT: In your book, you note the following:

In 1994, it was reported by American Medical News, the AMA’s weekly newspaper, that of every 100 birth-injury lawsuits filed, 47 were dropped by the plaintiffs or dismissed by the court prior to trial. Of the remaining 53 cases, 40 (three quarters) were settled by monetary payment. That leaves 13 cases. Of these, the doctor won 78%. In other words, plaintiffs won only three of the 13 that went to trial. This means that only 3% of birth injury cases result in a plaintiff‘s verdict.²

 

Are these figures still relatively accurate?

LASKA: Yes, so far as I can tell.

OBG MANAGEMENT: Why do you think so many cases (40%) are settled by monetary payment? Is there blatant negligence in those cases? Or is the insurance company simply reluctant to bear the burden of cost of seeing the case all the way to trial?

LASKA: Sorry, but this is a false dichotomy. Insurance companies never settle unless there is provable liability. The notion that an insurance company would settle a big injury case with marginal liability is simply a cultural myth of medicine.

Why do patients sue?

OBG MANAGEMENT: In your book, you say many injured patients sue just to find out what really went wrong because the doctor has not been communicative about all the events that transpired. If physicians were more straightforward about adverse outcomes and the reasons for them, do you think fewer patients would sue?

LASKA: Yes, I think there would be fewer suits, lower settlements, and greater trust. Doctors should stop demanding “tort reform” and look more closely at themselves.

If my book seems too toxic for ObGyns, another option is Medical Errors and Medical Narcissism by John D. Banja. He argues that physicians are self-obsessed, wanting to be seen as “perfect.” And when they do wrong, they follow a path driven by narcissism. Shock and concern are followed by rationalization, avoidance, and minimization.

By the way, most people would like doctors to communicate with them the way physicians communicate with patients (and one another) on television. Jurors are sometimes stunned to learn that the doctor being sued did not communicate with nurses about the problem as it arose, and then disappeared without talking to the injured patient.

OBG MANAGEMENT: You say that about one in eight patients who sustain injury in the hospital actually sues. Why do you think that figure is so low?

LASKA: The injuries sustained are not so severe that a lawyer can be convinced to take the case, or the patient simply does not know that she was injured by negligence.

Because it takes so much money to press a health-care liability case, the injury has to be severe to justify it. Here’s an example: The obstetrician cuts the baby’s face during a cesarean delivery. The parents are outraged, but if the baby heals nicely, there really isn’t much of a case that will bring enough money from a jury to justify a lawsuit.

OBG MANAGEMENT: In your book, you claim that juries are moved not by sympathy, but by anger. Could you elaborate?

LASKA: When a physician is sued, and, in response, points the finger at someone else, who points the finger right back, juries conclude that the team simply was not working together. And the refusal of anyone on that team to accept responsibility makes the jury angry. Doctors may call it “system breakdown,” but juries consider it malpractice—or, the term I now use, “health-care liability.”

Another reason juries get angry is the rude and condescending behavior that physicians sometimes exhibit in videotaped testimony. Sometimes doctors make fools of themselves in these videotapes by contradicting themselves, contradicting the medical records, contradicting the testimony of nurses, and so on. This kind of behavior will torpedo a case and lead to a higher verdict than it would have in the days before videotaping, when the deposition was merely read to the jury.

How do lawyers try these cases?

OBG MANAGEMENT: Has the way in which lawyers try cases changed?

LASKA: Most medical liability cases now end up in the hands of legal “specialists,” who have experience in a particular area. In addition, lawyers now share information better than in the past. ObGyns and other doctors don’t understand that health-care victims’ lawyers are working together as never before and learning to overcome the many defenses—some very tenuous—that are raised in a doctor’s defense.

A recent Tennessee case is an example. In Olinger v. University Medical Center, the defendant ObGyn (and his experts) testified that shoulder dystocia is a “sudden emergency” because it occurs in only 3% of deliveries.³ They also asserted that 90% of the time, shoulder dystocia is relieved by initial maneuvers, such as McRoberts’ maneuver.

In this case, because the doctor had delivered 4,000 babies and had encountered shoulder dystocia only 100 times, and because the legal case represented the first time initial maneuvers had failed to resolve the dystocia, the defense argued that the occurrence was a true “sudden emergency,” allowing the jury to be so instructed on that issue.

 

The doctor won his case—fine. But now that it is established in Tennessee law and Tennessee medicine that shoulder dystocia that cannot be resolved with “initial maneuvers” is a medical emergency, you can bet that victims’ lawyers are going to find ways to demonstrate that a particular case is one in which the doctor did not know how to deal with this particular “sudden emergency.” In short, the Olinger case provides a roadmap for how to win (or turn down) a shoulder dystocia case.

OBG MANAGEMENT: What do you think about proposals set forth to resolve the malpractice crisis?

LASKA: In the 1970s, physicians advocated malpractice review panels to end the so-called crisis. These panels fell from favor because they did not work. Now, the idea du jour is the establishment of special “malpractice courts.”

What will be the result? A cadre of superspecialists will develop who handle nothing but malpractice court cases. The typical lawyer will refer cases to one of these superspecialists (as they usually do now), and it will become easier to prove the standard of care nationwide. After all, why should the handling of a case involving shoulder dystocia be different in Phoenix than it is in Nashville?

Doctors, be careful what you wish for. Special malpractice courts are the first step toward national standards of care.

OBG MANAGEMENT: A final question: Who buys your book, Sue the Doctor and Win!, as far as you are able to gauge?

LASKA: The primary buyers have been MD/JDs, probably because they all wanted to write such a book. Nurse consultants have also been buying it, as well as “puppy” lawyers at malpractice firms.

By the way, the book has sold poorly. Everybody thinks they already know all they need to know about malpractice. That includes doctors and victim’s lawyers.

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First-trimester exposure to the antiepileptic drug valproate increases the risk of major congenital malformation, particularly neural tube defects and facial clefts, according to recent guidelines developed by the American Academy of Neurology (AAN) and the American Epilepsy Society (AES).^1-3 The guidelines recommend that women who have epilepsy avoid taking valproate during pregnancy.

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the AAN.

The guidelines also suggest that, if possible, women who have epilepsy avoid taking more than one epilepsy drug during pregnancy because the use of multiple antiseizure medications increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy. When a fetus is exposed to one of these drugs, cognitive development may be impaired.

Safe pregnancy is likely—if no seizures occur

Aside from the risks known to be associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have well-controlled epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

However, a just-published study suggests that the presence of seizures during pregnancy confers some degree of risk, according to data from Yi-Hua Chen, PhD, and colleagues, of Taipei Medical University and General Cathay Hospital in Taiwan.⁴

Chen and associates performed a retrospective cross-sectional study that linked two nationwide population-based data sets from Taiwan. The study focused on 1,016 women who had epilepsy and who delivered singleton infants from 2001 to 2003; these women had been diagnosed with epilepsy within 2 years prior to their index delivery. Women who had epilepsy were further stratified into two groups: those who did and those who did not have seizures during pregnancy. They were compared with 8,128 women who had no chronic disease.

Women who experienced seizures during pregnancy were more likely to give birth to preterm, small, or low-birth-weight babies than were women who did not have epilepsy. In addition, women who experienced seizures during pregnancy were more likely to give birth to a small-for-gestational-age infant than were women who had epilepsy but who did not have seizures.

Some previous studies had reported a link between adverse pregnancy outcomes and a mother’s epilepsy, but others found no association, Chen and colleagues observed.

“Our study further illuminates these conflicting data to suggest that it is the seizures themselves that seem to contribute greatly to the increased risk of infants being delivered preterm, of low birthweight, and small for gestational age. For women who remained seizure-free throughout pregnancy, null or mild risk was identified, compared with unaffected women,” they wrote.

As a safeguard, measure blood levels
of antiseizure drugs

The guidelines from the AAN and AES recommend that pregnant women who have epilepsy consider having their blood tested regularly.

 

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free,” said Harden.

Antiepileptic drugs should be administered at the lowest dosage and lowest plasma level that protects against tonic-clonic seizures and other complex partial seizures.⁵

Do not withdraw antiepileptic drugs during pregnancy

Some physicians attempt to discontinue an antiepileptic drug when a woman has gone 2 years without experiencing a seizure.⁵ In this scenario, the likelihood that seizures will recur within 6 and 12 months is 12% and 32%, respectively.⁶ Because of the risk that seizures will recur, and the increased likelihood of adverse outcomes associated with seizures during pregnancy, antiepileptic medication should not be discontinued during gestation.

Nor should a woman attempt to transition from one antiepileptic drug to another during pregnancy solely for the purpose of reducing teratogenicity.⁵ Doing so could precipitate seizures and exposes the fetus to the potentially hazardous effects of an additional antiseizure medication during a critical period. Moreover, there may be no advantage associated with switching drugs once a pregnancy has been established.⁷

Screen for malformations rigorously

Comprehensive screening for fetal anomalies early in the pregnancy is recommended for two main reasons:

• If a malformation is identified, the mother has the option of terminating the pregnancy
  
• Even if the patient decides not to terminate a gestation in which fetal anomaly has been identified, the information may help the practitioner determine the best mode and place of delivery.
  

Cesarean delivery may be warranted if the mother
has had recent seizures

Although most women who have epilepsy can expect to have a normal vaginal delivery, elective cesarean should be considered if the mother has experienced frequent seizures during the third trimester, or if she has a history of stress-related status epilepticus.⁵

 

Tonic-clonic seizures occur during labor in 1% to 2% of women who have epilepsy, and in an additional 1% to 2% of women in the 24 hours immediately following delivery.

Plasma levels of antiepileptic medication should be monitored during the third trimester and delivery to ensure that the medication is given in adequate strength to prevent seizures. In addition, the patient should be counseled about the importance of taking her medication consistently during this period.⁵

If the patient experiences a seizure during labor and delivery, treat her promptly with an intravenous benzodiazepine, preferably lorazepam.⁸ However, be aware that phenobarbital, primidone, and benzodiazepines remain in neonatal plasma for several days after delivery and may cause sedation or neonatal withdrawal syndrome.⁹

Do not give magnesium sulfate for epileptic seizures unless the seizures first appear during the third trimester or immediate postpartum period and could be associated with eclampsia. In such cases, treat the eclampsia and evaluate the patient for other potential causes of the seizures.⁵

First-trimester exposure to the antiepileptic drug valproate increases the risk of major congenital malformation, particularly neural tube defects and facial clefts, according to recent guidelines developed by the American Academy of Neurology (AAN) and the American Epilepsy Society (AES).^1-3 The guidelines recommend that women who have epilepsy avoid taking valproate during pregnancy.

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the AAN.

The guidelines also suggest that, if possible, women who have epilepsy avoid taking more than one epilepsy drug during pregnancy because the use of multiple antiseizure medications increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy. When a fetus is exposed to one of these drugs, cognitive development may be impaired.

Safe pregnancy is likely—if no seizures occur

Aside from the risks known to be associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have well-controlled epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

However, a just-published study suggests that the presence of seizures during pregnancy confers some degree of risk, according to data from Yi-Hua Chen, PhD, and colleagues, of Taipei Medical University and General Cathay Hospital in Taiwan.⁴

Chen and associates performed a retrospective cross-sectional study that linked two nationwide population-based data sets from Taiwan. The study focused on 1,016 women who had epilepsy and who delivered singleton infants from 2001 to 2003; these women had been diagnosed with epilepsy within 2 years prior to their index delivery. Women who had epilepsy were further stratified into two groups: those who did and those who did not have seizures during pregnancy. They were compared with 8,128 women who had no chronic disease.

Women who experienced seizures during pregnancy were more likely to give birth to preterm, small, or low-birth-weight babies than were women who did not have epilepsy. In addition, women who experienced seizures during pregnancy were more likely to give birth to a small-for-gestational-age infant than were women who had epilepsy but who did not have seizures.

Some previous studies had reported a link between adverse pregnancy outcomes and a mother’s epilepsy, but others found no association, Chen and colleagues observed.

“Our study further illuminates these conflicting data to suggest that it is the seizures themselves that seem to contribute greatly to the increased risk of infants being delivered preterm, of low birthweight, and small for gestational age. For women who remained seizure-free throughout pregnancy, null or mild risk was identified, compared with unaffected women,” they wrote.

As a safeguard, measure blood levels
of antiseizure drugs

The guidelines from the AAN and AES recommend that pregnant women who have epilepsy consider having their blood tested regularly.

 

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free,” said Harden.

Antiepileptic drugs should be administered at the lowest dosage and lowest plasma level that protects against tonic-clonic seizures and other complex partial seizures.⁵

Do not withdraw antiepileptic drugs during pregnancy

Some physicians attempt to discontinue an antiepileptic drug when a woman has gone 2 years without experiencing a seizure.⁵ In this scenario, the likelihood that seizures will recur within 6 and 12 months is 12% and 32%, respectively.⁶ Because of the risk that seizures will recur, and the increased likelihood of adverse outcomes associated with seizures during pregnancy, antiepileptic medication should not be discontinued during gestation.

Nor should a woman attempt to transition from one antiepileptic drug to another during pregnancy solely for the purpose of reducing teratogenicity.⁵ Doing so could precipitate seizures and exposes the fetus to the potentially hazardous effects of an additional antiseizure medication during a critical period. Moreover, there may be no advantage associated with switching drugs once a pregnancy has been established.⁷

Screen for malformations rigorously

Comprehensive screening for fetal anomalies early in the pregnancy is recommended for two main reasons:

• If a malformation is identified, the mother has the option of terminating the pregnancy
  
• Even if the patient decides not to terminate a gestation in which fetal anomaly has been identified, the information may help the practitioner determine the best mode and place of delivery.
  

Cesarean delivery may be warranted if the mother
has had recent seizures

Although most women who have epilepsy can expect to have a normal vaginal delivery, elective cesarean should be considered if the mother has experienced frequent seizures during the third trimester, or if she has a history of stress-related status epilepticus.⁵

 

Tonic-clonic seizures occur during labor in 1% to 2% of women who have epilepsy, and in an additional 1% to 2% of women in the 24 hours immediately following delivery.

Plasma levels of antiepileptic medication should be monitored during the third trimester and delivery to ensure that the medication is given in adequate strength to prevent seizures. In addition, the patient should be counseled about the importance of taking her medication consistently during this period.⁵

If the patient experiences a seizure during labor and delivery, treat her promptly with an intravenous benzodiazepine, preferably lorazepam.⁸ However, be aware that phenobarbital, primidone, and benzodiazepines remain in neonatal plasma for several days after delivery and may cause sedation or neonatal withdrawal syndrome.⁹

Do not give magnesium sulfate for epileptic seizures unless the seizures first appear during the third trimester or immediate postpartum period and could be associated with eclampsia. In such cases, treat the eclampsia and evaluate the patient for other potential causes of the seizures.⁵

First-trimester exposure to the antiepileptic drug valproate increases the risk of major congenital malformation, particularly neural tube defects and facial clefts, according to recent guidelines developed by the American Academy of Neurology (AAN) and the American Epilepsy Society (AES).^1-3 The guidelines recommend that women who have epilepsy avoid taking valproate during pregnancy.

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the AAN.

The guidelines also suggest that, if possible, women who have epilepsy avoid taking more than one epilepsy drug during pregnancy because the use of multiple antiseizure medications increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy. When a fetus is exposed to one of these drugs, cognitive development may be impaired.

Safe pregnancy is likely—if no seizures occur

Aside from the risks known to be associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have well-controlled epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

However, a just-published study suggests that the presence of seizures during pregnancy confers some degree of risk, according to data from Yi-Hua Chen, PhD, and colleagues, of Taipei Medical University and General Cathay Hospital in Taiwan.⁴

Chen and associates performed a retrospective cross-sectional study that linked two nationwide population-based data sets from Taiwan. The study focused on 1,016 women who had epilepsy and who delivered singleton infants from 2001 to 2003; these women had been diagnosed with epilepsy within 2 years prior to their index delivery. Women who had epilepsy were further stratified into two groups: those who did and those who did not have seizures during pregnancy. They were compared with 8,128 women who had no chronic disease.

Women who experienced seizures during pregnancy were more likely to give birth to preterm, small, or low-birth-weight babies than were women who did not have epilepsy. In addition, women who experienced seizures during pregnancy were more likely to give birth to a small-for-gestational-age infant than were women who had epilepsy but who did not have seizures.

Some previous studies had reported a link between adverse pregnancy outcomes and a mother’s epilepsy, but others found no association, Chen and colleagues observed.

“Our study further illuminates these conflicting data to suggest that it is the seizures themselves that seem to contribute greatly to the increased risk of infants being delivered preterm, of low birthweight, and small for gestational age. For women who remained seizure-free throughout pregnancy, null or mild risk was identified, compared with unaffected women,” they wrote.

As a safeguard, measure blood levels
of antiseizure drugs

The guidelines from the AAN and AES recommend that pregnant women who have epilepsy consider having their blood tested regularly.

 

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free,” said Harden.

Antiepileptic drugs should be administered at the lowest dosage and lowest plasma level that protects against tonic-clonic seizures and other complex partial seizures.⁵

Do not withdraw antiepileptic drugs during pregnancy

Some physicians attempt to discontinue an antiepileptic drug when a woman has gone 2 years without experiencing a seizure.⁵ In this scenario, the likelihood that seizures will recur within 6 and 12 months is 12% and 32%, respectively.⁶ Because of the risk that seizures will recur, and the increased likelihood of adverse outcomes associated with seizures during pregnancy, antiepileptic medication should not be discontinued during gestation.

Nor should a woman attempt to transition from one antiepileptic drug to another during pregnancy solely for the purpose of reducing teratogenicity.⁵ Doing so could precipitate seizures and exposes the fetus to the potentially hazardous effects of an additional antiseizure medication during a critical period. Moreover, there may be no advantage associated with switching drugs once a pregnancy has been established.⁷

Screen for malformations rigorously

Comprehensive screening for fetal anomalies early in the pregnancy is recommended for two main reasons:

• If a malformation is identified, the mother has the option of terminating the pregnancy
  
• Even if the patient decides not to terminate a gestation in which fetal anomaly has been identified, the information may help the practitioner determine the best mode and place of delivery.
  

Cesarean delivery may be warranted if the mother
has had recent seizures

Although most women who have epilepsy can expect to have a normal vaginal delivery, elective cesarean should be considered if the mother has experienced frequent seizures during the third trimester, or if she has a history of stress-related status epilepticus.⁵

 

Tonic-clonic seizures occur during labor in 1% to 2% of women who have epilepsy, and in an additional 1% to 2% of women in the 24 hours immediately following delivery.

Plasma levels of antiepileptic medication should be monitored during the third trimester and delivery to ensure that the medication is given in adequate strength to prevent seizures. In addition, the patient should be counseled about the importance of taking her medication consistently during this period.⁵

If the patient experiences a seizure during labor and delivery, treat her promptly with an intravenous benzodiazepine, preferably lorazepam.⁸ However, be aware that phenobarbital, primidone, and benzodiazepines remain in neonatal plasma for several days after delivery and may cause sedation or neonatal withdrawal syndrome.⁹

Do not give magnesium sulfate for epileptic seizures unless the seizures first appear during the third trimester or immediate postpartum period and could be associated with eclampsia. In such cases, treat the eclampsia and evaluate the patient for other potential causes of the seizures.⁵

First-trimester exposure to the antiepileptic drug valproate increases the risk of major congenital malformation, particularly neural tube defects and facial clefts, according to recent guidelines developed by the American Academy of Neurology and the American Epilepsy Society.^1-3 The guidelines recommend that women who have epilepsy avoid taking valproate during pregnancy.

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the American Academy of Neurology.

The guidelines also suggest that, if at all possible, women who have epilepsy avoid taking more than one epilepsy drug at a time during pregnancy because the use of more than one antiseizure medication increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy to lower the risk of diminished cognitive skills in children.

It is estimated that approximately 500,000 women of childbearing age in the United States have epilepsy, and that 3 to 5 of every 1,000 births are to women who have epilepsy. Most people who have epilepsy have well-controlled seizures and are otherwise healthy, said Harden.

Safe pregnancy is likely in women who have epilepsy

Aside from the risks associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

As a safeguard, measure blood levels of antiseizure drugs

Harden recommended that pregnant women who have epilepsy consider having their blood tested regularly.

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free.”

Guidelines cover range of issues

Here is a summary of the other main recommendations in the guidelines:

Avoid certain drugs; discourage smoking

• Besides avoiding valproate and antiepileptic drug polytherapy during the first trimester, women who have epilepsy should avoid these regimens throughout pregnancy to prevent adverse cognitive outcomes in the infant.
  
• Women who take antiepileptic drugs are probably at increased risk of a small-for-gestational-age baby and, possibly, delivering a newborn with an Apgar score below 7 at 1 minute.
  
• Women who have epilepsy and who smoke may increase the risk that they will develop premature contractions, premature labor, and premature delivery.
  

Monitor levels of some drugs

• Monitor levels of lamotrigine, carbamazepine, and phenytoin during pregnancy. Also monitor levels of levetiracetam and oxcarbazepine (a monohydroxy derivative). Blood levels of antiepileptic drugs tend to drop during pregnancy, and the dosage may need to be adjusted.
  

Seizure-free pregnancy is possible

• Counsel women who have epilepsy that remaining free from seizures for at least 9 months before pregnancy greatly increases the likelihood that they will remain seizure-free during pregnancy.
  

Folic acid may be beneficial

• Consider giving women who have epilepsy at least 0.4 mg of folic acid daily before they become pregnant, as it appears likely to lower the risk of major congenital malformation. It is unclear whether a higher daily dosage offers greater protective benefits.
  

 

Counsel the mother about breastfeeding concerns

• Women who have epilepsy and who choose to breastfeed should be counseled that primidone and levetiracetam probably pass into breast milk in significant amounts. In addition, gabapentin, lamotrigine, and topiramate may pass into breast milk in significant amounts. In contrast, valproate, phenobarbital, phenytoin, and carbamazepine probably do not pass into breast milk in clinically important amounts.
  

The guidelines were developed after a review of all scientific studies available on each topic and were published in the online issue of the journal Epilepsia. Their development was supported in part by the Milken Family Foundation.

“For too long, women living with epilepsy have feared the added risk of premature birth and other consequences of both their epilepsy and their medications,” said Howard R. Soule, PhD, chief science officer for the Milken Family Foundation. “The results of this project will help relieve the worries of these women and their families.”

For more on the guidelines, visit the American Academy of Neurology Web site at: www.aan.com/index.cfm?axon=redirect&&path=/go/practice/guidelines.

First-trimester exposure to the antiepileptic drug valproate increases the risk of major congenital malformation, particularly neural tube defects and facial clefts, according to recent guidelines developed by the American Academy of Neurology and the American Epilepsy Society.^1-3 The guidelines recommend that women who have epilepsy avoid taking valproate during pregnancy.

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the American Academy of Neurology.

The guidelines also suggest that, if at all possible, women who have epilepsy avoid taking more than one epilepsy drug at a time during pregnancy because the use of more than one antiseizure medication increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy to lower the risk of diminished cognitive skills in children.

It is estimated that approximately 500,000 women of childbearing age in the United States have epilepsy, and that 3 to 5 of every 1,000 births are to women who have epilepsy. Most people who have epilepsy have well-controlled seizures and are otherwise healthy, said Harden.

Safe pregnancy is likely in women who have epilepsy

Aside from the risks associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

As a safeguard, measure blood levels of antiseizure drugs

Harden recommended that pregnant women who have epilepsy consider having their blood tested regularly.

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free.”

Guidelines cover range of issues

Here is a summary of the other main recommendations in the guidelines:

Avoid certain drugs; discourage smoking

• Besides avoiding valproate and antiepileptic drug polytherapy during the first trimester, women who have epilepsy should avoid these regimens throughout pregnancy to prevent adverse cognitive outcomes in the infant.
  
• Women who take antiepileptic drugs are probably at increased risk of a small-for-gestational-age baby and, possibly, delivering a newborn with an Apgar score below 7 at 1 minute.
  
• Women who have epilepsy and who smoke may increase the risk that they will develop premature contractions, premature labor, and premature delivery.
  

Monitor levels of some drugs

• Monitor levels of lamotrigine, carbamazepine, and phenytoin during pregnancy. Also monitor levels of levetiracetam and oxcarbazepine (a monohydroxy derivative). Blood levels of antiepileptic drugs tend to drop during pregnancy, and the dosage may need to be adjusted.
  

Seizure-free pregnancy is possible

• Counsel women who have epilepsy that remaining free from seizures for at least 9 months before pregnancy greatly increases the likelihood that they will remain seizure-free during pregnancy.
  

Folic acid may be beneficial

• Consider giving women who have epilepsy at least 0.4 mg of folic acid daily before they become pregnant, as it appears likely to lower the risk of major congenital malformation. It is unclear whether a higher daily dosage offers greater protective benefits.
  

 

Counsel the mother about breastfeeding concerns

• Women who have epilepsy and who choose to breastfeed should be counseled that primidone and levetiracetam probably pass into breast milk in significant amounts. In addition, gabapentin, lamotrigine, and topiramate may pass into breast milk in significant amounts. In contrast, valproate, phenobarbital, phenytoin, and carbamazepine probably do not pass into breast milk in clinically important amounts.
  

The guidelines were developed after a review of all scientific studies available on each topic and were published in the online issue of the journal Epilepsia. Their development was supported in part by the Milken Family Foundation.

“For too long, women living with epilepsy have feared the added risk of premature birth and other consequences of both their epilepsy and their medications,” said Howard R. Soule, PhD, chief science officer for the Milken Family Foundation. “The results of this project will help relieve the worries of these women and their families.”

For more on the guidelines, visit the American Academy of Neurology Web site at: www.aan.com/index.cfm?axon=redirect&&path=/go/practice/guidelines.

First-trimester exposure to the antiepileptic drug valproate increases the risk of major congenital malformation, particularly neural tube defects and facial clefts, according to recent guidelines developed by the American Academy of Neurology and the American Epilepsy Society.^1-3 The guidelines recommend that women who have epilepsy avoid taking valproate during pregnancy.

“Good evidence shows that valproate is linked to an increased risk for fetal malformations and decreased thinking skills in children, whether used by itself or with other medications,” said lead guideline author Cynthia Harden, MD, director of the Epilepsy Division at the University of Miami’s Miller School of Medicine and member of the American Academy of Neurology.

The guidelines also suggest that, if at all possible, women who have epilepsy avoid taking more than one epilepsy drug at a time during pregnancy because the use of more than one antiseizure medication increases the risk of birth defects.

In addition, the guidelines recommend that physicians avoid prescribing the epilepsy drugs phenytoin and phenobarbital during pregnancy to lower the risk of diminished cognitive skills in children.

It is estimated that approximately 500,000 women of childbearing age in the United States have epilepsy, and that 3 to 5 of every 1,000 births are to women who have epilepsy. Most people who have epilepsy have well-controlled seizures and are otherwise healthy, said Harden.

Safe pregnancy is likely in women who have epilepsy

Aside from the risks associated with valproate, phenytoin, phenobarbital, and polytherapy, pregnancy in women who have epilepsy appears to be relatively safe.

“Overall, what we found should be very reassuring to every woman with epilepsy planning to become pregnant,” said Harden.

“These guidelines show that women with epilepsy are not at a substantially increased risk of having a cesarean section, late-pregnancy bleeding, or premature contractions or premature labor and delivery. Also, if a woman is seizure-free 9 months before she becomes pregnant, it’s likely that she will not have any seizures during the pregnancy.”

As a safeguard, measure blood levels of antiseizure drugs

Harden recommended that pregnant women who have epilepsy consider having their blood tested regularly.

“Levels of seizure medications in the blood tend to drop during pregnancy, so checking these levels and adjusting the medication doses should help to keep the levels in the effective range and the pregnant woman seizure-free.”

Guidelines cover range of issues

Here is a summary of the other main recommendations in the guidelines:

Avoid certain drugs; discourage smoking

• Besides avoiding valproate and antiepileptic drug polytherapy during the first trimester, women who have epilepsy should avoid these regimens throughout pregnancy to prevent adverse cognitive outcomes in the infant.
  
• Women who take antiepileptic drugs are probably at increased risk of a small-for-gestational-age baby and, possibly, delivering a newborn with an Apgar score below 7 at 1 minute.
  
• Women who have epilepsy and who smoke may increase the risk that they will develop premature contractions, premature labor, and premature delivery.
  

Monitor levels of some drugs

• Monitor levels of lamotrigine, carbamazepine, and phenytoin during pregnancy. Also monitor levels of levetiracetam and oxcarbazepine (a monohydroxy derivative). Blood levels of antiepileptic drugs tend to drop during pregnancy, and the dosage may need to be adjusted.
  

Seizure-free pregnancy is possible

• Counsel women who have epilepsy that remaining free from seizures for at least 9 months before pregnancy greatly increases the likelihood that they will remain seizure-free during pregnancy.
  

Folic acid may be beneficial

• Consider giving women who have epilepsy at least 0.4 mg of folic acid daily before they become pregnant, as it appears likely to lower the risk of major congenital malformation. It is unclear whether a higher daily dosage offers greater protective benefits.
  

 

Counsel the mother about breastfeeding concerns

• Women who have epilepsy and who choose to breastfeed should be counseled that primidone and levetiracetam probably pass into breast milk in significant amounts. In addition, gabapentin, lamotrigine, and topiramate may pass into breast milk in significant amounts. In contrast, valproate, phenobarbital, phenytoin, and carbamazepine probably do not pass into breast milk in clinically important amounts.
  

The guidelines were developed after a review of all scientific studies available on each topic and were published in the online issue of the journal Epilepsia. Their development was supported in part by the Milken Family Foundation.

“For too long, women living with epilepsy have feared the added risk of premature birth and other consequences of both their epilepsy and their medications,” said Howard R. Soule, PhD, chief science officer for the Milken Family Foundation. “The results of this project will help relieve the worries of these women and their families.”

For more on the guidelines, visit the American Academy of Neurology Web site at: www.aan.com/index.cfm?axon=redirect&&path=/go/practice/guidelines.

Women who have been treated for cervical intraepithelial neoplasia (CIN) face an elevated risk of recurrence and invasive cervical cancer. That’s the conclusion drawn from a recent population-based study of 37,142 women who were treated for CIN 1, 2, or 3 between 1986 and 2000.

In the first 6 years after treatment, the cumulative rate of CIN 2 or 3 in this group was:

• 14.0% in women originally treated for CIN 3
• 9.3% in women originally treated for CIN 2
• 5.6% in women originally treated for CIN 1.

After 6 years, annual rates of CIN 2 or 3 were less than 1%.

The overall incidence of invasive cancer was 37 cancers for every 100,000 woman-years in the group that had a history of CIN, versus 6 cancers for every 100,000 woman-years in the comparison cohort, which comprised 71,213 women who had normal cytology and no previous diagnosis of CIN.

Cryotherapy was the least “durable” treatment

In addition to the grade of CIN, the woman’s age and type of treatment had a bearing on the likelihood of recurrence. According to the study, the risk of invasive cervical cancer and recurrent CIN 2 or 3 was highest among women who were older than 40, previously treated for CIN 3, or treated with cryotherapy.

For example, among women 40 to 49 years old, the 6-year adjusted rate of CIN 2 or 3 ranged from 2.6% for treatment of CIN 1 using the loop electrosurgical procedure (LEEP), to 34.0% for treatment of CIN 3 using cryotherapy.

Implications of the findings

The study sheds new light on the long-term risks of abnormal cell growth and invasive cancer, and should help in the development of follow-up treatment guidelines for women who have a history of treatment for abnormal cells.

“We now have a much more clear idea of the risks of recurrent abnormal cells and invasive cervical cancer over time after treatment of these cells,” said Joy Melnikow, professor of family and community medicine and associate director of the UC Davis Center for Healthcare Policy and Research, who led the study.

Melnikow said the findings may help physicians determine the optimal intensity of follow-up after treatment of CIN. The findings may also help physicians and patients select a treatment.

For example, although cryotherapy was associated with a higher risk of recurrence, it carries a lower risk of other harmful effects than cone biopsy or LEEP, procedures that have been associated with preterm delivery, Melnikow explained.

This suggests that a younger woman who has CIN 2 and who plans to start a family might opt for cryotherapy, whereas an older woman who has CIN 3—and is therefore at greatest risk of recurrence—might opt for LEEP or cone biopsy.

“These data may help inform that treatment discussion, because we know more about how age and different treatments appear to influence risks,” Melnikow said.

She also noted that the study has different implications for health policy, depending on the health system and resources. In developing countries, where cervical cancer screening and treatment are more limited and the death rate is higher for cervical cancer, cryotherapy, a simpler and less expensive treatment method, is likely to be preferred.

Melnikow said the next step is to compare different treatment and surveillance strategies in terms of cost-effectiveness.

The study was published May 12 in the online issue of the Journal of the National Cancer Institute.

Women who have been treated for cervical intraepithelial neoplasia (CIN) face an elevated risk of recurrence and invasive cervical cancer. That’s the conclusion drawn from a recent population-based study of 37,142 women who were treated for CIN 1, 2, or 3 between 1986 and 2000.

In the first 6 years after treatment, the cumulative rate of CIN 2 or 3 in this group was:

• 14.0% in women originally treated for CIN 3
• 9.3% in women originally treated for CIN 2
• 5.6% in women originally treated for CIN 1.

After 6 years, annual rates of CIN 2 or 3 were less than 1%.

The overall incidence of invasive cancer was 37 cancers for every 100,000 woman-years in the group that had a history of CIN, versus 6 cancers for every 100,000 woman-years in the comparison cohort, which comprised 71,213 women who had normal cytology and no previous diagnosis of CIN.

Cryotherapy was the least “durable” treatment

In addition to the grade of CIN, the woman’s age and type of treatment had a bearing on the likelihood of recurrence. According to the study, the risk of invasive cervical cancer and recurrent CIN 2 or 3 was highest among women who were older than 40, previously treated for CIN 3, or treated with cryotherapy.

For example, among women 40 to 49 years old, the 6-year adjusted rate of CIN 2 or 3 ranged from 2.6% for treatment of CIN 1 using the loop electrosurgical procedure (LEEP), to 34.0% for treatment of CIN 3 using cryotherapy.

Implications of the findings

The study sheds new light on the long-term risks of abnormal cell growth and invasive cancer, and should help in the development of follow-up treatment guidelines for women who have a history of treatment for abnormal cells.

“We now have a much more clear idea of the risks of recurrent abnormal cells and invasive cervical cancer over time after treatment of these cells,” said Joy Melnikow, professor of family and community medicine and associate director of the UC Davis Center for Healthcare Policy and Research, who led the study.

Melnikow said the findings may help physicians determine the optimal intensity of follow-up after treatment of CIN. The findings may also help physicians and patients select a treatment.

For example, although cryotherapy was associated with a higher risk of recurrence, it carries a lower risk of other harmful effects than cone biopsy or LEEP, procedures that have been associated with preterm delivery, Melnikow explained.

This suggests that a younger woman who has CIN 2 and who plans to start a family might opt for cryotherapy, whereas an older woman who has CIN 3—and is therefore at greatest risk of recurrence—might opt for LEEP or cone biopsy.

“These data may help inform that treatment discussion, because we know more about how age and different treatments appear to influence risks,” Melnikow said.

She also noted that the study has different implications for health policy, depending on the health system and resources. In developing countries, where cervical cancer screening and treatment are more limited and the death rate is higher for cervical cancer, cryotherapy, a simpler and less expensive treatment method, is likely to be preferred.

Melnikow said the next step is to compare different treatment and surveillance strategies in terms of cost-effectiveness.

The study was published May 12 in the online issue of the Journal of the National Cancer Institute.

Women who have been treated for cervical intraepithelial neoplasia (CIN) face an elevated risk of recurrence and invasive cervical cancer. That’s the conclusion drawn from a recent population-based study of 37,142 women who were treated for CIN 1, 2, or 3 between 1986 and 2000.

In the first 6 years after treatment, the cumulative rate of CIN 2 or 3 in this group was:

• 14.0% in women originally treated for CIN 3
• 9.3% in women originally treated for CIN 2
• 5.6% in women originally treated for CIN 1.

After 6 years, annual rates of CIN 2 or 3 were less than 1%.

The overall incidence of invasive cancer was 37 cancers for every 100,000 woman-years in the group that had a history of CIN, versus 6 cancers for every 100,000 woman-years in the comparison cohort, which comprised 71,213 women who had normal cytology and no previous diagnosis of CIN.

Cryotherapy was the least “durable” treatment

In addition to the grade of CIN, the woman’s age and type of treatment had a bearing on the likelihood of recurrence. According to the study, the risk of invasive cervical cancer and recurrent CIN 2 or 3 was highest among women who were older than 40, previously treated for CIN 3, or treated with cryotherapy.

For example, among women 40 to 49 years old, the 6-year adjusted rate of CIN 2 or 3 ranged from 2.6% for treatment of CIN 1 using the loop electrosurgical procedure (LEEP), to 34.0% for treatment of CIN 3 using cryotherapy.

Implications of the findings

The study sheds new light on the long-term risks of abnormal cell growth and invasive cancer, and should help in the development of follow-up treatment guidelines for women who have a history of treatment for abnormal cells.

“We now have a much more clear idea of the risks of recurrent abnormal cells and invasive cervical cancer over time after treatment of these cells,” said Joy Melnikow, professor of family and community medicine and associate director of the UC Davis Center for Healthcare Policy and Research, who led the study.

Melnikow said the findings may help physicians determine the optimal intensity of follow-up after treatment of CIN. The findings may also help physicians and patients select a treatment.

For example, although cryotherapy was associated with a higher risk of recurrence, it carries a lower risk of other harmful effects than cone biopsy or LEEP, procedures that have been associated with preterm delivery, Melnikow explained.

This suggests that a younger woman who has CIN 2 and who plans to start a family might opt for cryotherapy, whereas an older woman who has CIN 3—and is therefore at greatest risk of recurrence—might opt for LEEP or cone biopsy.

“These data may help inform that treatment discussion, because we know more about how age and different treatments appear to influence risks,” Melnikow said.

She also noted that the study has different implications for health policy, depending on the health system and resources. In developing countries, where cervical cancer screening and treatment are more limited and the death rate is higher for cervical cancer, cryotherapy, a simpler and less expensive treatment method, is likely to be preferred.

Melnikow said the next step is to compare different treatment and surveillance strategies in terms of cost-effectiveness.

The study was published May 12 in the online issue of the Journal of the National Cancer Institute.

At Shawnee Mission Medical Center in Kansas City, Kansas, a delivery early this year placed the 3-day-old laborist program squarely in the spotlight.

The uterus ruptured in a patient who had placenta previa. She required immediate intervention, but her private ObGyn was 25 minutes away. A laborist stepped in and performed C-section within 10 minutes, while the private physician was still en route.

“And our neonatologist said, had we had to wait the extra 5 or 10 minutes it took for that doc to arrive and get started, there would have been a much worse outcome for that baby because it had lost 40% of its blood volume,” says Deb Ohnoutka, administrative director of women’s and children’s services.

Not all interventions involving a laborist are as dramatic, but the laborist, or OB hospitalist, model—in which a hospital employs board-certified ObGyns for 24/7 coverage of labor and delivery—is gradually taking hold.

Because the model is new, there are no concrete data on exactly how many hospitals employ laborists or whether safety has improved as a result. To get an idea of how this model is faring, OBG Management interviewed a number of program administrators and laborists, whose comments are woven into this article. They describe diminishing pressures on community ObGyns, improved job satisfaction among laborists, greater patient safety, and other benefits.

Whence the inspiration?

It all started in 2003, when Louis Weinstein, MD, now chairman of obstetrics and gynecology at Jefferson Medical College in Philadelphia, penned an opinion piece for the American Journal of Obstetrics and Gynecology on the need for a new way of practicing obstetrics.¹ Weinstein cited some of the pressures assailing the profession.

“The desire to control one’s personal life, coupled with an apparent decrease in aggregate productivity and the increasing cost of professional liability insurance,” he wrote, “have the potential to lead to a decrease in the available obstetric work force within the next decade.”¹

Weinstein now says that, in fact, roughly “30% of physicians will stop working in the next 7 years. People say there’s a shortage of physicians, but it’s really a shortage of working physicians. It’s because of physician dissatisfaction.”

The solution?

Weinstein points to the success of the hospitalist model, which originated in 1996. He proposed a similar paradigm for obstetrics.

“I just sat down and worked out this thing called the laborist movement. When you look at the hospitalist model, their safety is way up” and job satisfaction is improved, he says, noting that he expects the laborist model to have a similar impact.

It took a while for Weinstein’s proposal to percolate through the specialty.

“I wrote about it in 2003 and for 2 years nobody even talked to me about it,” he says. It wasn’t until 2005 that the discussion began.

People began to acknowledge that a significant change in practice was needed to improve quality of care, increase safety for the patient and her fetus, and reduce medical negligence actions for hospitals.

“The way we practice obstetrics is insane,” says Weinstein. “People can’t work like they’re working.”

 

Life in the “old days”

Krista Wills, MD, lead physician of OB hospitalists at Presbyterian Hospital in Albuquerque, clearly recalls the days before the program started. Everyone was stretched a little too thin back then.

“The patient would be in triage until the doc could come by and evaluate her and send her out,” says Wills.

Depending on the physician’s location and office schedule, that wait could be several hours.

“If the mom came in in active labor and had not had any prenatal care, the doc whose name was on the ED [emergency department] call roster would be called and would have to come in and do the delivery,” Wills says. One of the problems with this system was that unassigned patients “who haven’t had any prenatal care in general tend to be high-risk patients, and for the community physicians it was just becoming an increasing burden. People did absorb it before, but it was something that creates not exactly friction but physician dissatisfaction.”

Presbyterian Hospital began its OB hospitalist program in January 2006. In general, its laborists have four main responsibilities:

• “We labor and deliver all the babies that come from high-risk mothers” that are cared for by a private group of perinatologists based at the hospital, says Wills. “We accept all the maternal transports from all over the state. The majority of these moms have had care in a small town in New Mexico—one of our regional facilities or just a small town—and the mom is either very sick and requires tertiary care or the baby is going to be born prematurely and needs a level III NICU.”
  
• “We take care of the unassigned patients who drop into the ED or OB triage area.”
  
• “We first-assist for a majority of the C-sections performed in the hospital.”
  
• “We are also a backup for our community doctors.” (“We’re not trying to take away their billings or anything like that,” Wills adds. “We just want to decrease our unattended delivery rate. And we just want to be able to get patients through triage more quickly.”)
  

Safety and continuity of care are among the benefits

At Middle Tennessee Medical Center in Murfreesboro, where the laborist program has been in effect for almost 20 months, the principal benefit has been increased safety—although that isn’t the only advantage.

“We’ve had three instances already since November of 2006 where we feel that there would have been a significant negative outcome either with a mother or a baby if we had not had a physician in house ready to go when that particular obstetrical emergency presented,” says Andy Brown, MD, vice president of medical affairs. “So we do feel that [the laborist program] provides a very good standard of care for the hospital.”

Overall, ObGyns in the community have been pleased with the program.

“It has actually allowed them to increase the size of their practices because they’re in much better control of what happens during the routine office hours,” says Brown. “They have better control over their office schedules.”

And the patients of those physicians?

“The vast majority of patients would be relieved to realize that there is someone there for an emergent situation,” Brown says.

Concurring with that observation is C. Brent Boles, MD. “We are very happy with the program,” he says. “I’m speaking with two hats on because I’m the medical director of the laborist program [at Middle Tennessee Medical Center], but I’m also a private physician.”

Boles confirms that a drive for ever-increasing safety was one of the concerns that prompted creation of the program.

“I wouldn’t say that it was the principal driving force, but it was certainly one of the top two or three reasons. Probably the consistency or continuity of care that is now easy to provide for the service call patients and the immediate coverage of in-house emergencies are the two major benefits to the community.”

Another benefit of the laborist model: It makes a trial of labor after C-section [vaginal birth after C-section (VBAC)] possible in hospitals that have 24/7 coverage. At Shawnee Mission Medical Center, the laborist program has greatly increased the number of VBACs.

“We had actually stopped laboring VBACs,” says Ohnoutka. “We mostly sectioned them.” Since the laborist program began, “we’ve seen a huge increase. There are some docs who really and truly believe in laboring VBACs and have hated not to be able to do it. So [the laborist program] has driven some volume here because other hospitals in our community aren’t doing it.”

 

At Monmouth Medical Center in Long Branch, New Jersey, a laborist program has been in place for a little over 2 years.

“It’s going very well in the sense that the solo practitioners that we have in the area really do appreciate it,” says Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center. “It prevents disruption to their office practice as well as to their lifestyle.”

That does not mean the program is accepted wholeheartedly by every physician and patient, however.

“I think there may be some resistance from both sides in the sense that, traditionally, ObGyn has been a model where a patient has had a full ride,” says Joshi, “of demanding and expecting that her own physician will be the one to deliver her. That may be a bit of a barrier to overcome.”

Life as a laborist

From the point of view of the laborists themselves, the advantages of the job are many.

“I would say a lot less stress, a lot more free time,” says Kathryn Mills, MD, one of the laborists at Middle Tennessee Medical Center. “I have free time during the week if I’m not on a shift, so it’s great.”

Laura McMurray, MD, a laborist at Shawnee Mission Medical Center, is also enthusiastic.

“I love doing OB and this is the best of both worlds,” she says, “where you can do what you like to do—take care of patients—but you don’t have the call issues and the daily pressures of private practice. It allows you to have more time with your family and to be able to participate in a lot more of their activities.”

Krista Wills, MD, the head of the laborist program at Presbyterian Hospital in Albuquerque, is also a laborist herself. She is very happy with the job.

“I started practice in 1990,” she says. “At the time, a female ObGyn quit OB after roughly 10 years and went to GYN only. Her patient volume was built, her patients had aged with her, and now she could switch over to GYN.”

“If OB is truly your love but you need a more scheduled lifestyle, then being an OB hospitalist gives you that opportunity,” says Wills. “I love the OB part of ObGyn. I still get very excited for deliveries—it doesn’t matter if it’s two or three in the morning, I still get psyched with it.”

“We have no office; we have no overhead; our liability insurance is paid by the hospital. And it allows me to continue doing OB in a manner that doesn’t give me 60-hour workweeks and being up all day, then up all night, then up all day, which is really exhausting,” she adds.

 

If there is a downside, it is narrowing of the spectrum, says McMurray.

“You may not be doing the entire scope of what you might be doing in private practice in terms of GYN. You don’t really develop a relationship with the patient—a long-term relationship with the patient. I think that’s true of any type of emergency room, any situation in which you are doing more of a shift as opposed to being on call as a private practice sort of thing. But I don’t view those as negatives. Somebody might, but that’s part of how it’s set up.”

According to Boles, word of the advantages of working as a laborist is spreading among ObGyns as a whole.

“I get phone calls from physicians who are interested in finding out if we have any openings because they would love to close their private practice and walk away from the hassle.”

Does the laborist model pay for itself?

The answer depends on how you calculate its benefits.

“We don’t expect it to make a profit,” says Ohnoutka, “but we do hopefully expect it to get close to breaking even.”

“I think when you look at all the drivers, there are different ways to make that happen,” she says. “If a private doc consults, we can bill consultant fees. If we do a delivery for them, we can bill a delivery fee. But I think when you look at improved physician satisfaction and improved nursing satisfaction, when you look at decreasing liability because you have somebody here at all times, it will pay for itself in many other ways than just the bottom line.”

At Presbyterian Hospital, the case is more clear-cut.

“Our biggest thing is that we are able to increase the number of maternal transports that we are able to take from all over the state,” says Wills.

Because the NICU “traditionally is a profit-maker for hospitals because the babies are all insured or qualified for Medicaid, there is a downstream benefit: It helps out the women’s program overall, it helps out the children’s program overall, if you look at the bottom line,” she says.

At Middle Tennessee Medical Center, hospital administrators aren’t as concerned about the strict bottom line.

“With the goodwill in the local ObGyn community and with the standard of care that we are now able to provide for the community, I think that’s where the payoff comes in,” says Brown.

Will the model spread?

Louis Weinstein, MD, thinks it will. He predicts that, in 10 years, most hospitals with more than 2,000 deliveries a year will have a laborist program.

“Hospitals are offering $100 an hour for call and nobody will take them up on it,” he says. That makes a new model inevitable.

Like Weinstein, Boles sees lifestyle issues as a dominant force.

“Our three full-time laborists are very happy with their work schedule. When they’re working, they’re at the hospital. When it’s not their shift, they go away, they turn their beeper off, they don’t have to answer their cell phone, and they can go do whatever they want to do. So it’s a model that will become increasingly attractive for many, many people as the pressures on private practices increase.”

If the laborist model has significant warts, they have yet to reveal themselves, at least among the programs described here. It may be that the burden of business as usual has become so great that the model’s primary impact is relief. As it matures, areas in need of fine-tuning or overhaul should become apparent.

At Shawnee Mission Medical Center in Kansas City, Kansas, a delivery early this year placed the 3-day-old laborist program squarely in the spotlight.

The uterus ruptured in a patient who had placenta previa. She required immediate intervention, but her private ObGyn was 25 minutes away. A laborist stepped in and performed C-section within 10 minutes, while the private physician was still en route.

“And our neonatologist said, had we had to wait the extra 5 or 10 minutes it took for that doc to arrive and get started, there would have been a much worse outcome for that baby because it had lost 40% of its blood volume,” says Deb Ohnoutka, administrative director of women’s and children’s services.

Not all interventions involving a laborist are as dramatic, but the laborist, or OB hospitalist, model—in which a hospital employs board-certified ObGyns for 24/7 coverage of labor and delivery—is gradually taking hold.

Because the model is new, there are no concrete data on exactly how many hospitals employ laborists or whether safety has improved as a result. To get an idea of how this model is faring, OBG Management interviewed a number of program administrators and laborists, whose comments are woven into this article. They describe diminishing pressures on community ObGyns, improved job satisfaction among laborists, greater patient safety, and other benefits.

Whence the inspiration?

It all started in 2003, when Louis Weinstein, MD, now chairman of obstetrics and gynecology at Jefferson Medical College in Philadelphia, penned an opinion piece for the American Journal of Obstetrics and Gynecology on the need for a new way of practicing obstetrics.¹ Weinstein cited some of the pressures assailing the profession.

“The desire to control one’s personal life, coupled with an apparent decrease in aggregate productivity and the increasing cost of professional liability insurance,” he wrote, “have the potential to lead to a decrease in the available obstetric work force within the next decade.”¹

Weinstein now says that, in fact, roughly “30% of physicians will stop working in the next 7 years. People say there’s a shortage of physicians, but it’s really a shortage of working physicians. It’s because of physician dissatisfaction.”

The solution?

Weinstein points to the success of the hospitalist model, which originated in 1996. He proposed a similar paradigm for obstetrics.

“I just sat down and worked out this thing called the laborist movement. When you look at the hospitalist model, their safety is way up” and job satisfaction is improved, he says, noting that he expects the laborist model to have a similar impact.

It took a while for Weinstein’s proposal to percolate through the specialty.

“I wrote about it in 2003 and for 2 years nobody even talked to me about it,” he says. It wasn’t until 2005 that the discussion began.

People began to acknowledge that a significant change in practice was needed to improve quality of care, increase safety for the patient and her fetus, and reduce medical negligence actions for hospitals.

“The way we practice obstetrics is insane,” says Weinstein. “People can’t work like they’re working.”

 

Life in the “old days”

Krista Wills, MD, lead physician of OB hospitalists at Presbyterian Hospital in Albuquerque, clearly recalls the days before the program started. Everyone was stretched a little too thin back then.

“The patient would be in triage until the doc could come by and evaluate her and send her out,” says Wills.

Depending on the physician’s location and office schedule, that wait could be several hours.

“If the mom came in in active labor and had not had any prenatal care, the doc whose name was on the ED [emergency department] call roster would be called and would have to come in and do the delivery,” Wills says. One of the problems with this system was that unassigned patients “who haven’t had any prenatal care in general tend to be high-risk patients, and for the community physicians it was just becoming an increasing burden. People did absorb it before, but it was something that creates not exactly friction but physician dissatisfaction.”

Presbyterian Hospital began its OB hospitalist program in January 2006. In general, its laborists have four main responsibilities:

• “We labor and deliver all the babies that come from high-risk mothers” that are cared for by a private group of perinatologists based at the hospital, says Wills. “We accept all the maternal transports from all over the state. The majority of these moms have had care in a small town in New Mexico—one of our regional facilities or just a small town—and the mom is either very sick and requires tertiary care or the baby is going to be born prematurely and needs a level III NICU.”
  
• “We take care of the unassigned patients who drop into the ED or OB triage area.”
  
• “We first-assist for a majority of the C-sections performed in the hospital.”
  
• “We are also a backup for our community doctors.” (“We’re not trying to take away their billings or anything like that,” Wills adds. “We just want to decrease our unattended delivery rate. And we just want to be able to get patients through triage more quickly.”)
  

Safety and continuity of care are among the benefits

At Middle Tennessee Medical Center in Murfreesboro, where the laborist program has been in effect for almost 20 months, the principal benefit has been increased safety—although that isn’t the only advantage.

“We’ve had three instances already since November of 2006 where we feel that there would have been a significant negative outcome either with a mother or a baby if we had not had a physician in house ready to go when that particular obstetrical emergency presented,” says Andy Brown, MD, vice president of medical affairs. “So we do feel that [the laborist program] provides a very good standard of care for the hospital.”

Overall, ObGyns in the community have been pleased with the program.

“It has actually allowed them to increase the size of their practices because they’re in much better control of what happens during the routine office hours,” says Brown. “They have better control over their office schedules.”

And the patients of those physicians?

“The vast majority of patients would be relieved to realize that there is someone there for an emergent situation,” Brown says.

Concurring with that observation is C. Brent Boles, MD. “We are very happy with the program,” he says. “I’m speaking with two hats on because I’m the medical director of the laborist program [at Middle Tennessee Medical Center], but I’m also a private physician.”

Boles confirms that a drive for ever-increasing safety was one of the concerns that prompted creation of the program.

“I wouldn’t say that it was the principal driving force, but it was certainly one of the top two or three reasons. Probably the consistency or continuity of care that is now easy to provide for the service call patients and the immediate coverage of in-house emergencies are the two major benefits to the community.”

Another benefit of the laborist model: It makes a trial of labor after C-section [vaginal birth after C-section (VBAC)] possible in hospitals that have 24/7 coverage. At Shawnee Mission Medical Center, the laborist program has greatly increased the number of VBACs.

“We had actually stopped laboring VBACs,” says Ohnoutka. “We mostly sectioned them.” Since the laborist program began, “we’ve seen a huge increase. There are some docs who really and truly believe in laboring VBACs and have hated not to be able to do it. So [the laborist program] has driven some volume here because other hospitals in our community aren’t doing it.”

 

At Monmouth Medical Center in Long Branch, New Jersey, a laborist program has been in place for a little over 2 years.

“It’s going very well in the sense that the solo practitioners that we have in the area really do appreciate it,” says Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center. “It prevents disruption to their office practice as well as to their lifestyle.”

That does not mean the program is accepted wholeheartedly by every physician and patient, however.

“I think there may be some resistance from both sides in the sense that, traditionally, ObGyn has been a model where a patient has had a full ride,” says Joshi, “of demanding and expecting that her own physician will be the one to deliver her. That may be a bit of a barrier to overcome.”

Life as a laborist

From the point of view of the laborists themselves, the advantages of the job are many.

“I would say a lot less stress, a lot more free time,” says Kathryn Mills, MD, one of the laborists at Middle Tennessee Medical Center. “I have free time during the week if I’m not on a shift, so it’s great.”

Laura McMurray, MD, a laborist at Shawnee Mission Medical Center, is also enthusiastic.

“I love doing OB and this is the best of both worlds,” she says, “where you can do what you like to do—take care of patients—but you don’t have the call issues and the daily pressures of private practice. It allows you to have more time with your family and to be able to participate in a lot more of their activities.”

Krista Wills, MD, the head of the laborist program at Presbyterian Hospital in Albuquerque, is also a laborist herself. She is very happy with the job.

“I started practice in 1990,” she says. “At the time, a female ObGyn quit OB after roughly 10 years and went to GYN only. Her patient volume was built, her patients had aged with her, and now she could switch over to GYN.”

“If OB is truly your love but you need a more scheduled lifestyle, then being an OB hospitalist gives you that opportunity,” says Wills. “I love the OB part of ObGyn. I still get very excited for deliveries—it doesn’t matter if it’s two or three in the morning, I still get psyched with it.”

“We have no office; we have no overhead; our liability insurance is paid by the hospital. And it allows me to continue doing OB in a manner that doesn’t give me 60-hour workweeks and being up all day, then up all night, then up all day, which is really exhausting,” she adds.

 

If there is a downside, it is narrowing of the spectrum, says McMurray.

“You may not be doing the entire scope of what you might be doing in private practice in terms of GYN. You don’t really develop a relationship with the patient—a long-term relationship with the patient. I think that’s true of any type of emergency room, any situation in which you are doing more of a shift as opposed to being on call as a private practice sort of thing. But I don’t view those as negatives. Somebody might, but that’s part of how it’s set up.”

According to Boles, word of the advantages of working as a laborist is spreading among ObGyns as a whole.

“I get phone calls from physicians who are interested in finding out if we have any openings because they would love to close their private practice and walk away from the hassle.”

Does the laborist model pay for itself?

The answer depends on how you calculate its benefits.

“We don’t expect it to make a profit,” says Ohnoutka, “but we do hopefully expect it to get close to breaking even.”

“I think when you look at all the drivers, there are different ways to make that happen,” she says. “If a private doc consults, we can bill consultant fees. If we do a delivery for them, we can bill a delivery fee. But I think when you look at improved physician satisfaction and improved nursing satisfaction, when you look at decreasing liability because you have somebody here at all times, it will pay for itself in many other ways than just the bottom line.”

At Presbyterian Hospital, the case is more clear-cut.

“Our biggest thing is that we are able to increase the number of maternal transports that we are able to take from all over the state,” says Wills.

Because the NICU “traditionally is a profit-maker for hospitals because the babies are all insured or qualified for Medicaid, there is a downstream benefit: It helps out the women’s program overall, it helps out the children’s program overall, if you look at the bottom line,” she says.

At Middle Tennessee Medical Center, hospital administrators aren’t as concerned about the strict bottom line.

“With the goodwill in the local ObGyn community and with the standard of care that we are now able to provide for the community, I think that’s where the payoff comes in,” says Brown.

Will the model spread?

Louis Weinstein, MD, thinks it will. He predicts that, in 10 years, most hospitals with more than 2,000 deliveries a year will have a laborist program.

“Hospitals are offering $100 an hour for call and nobody will take them up on it,” he says. That makes a new model inevitable.

Like Weinstein, Boles sees lifestyle issues as a dominant force.

“Our three full-time laborists are very happy with their work schedule. When they’re working, they’re at the hospital. When it’s not their shift, they go away, they turn their beeper off, they don’t have to answer their cell phone, and they can go do whatever they want to do. So it’s a model that will become increasingly attractive for many, many people as the pressures on private practices increase.”

If the laborist model has significant warts, they have yet to reveal themselves, at least among the programs described here. It may be that the burden of business as usual has become so great that the model’s primary impact is relief. As it matures, areas in need of fine-tuning or overhaul should become apparent.

At Shawnee Mission Medical Center in Kansas City, Kansas, a delivery early this year placed the 3-day-old laborist program squarely in the spotlight.

The uterus ruptured in a patient who had placenta previa. She required immediate intervention, but her private ObGyn was 25 minutes away. A laborist stepped in and performed C-section within 10 minutes, while the private physician was still en route.

“And our neonatologist said, had we had to wait the extra 5 or 10 minutes it took for that doc to arrive and get started, there would have been a much worse outcome for that baby because it had lost 40% of its blood volume,” says Deb Ohnoutka, administrative director of women’s and children’s services.

Not all interventions involving a laborist are as dramatic, but the laborist, or OB hospitalist, model—in which a hospital employs board-certified ObGyns for 24/7 coverage of labor and delivery—is gradually taking hold.

Because the model is new, there are no concrete data on exactly how many hospitals employ laborists or whether safety has improved as a result. To get an idea of how this model is faring, OBG Management interviewed a number of program administrators and laborists, whose comments are woven into this article. They describe diminishing pressures on community ObGyns, improved job satisfaction among laborists, greater patient safety, and other benefits.

Whence the inspiration?

It all started in 2003, when Louis Weinstein, MD, now chairman of obstetrics and gynecology at Jefferson Medical College in Philadelphia, penned an opinion piece for the American Journal of Obstetrics and Gynecology on the need for a new way of practicing obstetrics.¹ Weinstein cited some of the pressures assailing the profession.

“The desire to control one’s personal life, coupled with an apparent decrease in aggregate productivity and the increasing cost of professional liability insurance,” he wrote, “have the potential to lead to a decrease in the available obstetric work force within the next decade.”¹

Weinstein now says that, in fact, roughly “30% of physicians will stop working in the next 7 years. People say there’s a shortage of physicians, but it’s really a shortage of working physicians. It’s because of physician dissatisfaction.”

The solution?

Weinstein points to the success of the hospitalist model, which originated in 1996. He proposed a similar paradigm for obstetrics.

“I just sat down and worked out this thing called the laborist movement. When you look at the hospitalist model, their safety is way up” and job satisfaction is improved, he says, noting that he expects the laborist model to have a similar impact.

It took a while for Weinstein’s proposal to percolate through the specialty.

“I wrote about it in 2003 and for 2 years nobody even talked to me about it,” he says. It wasn’t until 2005 that the discussion began.

People began to acknowledge that a significant change in practice was needed to improve quality of care, increase safety for the patient and her fetus, and reduce medical negligence actions for hospitals.

“The way we practice obstetrics is insane,” says Weinstein. “People can’t work like they’re working.”

 

Life in the “old days”

Krista Wills, MD, lead physician of OB hospitalists at Presbyterian Hospital in Albuquerque, clearly recalls the days before the program started. Everyone was stretched a little too thin back then.

“The patient would be in triage until the doc could come by and evaluate her and send her out,” says Wills.

Depending on the physician’s location and office schedule, that wait could be several hours.

“If the mom came in in active labor and had not had any prenatal care, the doc whose name was on the ED [emergency department] call roster would be called and would have to come in and do the delivery,” Wills says. One of the problems with this system was that unassigned patients “who haven’t had any prenatal care in general tend to be high-risk patients, and for the community physicians it was just becoming an increasing burden. People did absorb it before, but it was something that creates not exactly friction but physician dissatisfaction.”

Presbyterian Hospital began its OB hospitalist program in January 2006. In general, its laborists have four main responsibilities:

• “We labor and deliver all the babies that come from high-risk mothers” that are cared for by a private group of perinatologists based at the hospital, says Wills. “We accept all the maternal transports from all over the state. The majority of these moms have had care in a small town in New Mexico—one of our regional facilities or just a small town—and the mom is either very sick and requires tertiary care or the baby is going to be born prematurely and needs a level III NICU.”
  
• “We take care of the unassigned patients who drop into the ED or OB triage area.”
  
• “We first-assist for a majority of the C-sections performed in the hospital.”
  
• “We are also a backup for our community doctors.” (“We’re not trying to take away their billings or anything like that,” Wills adds. “We just want to decrease our unattended delivery rate. And we just want to be able to get patients through triage more quickly.”)
  

Safety and continuity of care are among the benefits

At Middle Tennessee Medical Center in Murfreesboro, where the laborist program has been in effect for almost 20 months, the principal benefit has been increased safety—although that isn’t the only advantage.

“We’ve had three instances already since November of 2006 where we feel that there would have been a significant negative outcome either with a mother or a baby if we had not had a physician in house ready to go when that particular obstetrical emergency presented,” says Andy Brown, MD, vice president of medical affairs. “So we do feel that [the laborist program] provides a very good standard of care for the hospital.”

Overall, ObGyns in the community have been pleased with the program.

“It has actually allowed them to increase the size of their practices because they’re in much better control of what happens during the routine office hours,” says Brown. “They have better control over their office schedules.”

And the patients of those physicians?

“The vast majority of patients would be relieved to realize that there is someone there for an emergent situation,” Brown says.

Concurring with that observation is C. Brent Boles, MD. “We are very happy with the program,” he says. “I’m speaking with two hats on because I’m the medical director of the laborist program [at Middle Tennessee Medical Center], but I’m also a private physician.”

Boles confirms that a drive for ever-increasing safety was one of the concerns that prompted creation of the program.

“I wouldn’t say that it was the principal driving force, but it was certainly one of the top two or three reasons. Probably the consistency or continuity of care that is now easy to provide for the service call patients and the immediate coverage of in-house emergencies are the two major benefits to the community.”

Another benefit of the laborist model: It makes a trial of labor after C-section [vaginal birth after C-section (VBAC)] possible in hospitals that have 24/7 coverage. At Shawnee Mission Medical Center, the laborist program has greatly increased the number of VBACs.

“We had actually stopped laboring VBACs,” says Ohnoutka. “We mostly sectioned them.” Since the laborist program began, “we’ve seen a huge increase. There are some docs who really and truly believe in laboring VBACs and have hated not to be able to do it. So [the laborist program] has driven some volume here because other hospitals in our community aren’t doing it.”

 

At Monmouth Medical Center in Long Branch, New Jersey, a laborist program has been in place for a little over 2 years.

“It’s going very well in the sense that the solo practitioners that we have in the area really do appreciate it,” says Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center. “It prevents disruption to their office practice as well as to their lifestyle.”

That does not mean the program is accepted wholeheartedly by every physician and patient, however.

“I think there may be some resistance from both sides in the sense that, traditionally, ObGyn has been a model where a patient has had a full ride,” says Joshi, “of demanding and expecting that her own physician will be the one to deliver her. That may be a bit of a barrier to overcome.”

Life as a laborist

From the point of view of the laborists themselves, the advantages of the job are many.

“I would say a lot less stress, a lot more free time,” says Kathryn Mills, MD, one of the laborists at Middle Tennessee Medical Center. “I have free time during the week if I’m not on a shift, so it’s great.”

Laura McMurray, MD, a laborist at Shawnee Mission Medical Center, is also enthusiastic.

“I love doing OB and this is the best of both worlds,” she says, “where you can do what you like to do—take care of patients—but you don’t have the call issues and the daily pressures of private practice. It allows you to have more time with your family and to be able to participate in a lot more of their activities.”

Krista Wills, MD, the head of the laborist program at Presbyterian Hospital in Albuquerque, is also a laborist herself. She is very happy with the job.

“I started practice in 1990,” she says. “At the time, a female ObGyn quit OB after roughly 10 years and went to GYN only. Her patient volume was built, her patients had aged with her, and now she could switch over to GYN.”

“If OB is truly your love but you need a more scheduled lifestyle, then being an OB hospitalist gives you that opportunity,” says Wills. “I love the OB part of ObGyn. I still get very excited for deliveries—it doesn’t matter if it’s two or three in the morning, I still get psyched with it.”

“We have no office; we have no overhead; our liability insurance is paid by the hospital. And it allows me to continue doing OB in a manner that doesn’t give me 60-hour workweeks and being up all day, then up all night, then up all day, which is really exhausting,” she adds.

 

If there is a downside, it is narrowing of the spectrum, says McMurray.

“You may not be doing the entire scope of what you might be doing in private practice in terms of GYN. You don’t really develop a relationship with the patient—a long-term relationship with the patient. I think that’s true of any type of emergency room, any situation in which you are doing more of a shift as opposed to being on call as a private practice sort of thing. But I don’t view those as negatives. Somebody might, but that’s part of how it’s set up.”

According to Boles, word of the advantages of working as a laborist is spreading among ObGyns as a whole.

“I get phone calls from physicians who are interested in finding out if we have any openings because they would love to close their private practice and walk away from the hassle.”

Does the laborist model pay for itself?

The answer depends on how you calculate its benefits.

“We don’t expect it to make a profit,” says Ohnoutka, “but we do hopefully expect it to get close to breaking even.”

“I think when you look at all the drivers, there are different ways to make that happen,” she says. “If a private doc consults, we can bill consultant fees. If we do a delivery for them, we can bill a delivery fee. But I think when you look at improved physician satisfaction and improved nursing satisfaction, when you look at decreasing liability because you have somebody here at all times, it will pay for itself in many other ways than just the bottom line.”

At Presbyterian Hospital, the case is more clear-cut.

“Our biggest thing is that we are able to increase the number of maternal transports that we are able to take from all over the state,” says Wills.

Because the NICU “traditionally is a profit-maker for hospitals because the babies are all insured or qualified for Medicaid, there is a downstream benefit: It helps out the women’s program overall, it helps out the children’s program overall, if you look at the bottom line,” she says.

At Middle Tennessee Medical Center, hospital administrators aren’t as concerned about the strict bottom line.

“With the goodwill in the local ObGyn community and with the standard of care that we are now able to provide for the community, I think that’s where the payoff comes in,” says Brown.

Will the model spread?

Louis Weinstein, MD, thinks it will. He predicts that, in 10 years, most hospitals with more than 2,000 deliveries a year will have a laborist program.

“Hospitals are offering $100 an hour for call and nobody will take them up on it,” he says. That makes a new model inevitable.

Like Weinstein, Boles sees lifestyle issues as a dominant force.

“Our three full-time laborists are very happy with their work schedule. When they’re working, they’re at the hospital. When it’s not their shift, they go away, they turn their beeper off, they don’t have to answer their cell phone, and they can go do whatever they want to do. So it’s a model that will become increasingly attractive for many, many people as the pressures on private practices increase.”

If the laborist model has significant warts, they have yet to reveal themselves, at least among the programs described here. It may be that the burden of business as usual has become so great that the model’s primary impact is relief. As it matures, areas in need of fine-tuning or overhaul should become apparent.

Patients, physicians, the media—in other words, just about everybody—are confused about the findings of the Women’s Health Initiative (WHI),¹ according to a recent survey.

Why? And is this state of confusion permanent? Most of all, how are your colleagues dealing with that lack of clarity in their practice?

Questions put to your peers

In early September, the Hormone Foundation, public education affiliate of the Endocrine Society, released the results of a national survey of doctors involved in menopause care.² The survey was designed to gauge the effects of the WHI on clinical practice and was conducted on behalf of the Hormone Foundation with financial support from Novogyne Pharmaceuticals. Among the findings:

• Only 15% of the physicians believe their patients’ perceptions of the risks of hormone replacement are accurate
  
• Only 18% of physicians—this includes ObGyns—report that they themselves have “no confusion at all” about the findings of the WHI
  
• 83% of physicians believe their patients are as confused now as when the WHI findings were released in 2002—or more so
  
• 81% of physicians believe the media are as, or more, confused as when the findings were released.²
  

So what is the state of menopause care today, 5 years after the WHI made its splash?

“There’s a lot of noise,” says Nanette Santoro, MD, director of reproductive endocrinology at Albert Einstein College of Medicine, Bronx, New York, and a member of the Hormone Foundation’s Women’s Health Task Force. “And there have been a lot of arguments back and forth.”

What can a physician do to achieve a little clarity?

Staying up-to-date on the clinical practice guidelines is the best way to combat confusion, Dr. Santoro says. A good starting point, she notes, is the Hormone Foundation Web site (Hormone. org), which links to the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine (ASRM), and the North American Menopause Society (NAMS), all of which publish reliable guidelines.

“I think that’s probably the best way of keeping abreast of what’s happening now if [physicians] are not really deeply into menopause care,” she says. “But getting filtered information, or getting information from pundits or from the media is, I think, more hazardous because the quality of that information can be variable. And the days of getting your information from pharmaceutical representatives are long gone in this area because, again, it is not sufficiently reliable.”

 

“Afraid of hormones”

In the years since early WHI findings were published, Anita L. Nelson, MD, has not noticed confusion so much as fear among her patients. Dr. Nelson is professor of obstetrics and gynecology at the David Geffen School of Medicine at UCLA in Los Angeles.

“I think the things that are concerning to patients by and large are breast cancer and, in women who have done more reading on it, some of them are concerned about dementia,” Dr. Nelson says. “But by and large, other than those focused issues, it is hormones that patients are afraid of, and they sort of wave their hands in this global aura of ‘badness’ that they’re afraid of.”

One reason is the WHI. “Obviously that contributed to it,” she says. But a bigger cause of fear among her patients, a large percentage of whom are referred, is the fact that “their physicians have been taking them off of therapy. They’re not offering it,” she says, “or they are putting up a sort of barrier by saying, ‘You have to go see Dr. Nelson before you can start taking those medications.’”

The problem doesn’t end there, she adds. “The sad thing is that they are by and large not offering them alternative medications while they’re waiting for the transition—or if they are, sometimes they are actually giving them hazardous drugs. One of my favorite things is when patients who have high blood pressure are denied estrogen but are given Bellergal [ergotamine, belladonna alkaloids, and phenobarbital], which has a vasoconstrictive medication in it.”

“We do want folks to review the data,” she says, noting that ObGyns are “true believers” and unlikely to quit prescribing hormone therapy (HT). It is the internists and the family medicine physicians “who still have significant misgivings about the safety of these therapies in recently menopausal women.”

Joanna Shulman, MD, agrees. She is associate professor and director of the medical student clerkship in obstetrics and gynecology at Mount Sinai School of Medicine in New York City.

“The internists I work with or that my patients see tend to be terrified of hormone therapy. So I think they tend to discourage their patients.”

Mea culpa, anyone?

Confusion over the WHI is an issue for another prominent ObGyn—Wulf H. Utian, MD, PhD, editor-in-chief of Menopause Management and executive director of NAMS. In an editorial in the September/October issue of Menopause Management, Dr. Utian faults the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) for starting a “firestorm in women’s health” by publicizing the abrupt termination of the estrogen–progestin arm of the WHI study.⁴

Utian notes that he pointed out his dismay over the WHI way back in 2002, when he wrote, again in Menopause Management: “The manner in which the study was terminated was poorly planned, abrupt, and inhumane. Predictably, the media response was enormous, ranging from thoughtful to sensational. Panic was caused, numerous women discontinued therapy, and women and their health providers alike have been thrown into a state of confusion, distrust, and quandary of what to do next.”⁴

Bruce Wineman, DO, concurs. Although he retired from practice as a reproductive endocrinologist at the Marshfield Clinic in Marshfield, Wisconsin, shortly before the WHI findings were first published, he maintains his license and stays active in the ASRM. “The worst part of the WHI is that they got so much press with it,” he says, “and that the group of women that they chose was exactly the group of women that was going to have the maximum amount of negative effect.”

Utian believes a mea culpa is in order. “There are reams of important and pertinent data coming out of all the substudies of the WHI,” he writes. “For these to be accepted with confidence, it is well time for the NIH to bring all their WHI investigators together to develop a transparent and comprehensive summary of their results. It is also time for the WHI investigators to cease their stubborn defense and misrepresentation of their 2002 data, and to return to scientific integrity.”³

Same view in the trenches

Mohamed Mitwally, MD, spends 90% of his day in clinical practice at the Reproductive Medicine and Fertility Center in Colorado Springs, Colorado. He estimates that roughly half of his perimenopausal and menopausal patients troubled by vasomotor and other symptoms are currently on HT. Since the WHI’s initial findings were published, Dr. Mitwally has “absolutely” had to spend considerably more time educating his patients—“and educating physicians,” he says. His patients are reluctant to take HT because of press attention to the WHI. And other physicians are reluctant to give HT because they understand that the WHI is a randomized trial “and so don’t question it.”

 

Dr. Mitwally blames two entities for this state of affairs. “The credit goes to the WHI,” he says. “They did a wonderful job of screwing people up” with a “very poorly designed study.” There is also “a lot of misinformation,” thanks to the media. “They just want to get any bad news and magnify it.”

In the wake of the WHI, Dr. Mitwally recalls, “it was like chaos” for 3 or 4 years—and there is still a lot of confusion.

Nevertheless, when a patient complains of moderate or severe vasomotor symptoms, Dr. Mitwally usually turns to HT as a first-line therapy. “It is excellent for these patients,” he says, although he emphasizes that “every patient should be managed separately.”

“I think the most important thing in the whole issue of HT is that physicians should leave these patients to subspecialists,” he says, by which he means reproductive endocrinologists and ObGyns with expertise in menopause care.

Plethora of products

One of the more surprising impacts of the WHI is the array of estrogen products now available. Because the WHI was expected to confirm observational data that suggested that estrogen reduced the risk of cardiovascular disease, the number of products in development skyrocketed.

“I think something like 35 compounds got approved while the study was under way, so there is more stuff than ever,” says Dr. Santoro. “But that actually was attractive to some people in the survey and has been found to be attractive to patients because it does give more choices the way things are going, which is toward more of a customized approach to giving hormones.”

Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center in Long Branch, New Jersey, a federally funded qualified health migrant center (FQHC), says the broader array of estrogen products adds to the time she spends educating patients.

“We do tell them about the other forms of estrogen and their bioeffectiveness and what they would achieve for this particular woman,” she says.

For patients who report moderate to severe menopausal symptoms, Dr. Joshi considers estrogen a first-line therapy, but recommends concurrent lifestyle changes.

“Of course, the WHI has not disappeared,” she says, so concerns about risks remain. “But in the transition, when the symptoms are paramount, I would tailor the treatment to what the woman wants to get out of it. But I think it is important for the woman to understand that this is not a panacea and that it will not cure all her symptoms. Therefore, lifestyle changes and getting hormone replacement therapy should go concurrently.”

As for alternative therapies, women are increasingly likely to ask for or about them.

“We talk about that,” says Dr. Shulman. “If they’re miserable and they don’t think they’re appropriate candidates for estrogen, we talk about other things. Or some people will come in and say, ‘I don’t want to take estrogen. Is there anything else?’”

In these cases, Dr. Shulman recommends a number of options. “Effexor has shown some benefit, apparently, in the literature,” she says. “And I mention black cohosh, which is in a lot of popular over-the-counter type remedies and which, apparently, recently was shown to have possibly some benefit.” Of course, “there’s a tremendous placebo effect with all of these,” she observes.

“And then I suggest things like getting plenty of exercise and eating sensibly, and I take my other patients’ recommendations. One patient told me that she takes a cool shower every night before going to bed and finds it beneficial, so I don’t know—it’s one of those ‘can’t hurt, might help’ things.”

Estrogen got a “bad name”

When she looks back over the past 5 years, Dr. Shulman thinks the WHI’s effects have been destructive in many ways.

“I think the most important thing is that [HT] got an undeservedly bad name when the Women’s Health Initiative was published,” she says. The WHI “really did a disservice for women who could benefit from [HT] enormously and weren’t really at risk—not just for vasomotor symptoms but also emotional lability, depression, increased anxiety, things like that.”

“I have many women for whom I did prescribe estrogen, and they’re still on it and will probably never get off because they think that I saved their lives. So for women to be scared unfairly by the Women’s Health Initiative and to have to suffer with vasomotor and emotional problems is really a disservice.”

Dr. Wineman agrees, and points out that even some professional organizations are beginning to reconsider the initial WHI findings. “They’re beginning to say, ‘I really believe that there are certain women who would probably benefit a great deal more than we once thought, and perhaps we jumped to some wrong conclusions.’”

Patients, physicians, the media—in other words, just about everybody—are confused about the findings of the Women’s Health Initiative (WHI),¹ according to a recent survey.

Why? And is this state of confusion permanent? Most of all, how are your colleagues dealing with that lack of clarity in their practice?

Questions put to your peers

In early September, the Hormone Foundation, public education affiliate of the Endocrine Society, released the results of a national survey of doctors involved in menopause care.² The survey was designed to gauge the effects of the WHI on clinical practice and was conducted on behalf of the Hormone Foundation with financial support from Novogyne Pharmaceuticals. Among the findings:

• Only 15% of the physicians believe their patients’ perceptions of the risks of hormone replacement are accurate
  
• Only 18% of physicians—this includes ObGyns—report that they themselves have “no confusion at all” about the findings of the WHI
  
• 83% of physicians believe their patients are as confused now as when the WHI findings were released in 2002—or more so
  
• 81% of physicians believe the media are as, or more, confused as when the findings were released.²
  

So what is the state of menopause care today, 5 years after the WHI made its splash?

“There’s a lot of noise,” says Nanette Santoro, MD, director of reproductive endocrinology at Albert Einstein College of Medicine, Bronx, New York, and a member of the Hormone Foundation’s Women’s Health Task Force. “And there have been a lot of arguments back and forth.”

What can a physician do to achieve a little clarity?

Staying up-to-date on the clinical practice guidelines is the best way to combat confusion, Dr. Santoro says. A good starting point, she notes, is the Hormone Foundation Web site (Hormone. org), which links to the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine (ASRM), and the North American Menopause Society (NAMS), all of which publish reliable guidelines.

“I think that’s probably the best way of keeping abreast of what’s happening now if [physicians] are not really deeply into menopause care,” she says. “But getting filtered information, or getting information from pundits or from the media is, I think, more hazardous because the quality of that information can be variable. And the days of getting your information from pharmaceutical representatives are long gone in this area because, again, it is not sufficiently reliable.”

 

“Afraid of hormones”

In the years since early WHI findings were published, Anita L. Nelson, MD, has not noticed confusion so much as fear among her patients. Dr. Nelson is professor of obstetrics and gynecology at the David Geffen School of Medicine at UCLA in Los Angeles.

“I think the things that are concerning to patients by and large are breast cancer and, in women who have done more reading on it, some of them are concerned about dementia,” Dr. Nelson says. “But by and large, other than those focused issues, it is hormones that patients are afraid of, and they sort of wave their hands in this global aura of ‘badness’ that they’re afraid of.”

One reason is the WHI. “Obviously that contributed to it,” she says. But a bigger cause of fear among her patients, a large percentage of whom are referred, is the fact that “their physicians have been taking them off of therapy. They’re not offering it,” she says, “or they are putting up a sort of barrier by saying, ‘You have to go see Dr. Nelson before you can start taking those medications.’”

The problem doesn’t end there, she adds. “The sad thing is that they are by and large not offering them alternative medications while they’re waiting for the transition—or if they are, sometimes they are actually giving them hazardous drugs. One of my favorite things is when patients who have high blood pressure are denied estrogen but are given Bellergal [ergotamine, belladonna alkaloids, and phenobarbital], which has a vasoconstrictive medication in it.”

“We do want folks to review the data,” she says, noting that ObGyns are “true believers” and unlikely to quit prescribing hormone therapy (HT). It is the internists and the family medicine physicians “who still have significant misgivings about the safety of these therapies in recently menopausal women.”

Joanna Shulman, MD, agrees. She is associate professor and director of the medical student clerkship in obstetrics and gynecology at Mount Sinai School of Medicine in New York City.

“The internists I work with or that my patients see tend to be terrified of hormone therapy. So I think they tend to discourage their patients.”

Mea culpa, anyone?

Confusion over the WHI is an issue for another prominent ObGyn—Wulf H. Utian, MD, PhD, editor-in-chief of Menopause Management and executive director of NAMS. In an editorial in the September/October issue of Menopause Management, Dr. Utian faults the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) for starting a “firestorm in women’s health” by publicizing the abrupt termination of the estrogen–progestin arm of the WHI study.⁴

Utian notes that he pointed out his dismay over the WHI way back in 2002, when he wrote, again in Menopause Management: “The manner in which the study was terminated was poorly planned, abrupt, and inhumane. Predictably, the media response was enormous, ranging from thoughtful to sensational. Panic was caused, numerous women discontinued therapy, and women and their health providers alike have been thrown into a state of confusion, distrust, and quandary of what to do next.”⁴

Bruce Wineman, DO, concurs. Although he retired from practice as a reproductive endocrinologist at the Marshfield Clinic in Marshfield, Wisconsin, shortly before the WHI findings were first published, he maintains his license and stays active in the ASRM. “The worst part of the WHI is that they got so much press with it,” he says, “and that the group of women that they chose was exactly the group of women that was going to have the maximum amount of negative effect.”

Utian believes a mea culpa is in order. “There are reams of important and pertinent data coming out of all the substudies of the WHI,” he writes. “For these to be accepted with confidence, it is well time for the NIH to bring all their WHI investigators together to develop a transparent and comprehensive summary of their results. It is also time for the WHI investigators to cease their stubborn defense and misrepresentation of their 2002 data, and to return to scientific integrity.”³

Same view in the trenches

Mohamed Mitwally, MD, spends 90% of his day in clinical practice at the Reproductive Medicine and Fertility Center in Colorado Springs, Colorado. He estimates that roughly half of his perimenopausal and menopausal patients troubled by vasomotor and other symptoms are currently on HT. Since the WHI’s initial findings were published, Dr. Mitwally has “absolutely” had to spend considerably more time educating his patients—“and educating physicians,” he says. His patients are reluctant to take HT because of press attention to the WHI. And other physicians are reluctant to give HT because they understand that the WHI is a randomized trial “and so don’t question it.”

 

Dr. Mitwally blames two entities for this state of affairs. “The credit goes to the WHI,” he says. “They did a wonderful job of screwing people up” with a “very poorly designed study.” There is also “a lot of misinformation,” thanks to the media. “They just want to get any bad news and magnify it.”

In the wake of the WHI, Dr. Mitwally recalls, “it was like chaos” for 3 or 4 years—and there is still a lot of confusion.

Nevertheless, when a patient complains of moderate or severe vasomotor symptoms, Dr. Mitwally usually turns to HT as a first-line therapy. “It is excellent for these patients,” he says, although he emphasizes that “every patient should be managed separately.”

“I think the most important thing in the whole issue of HT is that physicians should leave these patients to subspecialists,” he says, by which he means reproductive endocrinologists and ObGyns with expertise in menopause care.

Plethora of products

One of the more surprising impacts of the WHI is the array of estrogen products now available. Because the WHI was expected to confirm observational data that suggested that estrogen reduced the risk of cardiovascular disease, the number of products in development skyrocketed.

“I think something like 35 compounds got approved while the study was under way, so there is more stuff than ever,” says Dr. Santoro. “But that actually was attractive to some people in the survey and has been found to be attractive to patients because it does give more choices the way things are going, which is toward more of a customized approach to giving hormones.”

Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center in Long Branch, New Jersey, a federally funded qualified health migrant center (FQHC), says the broader array of estrogen products adds to the time she spends educating patients.

“We do tell them about the other forms of estrogen and their bioeffectiveness and what they would achieve for this particular woman,” she says.

For patients who report moderate to severe menopausal symptoms, Dr. Joshi considers estrogen a first-line therapy, but recommends concurrent lifestyle changes.

“Of course, the WHI has not disappeared,” she says, so concerns about risks remain. “But in the transition, when the symptoms are paramount, I would tailor the treatment to what the woman wants to get out of it. But I think it is important for the woman to understand that this is not a panacea and that it will not cure all her symptoms. Therefore, lifestyle changes and getting hormone replacement therapy should go concurrently.”

As for alternative therapies, women are increasingly likely to ask for or about them.

“We talk about that,” says Dr. Shulman. “If they’re miserable and they don’t think they’re appropriate candidates for estrogen, we talk about other things. Or some people will come in and say, ‘I don’t want to take estrogen. Is there anything else?’”

In these cases, Dr. Shulman recommends a number of options. “Effexor has shown some benefit, apparently, in the literature,” she says. “And I mention black cohosh, which is in a lot of popular over-the-counter type remedies and which, apparently, recently was shown to have possibly some benefit.” Of course, “there’s a tremendous placebo effect with all of these,” she observes.

“And then I suggest things like getting plenty of exercise and eating sensibly, and I take my other patients’ recommendations. One patient told me that she takes a cool shower every night before going to bed and finds it beneficial, so I don’t know—it’s one of those ‘can’t hurt, might help’ things.”

Estrogen got a “bad name”

When she looks back over the past 5 years, Dr. Shulman thinks the WHI’s effects have been destructive in many ways.

“I think the most important thing is that [HT] got an undeservedly bad name when the Women’s Health Initiative was published,” she says. The WHI “really did a disservice for women who could benefit from [HT] enormously and weren’t really at risk—not just for vasomotor symptoms but also emotional lability, depression, increased anxiety, things like that.”

“I have many women for whom I did prescribe estrogen, and they’re still on it and will probably never get off because they think that I saved their lives. So for women to be scared unfairly by the Women’s Health Initiative and to have to suffer with vasomotor and emotional problems is really a disservice.”

Dr. Wineman agrees, and points out that even some professional organizations are beginning to reconsider the initial WHI findings. “They’re beginning to say, ‘I really believe that there are certain women who would probably benefit a great deal more than we once thought, and perhaps we jumped to some wrong conclusions.’”

Patients, physicians, the media—in other words, just about everybody—are confused about the findings of the Women’s Health Initiative (WHI),¹ according to a recent survey.

Why? And is this state of confusion permanent? Most of all, how are your colleagues dealing with that lack of clarity in their practice?

Questions put to your peers

In early September, the Hormone Foundation, public education affiliate of the Endocrine Society, released the results of a national survey of doctors involved in menopause care.² The survey was designed to gauge the effects of the WHI on clinical practice and was conducted on behalf of the Hormone Foundation with financial support from Novogyne Pharmaceuticals. Among the findings:

• Only 15% of the physicians believe their patients’ perceptions of the risks of hormone replacement are accurate
  
• Only 18% of physicians—this includes ObGyns—report that they themselves have “no confusion at all” about the findings of the WHI
  
• 83% of physicians believe their patients are as confused now as when the WHI findings were released in 2002—or more so
  
• 81% of physicians believe the media are as, or more, confused as when the findings were released.²
  

So what is the state of menopause care today, 5 years after the WHI made its splash?

“There’s a lot of noise,” says Nanette Santoro, MD, director of reproductive endocrinology at Albert Einstein College of Medicine, Bronx, New York, and a member of the Hormone Foundation’s Women’s Health Task Force. “And there have been a lot of arguments back and forth.”

What can a physician do to achieve a little clarity?

Staying up-to-date on the clinical practice guidelines is the best way to combat confusion, Dr. Santoro says. A good starting point, she notes, is the Hormone Foundation Web site (Hormone. org), which links to the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine (ASRM), and the North American Menopause Society (NAMS), all of which publish reliable guidelines.

“I think that’s probably the best way of keeping abreast of what’s happening now if [physicians] are not really deeply into menopause care,” she says. “But getting filtered information, or getting information from pundits or from the media is, I think, more hazardous because the quality of that information can be variable. And the days of getting your information from pharmaceutical representatives are long gone in this area because, again, it is not sufficiently reliable.”

 

“Afraid of hormones”

In the years since early WHI findings were published, Anita L. Nelson, MD, has not noticed confusion so much as fear among her patients. Dr. Nelson is professor of obstetrics and gynecology at the David Geffen School of Medicine at UCLA in Los Angeles.

“I think the things that are concerning to patients by and large are breast cancer and, in women who have done more reading on it, some of them are concerned about dementia,” Dr. Nelson says. “But by and large, other than those focused issues, it is hormones that patients are afraid of, and they sort of wave their hands in this global aura of ‘badness’ that they’re afraid of.”

One reason is the WHI. “Obviously that contributed to it,” she says. But a bigger cause of fear among her patients, a large percentage of whom are referred, is the fact that “their physicians have been taking them off of therapy. They’re not offering it,” she says, “or they are putting up a sort of barrier by saying, ‘You have to go see Dr. Nelson before you can start taking those medications.’”

The problem doesn’t end there, she adds. “The sad thing is that they are by and large not offering them alternative medications while they’re waiting for the transition—or if they are, sometimes they are actually giving them hazardous drugs. One of my favorite things is when patients who have high blood pressure are denied estrogen but are given Bellergal [ergotamine, belladonna alkaloids, and phenobarbital], which has a vasoconstrictive medication in it.”

“We do want folks to review the data,” she says, noting that ObGyns are “true believers” and unlikely to quit prescribing hormone therapy (HT). It is the internists and the family medicine physicians “who still have significant misgivings about the safety of these therapies in recently menopausal women.”

Joanna Shulman, MD, agrees. She is associate professor and director of the medical student clerkship in obstetrics and gynecology at Mount Sinai School of Medicine in New York City.

“The internists I work with or that my patients see tend to be terrified of hormone therapy. So I think they tend to discourage their patients.”

Mea culpa, anyone?

Confusion over the WHI is an issue for another prominent ObGyn—Wulf H. Utian, MD, PhD, editor-in-chief of Menopause Management and executive director of NAMS. In an editorial in the September/October issue of Menopause Management, Dr. Utian faults the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) for starting a “firestorm in women’s health” by publicizing the abrupt termination of the estrogen–progestin arm of the WHI study.⁴

Utian notes that he pointed out his dismay over the WHI way back in 2002, when he wrote, again in Menopause Management: “The manner in which the study was terminated was poorly planned, abrupt, and inhumane. Predictably, the media response was enormous, ranging from thoughtful to sensational. Panic was caused, numerous women discontinued therapy, and women and their health providers alike have been thrown into a state of confusion, distrust, and quandary of what to do next.”⁴

Bruce Wineman, DO, concurs. Although he retired from practice as a reproductive endocrinologist at the Marshfield Clinic in Marshfield, Wisconsin, shortly before the WHI findings were first published, he maintains his license and stays active in the ASRM. “The worst part of the WHI is that they got so much press with it,” he says, “and that the group of women that they chose was exactly the group of women that was going to have the maximum amount of negative effect.”

Utian believes a mea culpa is in order. “There are reams of important and pertinent data coming out of all the substudies of the WHI,” he writes. “For these to be accepted with confidence, it is well time for the NIH to bring all their WHI investigators together to develop a transparent and comprehensive summary of their results. It is also time for the WHI investigators to cease their stubborn defense and misrepresentation of their 2002 data, and to return to scientific integrity.”³

Same view in the trenches

Mohamed Mitwally, MD, spends 90% of his day in clinical practice at the Reproductive Medicine and Fertility Center in Colorado Springs, Colorado. He estimates that roughly half of his perimenopausal and menopausal patients troubled by vasomotor and other symptoms are currently on HT. Since the WHI’s initial findings were published, Dr. Mitwally has “absolutely” had to spend considerably more time educating his patients—“and educating physicians,” he says. His patients are reluctant to take HT because of press attention to the WHI. And other physicians are reluctant to give HT because they understand that the WHI is a randomized trial “and so don’t question it.”

 

Dr. Mitwally blames two entities for this state of affairs. “The credit goes to the WHI,” he says. “They did a wonderful job of screwing people up” with a “very poorly designed study.” There is also “a lot of misinformation,” thanks to the media. “They just want to get any bad news and magnify it.”

In the wake of the WHI, Dr. Mitwally recalls, “it was like chaos” for 3 or 4 years—and there is still a lot of confusion.

Nevertheless, when a patient complains of moderate or severe vasomotor symptoms, Dr. Mitwally usually turns to HT as a first-line therapy. “It is excellent for these patients,” he says, although he emphasizes that “every patient should be managed separately.”

“I think the most important thing in the whole issue of HT is that physicians should leave these patients to subspecialists,” he says, by which he means reproductive endocrinologists and ObGyns with expertise in menopause care.

Plethora of products

One of the more surprising impacts of the WHI is the array of estrogen products now available. Because the WHI was expected to confirm observational data that suggested that estrogen reduced the risk of cardiovascular disease, the number of products in development skyrocketed.

“I think something like 35 compounds got approved while the study was under way, so there is more stuff than ever,” says Dr. Santoro. “But that actually was attractive to some people in the survey and has been found to be attractive to patients because it does give more choices the way things are going, which is toward more of a customized approach to giving hormones.”

Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center in Long Branch, New Jersey, a federally funded qualified health migrant center (FQHC), says the broader array of estrogen products adds to the time she spends educating patients.

“We do tell them about the other forms of estrogen and their bioeffectiveness and what they would achieve for this particular woman,” she says.

For patients who report moderate to severe menopausal symptoms, Dr. Joshi considers estrogen a first-line therapy, but recommends concurrent lifestyle changes.

“Of course, the WHI has not disappeared,” she says, so concerns about risks remain. “But in the transition, when the symptoms are paramount, I would tailor the treatment to what the woman wants to get out of it. But I think it is important for the woman to understand that this is not a panacea and that it will not cure all her symptoms. Therefore, lifestyle changes and getting hormone replacement therapy should go concurrently.”

As for alternative therapies, women are increasingly likely to ask for or about them.

“We talk about that,” says Dr. Shulman. “If they’re miserable and they don’t think they’re appropriate candidates for estrogen, we talk about other things. Or some people will come in and say, ‘I don’t want to take estrogen. Is there anything else?’”

In these cases, Dr. Shulman recommends a number of options. “Effexor has shown some benefit, apparently, in the literature,” she says. “And I mention black cohosh, which is in a lot of popular over-the-counter type remedies and which, apparently, recently was shown to have possibly some benefit.” Of course, “there’s a tremendous placebo effect with all of these,” she observes.

“And then I suggest things like getting plenty of exercise and eating sensibly, and I take my other patients’ recommendations. One patient told me that she takes a cool shower every night before going to bed and finds it beneficial, so I don’t know—it’s one of those ‘can’t hurt, might help’ things.”

Estrogen got a “bad name”

When she looks back over the past 5 years, Dr. Shulman thinks the WHI’s effects have been destructive in many ways.

“I think the most important thing is that [HT] got an undeservedly bad name when the Women’s Health Initiative was published,” she says. The WHI “really did a disservice for women who could benefit from [HT] enormously and weren’t really at risk—not just for vasomotor symptoms but also emotional lability, depression, increased anxiety, things like that.”

“I have many women for whom I did prescribe estrogen, and they’re still on it and will probably never get off because they think that I saved their lives. So for women to be scared unfairly by the Women’s Health Initiative and to have to suffer with vasomotor and emotional problems is really a disservice.”

Dr. Wineman agrees, and points out that even some professional organizations are beginning to reconsider the initial WHI findings. “They’re beginning to say, ‘I really believe that there are certain women who would probably benefit a great deal more than we once thought, and perhaps we jumped to some wrong conclusions.’”

T. Murphy Goodwin, MD, a contributor to the new American College of Obstetricians and Gynecologists practice bulletin on nausea and vomiting of pregnancy (NVP),¹ tells why it is important to ask every patient about nausea and vomiting, when to intervene, and what the best treatments are—including a substitute compound for the no-longer-available drug Bendectin.

Dr. Goodwin is professor of obstetrics and gynecology at the Keck School of Medicine, University of Southern California, Los Angeles.

Many patients assume they must endure nausea, vomiting

• Women do not always mention nausea and vomiting, believing they must “live with it.” Prompt intervention can stave off more severe NVP, so it makes sense for Ob/Gyns to raise the subject early.
  

OBG MANAGEMENT: What new information in the American College of Obstetricians and Gynecologists (ACOG) practice bulletin should the Ob/Gyn be aware of?

GOODWIN: Rather than “new information,” I would call it a change in emphasis. Previously, the focus was almost exclusively on life-threatening hyperemesis gravidarum, while lesser degrees of nausea and vomiting of pregnancy went untreated or undertreated. In reality, approximately 35% of gravidas have NVP severe enough to interfere with their daily routine. Fortunately, effective therapy is available.

OBG MANAGEMENT: Some authorities believe NVP is a continuum between mild upset and hyperemesis gravidarum. How would such a continuum affect patient care?

GOODWIN: Epidemiologic studies suggest that women with mild NVP and those with hyperemesis are significantly similar, strongly supporting the notion of a continuum.² This fact underscores the importance of treating NVP in its early stages, before it advances to hyperemesis.

My own sense is that a small group of women with hyperemesis are predisposed to it because of rare genetic disorders such as mitochondrial mutations.

OBG MANAGEMENT: Since so many women experience NVP, should obstetricians routinely ask about it, including its psychosocial effects?

GOODWIN: Yes. This is important because of the continuum we mentioned—and because many women consider NVP “normal” and may not mention it unless they are asked.

OBG MANAGEMENT: Do you think some physicians share this mindset?

GOODWIN: Undoubtedly. Studies have shown that as many as 50% of women with severe NVP are not offered antiemetic therapy.^3,4 But the days of letting the condition “run its course” are past. Now the best strategy is asking about it—and intervening early.

What causes NVP?

• The factors at play in each patient help determine the best treatment. NVP is more likely with high levels of hCG and estrogen.
  

OBG MANAGEMENT: In a 2002 study,⁵ you concluded that NVP is actually a syndrome rather than a single condition.

How would this concept affect management of NVP?

GOODWIN: Women who are susceptible to NVP because of a vestibular mechanism might respond to a medical regimen that works at that site. Still other women may have “background” gastrointestinal motility dysfunction that makes them more susceptible to NVP; in that case, therapies to treat motility abnormalities would be appropriate. Others may have a strong behavioral overlay and would be expected to respond to the kinds of treatment used for anticipatory nausea and vomiting associated with chemotherapy.

These are theoretical scenarios at present, but a new paradigm will allow new ways of thinking about therapy.

OBG MANAGEMENT: In the early 1990s, you and your colleagues⁶ reported your study on the link between human chorionic gonadotropin (hCG) and NVP. What is the association?

GOODWIN: A temporal association has attracted the attention of obstetricians for years. In addition, biochemical hyperthyroidism and NVP are strongly associated. Fifty percent to 70% of women with hyperemesis gravidarum have transient hyperthyroidism, with no goiter.⁷ (If a goiter is present, suspect primary thyroid disorder.) Because hCG causes the biochemical hyperthyroidism related to pregnancy, and because hyperthyroidism by itself rarely causes vomiting, hCG is implicated. However, it remains unclear how hCG would cause NVP—perhaps by stimulating the ovary to produce more estrogen, which causes emesis, or through some other, unknown step.

 

Interestingly, a number of “high-hCG” conditions are associated with increased NVP: molar pregnancy, multiple gestation, and Down’s syndrome. Conversely, trisomy 18 is a “low-hCG” condition anecdotally associated with reduced NVP.

OBG MANAGEMENT: What is estrogen’s role?

GOODWIN: Estradiol and hCG are the only 2 hormones ever found to differ when women with NVP are compared to controls. Women who get sick with estrogen exposure are much more likely to develop NVP. Some studies have found increased estradiol levels in women with NVP, compared with controls.^6,8 Conversely, low estradiol levels may reduce the risk of NVP. Take smoking, for example. It is associated with lower hCG and estradiol levels, and smokers are less likely than non-smokers to have NVP.

Studies also have focused on a possible link between cytokines and hyperemesis, and between hyperemesis and tumor necrosis factor alpha.

OBG MANAGEMENT: Do these findings alter clinical management?

GOODWIN: No. The findings about etiology do not affect management at present.

NVP can be protective or perilous

• Some degree of nausea and vomiting affects the vast majority of pregnancies. Unless it is severe, however, NVP appears to have a protective effect on the fetus.
  

OBG MANAGEMENT: What is the prevalence of NVP, and what are its characteristics?

GOODWIN: About 70% to 85% of gravidas experience it.⁹ In the spectrum of NVP, about 50% of women experience both nausea and vomiting, 25% experience nausea alone, and 25% are unaffected.¹⁰

Hyperemesis gravidarum affects roughly 3 to 20 of every 1,000 pregnancies.

It generally is categorized according to the level of intervention required:

• Mild NVP does not affect daily life.
  
• Moderate NVP interferes with daily life.
  
• Severe NVP, or hyperemesis, requires fluid and/or nutritional support. Hyperemesis is further defined as persistent vomiting, weight loss exceeding 5% of prepregnancy weight, and significant ketonuria, with or without electrolyte disturbances. Hospitalization usually is required.
  

OBG MANAGEMENT: What is the clinical course?

GOODWIN: NVP almost always appears before 10 weeks’ gestation. If it begins any later, it is likely the patient has a different condition associated with nausea and vomiting.

One study found that most women develop NVP at about 4 to 7 weeks’ gestation, and that it resolves at less than 10 weeks in about 30% of women, at 10 to 12 weeks in another 30%, and at 12 to 16 weeks in another 30%.¹⁰

As for diurnal changes, symptoms tend to occur with greater frequency early in the day.

OBG MANAGEMENT: Is NVP ever harmful for the fetus?

GOODWIN: It is associated with improved fetal outcomes unless hyperemesis supervenes. Then it is associated with mild fetal growth delays and rare cases of fetal death.

We lack studies of the long-term effects of severe NVP on the fetus, but starvation and weight loss in women during famine have been shown to cause many diverse problems in offspring later in adult life.

OBG MANAGEMENT: What do you make of evidence that suggests NVP plays a protective role in pregnancy?

GOODWIN: If true, it likely represents a vestigial response that is no longer beneficial—similar to thrombophilias in pregnancy, which played an important role protecting women against bleeding at childbirth but now are more of a clinical problem because of the associated thrombosis.

 

Effects on the mother and predisposing factors

• Even at milder levels, physical discomfort is considerable. Predisposing factors include a female fetus, history of hyperemesis, migraine headaches, and a tendency to develop motion sickness.
  

OBG MANAGEMENT: How does NVP affect the mother?

GOODWIN: Serious sequelae are limited to hyperemesis, in which case Mallory-Weiss tears, splenic avulsion, esophageal rupture, pneumothorax, acute tubular necrosis, peripheral neuropathy (due to deficiencies of vitamins B6and B12), or Wernicke’s encephalopathy can result. This last condition is the most serious potential complication, and it can be difficult to recognize. Look for signs of confusion, memory loss, and blunted affect.

Even at milder levels of NVP, however, physical discomfort can be considerable. One prospective study using the McGill Nausea Questionnaire found the nausea experienced by pregnant women to be similar in character and intensity to that experienced by cancer patients on chemotherapy.¹¹

OBG MANAGEMENT: Are there predisposing factors?

GOODWIN: Yes. They include a history of illness upon exposure to estrogen (for example, oral contraceptives), as well as a history of motion sickness and migraine.

Hyperemesis is more likely when the fetus is female. Women who had hyperemesis in a previous pregnancy are likely to experience it again in their next gestation, and their daughters and sisters also are more likely to develop it.

We also know that inherited and acquired disorders of mitochondria commonly manifest as migraine and/or gastrointestinal disease, including nausea and vomiting.¹²

Predisposing factors also include pregnancy-related conditions: multiple gestation; gestational trophoblastic disease; and fetal anomalies such as triploidy, Down’s syndrome, and hydrops fetalis. Overall, the chance of fetal defects associated with hyperemesis is extremely small.

The work-up: key signs and tests

• In severe cases, look for Wernicke’s encephalopathy, dehydration, weight loss, other causes of nausea and vomiting, and abnormal lab values.
  

OBG MANAGEMENT: Let’s say you have a patient at 8 weeks’ gestation who complains of persistent nausea and vomiting. What is an appropriate work-up?

GOODWIN: Physical assessment is necessary only in severe cases. If nausea and vomiting last more than 3 weeks, signs of Wernicke’s encephalopathy should be sought (this condition is never reported as early as 8 weeks).

Other important signs to look for are dehydration and evidence of other diseases that can cause nausea and vomiting (TABLE). If the patient has experienced vomiting throughout her pregnancy, but it suddenly becomes acute, another condition may be responsible.

It also is important to be aware that abdominal pain, fever, and headache do not represent NVP, but usually reflect other conditions associated with nausea and vomiting.

I ask about the duration and severity of NVP, and whether the woman has lost weight as a result. Weight loss is very important: Women who can’t sustain their weight need nutritional therapy.

OBG MANAGEMENT: Do you order lab tests?

GOODWIN: Yes. In severe cases, I get a liver panel and check amylase, lipase, and electrolytes. A number of abnormalities have been documented when hyperemesis is present. They include elevated liver enzymes, serum bilirubin, and serum amylase or lipase measurements, as well as increased free thyroxine and suppressed thyroid-stimulating hormone.

Serum hCG measurements are generally not useful, however, in exploring whether the patient’s vomiting is caused by hyperemesis gravidarum.

Imaging is necessary only to check for predisposing causes such as twins or molar gestation.

TABLE

Differential diagnosis of nausea and vomiting of pregnancy

 

Gastrointestinal disorders
Appendicitis
Biliary tract disease
Esophagitis
Gastroenteritis
Gastroparesis
Hepatitis
Intestinal obstruction
Pancreatitis
Peptic ulcer disease
Genitourinary disorders
Acute renal failure
Degenerating fibroid
Nephrolithiasis
Pyelonephritis
Torsion
Metabolic disorders
Addison’s disease
Diabetic ketoacidosis
Hyperparathyroidism
Hyperthyroidism
Porphyria
Pregnancy-related
Acute fatty liver of pregnancy
Preeclampsia
Pregnancy-induced hypertension
Miscellaneous
Central nervous system lesions
Drug toxicity/side effects
Eating disorder
Migraine
Pseudotumor cerebri
Vestibular lesions
Adapted from Goodwin TM21

Do vitamins, rest, diet, ginger, or acupuncture help?

• Vitamins may help prevent NVP. For mild NVP, simple lifestyle changes or alternative remedies may suffice.
  

OBG MANAGEMENT: Would your first step with the patient described earlier be lifestyle and dietary adjustments?

GOODWIN: The first step in this case should have been prevention. Two studies have found that multivitamins given at conception help reduce the severity of NVP.^13,14

As for lifestyle changes, I would recommend rest and instruct the patient to avoid foods, activities, and other stimuli that exacerbate symptoms. Small, frequent meals are usually suggested to take the place of 3 large daily meals.

Scientifically, however, almost nothing is known about these common recommendations, though 1 study showed protein liquid meals reduced nausea and gastric-motility abnormalities more than carbohydrate or fatty meals with the same caloric content.¹⁵

OBG MANAGEMENT: Do you ever recommend alternative remedies such as ginger powder or stimulation of the P6 acupuncture point (eg, via acupuncture, Sea-Band, or ReliefBand)?

GOODWIN: As the ACOG guidelines point out, they are worth a try. When the patient wants to take ginger, I recommend 250 mg by mouth 3 to 4 times daily.

When to start drug therapy

• Pyridoxine (vitamin B₆) is the first choice, followed by a combination of pyridoxine and doxylamine, which together form the drug Bendectin (no longer available in the US).
  

OBG MANAGEMENT: When do you opt for drug therapy?

GOODWIN: When symptoms interfere with daily life and the remedies already mentioned fail or patients choose not to use them. In such cases, pyridoxine (vitamin B6) is my first choice. I recommend 10 to 25 mg 3 or 4 times daily. In 1 randomized, controlled trial,¹⁶ 25 mg of pyridoxine every 8 hours led to a significant reduction in severe vomiting. In another, 10 mg of pyridoxine every 8 hours decreased both nausea and vomiting compared to placebo.¹⁷

When pyridoxine alone fails to ease NVP, I add doxylamine (see “Stepwise drug treatment of nausea and vomiting of pregnancy”). When it was commercially available, Bendectin contained the pyridoxine-doxylamine combination (10 mg of each) in 1 pill and was the most commonly prescribed agent, but it is no longer offered in the US. In Canada, it is sold as Diclectin.

The teratogenicity of Bendectin has never been proven despite extensive study, and a 1998 review described the agent’s safety.

Although the manufacturer voluntarily removed the drug in the early 1980s because of lawsuits alleging birth defects, teratogenicity has never been proven despite extensive study. A 1998 review described Diclectin’s safety.¹⁸

Fortunately, the combination of pyridoxine and doxylamine is still available—though not in a single pill. Some pharmacies will compound it, or the patient can be given pyridoxine in combination with the over-the-counter sleep aid Unisom, which contains 25 mg doxylamine succinate per tablet.

If pyridoxine alone is ineffective, I generally add 12.5 mg of doxylamine (half a Unisom tablet) to each dose. The patient should be instructed to buy Unisom in tablet form, rather than gel caps, as the active ingredient in the latter is not doxylamine.

 

Adding other drugs

• When pyridoxine is insufficient (alone or in combination with doxylamine), add promethazine, dimenhydrinate, or another agent.
  

OBG MANAGEMENT: How safe are antiemetics in pregnancy?

GOODWIN: The safety of antihistamines for use in pregnancy is well established. There are fewer data for phenothiazines, but they also appear to be quite safe.

As for 5-HT3-receptor antagonists, no teratogenicity has been found for ondansetron, which is used to treat nausea and vomiting associated with chemotherapy. However, in the only randomized trial, it did not appear to offer benefit over promethazine (a drug with characteristics of both antihistamines and phenothiazines and a good safety profile). Another drug, granisetron, has not been studied in regard to NVP.

OBG MANAGEMENT: What drugs do you prescribe besides pyridoxine and doxylamine?

GOODWIN: If the combination of pyridoxine and doxylamine fails to provide relief, I add 12.5 to 25 mg of promethazine every 4 hours (orally or rectally) or 50 to 100 mg of dimenhydrinate every 4 to 6 hours (orally or rectally, but not exceeding 200 mg daily when the patient is also taking doxylamine).

If this regimen fails to ease the patient’s symptoms, other combinations can be suggested.

OBG MANAGEMENT: Any caveats?

GOODWIN: I never give droperidol, a butyrophenone, because the US Food and Drug Administration has warned of an association with cardiac arrhythmias. This linkage may be overstated, but since there are safe alternatives, I avoid this agent.

Last resort: corticosteroids

• Corticosteroids may help resolve refractory hyperemesis gravidarum.
  

OBG MANAGEMENT: What about corticosteroids? What is their safety profile for NVP?

GOODWIN: They do not appear to be teratogenic unless they are given during the first 10 weeks of gestation; then they are associated with a slightly increased risk of oral clefts.¹⁹ Even so, they should be a last resort—and then only in refractory cases involving weight loss and the need for enteral or parenteral nutrition. The literature is mixed on the efficacy, but I find that a subset of patients have a dramatic response to corticosteroids.

The usual regimen is 16 mg methylprednisolone 3 times daily for 3 days, followed by tapering over 2 weeks, declining in 4-mg increments. If vomiting occurs during the taper, increase the dose by 4 mg for 1 week, then continue tapering. If vomiting recurs after tapering, restart the drug at 8 to 12 mg/day. All told, therapy should be limited to 4 to 6 weeks.

If there is no improvement during the initial 3 days of therapy, stop the drug altogether.

The steroid can be given orally or intravenously. It also is important to give 1,200 mg daily of calcium throughout the regimen.

Hydration and nutrition for hyperemesis

• Give fluids and nutritional support to maintain weight.
  

OBG MANAGEMENT: Do you hydrate the patient? What about enteral or parenteral nutrition?

The most extreme psychosocial effect of NVP is the decision to terminate an otherwise desired pregnancy.

GOODWIN: Yes. If she is dehydrated, I replace fluids, taking care to give intravenous thiamine before dextrose if she has been vomiting longer than 3 weeks. Otherwise, Wernicke’s encephalopathy may develop.

I prefer enteral nutrition, provided the patient can tolerate it and a good nutrition team is available to support both physician and patient.

Generally, hospitalization is warranted for women who cannot maintain hydration or nutrition or when the patient and her family cannot cope with the condition. However, depending on community resources, outpatient hydration/nutrition may be a feasible option.

When she is able to tolerate oral hydration and maintain weight—with or without nutritional support—she can be discharged.

Crippling psychosocial effects

• Acknowledging NVP’s disruptive effect—at all levels of severity—is critical. Let her know you aren’t minimizing its impact, and that a range of options are at her disposal.
  

OBG MANAGEMENT: One aspect of NVP often overlooked is the psychosocial impact. Would you say it is considerable?

GOODWIN: Yes. In some cases, it can be crippling. Unfortunately, this dimension is rarely addressed by the physician. Effects can include reduced job efficiency, lost work time (in 1 study, a mean of 62 hours¹⁰), and a negative impact on family relationships and mental health. The most extreme effect, of course, is the decision to terminate an otherwise desired pregnancy.

These effects are not limited to hyperemesis; NVP involves psychosocial morbidity at all levels of severity.³ One study concluded that the severity of NVP fails to adequately reflect the distress it causes.³

The patient’s sense of her condition is critical. It is important to find out what effects NVP is having on her daily routine and let her know you aren’t minimizing its impact—also that a range of options are at her disposal.

 

OBG MANAGEMENT: In the past, haven’t a number of psychodynamic causes been proposed for NVP?

GOODWIN: Yes. These included speculation that the woman was subconsciously rejecting the pregnancy, “hysterical,” maternally dependent or too independent, or denying her femininity. Fortunately, these ideas have been discredited.

Severe NVP does have psychological effects, however. Simpson et al²⁰ found that women with hyperemesis gravidarum were more likely to experience anxiety, depression, somatization, psychoticism, and symptoms of obsessive-compulsive disorder. After delivery, however, they returned to normal and were no more likely than other nonpregnant women to experience these conditions.

NVP is not more likely to occur during an unwanted pregnancy. The rates are about the same as for desired gestations.

OBG MANAGEMENT: Is NVP ever the result of a psychologic condition?

GOODWIN: Very rarely, although a behavioral component may be involved—eg, vomiting as a conditioned response. However, this does not mean that the patient has a disease or is responsible for her own condition.

That kind of thinking is one reason women hesitate to raise the subject.

Dr. Goodwin reports no financial relationships relevant to this article.

T. Murphy Goodwin, MD, a contributor to the new American College of Obstetricians and Gynecologists practice bulletin on nausea and vomiting of pregnancy (NVP),¹ tells why it is important to ask every patient about nausea and vomiting, when to intervene, and what the best treatments are—including a substitute compound for the no-longer-available drug Bendectin.

Dr. Goodwin is professor of obstetrics and gynecology at the Keck School of Medicine, University of Southern California, Los Angeles.

Many patients assume they must endure nausea, vomiting

• Women do not always mention nausea and vomiting, believing they must “live with it.” Prompt intervention can stave off more severe NVP, so it makes sense for Ob/Gyns to raise the subject early.
  

OBG MANAGEMENT: What new information in the American College of Obstetricians and Gynecologists (ACOG) practice bulletin should the Ob/Gyn be aware of?

GOODWIN: Rather than “new information,” I would call it a change in emphasis. Previously, the focus was almost exclusively on life-threatening hyperemesis gravidarum, while lesser degrees of nausea and vomiting of pregnancy went untreated or undertreated. In reality, approximately 35% of gravidas have NVP severe enough to interfere with their daily routine. Fortunately, effective therapy is available.

OBG MANAGEMENT: Some authorities believe NVP is a continuum between mild upset and hyperemesis gravidarum. How would such a continuum affect patient care?

GOODWIN: Epidemiologic studies suggest that women with mild NVP and those with hyperemesis are significantly similar, strongly supporting the notion of a continuum.² This fact underscores the importance of treating NVP in its early stages, before it advances to hyperemesis.

My own sense is that a small group of women with hyperemesis are predisposed to it because of rare genetic disorders such as mitochondrial mutations.

OBG MANAGEMENT: Since so many women experience NVP, should obstetricians routinely ask about it, including its psychosocial effects?

GOODWIN: Yes. This is important because of the continuum we mentioned—and because many women consider NVP “normal” and may not mention it unless they are asked.

OBG MANAGEMENT: Do you think some physicians share this mindset?

GOODWIN: Undoubtedly. Studies have shown that as many as 50% of women with severe NVP are not offered antiemetic therapy.^3,4 But the days of letting the condition “run its course” are past. Now the best strategy is asking about it—and intervening early.

What causes NVP?

• The factors at play in each patient help determine the best treatment. NVP is more likely with high levels of hCG and estrogen.
  

OBG MANAGEMENT: In a 2002 study,⁵ you concluded that NVP is actually a syndrome rather than a single condition.

How would this concept affect management of NVP?

GOODWIN: Women who are susceptible to NVP because of a vestibular mechanism might respond to a medical regimen that works at that site. Still other women may have “background” gastrointestinal motility dysfunction that makes them more susceptible to NVP; in that case, therapies to treat motility abnormalities would be appropriate. Others may have a strong behavioral overlay and would be expected to respond to the kinds of treatment used for anticipatory nausea and vomiting associated with chemotherapy.

These are theoretical scenarios at present, but a new paradigm will allow new ways of thinking about therapy.

OBG MANAGEMENT: In the early 1990s, you and your colleagues⁶ reported your study on the link between human chorionic gonadotropin (hCG) and NVP. What is the association?

GOODWIN: A temporal association has attracted the attention of obstetricians for years. In addition, biochemical hyperthyroidism and NVP are strongly associated. Fifty percent to 70% of women with hyperemesis gravidarum have transient hyperthyroidism, with no goiter.⁷ (If a goiter is present, suspect primary thyroid disorder.) Because hCG causes the biochemical hyperthyroidism related to pregnancy, and because hyperthyroidism by itself rarely causes vomiting, hCG is implicated. However, it remains unclear how hCG would cause NVP—perhaps by stimulating the ovary to produce more estrogen, which causes emesis, or through some other, unknown step.

 

Interestingly, a number of “high-hCG” conditions are associated with increased NVP: molar pregnancy, multiple gestation, and Down’s syndrome. Conversely, trisomy 18 is a “low-hCG” condition anecdotally associated with reduced NVP.

OBG MANAGEMENT: What is estrogen’s role?

GOODWIN: Estradiol and hCG are the only 2 hormones ever found to differ when women with NVP are compared to controls. Women who get sick with estrogen exposure are much more likely to develop NVP. Some studies have found increased estradiol levels in women with NVP, compared with controls.^6,8 Conversely, low estradiol levels may reduce the risk of NVP. Take smoking, for example. It is associated with lower hCG and estradiol levels, and smokers are less likely than non-smokers to have NVP.

Studies also have focused on a possible link between cytokines and hyperemesis, and between hyperemesis and tumor necrosis factor alpha.

OBG MANAGEMENT: Do these findings alter clinical management?

GOODWIN: No. The findings about etiology do not affect management at present.

NVP can be protective or perilous

• Some degree of nausea and vomiting affects the vast majority of pregnancies. Unless it is severe, however, NVP appears to have a protective effect on the fetus.
  

OBG MANAGEMENT: What is the prevalence of NVP, and what are its characteristics?

GOODWIN: About 70% to 85% of gravidas experience it.⁹ In the spectrum of NVP, about 50% of women experience both nausea and vomiting, 25% experience nausea alone, and 25% are unaffected.¹⁰

Hyperemesis gravidarum affects roughly 3 to 20 of every 1,000 pregnancies.

It generally is categorized according to the level of intervention required:

• Mild NVP does not affect daily life.
  
• Moderate NVP interferes with daily life.
  
• Severe NVP, or hyperemesis, requires fluid and/or nutritional support. Hyperemesis is further defined as persistent vomiting, weight loss exceeding 5% of prepregnancy weight, and significant ketonuria, with or without electrolyte disturbances. Hospitalization usually is required.
  

OBG MANAGEMENT: What is the clinical course?

GOODWIN: NVP almost always appears before 10 weeks’ gestation. If it begins any later, it is likely the patient has a different condition associated with nausea and vomiting.

One study found that most women develop NVP at about 4 to 7 weeks’ gestation, and that it resolves at less than 10 weeks in about 30% of women, at 10 to 12 weeks in another 30%, and at 12 to 16 weeks in another 30%.¹⁰

As for diurnal changes, symptoms tend to occur with greater frequency early in the day.

OBG MANAGEMENT: Is NVP ever harmful for the fetus?

GOODWIN: It is associated with improved fetal outcomes unless hyperemesis supervenes. Then it is associated with mild fetal growth delays and rare cases of fetal death.

We lack studies of the long-term effects of severe NVP on the fetus, but starvation and weight loss in women during famine have been shown to cause many diverse problems in offspring later in adult life.

OBG MANAGEMENT: What do you make of evidence that suggests NVP plays a protective role in pregnancy?

GOODWIN: If true, it likely represents a vestigial response that is no longer beneficial—similar to thrombophilias in pregnancy, which played an important role protecting women against bleeding at childbirth but now are more of a clinical problem because of the associated thrombosis.

 

Effects on the mother and predisposing factors

• Even at milder levels, physical discomfort is considerable. Predisposing factors include a female fetus, history of hyperemesis, migraine headaches, and a tendency to develop motion sickness.
  

OBG MANAGEMENT: How does NVP affect the mother?

GOODWIN: Serious sequelae are limited to hyperemesis, in which case Mallory-Weiss tears, splenic avulsion, esophageal rupture, pneumothorax, acute tubular necrosis, peripheral neuropathy (due to deficiencies of vitamins B6and B12), or Wernicke’s encephalopathy can result. This last condition is the most serious potential complication, and it can be difficult to recognize. Look for signs of confusion, memory loss, and blunted affect.

Even at milder levels of NVP, however, physical discomfort can be considerable. One prospective study using the McGill Nausea Questionnaire found the nausea experienced by pregnant women to be similar in character and intensity to that experienced by cancer patients on chemotherapy.¹¹

OBG MANAGEMENT: Are there predisposing factors?

GOODWIN: Yes. They include a history of illness upon exposure to estrogen (for example, oral contraceptives), as well as a history of motion sickness and migraine.

Hyperemesis is more likely when the fetus is female. Women who had hyperemesis in a previous pregnancy are likely to experience it again in their next gestation, and their daughters and sisters also are more likely to develop it.

We also know that inherited and acquired disorders of mitochondria commonly manifest as migraine and/or gastrointestinal disease, including nausea and vomiting.¹²

Predisposing factors also include pregnancy-related conditions: multiple gestation; gestational trophoblastic disease; and fetal anomalies such as triploidy, Down’s syndrome, and hydrops fetalis. Overall, the chance of fetal defects associated with hyperemesis is extremely small.

The work-up: key signs and tests

• In severe cases, look for Wernicke’s encephalopathy, dehydration, weight loss, other causes of nausea and vomiting, and abnormal lab values.
  

OBG MANAGEMENT: Let’s say you have a patient at 8 weeks’ gestation who complains of persistent nausea and vomiting. What is an appropriate work-up?

GOODWIN: Physical assessment is necessary only in severe cases. If nausea and vomiting last more than 3 weeks, signs of Wernicke’s encephalopathy should be sought (this condition is never reported as early as 8 weeks).

Other important signs to look for are dehydration and evidence of other diseases that can cause nausea and vomiting (TABLE). If the patient has experienced vomiting throughout her pregnancy, but it suddenly becomes acute, another condition may be responsible.

It also is important to be aware that abdominal pain, fever, and headache do not represent NVP, but usually reflect other conditions associated with nausea and vomiting.

I ask about the duration and severity of NVP, and whether the woman has lost weight as a result. Weight loss is very important: Women who can’t sustain their weight need nutritional therapy.

OBG MANAGEMENT: Do you order lab tests?

GOODWIN: Yes. In severe cases, I get a liver panel and check amylase, lipase, and electrolytes. A number of abnormalities have been documented when hyperemesis is present. They include elevated liver enzymes, serum bilirubin, and serum amylase or lipase measurements, as well as increased free thyroxine and suppressed thyroid-stimulating hormone.

Serum hCG measurements are generally not useful, however, in exploring whether the patient’s vomiting is caused by hyperemesis gravidarum.

Imaging is necessary only to check for predisposing causes such as twins or molar gestation.

TABLE

Differential diagnosis of nausea and vomiting of pregnancy

 

Gastrointestinal disorders
Appendicitis
Biliary tract disease
Esophagitis
Gastroenteritis
Gastroparesis
Hepatitis
Intestinal obstruction
Pancreatitis
Peptic ulcer disease
Genitourinary disorders
Acute renal failure
Degenerating fibroid
Nephrolithiasis
Pyelonephritis
Torsion
Metabolic disorders
Addison’s disease
Diabetic ketoacidosis
Hyperparathyroidism
Hyperthyroidism
Porphyria
Pregnancy-related
Acute fatty liver of pregnancy
Preeclampsia
Pregnancy-induced hypertension
Miscellaneous
Central nervous system lesions
Drug toxicity/side effects
Eating disorder
Migraine
Pseudotumor cerebri
Vestibular lesions
Adapted from Goodwin TM21

Do vitamins, rest, diet, ginger, or acupuncture help?

• Vitamins may help prevent NVP. For mild NVP, simple lifestyle changes or alternative remedies may suffice.
  

OBG MANAGEMENT: Would your first step with the patient described earlier be lifestyle and dietary adjustments?

GOODWIN: The first step in this case should have been prevention. Two studies have found that multivitamins given at conception help reduce the severity of NVP.^13,14

As for lifestyle changes, I would recommend rest and instruct the patient to avoid foods, activities, and other stimuli that exacerbate symptoms. Small, frequent meals are usually suggested to take the place of 3 large daily meals.

Scientifically, however, almost nothing is known about these common recommendations, though 1 study showed protein liquid meals reduced nausea and gastric-motility abnormalities more than carbohydrate or fatty meals with the same caloric content.¹⁵

OBG MANAGEMENT: Do you ever recommend alternative remedies such as ginger powder or stimulation of the P6 acupuncture point (eg, via acupuncture, Sea-Band, or ReliefBand)?

GOODWIN: As the ACOG guidelines point out, they are worth a try. When the patient wants to take ginger, I recommend 250 mg by mouth 3 to 4 times daily.

When to start drug therapy

• Pyridoxine (vitamin B₆) is the first choice, followed by a combination of pyridoxine and doxylamine, which together form the drug Bendectin (no longer available in the US).
  

OBG MANAGEMENT: When do you opt for drug therapy?

GOODWIN: When symptoms interfere with daily life and the remedies already mentioned fail or patients choose not to use them. In such cases, pyridoxine (vitamin B6) is my first choice. I recommend 10 to 25 mg 3 or 4 times daily. In 1 randomized, controlled trial,¹⁶ 25 mg of pyridoxine every 8 hours led to a significant reduction in severe vomiting. In another, 10 mg of pyridoxine every 8 hours decreased both nausea and vomiting compared to placebo.¹⁷

When pyridoxine alone fails to ease NVP, I add doxylamine (see “Stepwise drug treatment of nausea and vomiting of pregnancy”). When it was commercially available, Bendectin contained the pyridoxine-doxylamine combination (10 mg of each) in 1 pill and was the most commonly prescribed agent, but it is no longer offered in the US. In Canada, it is sold as Diclectin.

The teratogenicity of Bendectin has never been proven despite extensive study, and a 1998 review described the agent’s safety.

Although the manufacturer voluntarily removed the drug in the early 1980s because of lawsuits alleging birth defects, teratogenicity has never been proven despite extensive study. A 1998 review described Diclectin’s safety.¹⁸

Fortunately, the combination of pyridoxine and doxylamine is still available—though not in a single pill. Some pharmacies will compound it, or the patient can be given pyridoxine in combination with the over-the-counter sleep aid Unisom, which contains 25 mg doxylamine succinate per tablet.

If pyridoxine alone is ineffective, I generally add 12.5 mg of doxylamine (half a Unisom tablet) to each dose. The patient should be instructed to buy Unisom in tablet form, rather than gel caps, as the active ingredient in the latter is not doxylamine.

 

Adding other drugs

• When pyridoxine is insufficient (alone or in combination with doxylamine), add promethazine, dimenhydrinate, or another agent.
  

OBG MANAGEMENT: How safe are antiemetics in pregnancy?

GOODWIN: The safety of antihistamines for use in pregnancy is well established. There are fewer data for phenothiazines, but they also appear to be quite safe.

As for 5-HT3-receptor antagonists, no teratogenicity has been found for ondansetron, which is used to treat nausea and vomiting associated with chemotherapy. However, in the only randomized trial, it did not appear to offer benefit over promethazine (a drug with characteristics of both antihistamines and phenothiazines and a good safety profile). Another drug, granisetron, has not been studied in regard to NVP.

OBG MANAGEMENT: What drugs do you prescribe besides pyridoxine and doxylamine?

GOODWIN: If the combination of pyridoxine and doxylamine fails to provide relief, I add 12.5 to 25 mg of promethazine every 4 hours (orally or rectally) or 50 to 100 mg of dimenhydrinate every 4 to 6 hours (orally or rectally, but not exceeding 200 mg daily when the patient is also taking doxylamine).

If this regimen fails to ease the patient’s symptoms, other combinations can be suggested.

OBG MANAGEMENT: Any caveats?

GOODWIN: I never give droperidol, a butyrophenone, because the US Food and Drug Administration has warned of an association with cardiac arrhythmias. This linkage may be overstated, but since there are safe alternatives, I avoid this agent.

Last resort: corticosteroids

• Corticosteroids may help resolve refractory hyperemesis gravidarum.
  

OBG MANAGEMENT: What about corticosteroids? What is their safety profile for NVP?

GOODWIN: They do not appear to be teratogenic unless they are given during the first 10 weeks of gestation; then they are associated with a slightly increased risk of oral clefts.¹⁹ Even so, they should be a last resort—and then only in refractory cases involving weight loss and the need for enteral or parenteral nutrition. The literature is mixed on the efficacy, but I find that a subset of patients have a dramatic response to corticosteroids.

The usual regimen is 16 mg methylprednisolone 3 times daily for 3 days, followed by tapering over 2 weeks, declining in 4-mg increments. If vomiting occurs during the taper, increase the dose by 4 mg for 1 week, then continue tapering. If vomiting recurs after tapering, restart the drug at 8 to 12 mg/day. All told, therapy should be limited to 4 to 6 weeks.

If there is no improvement during the initial 3 days of therapy, stop the drug altogether.

The steroid can be given orally or intravenously. It also is important to give 1,200 mg daily of calcium throughout the regimen.

Hydration and nutrition for hyperemesis

• Give fluids and nutritional support to maintain weight.
  

OBG MANAGEMENT: Do you hydrate the patient? What about enteral or parenteral nutrition?

The most extreme psychosocial effect of NVP is the decision to terminate an otherwise desired pregnancy.

GOODWIN: Yes. If she is dehydrated, I replace fluids, taking care to give intravenous thiamine before dextrose if she has been vomiting longer than 3 weeks. Otherwise, Wernicke’s encephalopathy may develop.

I prefer enteral nutrition, provided the patient can tolerate it and a good nutrition team is available to support both physician and patient.

Generally, hospitalization is warranted for women who cannot maintain hydration or nutrition or when the patient and her family cannot cope with the condition. However, depending on community resources, outpatient hydration/nutrition may be a feasible option.

When she is able to tolerate oral hydration and maintain weight—with or without nutritional support—she can be discharged.

Crippling psychosocial effects

• Acknowledging NVP’s disruptive effect—at all levels of severity—is critical. Let her know you aren’t minimizing its impact, and that a range of options are at her disposal.
  

OBG MANAGEMENT: One aspect of NVP often overlooked is the psychosocial impact. Would you say it is considerable?

GOODWIN: Yes. In some cases, it can be crippling. Unfortunately, this dimension is rarely addressed by the physician. Effects can include reduced job efficiency, lost work time (in 1 study, a mean of 62 hours¹⁰), and a negative impact on family relationships and mental health. The most extreme effect, of course, is the decision to terminate an otherwise desired pregnancy.

These effects are not limited to hyperemesis; NVP involves psychosocial morbidity at all levels of severity.³ One study concluded that the severity of NVP fails to adequately reflect the distress it causes.³

The patient’s sense of her condition is critical. It is important to find out what effects NVP is having on her daily routine and let her know you aren’t minimizing its impact—also that a range of options are at her disposal.

 

OBG MANAGEMENT: In the past, haven’t a number of psychodynamic causes been proposed for NVP?

GOODWIN: Yes. These included speculation that the woman was subconsciously rejecting the pregnancy, “hysterical,” maternally dependent or too independent, or denying her femininity. Fortunately, these ideas have been discredited.

Severe NVP does have psychological effects, however. Simpson et al²⁰ found that women with hyperemesis gravidarum were more likely to experience anxiety, depression, somatization, psychoticism, and symptoms of obsessive-compulsive disorder. After delivery, however, they returned to normal and were no more likely than other nonpregnant women to experience these conditions.

NVP is not more likely to occur during an unwanted pregnancy. The rates are about the same as for desired gestations.

OBG MANAGEMENT: Is NVP ever the result of a psychologic condition?

GOODWIN: Very rarely, although a behavioral component may be involved—eg, vomiting as a conditioned response. However, this does not mean that the patient has a disease or is responsible for her own condition.

That kind of thinking is one reason women hesitate to raise the subject.

Dr. Goodwin reports no financial relationships relevant to this article.

T. Murphy Goodwin, MD, a contributor to the new American College of Obstetricians and Gynecologists practice bulletin on nausea and vomiting of pregnancy (NVP),¹ tells why it is important to ask every patient about nausea and vomiting, when to intervene, and what the best treatments are—including a substitute compound for the no-longer-available drug Bendectin.

Dr. Goodwin is professor of obstetrics and gynecology at the Keck School of Medicine, University of Southern California, Los Angeles.

Many patients assume they must endure nausea, vomiting

• Women do not always mention nausea and vomiting, believing they must “live with it.” Prompt intervention can stave off more severe NVP, so it makes sense for Ob/Gyns to raise the subject early.
  

OBG MANAGEMENT: What new information in the American College of Obstetricians and Gynecologists (ACOG) practice bulletin should the Ob/Gyn be aware of?

GOODWIN: Rather than “new information,” I would call it a change in emphasis. Previously, the focus was almost exclusively on life-threatening hyperemesis gravidarum, while lesser degrees of nausea and vomiting of pregnancy went untreated or undertreated. In reality, approximately 35% of gravidas have NVP severe enough to interfere with their daily routine. Fortunately, effective therapy is available.

OBG MANAGEMENT: Some authorities believe NVP is a continuum between mild upset and hyperemesis gravidarum. How would such a continuum affect patient care?

GOODWIN: Epidemiologic studies suggest that women with mild NVP and those with hyperemesis are significantly similar, strongly supporting the notion of a continuum.² This fact underscores the importance of treating NVP in its early stages, before it advances to hyperemesis.

My own sense is that a small group of women with hyperemesis are predisposed to it because of rare genetic disorders such as mitochondrial mutations.

OBG MANAGEMENT: Since so many women experience NVP, should obstetricians routinely ask about it, including its psychosocial effects?

GOODWIN: Yes. This is important because of the continuum we mentioned—and because many women consider NVP “normal” and may not mention it unless they are asked.

OBG MANAGEMENT: Do you think some physicians share this mindset?

GOODWIN: Undoubtedly. Studies have shown that as many as 50% of women with severe NVP are not offered antiemetic therapy.^3,4 But the days of letting the condition “run its course” are past. Now the best strategy is asking about it—and intervening early.

What causes NVP?

• The factors at play in each patient help determine the best treatment. NVP is more likely with high levels of hCG and estrogen.
  

OBG MANAGEMENT: In a 2002 study,⁵ you concluded that NVP is actually a syndrome rather than a single condition.

How would this concept affect management of NVP?

GOODWIN: Women who are susceptible to NVP because of a vestibular mechanism might respond to a medical regimen that works at that site. Still other women may have “background” gastrointestinal motility dysfunction that makes them more susceptible to NVP; in that case, therapies to treat motility abnormalities would be appropriate. Others may have a strong behavioral overlay and would be expected to respond to the kinds of treatment used for anticipatory nausea and vomiting associated with chemotherapy.

These are theoretical scenarios at present, but a new paradigm will allow new ways of thinking about therapy.

OBG MANAGEMENT: In the early 1990s, you and your colleagues⁶ reported your study on the link between human chorionic gonadotropin (hCG) and NVP. What is the association?

GOODWIN: A temporal association has attracted the attention of obstetricians for years. In addition, biochemical hyperthyroidism and NVP are strongly associated. Fifty percent to 70% of women with hyperemesis gravidarum have transient hyperthyroidism, with no goiter.⁷ (If a goiter is present, suspect primary thyroid disorder.) Because hCG causes the biochemical hyperthyroidism related to pregnancy, and because hyperthyroidism by itself rarely causes vomiting, hCG is implicated. However, it remains unclear how hCG would cause NVP—perhaps by stimulating the ovary to produce more estrogen, which causes emesis, or through some other, unknown step.

 

Interestingly, a number of “high-hCG” conditions are associated with increased NVP: molar pregnancy, multiple gestation, and Down’s syndrome. Conversely, trisomy 18 is a “low-hCG” condition anecdotally associated with reduced NVP.

OBG MANAGEMENT: What is estrogen’s role?

GOODWIN: Estradiol and hCG are the only 2 hormones ever found to differ when women with NVP are compared to controls. Women who get sick with estrogen exposure are much more likely to develop NVP. Some studies have found increased estradiol levels in women with NVP, compared with controls.^6,8 Conversely, low estradiol levels may reduce the risk of NVP. Take smoking, for example. It is associated with lower hCG and estradiol levels, and smokers are less likely than non-smokers to have NVP.

Studies also have focused on a possible link between cytokines and hyperemesis, and between hyperemesis and tumor necrosis factor alpha.

OBG MANAGEMENT: Do these findings alter clinical management?

GOODWIN: No. The findings about etiology do not affect management at present.

NVP can be protective or perilous

• Some degree of nausea and vomiting affects the vast majority of pregnancies. Unless it is severe, however, NVP appears to have a protective effect on the fetus.
  

OBG MANAGEMENT: What is the prevalence of NVP, and what are its characteristics?

GOODWIN: About 70% to 85% of gravidas experience it.⁹ In the spectrum of NVP, about 50% of women experience both nausea and vomiting, 25% experience nausea alone, and 25% are unaffected.¹⁰

Hyperemesis gravidarum affects roughly 3 to 20 of every 1,000 pregnancies.

It generally is categorized according to the level of intervention required:

• Mild NVP does not affect daily life.
  
• Moderate NVP interferes with daily life.
  
• Severe NVP, or hyperemesis, requires fluid and/or nutritional support. Hyperemesis is further defined as persistent vomiting, weight loss exceeding 5% of prepregnancy weight, and significant ketonuria, with or without electrolyte disturbances. Hospitalization usually is required.
  

OBG MANAGEMENT: What is the clinical course?

GOODWIN: NVP almost always appears before 10 weeks’ gestation. If it begins any later, it is likely the patient has a different condition associated with nausea and vomiting.

One study found that most women develop NVP at about 4 to 7 weeks’ gestation, and that it resolves at less than 10 weeks in about 30% of women, at 10 to 12 weeks in another 30%, and at 12 to 16 weeks in another 30%.¹⁰

As for diurnal changes, symptoms tend to occur with greater frequency early in the day.

OBG MANAGEMENT: Is NVP ever harmful for the fetus?

GOODWIN: It is associated with improved fetal outcomes unless hyperemesis supervenes. Then it is associated with mild fetal growth delays and rare cases of fetal death.

We lack studies of the long-term effects of severe NVP on the fetus, but starvation and weight loss in women during famine have been shown to cause many diverse problems in offspring later in adult life.

OBG MANAGEMENT: What do you make of evidence that suggests NVP plays a protective role in pregnancy?

GOODWIN: If true, it likely represents a vestigial response that is no longer beneficial—similar to thrombophilias in pregnancy, which played an important role protecting women against bleeding at childbirth but now are more of a clinical problem because of the associated thrombosis.

 

Effects on the mother and predisposing factors

• Even at milder levels, physical discomfort is considerable. Predisposing factors include a female fetus, history of hyperemesis, migraine headaches, and a tendency to develop motion sickness.
  

OBG MANAGEMENT: How does NVP affect the mother?

GOODWIN: Serious sequelae are limited to hyperemesis, in which case Mallory-Weiss tears, splenic avulsion, esophageal rupture, pneumothorax, acute tubular necrosis, peripheral neuropathy (due to deficiencies of vitamins B6and B12), or Wernicke’s encephalopathy can result. This last condition is the most serious potential complication, and it can be difficult to recognize. Look for signs of confusion, memory loss, and blunted affect.

Even at milder levels of NVP, however, physical discomfort can be considerable. One prospective study using the McGill Nausea Questionnaire found the nausea experienced by pregnant women to be similar in character and intensity to that experienced by cancer patients on chemotherapy.¹¹

OBG MANAGEMENT: Are there predisposing factors?

GOODWIN: Yes. They include a history of illness upon exposure to estrogen (for example, oral contraceptives), as well as a history of motion sickness and migraine.

Hyperemesis is more likely when the fetus is female. Women who had hyperemesis in a previous pregnancy are likely to experience it again in their next gestation, and their daughters and sisters also are more likely to develop it.

We also know that inherited and acquired disorders of mitochondria commonly manifest as migraine and/or gastrointestinal disease, including nausea and vomiting.¹²

Predisposing factors also include pregnancy-related conditions: multiple gestation; gestational trophoblastic disease; and fetal anomalies such as triploidy, Down’s syndrome, and hydrops fetalis. Overall, the chance of fetal defects associated with hyperemesis is extremely small.

The work-up: key signs and tests

• In severe cases, look for Wernicke’s encephalopathy, dehydration, weight loss, other causes of nausea and vomiting, and abnormal lab values.
  

OBG MANAGEMENT: Let’s say you have a patient at 8 weeks’ gestation who complains of persistent nausea and vomiting. What is an appropriate work-up?

GOODWIN: Physical assessment is necessary only in severe cases. If nausea and vomiting last more than 3 weeks, signs of Wernicke’s encephalopathy should be sought (this condition is never reported as early as 8 weeks).

Other important signs to look for are dehydration and evidence of other diseases that can cause nausea and vomiting (TABLE). If the patient has experienced vomiting throughout her pregnancy, but it suddenly becomes acute, another condition may be responsible.

It also is important to be aware that abdominal pain, fever, and headache do not represent NVP, but usually reflect other conditions associated with nausea and vomiting.

I ask about the duration and severity of NVP, and whether the woman has lost weight as a result. Weight loss is very important: Women who can’t sustain their weight need nutritional therapy.

OBG MANAGEMENT: Do you order lab tests?

GOODWIN: Yes. In severe cases, I get a liver panel and check amylase, lipase, and electrolytes. A number of abnormalities have been documented when hyperemesis is present. They include elevated liver enzymes, serum bilirubin, and serum amylase or lipase measurements, as well as increased free thyroxine and suppressed thyroid-stimulating hormone.

Serum hCG measurements are generally not useful, however, in exploring whether the patient’s vomiting is caused by hyperemesis gravidarum.

Imaging is necessary only to check for predisposing causes such as twins or molar gestation.

TABLE

Differential diagnosis of nausea and vomiting of pregnancy

 

Gastrointestinal disorders
Appendicitis
Biliary tract disease
Esophagitis
Gastroenteritis
Gastroparesis
Hepatitis
Intestinal obstruction
Pancreatitis
Peptic ulcer disease
Genitourinary disorders
Acute renal failure
Degenerating fibroid
Nephrolithiasis
Pyelonephritis
Torsion
Metabolic disorders
Addison’s disease
Diabetic ketoacidosis
Hyperparathyroidism
Hyperthyroidism
Porphyria
Pregnancy-related
Acute fatty liver of pregnancy
Preeclampsia
Pregnancy-induced hypertension
Miscellaneous
Central nervous system lesions
Drug toxicity/side effects
Eating disorder
Migraine
Pseudotumor cerebri
Vestibular lesions
Adapted from Goodwin TM21

Do vitamins, rest, diet, ginger, or acupuncture help?

• Vitamins may help prevent NVP. For mild NVP, simple lifestyle changes or alternative remedies may suffice.
  

OBG MANAGEMENT: Would your first step with the patient described earlier be lifestyle and dietary adjustments?

GOODWIN: The first step in this case should have been prevention. Two studies have found that multivitamins given at conception help reduce the severity of NVP.^13,14

As for lifestyle changes, I would recommend rest and instruct the patient to avoid foods, activities, and other stimuli that exacerbate symptoms. Small, frequent meals are usually suggested to take the place of 3 large daily meals.

Scientifically, however, almost nothing is known about these common recommendations, though 1 study showed protein liquid meals reduced nausea and gastric-motility abnormalities more than carbohydrate or fatty meals with the same caloric content.¹⁵

OBG MANAGEMENT: Do you ever recommend alternative remedies such as ginger powder or stimulation of the P6 acupuncture point (eg, via acupuncture, Sea-Band, or ReliefBand)?

GOODWIN: As the ACOG guidelines point out, they are worth a try. When the patient wants to take ginger, I recommend 250 mg by mouth 3 to 4 times daily.

When to start drug therapy

• Pyridoxine (vitamin B₆) is the first choice, followed by a combination of pyridoxine and doxylamine, which together form the drug Bendectin (no longer available in the US).
  

OBG MANAGEMENT: When do you opt for drug therapy?

GOODWIN: When symptoms interfere with daily life and the remedies already mentioned fail or patients choose not to use them. In such cases, pyridoxine (vitamin B6) is my first choice. I recommend 10 to 25 mg 3 or 4 times daily. In 1 randomized, controlled trial,¹⁶ 25 mg of pyridoxine every 8 hours led to a significant reduction in severe vomiting. In another, 10 mg of pyridoxine every 8 hours decreased both nausea and vomiting compared to placebo.¹⁷

When pyridoxine alone fails to ease NVP, I add doxylamine (see “Stepwise drug treatment of nausea and vomiting of pregnancy”). When it was commercially available, Bendectin contained the pyridoxine-doxylamine combination (10 mg of each) in 1 pill and was the most commonly prescribed agent, but it is no longer offered in the US. In Canada, it is sold as Diclectin.

The teratogenicity of Bendectin has never been proven despite extensive study, and a 1998 review described the agent’s safety.

Although the manufacturer voluntarily removed the drug in the early 1980s because of lawsuits alleging birth defects, teratogenicity has never been proven despite extensive study. A 1998 review described Diclectin’s safety.¹⁸

Fortunately, the combination of pyridoxine and doxylamine is still available—though not in a single pill. Some pharmacies will compound it, or the patient can be given pyridoxine in combination with the over-the-counter sleep aid Unisom, which contains 25 mg doxylamine succinate per tablet.

If pyridoxine alone is ineffective, I generally add 12.5 mg of doxylamine (half a Unisom tablet) to each dose. The patient should be instructed to buy Unisom in tablet form, rather than gel caps, as the active ingredient in the latter is not doxylamine.

 

Adding other drugs

• When pyridoxine is insufficient (alone or in combination with doxylamine), add promethazine, dimenhydrinate, or another agent.
  

OBG MANAGEMENT: How safe are antiemetics in pregnancy?

GOODWIN: The safety of antihistamines for use in pregnancy is well established. There are fewer data for phenothiazines, but they also appear to be quite safe.

As for 5-HT3-receptor antagonists, no teratogenicity has been found for ondansetron, which is used to treat nausea and vomiting associated with chemotherapy. However, in the only randomized trial, it did not appear to offer benefit over promethazine (a drug with characteristics of both antihistamines and phenothiazines and a good safety profile). Another drug, granisetron, has not been studied in regard to NVP.

OBG MANAGEMENT: What drugs do you prescribe besides pyridoxine and doxylamine?

GOODWIN: If the combination of pyridoxine and doxylamine fails to provide relief, I add 12.5 to 25 mg of promethazine every 4 hours (orally or rectally) or 50 to 100 mg of dimenhydrinate every 4 to 6 hours (orally or rectally, but not exceeding 200 mg daily when the patient is also taking doxylamine).

If this regimen fails to ease the patient’s symptoms, other combinations can be suggested.

OBG MANAGEMENT: Any caveats?

GOODWIN: I never give droperidol, a butyrophenone, because the US Food and Drug Administration has warned of an association with cardiac arrhythmias. This linkage may be overstated, but since there are safe alternatives, I avoid this agent.

Last resort: corticosteroids

• Corticosteroids may help resolve refractory hyperemesis gravidarum.
  

OBG MANAGEMENT: What about corticosteroids? What is their safety profile for NVP?

GOODWIN: They do not appear to be teratogenic unless they are given during the first 10 weeks of gestation; then they are associated with a slightly increased risk of oral clefts.¹⁹ Even so, they should be a last resort—and then only in refractory cases involving weight loss and the need for enteral or parenteral nutrition. The literature is mixed on the efficacy, but I find that a subset of patients have a dramatic response to corticosteroids.

The usual regimen is 16 mg methylprednisolone 3 times daily for 3 days, followed by tapering over 2 weeks, declining in 4-mg increments. If vomiting occurs during the taper, increase the dose by 4 mg for 1 week, then continue tapering. If vomiting recurs after tapering, restart the drug at 8 to 12 mg/day. All told, therapy should be limited to 4 to 6 weeks.

If there is no improvement during the initial 3 days of therapy, stop the drug altogether.

The steroid can be given orally or intravenously. It also is important to give 1,200 mg daily of calcium throughout the regimen.

Hydration and nutrition for hyperemesis

• Give fluids and nutritional support to maintain weight.
  

OBG MANAGEMENT: Do you hydrate the patient? What about enteral or parenteral nutrition?

The most extreme psychosocial effect of NVP is the decision to terminate an otherwise desired pregnancy.

GOODWIN: Yes. If she is dehydrated, I replace fluids, taking care to give intravenous thiamine before dextrose if she has been vomiting longer than 3 weeks. Otherwise, Wernicke’s encephalopathy may develop.

I prefer enteral nutrition, provided the patient can tolerate it and a good nutrition team is available to support both physician and patient.

Generally, hospitalization is warranted for women who cannot maintain hydration or nutrition or when the patient and her family cannot cope with the condition. However, depending on community resources, outpatient hydration/nutrition may be a feasible option.

When she is able to tolerate oral hydration and maintain weight—with or without nutritional support—she can be discharged.

Crippling psychosocial effects

• Acknowledging NVP’s disruptive effect—at all levels of severity—is critical. Let her know you aren’t minimizing its impact, and that a range of options are at her disposal.
  

OBG MANAGEMENT: One aspect of NVP often overlooked is the psychosocial impact. Would you say it is considerable?

GOODWIN: Yes. In some cases, it can be crippling. Unfortunately, this dimension is rarely addressed by the physician. Effects can include reduced job efficiency, lost work time (in 1 study, a mean of 62 hours¹⁰), and a negative impact on family relationships and mental health. The most extreme effect, of course, is the decision to terminate an otherwise desired pregnancy.

These effects are not limited to hyperemesis; NVP involves psychosocial morbidity at all levels of severity.³ One study concluded that the severity of NVP fails to adequately reflect the distress it causes.³

The patient’s sense of her condition is critical. It is important to find out what effects NVP is having on her daily routine and let her know you aren’t minimizing its impact—also that a range of options are at her disposal.

 

OBG MANAGEMENT: In the past, haven’t a number of psychodynamic causes been proposed for NVP?

GOODWIN: Yes. These included speculation that the woman was subconsciously rejecting the pregnancy, “hysterical,” maternally dependent or too independent, or denying her femininity. Fortunately, these ideas have been discredited.

Severe NVP does have psychological effects, however. Simpson et al²⁰ found that women with hyperemesis gravidarum were more likely to experience anxiety, depression, somatization, psychoticism, and symptoms of obsessive-compulsive disorder. After delivery, however, they returned to normal and were no more likely than other nonpregnant women to experience these conditions.

NVP is not more likely to occur during an unwanted pregnancy. The rates are about the same as for desired gestations.

OBG MANAGEMENT: Is NVP ever the result of a psychologic condition?

GOODWIN: Very rarely, although a behavioral component may be involved—eg, vomiting as a conditioned response. However, this does not mean that the patient has a disease or is responsible for her own condition.

That kind of thinking is one reason women hesitate to raise the subject.

Dr. Goodwin reports no financial relationships relevant to this article.