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Psychotropic Drugs May Be Needed in Pregnancy : Maternal psychiatric illness, if inadequately treated or untreated, may result in poor compliance with care.

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Psychotropic Drugs May Be Needed in Pregnancy : Maternal psychiatric illness, if inadequately treated or untreated, may result in poor compliance with care.

KOLOA, HAWAII — Although labeling typically doesn't support the use of psychotropic drugs in pregnant women, the drugs might be needed during pregnancy, according to an observational study done at Emory University, Atlanta.

“What I want you to recognize is that you're going to expose the child to something, be it illness or treatment, and in the context of that, some decisions are far worse than others,” Dr. Zachary N. Stowe said at the annual meeting of the American College of Psychiatrists. “Abruptly stopping or changing treatment at knowledge of conception is an effort on your part to reduce your anxiety. It doesn't change outcome. In fact, it probably worsens outcome,” Dr. Stowe asserted.

The need for treatment cannot be ignored. A large number of women who become pregnant have a mental health problem.

“We're talking about [400,000] or 500,000 women every year with a neuropsychiatric illness that” begins before family planning, or that might have been treated or needed to be treated during family planning, said Dr. Stowe, who is director of the women's mental health program at Emory University.

And with 4 million U.S. deliveries per year, he pointed out, “over 50% of pregnancies are unplanned.”

Studies of antenatal depression and its consequences led the American College of Obstetricians and Gynecologists to issue the following guideline statement in November 2007:

“Maternal psychiatric illness, if inadequately treated or untreated, may result in poor compliance with prenatal care, inadequate nutrition, exposure to additional medications or herbal remedies, increased alcohol and tobacco use, deficits in mother-infant bonding, and disruptions within the family environment.”

Other antenatal depression study findings include increases in suicide, postpartum depression, premature birth, low birth weight, neonatal complications, and fetal demise, said Dr. Stowe.

In the observational study that he and his colleagues conducted, pregnant women who had depression decided for themselves whether to discontinue their antidepressant medication.

Of the women who discontinued, 68% became “sick” before delivery, said Dr. Stowe. The other 32% were able to stop taking their antidepressant safely, but 25% who stayed on their antidepressant still became sick.

For women with bipolar disorder who discontinued their mood-stabilizing medication, 85% became sick before delivery.

A big problem, of course, is the typical drug labeling statement that “use in pregnancy is not recommended unless the potential benefits justify the potential risks to the fetus,” which Dr. Stowe called “handwashing.”

There's no question that psychotropic drugs will reach the fetus. Psychotropic medicines are designed to get past the blood-brain barrier and reach the brain, which means they will likely pass through the placental barrier without any difficulty. His own unpublished research has supported this, but he wondered if it is always harmful.

“You can actually statistically argue that antidepressants reduce your risk of birth defects,” he said. “To date, we have no confirmed evidence of increased birth defects on our antidepressants.”

In some psychotropic categories, however, some drugs are better than others—or much worse.

“Valproate has consistently the highest placental passage of any medicine we've studied, and it has the worst outcome,” said Dr. Stowe. “It is worse than Accutane.”

“In my opinion, there is no justification for first-line use of valproic acid in women of reproductive years,” he continued. In babies whose mothers used valproic acid during pregnancy, “the mean IQ drop is 15 points. One in 10 children is mentally retarded,” he said.

On the other hand, “lamotrigine is the cleanest anticonvulsant we've seen. It is emerging as the number-one treatment for epilepsy during pregnancy. The overall malformation rate is lower than the national average,” he pointed out.

A recent, not-yet-published study of the use of lamotrigine in 26 women with bipolar disorder found that they did well if they continued the drug throughout pregnancy but not if they discontinued.

A higher dosage is needed for treatment of bipolar disorder, just as it is needed for epilepsy, Dr. Stowe said.

Another unpublished study found that pregnant women using olanzapine “failed their blood sugar test, independent of dose,” he said. “We should not trade gestational diabetes to treat mental illness during pregnancy, because what you're actually trading is the risk for adult-onset diabetes after pregnancy. Gestational diabetes is a well-known risk factor for that.”

Not much is known about the use of atypical antipsychotic drugs during pregnancy, he said.

As for pregnant women using lithium, be aware that dehydration at birth can cause lithium toxicity in the infant, he said (Am. J. Psychiatry 2005;162:2162–70).

Switching drugs during the course of pregnancy with the thought that drug B has more safety data than drug A is entering “the world of the unknown,” Dr. Stowe said, “because all the data for medicine B were not derived from babies that first got medicine A. Everything we know about teratology says two medicines are worse than one. And please remember, the later trimesters can be just as important as the first trimester.”

 

 

Given the uncertainties of sexual behavior and the possibility of undetected pregnancy in female patients, “you should treat all women as though they are pregnant, starting at age 9. From 9 to 49, they are pregnant until proven otherwise,” he said.

Regarding the possibility of passing medications to infants during breast-feeding, “the dose in pregnancy is huge compared to the dose in lactation. Worrying about the medicine in lactation, if you used it in pregnancy, is really a waste of time. Our medicines in the bloodstream for antidepressants are nanograms per milliliter; for anticonvulsants they are in micrograms per milliliter. That's what gets into breast milk,” he said.

Dr. Stowe is on advisory boards for Bristol-Myers Squibb Co. and GlaxoSmithKline Inc. He has received grants from GlaxoSmithKline, Pfizer Inc., and Wyeth Pharmaceuticals. He is on the speakers bureaus of Eli Lilly, GlaxoSmithKline, Pfizer, and Wyeth Pharmaceuticals.

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KOLOA, HAWAII — Although labeling typically doesn't support the use of psychotropic drugs in pregnant women, the drugs might be needed during pregnancy, according to an observational study done at Emory University, Atlanta.

“What I want you to recognize is that you're going to expose the child to something, be it illness or treatment, and in the context of that, some decisions are far worse than others,” Dr. Zachary N. Stowe said at the annual meeting of the American College of Psychiatrists. “Abruptly stopping or changing treatment at knowledge of conception is an effort on your part to reduce your anxiety. It doesn't change outcome. In fact, it probably worsens outcome,” Dr. Stowe asserted.

The need for treatment cannot be ignored. A large number of women who become pregnant have a mental health problem.

“We're talking about [400,000] or 500,000 women every year with a neuropsychiatric illness that” begins before family planning, or that might have been treated or needed to be treated during family planning, said Dr. Stowe, who is director of the women's mental health program at Emory University.

And with 4 million U.S. deliveries per year, he pointed out, “over 50% of pregnancies are unplanned.”

Studies of antenatal depression and its consequences led the American College of Obstetricians and Gynecologists to issue the following guideline statement in November 2007:

“Maternal psychiatric illness, if inadequately treated or untreated, may result in poor compliance with prenatal care, inadequate nutrition, exposure to additional medications or herbal remedies, increased alcohol and tobacco use, deficits in mother-infant bonding, and disruptions within the family environment.”

Other antenatal depression study findings include increases in suicide, postpartum depression, premature birth, low birth weight, neonatal complications, and fetal demise, said Dr. Stowe.

In the observational study that he and his colleagues conducted, pregnant women who had depression decided for themselves whether to discontinue their antidepressant medication.

Of the women who discontinued, 68% became “sick” before delivery, said Dr. Stowe. The other 32% were able to stop taking their antidepressant safely, but 25% who stayed on their antidepressant still became sick.

For women with bipolar disorder who discontinued their mood-stabilizing medication, 85% became sick before delivery.

A big problem, of course, is the typical drug labeling statement that “use in pregnancy is not recommended unless the potential benefits justify the potential risks to the fetus,” which Dr. Stowe called “handwashing.”

There's no question that psychotropic drugs will reach the fetus. Psychotropic medicines are designed to get past the blood-brain barrier and reach the brain, which means they will likely pass through the placental barrier without any difficulty. His own unpublished research has supported this, but he wondered if it is always harmful.

“You can actually statistically argue that antidepressants reduce your risk of birth defects,” he said. “To date, we have no confirmed evidence of increased birth defects on our antidepressants.”

In some psychotropic categories, however, some drugs are better than others—or much worse.

“Valproate has consistently the highest placental passage of any medicine we've studied, and it has the worst outcome,” said Dr. Stowe. “It is worse than Accutane.”

“In my opinion, there is no justification for first-line use of valproic acid in women of reproductive years,” he continued. In babies whose mothers used valproic acid during pregnancy, “the mean IQ drop is 15 points. One in 10 children is mentally retarded,” he said.

On the other hand, “lamotrigine is the cleanest anticonvulsant we've seen. It is emerging as the number-one treatment for epilepsy during pregnancy. The overall malformation rate is lower than the national average,” he pointed out.

A recent, not-yet-published study of the use of lamotrigine in 26 women with bipolar disorder found that they did well if they continued the drug throughout pregnancy but not if they discontinued.

A higher dosage is needed for treatment of bipolar disorder, just as it is needed for epilepsy, Dr. Stowe said.

Another unpublished study found that pregnant women using olanzapine “failed their blood sugar test, independent of dose,” he said. “We should not trade gestational diabetes to treat mental illness during pregnancy, because what you're actually trading is the risk for adult-onset diabetes after pregnancy. Gestational diabetes is a well-known risk factor for that.”

Not much is known about the use of atypical antipsychotic drugs during pregnancy, he said.

As for pregnant women using lithium, be aware that dehydration at birth can cause lithium toxicity in the infant, he said (Am. J. Psychiatry 2005;162:2162–70).

Switching drugs during the course of pregnancy with the thought that drug B has more safety data than drug A is entering “the world of the unknown,” Dr. Stowe said, “because all the data for medicine B were not derived from babies that first got medicine A. Everything we know about teratology says two medicines are worse than one. And please remember, the later trimesters can be just as important as the first trimester.”

 

 

Given the uncertainties of sexual behavior and the possibility of undetected pregnancy in female patients, “you should treat all women as though they are pregnant, starting at age 9. From 9 to 49, they are pregnant until proven otherwise,” he said.

Regarding the possibility of passing medications to infants during breast-feeding, “the dose in pregnancy is huge compared to the dose in lactation. Worrying about the medicine in lactation, if you used it in pregnancy, is really a waste of time. Our medicines in the bloodstream for antidepressants are nanograms per milliliter; for anticonvulsants they are in micrograms per milliliter. That's what gets into breast milk,” he said.

Dr. Stowe is on advisory boards for Bristol-Myers Squibb Co. and GlaxoSmithKline Inc. He has received grants from GlaxoSmithKline, Pfizer Inc., and Wyeth Pharmaceuticals. He is on the speakers bureaus of Eli Lilly, GlaxoSmithKline, Pfizer, and Wyeth Pharmaceuticals.

KOLOA, HAWAII — Although labeling typically doesn't support the use of psychotropic drugs in pregnant women, the drugs might be needed during pregnancy, according to an observational study done at Emory University, Atlanta.

“What I want you to recognize is that you're going to expose the child to something, be it illness or treatment, and in the context of that, some decisions are far worse than others,” Dr. Zachary N. Stowe said at the annual meeting of the American College of Psychiatrists. “Abruptly stopping or changing treatment at knowledge of conception is an effort on your part to reduce your anxiety. It doesn't change outcome. In fact, it probably worsens outcome,” Dr. Stowe asserted.

The need for treatment cannot be ignored. A large number of women who become pregnant have a mental health problem.

“We're talking about [400,000] or 500,000 women every year with a neuropsychiatric illness that” begins before family planning, or that might have been treated or needed to be treated during family planning, said Dr. Stowe, who is director of the women's mental health program at Emory University.

And with 4 million U.S. deliveries per year, he pointed out, “over 50% of pregnancies are unplanned.”

Studies of antenatal depression and its consequences led the American College of Obstetricians and Gynecologists to issue the following guideline statement in November 2007:

“Maternal psychiatric illness, if inadequately treated or untreated, may result in poor compliance with prenatal care, inadequate nutrition, exposure to additional medications or herbal remedies, increased alcohol and tobacco use, deficits in mother-infant bonding, and disruptions within the family environment.”

Other antenatal depression study findings include increases in suicide, postpartum depression, premature birth, low birth weight, neonatal complications, and fetal demise, said Dr. Stowe.

In the observational study that he and his colleagues conducted, pregnant women who had depression decided for themselves whether to discontinue their antidepressant medication.

Of the women who discontinued, 68% became “sick” before delivery, said Dr. Stowe. The other 32% were able to stop taking their antidepressant safely, but 25% who stayed on their antidepressant still became sick.

For women with bipolar disorder who discontinued their mood-stabilizing medication, 85% became sick before delivery.

A big problem, of course, is the typical drug labeling statement that “use in pregnancy is not recommended unless the potential benefits justify the potential risks to the fetus,” which Dr. Stowe called “handwashing.”

There's no question that psychotropic drugs will reach the fetus. Psychotropic medicines are designed to get past the blood-brain barrier and reach the brain, which means they will likely pass through the placental barrier without any difficulty. His own unpublished research has supported this, but he wondered if it is always harmful.

“You can actually statistically argue that antidepressants reduce your risk of birth defects,” he said. “To date, we have no confirmed evidence of increased birth defects on our antidepressants.”

In some psychotropic categories, however, some drugs are better than others—or much worse.

“Valproate has consistently the highest placental passage of any medicine we've studied, and it has the worst outcome,” said Dr. Stowe. “It is worse than Accutane.”

“In my opinion, there is no justification for first-line use of valproic acid in women of reproductive years,” he continued. In babies whose mothers used valproic acid during pregnancy, “the mean IQ drop is 15 points. One in 10 children is mentally retarded,” he said.

On the other hand, “lamotrigine is the cleanest anticonvulsant we've seen. It is emerging as the number-one treatment for epilepsy during pregnancy. The overall malformation rate is lower than the national average,” he pointed out.

A recent, not-yet-published study of the use of lamotrigine in 26 women with bipolar disorder found that they did well if they continued the drug throughout pregnancy but not if they discontinued.

A higher dosage is needed for treatment of bipolar disorder, just as it is needed for epilepsy, Dr. Stowe said.

Another unpublished study found that pregnant women using olanzapine “failed their blood sugar test, independent of dose,” he said. “We should not trade gestational diabetes to treat mental illness during pregnancy, because what you're actually trading is the risk for adult-onset diabetes after pregnancy. Gestational diabetes is a well-known risk factor for that.”

Not much is known about the use of atypical antipsychotic drugs during pregnancy, he said.

As for pregnant women using lithium, be aware that dehydration at birth can cause lithium toxicity in the infant, he said (Am. J. Psychiatry 2005;162:2162–70).

Switching drugs during the course of pregnancy with the thought that drug B has more safety data than drug A is entering “the world of the unknown,” Dr. Stowe said, “because all the data for medicine B were not derived from babies that first got medicine A. Everything we know about teratology says two medicines are worse than one. And please remember, the later trimesters can be just as important as the first trimester.”

 

 

Given the uncertainties of sexual behavior and the possibility of undetected pregnancy in female patients, “you should treat all women as though they are pregnant, starting at age 9. From 9 to 49, they are pregnant until proven otherwise,” he said.

Regarding the possibility of passing medications to infants during breast-feeding, “the dose in pregnancy is huge compared to the dose in lactation. Worrying about the medicine in lactation, if you used it in pregnancy, is really a waste of time. Our medicines in the bloodstream for antidepressants are nanograms per milliliter; for anticonvulsants they are in micrograms per milliliter. That's what gets into breast milk,” he said.

Dr. Stowe is on advisory boards for Bristol-Myers Squibb Co. and GlaxoSmithKline Inc. He has received grants from GlaxoSmithKline, Pfizer Inc., and Wyeth Pharmaceuticals. He is on the speakers bureaus of Eli Lilly, GlaxoSmithKline, Pfizer, and Wyeth Pharmaceuticals.

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Preterm Birth Tied to Lower Reproduction Rate as Adult

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Preterm Birth Tied to Lower Reproduction Rate as Adult

Men and women who were born preterm have lower reproduction rates than those born at term, and their reproductive success declines in tandem with their gestational age at birth, according to a population-based study of Norwegians.

Women born preterm also are at increased risk of delivering their own infants preterm, Dr. Geeta K. Swamy of Duke University Medical Center, Durham, N.C., and her associates said in the March 26 issue of JAMA.

The investigators used a “comprehensive, detailed, and highly accurate” medical registry of the long-term reproductive success of 1,167,506 people born in Norway from 1967 to 1976. Approximately 5% of cases were preterm and, as expected, infant and childhood mortality were higher in this group. For both men and women, reproduction appeared considerably lower for those born preterm, and appeared to directly increase until about 35 weeks of gestation. Among women born at 22–27 weeks' gestation, 25% subsequently reproduced, compared with 68% of women who had been born at term. Of men born at 22–27 weeks, 14% reproduced, compared with 50% of those born at term.

Women born preterm had a similar “dose-dependent” risk of delivering their own infants preterm. For women born at 22–27 weeks' gestation, the preterm birth rate was 14%; those born at 28–32 weeks had a preterm birth rate slightly higher than 9%, and those born at 33–36 weeks had a rate slightly lower than 9%. Women born at term had a 6% rate of delivering preterm.

Similar patterns were seen for fetal stillbirths and for infant mortality, the investigators said (JAMA 2008;299:1429–36).

Dr. Swamy and her associates speculated that “while biological factors may be at the root of the problem, interrelated social and economic stressors likely also diminish reproductive ability.”

Lingering medical or cognitive problems among survivors of preterm birth may account for difficulties finding a mate. Educational achievement was lower among adults born preterm, but could have resulted directly from preterm birth or more indirectly from being born into “a high-risk social setting with poor parental education and a high rate of unmarried parents,” the researchers said.

In an editorial comment accompanying this report, Dr. Melissa M. Adams and Dr. Wanda D. Barfield of the Centers for Disease Control and Prevention, Atlanta, said the findings “should be interpreted with caution” because “the majority of preterm infants have good health and good reproduction.” On the other hand, reproductive trends in Norway represent “a best-case scenario” given that country's homogeneous population and universal access to health care (JAMA 2008;299:1477–8).

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Men and women who were born preterm have lower reproduction rates than those born at term, and their reproductive success declines in tandem with their gestational age at birth, according to a population-based study of Norwegians.

Women born preterm also are at increased risk of delivering their own infants preterm, Dr. Geeta K. Swamy of Duke University Medical Center, Durham, N.C., and her associates said in the March 26 issue of JAMA.

The investigators used a “comprehensive, detailed, and highly accurate” medical registry of the long-term reproductive success of 1,167,506 people born in Norway from 1967 to 1976. Approximately 5% of cases were preterm and, as expected, infant and childhood mortality were higher in this group. For both men and women, reproduction appeared considerably lower for those born preterm, and appeared to directly increase until about 35 weeks of gestation. Among women born at 22–27 weeks' gestation, 25% subsequently reproduced, compared with 68% of women who had been born at term. Of men born at 22–27 weeks, 14% reproduced, compared with 50% of those born at term.

Women born preterm had a similar “dose-dependent” risk of delivering their own infants preterm. For women born at 22–27 weeks' gestation, the preterm birth rate was 14%; those born at 28–32 weeks had a preterm birth rate slightly higher than 9%, and those born at 33–36 weeks had a rate slightly lower than 9%. Women born at term had a 6% rate of delivering preterm.

Similar patterns were seen for fetal stillbirths and for infant mortality, the investigators said (JAMA 2008;299:1429–36).

Dr. Swamy and her associates speculated that “while biological factors may be at the root of the problem, interrelated social and economic stressors likely also diminish reproductive ability.”

Lingering medical or cognitive problems among survivors of preterm birth may account for difficulties finding a mate. Educational achievement was lower among adults born preterm, but could have resulted directly from preterm birth or more indirectly from being born into “a high-risk social setting with poor parental education and a high rate of unmarried parents,” the researchers said.

In an editorial comment accompanying this report, Dr. Melissa M. Adams and Dr. Wanda D. Barfield of the Centers for Disease Control and Prevention, Atlanta, said the findings “should be interpreted with caution” because “the majority of preterm infants have good health and good reproduction.” On the other hand, reproductive trends in Norway represent “a best-case scenario” given that country's homogeneous population and universal access to health care (JAMA 2008;299:1477–8).

ELSEVIER GLOBAL MEDICAL NEWS

Men and women who were born preterm have lower reproduction rates than those born at term, and their reproductive success declines in tandem with their gestational age at birth, according to a population-based study of Norwegians.

Women born preterm also are at increased risk of delivering their own infants preterm, Dr. Geeta K. Swamy of Duke University Medical Center, Durham, N.C., and her associates said in the March 26 issue of JAMA.

The investigators used a “comprehensive, detailed, and highly accurate” medical registry of the long-term reproductive success of 1,167,506 people born in Norway from 1967 to 1976. Approximately 5% of cases were preterm and, as expected, infant and childhood mortality were higher in this group. For both men and women, reproduction appeared considerably lower for those born preterm, and appeared to directly increase until about 35 weeks of gestation. Among women born at 22–27 weeks' gestation, 25% subsequently reproduced, compared with 68% of women who had been born at term. Of men born at 22–27 weeks, 14% reproduced, compared with 50% of those born at term.

Women born preterm had a similar “dose-dependent” risk of delivering their own infants preterm. For women born at 22–27 weeks' gestation, the preterm birth rate was 14%; those born at 28–32 weeks had a preterm birth rate slightly higher than 9%, and those born at 33–36 weeks had a rate slightly lower than 9%. Women born at term had a 6% rate of delivering preterm.

Similar patterns were seen for fetal stillbirths and for infant mortality, the investigators said (JAMA 2008;299:1429–36).

Dr. Swamy and her associates speculated that “while biological factors may be at the root of the problem, interrelated social and economic stressors likely also diminish reproductive ability.”

Lingering medical or cognitive problems among survivors of preterm birth may account for difficulties finding a mate. Educational achievement was lower among adults born preterm, but could have resulted directly from preterm birth or more indirectly from being born into “a high-risk social setting with poor parental education and a high rate of unmarried parents,” the researchers said.

In an editorial comment accompanying this report, Dr. Melissa M. Adams and Dr. Wanda D. Barfield of the Centers for Disease Control and Prevention, Atlanta, said the findings “should be interpreted with caution” because “the majority of preterm infants have good health and good reproduction.” On the other hand, reproductive trends in Norway represent “a best-case scenario” given that country's homogeneous population and universal access to health care (JAMA 2008;299:1477–8).

ELSEVIER GLOBAL MEDICAL NEWS

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Manual Placenta Removal May Not Up Blood Loss

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DALLAS — Manual removal of the placenta during cesarean delivery did not significantly increase maternal blood loss when compared with spontaneous removal in a prospective, randomized controlled trial of 86 women.

The study's primary outcome of change in hematocrit was not significantly different between the 40 women whose placenta was delivered manually and the 46 women whose placenta was delivered spontaneously (4.4% vs. 4.9%). Mean pre- and postoperative hematocrit levels were 35% and 31% versus 35% and 30%, Dr. Shawana Swann reported at the annual meeting of the Society for Maternal-Fetal Medicine.

In addition, there was no difference in the percentage of patients with a drop in hematocrit of greater than 3% (28% vs. 35%) or greater than 5% (15% vs. 17%), said Dr. Swann of the Medical University of South Carolina in Charleston. None of the women in the study developed endometritis or received blood transfusions during hospitalization.

Placental delivery time was shorter in the manual group with a mean time of 49 seconds versus 71 seconds in the spontaneous group. This was statistically significant, but not clinically significant, as the difference was just 22 seconds, said Dr. Swann, who presented the results on behalf of principal investigator Dr. Eva Pressman of the University of Rochester (N.Y.) and their associates.

The manual and spontaneous groups were similar in terms of age (32 vs. 31 years), parity (1), and median gestational age (39 weeks).

“We believe providers should not base the mode of placental delivery on blood loss considerations for scheduled cesarean deliveries,” Dr. Swann said.

Proponents of manual removal suggest that faster placental removal leads to more rapid closure of the uterine incision and therefore less bleeding from this site.

Those preferring spontaneous separation and controlled cord traction contend that allowing dilated sinuses in the uterine wall to contract prior to placental expulsion decreases bleeding from the placental bed, and that this method is associated with lower rates of infection, she said.

An audience member asked why the findings were different from those of more than a dozen previous trials comparing the two methods of placental removal, including a recent meta-analysis of six randomized trials involving more than 1,700 women (Am. J. Obstet. Gynecol. 2005;193:1607–17).

The investigators who conducted the meta-analysis had reported that a benefit for spontaneous removal was usually found in the few studies that recorded blood loss or changes in hemoglobin/hematocrit level. They concluded that spontaneous removal should be preferred to manual removal, given the significant decrease in endometritis (odds ratio 0.62) demonstrated in the five studies that reported this outcome.

Dr. Swann responded that most studies performed prior to 2002 used estimated blood loss rather than hematocrit levels as the outcomes measure. Limitations of the current study, she said, included not collecting data on body mass index, which may affect blood loss and rates of infection, and the fact that hematocrit levels can be affected by administration of intravenous fluid and extravascular fluid shifts during cesarean delivery.

The study was sponsored by the Medical University of South Carolina and the University of Rochester.

Dr. Swann did not disclose any relevant financial conflicts of interest.

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DALLAS — Manual removal of the placenta during cesarean delivery did not significantly increase maternal blood loss when compared with spontaneous removal in a prospective, randomized controlled trial of 86 women.

The study's primary outcome of change in hematocrit was not significantly different between the 40 women whose placenta was delivered manually and the 46 women whose placenta was delivered spontaneously (4.4% vs. 4.9%). Mean pre- and postoperative hematocrit levels were 35% and 31% versus 35% and 30%, Dr. Shawana Swann reported at the annual meeting of the Society for Maternal-Fetal Medicine.

In addition, there was no difference in the percentage of patients with a drop in hematocrit of greater than 3% (28% vs. 35%) or greater than 5% (15% vs. 17%), said Dr. Swann of the Medical University of South Carolina in Charleston. None of the women in the study developed endometritis or received blood transfusions during hospitalization.

Placental delivery time was shorter in the manual group with a mean time of 49 seconds versus 71 seconds in the spontaneous group. This was statistically significant, but not clinically significant, as the difference was just 22 seconds, said Dr. Swann, who presented the results on behalf of principal investigator Dr. Eva Pressman of the University of Rochester (N.Y.) and their associates.

The manual and spontaneous groups were similar in terms of age (32 vs. 31 years), parity (1), and median gestational age (39 weeks).

“We believe providers should not base the mode of placental delivery on blood loss considerations for scheduled cesarean deliveries,” Dr. Swann said.

Proponents of manual removal suggest that faster placental removal leads to more rapid closure of the uterine incision and therefore less bleeding from this site.

Those preferring spontaneous separation and controlled cord traction contend that allowing dilated sinuses in the uterine wall to contract prior to placental expulsion decreases bleeding from the placental bed, and that this method is associated with lower rates of infection, she said.

An audience member asked why the findings were different from those of more than a dozen previous trials comparing the two methods of placental removal, including a recent meta-analysis of six randomized trials involving more than 1,700 women (Am. J. Obstet. Gynecol. 2005;193:1607–17).

The investigators who conducted the meta-analysis had reported that a benefit for spontaneous removal was usually found in the few studies that recorded blood loss or changes in hemoglobin/hematocrit level. They concluded that spontaneous removal should be preferred to manual removal, given the significant decrease in endometritis (odds ratio 0.62) demonstrated in the five studies that reported this outcome.

Dr. Swann responded that most studies performed prior to 2002 used estimated blood loss rather than hematocrit levels as the outcomes measure. Limitations of the current study, she said, included not collecting data on body mass index, which may affect blood loss and rates of infection, and the fact that hematocrit levels can be affected by administration of intravenous fluid and extravascular fluid shifts during cesarean delivery.

The study was sponsored by the Medical University of South Carolina and the University of Rochester.

Dr. Swann did not disclose any relevant financial conflicts of interest.

DALLAS — Manual removal of the placenta during cesarean delivery did not significantly increase maternal blood loss when compared with spontaneous removal in a prospective, randomized controlled trial of 86 women.

The study's primary outcome of change in hematocrit was not significantly different between the 40 women whose placenta was delivered manually and the 46 women whose placenta was delivered spontaneously (4.4% vs. 4.9%). Mean pre- and postoperative hematocrit levels were 35% and 31% versus 35% and 30%, Dr. Shawana Swann reported at the annual meeting of the Society for Maternal-Fetal Medicine.

In addition, there was no difference in the percentage of patients with a drop in hematocrit of greater than 3% (28% vs. 35%) or greater than 5% (15% vs. 17%), said Dr. Swann of the Medical University of South Carolina in Charleston. None of the women in the study developed endometritis or received blood transfusions during hospitalization.

Placental delivery time was shorter in the manual group with a mean time of 49 seconds versus 71 seconds in the spontaneous group. This was statistically significant, but not clinically significant, as the difference was just 22 seconds, said Dr. Swann, who presented the results on behalf of principal investigator Dr. Eva Pressman of the University of Rochester (N.Y.) and their associates.

The manual and spontaneous groups were similar in terms of age (32 vs. 31 years), parity (1), and median gestational age (39 weeks).

“We believe providers should not base the mode of placental delivery on blood loss considerations for scheduled cesarean deliveries,” Dr. Swann said.

Proponents of manual removal suggest that faster placental removal leads to more rapid closure of the uterine incision and therefore less bleeding from this site.

Those preferring spontaneous separation and controlled cord traction contend that allowing dilated sinuses in the uterine wall to contract prior to placental expulsion decreases bleeding from the placental bed, and that this method is associated with lower rates of infection, she said.

An audience member asked why the findings were different from those of more than a dozen previous trials comparing the two methods of placental removal, including a recent meta-analysis of six randomized trials involving more than 1,700 women (Am. J. Obstet. Gynecol. 2005;193:1607–17).

The investigators who conducted the meta-analysis had reported that a benefit for spontaneous removal was usually found in the few studies that recorded blood loss or changes in hemoglobin/hematocrit level. They concluded that spontaneous removal should be preferred to manual removal, given the significant decrease in endometritis (odds ratio 0.62) demonstrated in the five studies that reported this outcome.

Dr. Swann responded that most studies performed prior to 2002 used estimated blood loss rather than hematocrit levels as the outcomes measure. Limitations of the current study, she said, included not collecting data on body mass index, which may affect blood loss and rates of infection, and the fact that hematocrit levels can be affected by administration of intravenous fluid and extravascular fluid shifts during cesarean delivery.

The study was sponsored by the Medical University of South Carolina and the University of Rochester.

Dr. Swann did not disclose any relevant financial conflicts of interest.

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Breast-Feeding May Protect vs. Type 2 Diabetes

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Breast-fed babies may be protected against developing type 2 diabetes during childhood, regardless of ethnicity, according to results from an adjunct study to the ongoing SEARCH for Diabetes in Youth study.

The dramatic increase in type 2 diabetes in youth has inspired researchers to identify behaviors that might prevent both obesity and type 2 diabetes, wrote Elizabeth J. Mayer-Davis, Ph.D., of the University of South Carolina, Columbia, and her colleagues.

Their case-control study, conducted at two of the SEARCH for Diabetes in Youth study sites, included 80 participants aged 10–21 years with type 2 diabetes and 167 age-matched controls (Diabetes Care 2008;31:470–5).

Overall, the prevalence of breast-feeding for any length of time was significantly lower among youth with type 2 diabetes, compared with controls (31% vs. 64%).

When the study population was divided into three ethnic groups, the prevalence of breast-feeding was lower among black youth with type 2 diabetes than among controls (20% vs. 27%), although this difference was not statistically significant. But the difference remained significant among Hispanics (50% vs. 84%), and among non-Hispanic whites (39% vs. 78%).

The researchers noted previous evidence that a lower prevalence of breast-feeding among blacks, compared with other ethnicities, might be a confounding variable.

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Breast-fed babies may be protected against developing type 2 diabetes during childhood, regardless of ethnicity, according to results from an adjunct study to the ongoing SEARCH for Diabetes in Youth study.

The dramatic increase in type 2 diabetes in youth has inspired researchers to identify behaviors that might prevent both obesity and type 2 diabetes, wrote Elizabeth J. Mayer-Davis, Ph.D., of the University of South Carolina, Columbia, and her colleagues.

Their case-control study, conducted at two of the SEARCH for Diabetes in Youth study sites, included 80 participants aged 10–21 years with type 2 diabetes and 167 age-matched controls (Diabetes Care 2008;31:470–5).

Overall, the prevalence of breast-feeding for any length of time was significantly lower among youth with type 2 diabetes, compared with controls (31% vs. 64%).

When the study population was divided into three ethnic groups, the prevalence of breast-feeding was lower among black youth with type 2 diabetes than among controls (20% vs. 27%), although this difference was not statistically significant. But the difference remained significant among Hispanics (50% vs. 84%), and among non-Hispanic whites (39% vs. 78%).

The researchers noted previous evidence that a lower prevalence of breast-feeding among blacks, compared with other ethnicities, might be a confounding variable.

Breast-fed babies may be protected against developing type 2 diabetes during childhood, regardless of ethnicity, according to results from an adjunct study to the ongoing SEARCH for Diabetes in Youth study.

The dramatic increase in type 2 diabetes in youth has inspired researchers to identify behaviors that might prevent both obesity and type 2 diabetes, wrote Elizabeth J. Mayer-Davis, Ph.D., of the University of South Carolina, Columbia, and her colleagues.

Their case-control study, conducted at two of the SEARCH for Diabetes in Youth study sites, included 80 participants aged 10–21 years with type 2 diabetes and 167 age-matched controls (Diabetes Care 2008;31:470–5).

Overall, the prevalence of breast-feeding for any length of time was significantly lower among youth with type 2 diabetes, compared with controls (31% vs. 64%).

When the study population was divided into three ethnic groups, the prevalence of breast-feeding was lower among black youth with type 2 diabetes than among controls (20% vs. 27%), although this difference was not statistically significant. But the difference remained significant among Hispanics (50% vs. 84%), and among non-Hispanic whites (39% vs. 78%).

The researchers noted previous evidence that a lower prevalence of breast-feeding among blacks, compared with other ethnicities, might be a confounding variable.

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Asthma in Preemies May Be Linked To Chorioamnionitis in Mothers

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PHILADELPHIA — Children born prematurely to mothers who developed chorioamnionitis during pregnancy were about fourfold more likely to develop asthma and wheezing during the first 2 years of life, compared with term infants born to mothers without chorioamnionitis, based on data collected on nearly 1,100 children.

The finding needs to be extended by following the children to an older age and by studying other populations. If the findings are confirmed in such studies, earlier treatment and resolution of chorioamnionitis may have important implications for the future respiratory health of affected children, Dr. Rajesh Kumar said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“A lot of the chorioamnionitis was subclinical. We don't know if treatment will prevent the effect of chorioamnionitis on recurrent wheezing, but this would be an area for future study,” he said in an interview.

“What was surprising was the degree of association that chorioamnionitis had with wheezing and asthma,” whereas no link was seen between prematurity, chorioamnionitis, and food allergy or eczema, said Dr. Kumar, a pediatric allergy and asthma specialist at Children's Memorial Hospital and Northwestern University in Chicago. Atopy does not appear to play a role.

An alternative, physiological explanation is that chorioamnionitis produces a strong, proinflammatory response that boosts levels of various cytokines, such as tumor necrosis factor-α, and interleukin-6 and -8. Cytokines like these may trigger premature birth, and may also lead to chronic respiratory disease in the fetus.

Results from some prior studies had shown a link between prematurity and an increased risk for asthma, but this link was not confirmed in all studies. Prior studies did not consider the underlying pathogenesis that led to premature birth, which may account for the inconsistency, Dr. Kumar said.

His analysis was based on data from children in the Boston Birth Cohort, an ongoing study at Boston Medical Center that began in 1998. Included were 771 term and 325 preterm infants who completed at least one postnatal examination. These numbers make the analysis one of the few prospective studies large enough to allow stratification of the infants in groups according to the severity of prematurity and the presence of chorioamnionitis, he noted. The average age of the children at their last follow-up visit was 2.2 years.

The analysis adjusted for several infant and maternal variables, including breast-feeding, postnatal passive smoking, maternal smoking during pregnancy, and maternal educational status. Infants born at less than 33 weeks' gestation to mothers who had chorioamnionitis were 4.0-fold more likely to wheeze and 4.4-fold more likely to have asthma, compared with infants born at 37 weeks or beyond to mothers without chorioamnionitis. (See graph.) Both differences were highly statistically significant. In contrast, infants born before 33 weeks to mothers without chorioamnionitis were 2.7-fold more likely to wheeze (a significant difference), but were no more likely to have asthma than were term infants.

“One of the major issues in our study was that our primary outcome was recurrent wheezing of early childhood. We also evaluated physician-diagnosed asthma, but this is a bit less clear of a diagnosis at a young age. We will continue to follow these children [until] they are 6 years of age to see if the effects of chorioamnionitis on physician-diagnosed asthma will truly equate to persistent asthma by the time the children are older,” Dr. Kumar said.

The associations were even stronger in infants born to African American mothers, about 62% of the study cohort. In this subgroup, infants born at less than 33 weeks to mothers with chorioamnionitis were 5.4-fold more likely to have wheezing and 5.2-fold more likely to have asthma than infants born at term to black mothers without chorioamnionitis. Both differences were highly significant. Again, infants born at less than 33 weeks to mothers without chorioamnionitis were 3.8-fold more likely to wheeze, but did not have a significantly increased risk for developing asthma.

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PHILADELPHIA — Children born prematurely to mothers who developed chorioamnionitis during pregnancy were about fourfold more likely to develop asthma and wheezing during the first 2 years of life, compared with term infants born to mothers without chorioamnionitis, based on data collected on nearly 1,100 children.

The finding needs to be extended by following the children to an older age and by studying other populations. If the findings are confirmed in such studies, earlier treatment and resolution of chorioamnionitis may have important implications for the future respiratory health of affected children, Dr. Rajesh Kumar said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“A lot of the chorioamnionitis was subclinical. We don't know if treatment will prevent the effect of chorioamnionitis on recurrent wheezing, but this would be an area for future study,” he said in an interview.

“What was surprising was the degree of association that chorioamnionitis had with wheezing and asthma,” whereas no link was seen between prematurity, chorioamnionitis, and food allergy or eczema, said Dr. Kumar, a pediatric allergy and asthma specialist at Children's Memorial Hospital and Northwestern University in Chicago. Atopy does not appear to play a role.

An alternative, physiological explanation is that chorioamnionitis produces a strong, proinflammatory response that boosts levels of various cytokines, such as tumor necrosis factor-α, and interleukin-6 and -8. Cytokines like these may trigger premature birth, and may also lead to chronic respiratory disease in the fetus.

Results from some prior studies had shown a link between prematurity and an increased risk for asthma, but this link was not confirmed in all studies. Prior studies did not consider the underlying pathogenesis that led to premature birth, which may account for the inconsistency, Dr. Kumar said.

His analysis was based on data from children in the Boston Birth Cohort, an ongoing study at Boston Medical Center that began in 1998. Included were 771 term and 325 preterm infants who completed at least one postnatal examination. These numbers make the analysis one of the few prospective studies large enough to allow stratification of the infants in groups according to the severity of prematurity and the presence of chorioamnionitis, he noted. The average age of the children at their last follow-up visit was 2.2 years.

The analysis adjusted for several infant and maternal variables, including breast-feeding, postnatal passive smoking, maternal smoking during pregnancy, and maternal educational status. Infants born at less than 33 weeks' gestation to mothers who had chorioamnionitis were 4.0-fold more likely to wheeze and 4.4-fold more likely to have asthma, compared with infants born at 37 weeks or beyond to mothers without chorioamnionitis. (See graph.) Both differences were highly statistically significant. In contrast, infants born before 33 weeks to mothers without chorioamnionitis were 2.7-fold more likely to wheeze (a significant difference), but were no more likely to have asthma than were term infants.

“One of the major issues in our study was that our primary outcome was recurrent wheezing of early childhood. We also evaluated physician-diagnosed asthma, but this is a bit less clear of a diagnosis at a young age. We will continue to follow these children [until] they are 6 years of age to see if the effects of chorioamnionitis on physician-diagnosed asthma will truly equate to persistent asthma by the time the children are older,” Dr. Kumar said.

The associations were even stronger in infants born to African American mothers, about 62% of the study cohort. In this subgroup, infants born at less than 33 weeks to mothers with chorioamnionitis were 5.4-fold more likely to have wheezing and 5.2-fold more likely to have asthma than infants born at term to black mothers without chorioamnionitis. Both differences were highly significant. Again, infants born at less than 33 weeks to mothers without chorioamnionitis were 3.8-fold more likely to wheeze, but did not have a significantly increased risk for developing asthma.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Children born prematurely to mothers who developed chorioamnionitis during pregnancy were about fourfold more likely to develop asthma and wheezing during the first 2 years of life, compared with term infants born to mothers without chorioamnionitis, based on data collected on nearly 1,100 children.

The finding needs to be extended by following the children to an older age and by studying other populations. If the findings are confirmed in such studies, earlier treatment and resolution of chorioamnionitis may have important implications for the future respiratory health of affected children, Dr. Rajesh Kumar said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“A lot of the chorioamnionitis was subclinical. We don't know if treatment will prevent the effect of chorioamnionitis on recurrent wheezing, but this would be an area for future study,” he said in an interview.

“What was surprising was the degree of association that chorioamnionitis had with wheezing and asthma,” whereas no link was seen between prematurity, chorioamnionitis, and food allergy or eczema, said Dr. Kumar, a pediatric allergy and asthma specialist at Children's Memorial Hospital and Northwestern University in Chicago. Atopy does not appear to play a role.

An alternative, physiological explanation is that chorioamnionitis produces a strong, proinflammatory response that boosts levels of various cytokines, such as tumor necrosis factor-α, and interleukin-6 and -8. Cytokines like these may trigger premature birth, and may also lead to chronic respiratory disease in the fetus.

Results from some prior studies had shown a link between prematurity and an increased risk for asthma, but this link was not confirmed in all studies. Prior studies did not consider the underlying pathogenesis that led to premature birth, which may account for the inconsistency, Dr. Kumar said.

His analysis was based on data from children in the Boston Birth Cohort, an ongoing study at Boston Medical Center that began in 1998. Included were 771 term and 325 preterm infants who completed at least one postnatal examination. These numbers make the analysis one of the few prospective studies large enough to allow stratification of the infants in groups according to the severity of prematurity and the presence of chorioamnionitis, he noted. The average age of the children at their last follow-up visit was 2.2 years.

The analysis adjusted for several infant and maternal variables, including breast-feeding, postnatal passive smoking, maternal smoking during pregnancy, and maternal educational status. Infants born at less than 33 weeks' gestation to mothers who had chorioamnionitis were 4.0-fold more likely to wheeze and 4.4-fold more likely to have asthma, compared with infants born at 37 weeks or beyond to mothers without chorioamnionitis. (See graph.) Both differences were highly statistically significant. In contrast, infants born before 33 weeks to mothers without chorioamnionitis were 2.7-fold more likely to wheeze (a significant difference), but were no more likely to have asthma than were term infants.

“One of the major issues in our study was that our primary outcome was recurrent wheezing of early childhood. We also evaluated physician-diagnosed asthma, but this is a bit less clear of a diagnosis at a young age. We will continue to follow these children [until] they are 6 years of age to see if the effects of chorioamnionitis on physician-diagnosed asthma will truly equate to persistent asthma by the time the children are older,” Dr. Kumar said.

The associations were even stronger in infants born to African American mothers, about 62% of the study cohort. In this subgroup, infants born at less than 33 weeks to mothers with chorioamnionitis were 5.4-fold more likely to have wheezing and 5.2-fold more likely to have asthma than infants born at term to black mothers without chorioamnionitis. Both differences were highly significant. Again, infants born at less than 33 weeks to mothers without chorioamnionitis were 3.8-fold more likely to wheeze, but did not have a significantly increased risk for developing asthma.

ELSEVIER GLOBAL MEDICAL NEWS

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Intergenerational Link Found in Breech Delivery

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Men and women who were delivered in breech presentation have more than twice the risk of having their firstborn children delivered in breech position, according to a study published online in BMJ.

A population-based study by researchers at the University of Bergen, Norway, found the intergenerational recurrence risk of breech delivery in offspring was equally high when transmitted through fathers and mothers.

Tone Irene Nordtveit, a Ph.D. student, and colleagues cited genetic inheritance predominantly through the fetus as a factor in the observed pattern of familial predisposition to breech delivery at term. Breech delivery is associated with significantly increased perinatal mortality and morbidity (BMJ 2008 [doi:10.1136/bmj.39505.436539.BE]).

The data were taken from the Medical Birth Registry of Norway, including all births reported from 1967 to 2004. In Norway, all live births and stillbirths of at least 16 weeks' gestation are registered, for a total of 2.2 million births.

Several factors are associated with an increased risk of breech delivery, such as older mother, first baby, and low gestational age and birth weight. But these account for one in seven of all breech births, according to the study. The researchers said the current findings are important because there are no data that show whether genes also could be a factor in breech delivery.

“A considerable number of breech presentations are not detected before labor, despite careful antenatal surveillance,” Ms. Nordtveit said in an interview. The proportion of undiagnosed breech deliveries at admission to hospital has been reported to be as high as 31%. “To avoid undiagnosed breech deliveries, information about the mother's and the father's own presentation at birth will be valuable in the evaluation of fetal presentation in the third trimester.”

The researchers linked the birth records of mothers and fathers by national identification numbers to birth records of their offspring, providing 451,393 generation files on mothers and their offspring and 295,253 records of fathers and their offspring. All births delivered in breech position were considered breech delivery, regardless of whether they involved elective or emergency cesarean section.

The researchers then excluded multiple pregnancies and infants who weighed less than 500 g in both generations and restricted the study to firstborn offspring in the second generation. As a result, the study had 232,704 mother-offspring units and 154,851 father-offspring units. All of the mothers and fathers were born during 1967–1986, and 98% of the second generation was born during 1987–2004. The proportion of breech births was 2.5% in 1967–1976, 3.0% in 1977–1986, 3.2% in 1987–1996, and 3.5% in 1997–2004.

Among 318,855 males and 301,438 females who were born in 1967–1976, 96.8% and 97.6%, respectively, lived to age 18 years. The mortality in those delivered in breech position was four times the mortality of those delivered in the cephalic presentation.

The highest risk of recurrence of breech delivery was seen in babies of firstborn men and women who themselves were delivered in breech position at term, with an odds ratio of 2.2.

The strongest risks were found for vaginally delivered offspring and were equally strong for men and women. There was no recurrence between generations for men and women born preterm. The prevalence of breech presentation is 15% at 29–32 weeks' gestation and 3%–4% at term.

Men delivered in breech presentation seem to carry genes predisposing to breech delivery that are transferred to their offspring, increasing their partners' risk of breech deliveries. Fetal genes also can be transmitted from women delivered in breech, according to the study.

The researchers said they had no conflict to report.

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Men and women who were delivered in breech presentation have more than twice the risk of having their firstborn children delivered in breech position, according to a study published online in BMJ.

A population-based study by researchers at the University of Bergen, Norway, found the intergenerational recurrence risk of breech delivery in offspring was equally high when transmitted through fathers and mothers.

Tone Irene Nordtveit, a Ph.D. student, and colleagues cited genetic inheritance predominantly through the fetus as a factor in the observed pattern of familial predisposition to breech delivery at term. Breech delivery is associated with significantly increased perinatal mortality and morbidity (BMJ 2008 [doi:10.1136/bmj.39505.436539.BE]).

The data were taken from the Medical Birth Registry of Norway, including all births reported from 1967 to 2004. In Norway, all live births and stillbirths of at least 16 weeks' gestation are registered, for a total of 2.2 million births.

Several factors are associated with an increased risk of breech delivery, such as older mother, first baby, and low gestational age and birth weight. But these account for one in seven of all breech births, according to the study. The researchers said the current findings are important because there are no data that show whether genes also could be a factor in breech delivery.

“A considerable number of breech presentations are not detected before labor, despite careful antenatal surveillance,” Ms. Nordtveit said in an interview. The proportion of undiagnosed breech deliveries at admission to hospital has been reported to be as high as 31%. “To avoid undiagnosed breech deliveries, information about the mother's and the father's own presentation at birth will be valuable in the evaluation of fetal presentation in the third trimester.”

The researchers linked the birth records of mothers and fathers by national identification numbers to birth records of their offspring, providing 451,393 generation files on mothers and their offspring and 295,253 records of fathers and their offspring. All births delivered in breech position were considered breech delivery, regardless of whether they involved elective or emergency cesarean section.

The researchers then excluded multiple pregnancies and infants who weighed less than 500 g in both generations and restricted the study to firstborn offspring in the second generation. As a result, the study had 232,704 mother-offspring units and 154,851 father-offspring units. All of the mothers and fathers were born during 1967–1986, and 98% of the second generation was born during 1987–2004. The proportion of breech births was 2.5% in 1967–1976, 3.0% in 1977–1986, 3.2% in 1987–1996, and 3.5% in 1997–2004.

Among 318,855 males and 301,438 females who were born in 1967–1976, 96.8% and 97.6%, respectively, lived to age 18 years. The mortality in those delivered in breech position was four times the mortality of those delivered in the cephalic presentation.

The highest risk of recurrence of breech delivery was seen in babies of firstborn men and women who themselves were delivered in breech position at term, with an odds ratio of 2.2.

The strongest risks were found for vaginally delivered offspring and were equally strong for men and women. There was no recurrence between generations for men and women born preterm. The prevalence of breech presentation is 15% at 29–32 weeks' gestation and 3%–4% at term.

Men delivered in breech presentation seem to carry genes predisposing to breech delivery that are transferred to their offspring, increasing their partners' risk of breech deliveries. Fetal genes also can be transmitted from women delivered in breech, according to the study.

The researchers said they had no conflict to report.

Men and women who were delivered in breech presentation have more than twice the risk of having their firstborn children delivered in breech position, according to a study published online in BMJ.

A population-based study by researchers at the University of Bergen, Norway, found the intergenerational recurrence risk of breech delivery in offspring was equally high when transmitted through fathers and mothers.

Tone Irene Nordtveit, a Ph.D. student, and colleagues cited genetic inheritance predominantly through the fetus as a factor in the observed pattern of familial predisposition to breech delivery at term. Breech delivery is associated with significantly increased perinatal mortality and morbidity (BMJ 2008 [doi:10.1136/bmj.39505.436539.BE]).

The data were taken from the Medical Birth Registry of Norway, including all births reported from 1967 to 2004. In Norway, all live births and stillbirths of at least 16 weeks' gestation are registered, for a total of 2.2 million births.

Several factors are associated with an increased risk of breech delivery, such as older mother, first baby, and low gestational age and birth weight. But these account for one in seven of all breech births, according to the study. The researchers said the current findings are important because there are no data that show whether genes also could be a factor in breech delivery.

“A considerable number of breech presentations are not detected before labor, despite careful antenatal surveillance,” Ms. Nordtveit said in an interview. The proportion of undiagnosed breech deliveries at admission to hospital has been reported to be as high as 31%. “To avoid undiagnosed breech deliveries, information about the mother's and the father's own presentation at birth will be valuable in the evaluation of fetal presentation in the third trimester.”

The researchers linked the birth records of mothers and fathers by national identification numbers to birth records of their offspring, providing 451,393 generation files on mothers and their offspring and 295,253 records of fathers and their offspring. All births delivered in breech position were considered breech delivery, regardless of whether they involved elective or emergency cesarean section.

The researchers then excluded multiple pregnancies and infants who weighed less than 500 g in both generations and restricted the study to firstborn offspring in the second generation. As a result, the study had 232,704 mother-offspring units and 154,851 father-offspring units. All of the mothers and fathers were born during 1967–1986, and 98% of the second generation was born during 1987–2004. The proportion of breech births was 2.5% in 1967–1976, 3.0% in 1977–1986, 3.2% in 1987–1996, and 3.5% in 1997–2004.

Among 318,855 males and 301,438 females who were born in 1967–1976, 96.8% and 97.6%, respectively, lived to age 18 years. The mortality in those delivered in breech position was four times the mortality of those delivered in the cephalic presentation.

The highest risk of recurrence of breech delivery was seen in babies of firstborn men and women who themselves were delivered in breech position at term, with an odds ratio of 2.2.

The strongest risks were found for vaginally delivered offspring and were equally strong for men and women. There was no recurrence between generations for men and women born preterm. The prevalence of breech presentation is 15% at 29–32 weeks' gestation and 3%–4% at term.

Men delivered in breech presentation seem to carry genes predisposing to breech delivery that are transferred to their offspring, increasing their partners' risk of breech deliveries. Fetal genes also can be transmitted from women delivered in breech, according to the study.

The researchers said they had no conflict to report.

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Mid-Pregnancy Cervix Length May Predict Risk of C-Section

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In primiparous women, cervical length at 22–24 weeks' gestation predicts the need for emergency cesarean delivery during labor at term, according to a study of data from more than 27,000 women at hospitals in England.

A long cervix (40–67 mm) at mid-pregnancy was associated with a high risk of intrapartum cesarean delivery at term because of failure of labor to progress, and this risk declined with a decreasing length of the cervix.

“We hypothesize that poor progress during labor at term is determined by the development of the uterus at much earlier stages of pregnancy,” Dr. Gordon C. S. Smith of Cambridge University (U.K.) and his associates wrote in the New England Journal of Medicine.

Animal studies have suggested that preparation of the uterus for labor begins at relatively early stages of gestation.

To explore this issue in humans, Dr. Smith and his coinvestigators conducted a secondary analysis of data collected in a large multicenter study of pregnancy interventions.

That study, which was conducted at eight hospitals in and around London between 1998 and 2006, had included data from transvaginal ultrasound assessment of cervical length at a median of 23 weeks' gestation in 27,472 primiparous women.

A total of 5,542 of the women went on to require cesarean section, almost always because their labor failed to progress.

The rate of caesarean delivery was lowest (16%) among women with a cervical length in the lowest quartile at mid-pregnancy.

The rate of cesarean delivery rose significantly among women in the second quartile (18%), rose significantly again among women in the third quartile (22%), and rose significantly again among women in the highest quartile (26%) of cervical length.

“Rates of cesarean delivery started to rise at a cervical length of 25 mm and plateaued at a cervical length of 50 mm, approximately doubling across the range of observed values,” Dr. Smith and his associates reported (N. Engl. J. Med. 2008;358:1346–53).

“Adjustment for a range of characteristics (maternal age, body mass index, smoking status, race or ethnic group, gestational age at birth, spontaneous or induced labor, birth weight percentile, and hospital of delivery) slightly attenuated but did not eliminate the significant association between cervical length and risk of cesarean delivery at term,” the researchers concluded.

Further study is needed to investigate the possibility that a long cervix in mid-pregnancy may signal dysfunctional development of the uterus, “which is ultimately manifested in the need for cesarean delivery at term,” Dr. Smith and his associates said.

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In primiparous women, cervical length at 22–24 weeks' gestation predicts the need for emergency cesarean delivery during labor at term, according to a study of data from more than 27,000 women at hospitals in England.

A long cervix (40–67 mm) at mid-pregnancy was associated with a high risk of intrapartum cesarean delivery at term because of failure of labor to progress, and this risk declined with a decreasing length of the cervix.

“We hypothesize that poor progress during labor at term is determined by the development of the uterus at much earlier stages of pregnancy,” Dr. Gordon C. S. Smith of Cambridge University (U.K.) and his associates wrote in the New England Journal of Medicine.

Animal studies have suggested that preparation of the uterus for labor begins at relatively early stages of gestation.

To explore this issue in humans, Dr. Smith and his coinvestigators conducted a secondary analysis of data collected in a large multicenter study of pregnancy interventions.

That study, which was conducted at eight hospitals in and around London between 1998 and 2006, had included data from transvaginal ultrasound assessment of cervical length at a median of 23 weeks' gestation in 27,472 primiparous women.

A total of 5,542 of the women went on to require cesarean section, almost always because their labor failed to progress.

The rate of caesarean delivery was lowest (16%) among women with a cervical length in the lowest quartile at mid-pregnancy.

The rate of cesarean delivery rose significantly among women in the second quartile (18%), rose significantly again among women in the third quartile (22%), and rose significantly again among women in the highest quartile (26%) of cervical length.

“Rates of cesarean delivery started to rise at a cervical length of 25 mm and plateaued at a cervical length of 50 mm, approximately doubling across the range of observed values,” Dr. Smith and his associates reported (N. Engl. J. Med. 2008;358:1346–53).

“Adjustment for a range of characteristics (maternal age, body mass index, smoking status, race or ethnic group, gestational age at birth, spontaneous or induced labor, birth weight percentile, and hospital of delivery) slightly attenuated but did not eliminate the significant association between cervical length and risk of cesarean delivery at term,” the researchers concluded.

Further study is needed to investigate the possibility that a long cervix in mid-pregnancy may signal dysfunctional development of the uterus, “which is ultimately manifested in the need for cesarean delivery at term,” Dr. Smith and his associates said.

In primiparous women, cervical length at 22–24 weeks' gestation predicts the need for emergency cesarean delivery during labor at term, according to a study of data from more than 27,000 women at hospitals in England.

A long cervix (40–67 mm) at mid-pregnancy was associated with a high risk of intrapartum cesarean delivery at term because of failure of labor to progress, and this risk declined with a decreasing length of the cervix.

“We hypothesize that poor progress during labor at term is determined by the development of the uterus at much earlier stages of pregnancy,” Dr. Gordon C. S. Smith of Cambridge University (U.K.) and his associates wrote in the New England Journal of Medicine.

Animal studies have suggested that preparation of the uterus for labor begins at relatively early stages of gestation.

To explore this issue in humans, Dr. Smith and his coinvestigators conducted a secondary analysis of data collected in a large multicenter study of pregnancy interventions.

That study, which was conducted at eight hospitals in and around London between 1998 and 2006, had included data from transvaginal ultrasound assessment of cervical length at a median of 23 weeks' gestation in 27,472 primiparous women.

A total of 5,542 of the women went on to require cesarean section, almost always because their labor failed to progress.

The rate of caesarean delivery was lowest (16%) among women with a cervical length in the lowest quartile at mid-pregnancy.

The rate of cesarean delivery rose significantly among women in the second quartile (18%), rose significantly again among women in the third quartile (22%), and rose significantly again among women in the highest quartile (26%) of cervical length.

“Rates of cesarean delivery started to rise at a cervical length of 25 mm and plateaued at a cervical length of 50 mm, approximately doubling across the range of observed values,” Dr. Smith and his associates reported (N. Engl. J. Med. 2008;358:1346–53).

“Adjustment for a range of characteristics (maternal age, body mass index, smoking status, race or ethnic group, gestational age at birth, spontaneous or induced labor, birth weight percentile, and hospital of delivery) slightly attenuated but did not eliminate the significant association between cervical length and risk of cesarean delivery at term,” the researchers concluded.

Further study is needed to investigate the possibility that a long cervix in mid-pregnancy may signal dysfunctional development of the uterus, “which is ultimately manifested in the need for cesarean delivery at term,” Dr. Smith and his associates said.

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Teamwork Cuts Obstetric Adverse Events by Half

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DALLAS — A comprehensive patient-safety strategy cut obstetric adverse events in half and lowered malpractice costs by nearly 40% at the Yale-New Haven Hospital.

The composite rate of adverse events in the obstetrics and gynecology department was 3% in October 2004 when the project started but decreased to 1.5% by February 2007, Dr. Edmund Funai said at the annual meeting of the Society for Maternal-Fetal Medicine. The difference was significant.

In the summer of 2004, only 15% of nurses and 40% of physicians reported that teamwork was high in the department, whereas 75% of both groups felt that teamwork was high in the department in the fall of 2006.

Malpractice premiums dropped significantly from a high of $95,000 per year in 2003 to a low of $53,000 in 2007.

“Granted this is a very complex marker, which is subject to the vagaries of the local legal climate; however, if I showed you a similar slide that reported new [malpractice] cases in each year, you'd see a similar trend,” said Dr. Funai of the department of obstetrics, gynecology, and reproductive services, Yale University, New Haven, Conn.

The initiative included these primary components:

▸ An independent review of the service.

▸ Creation of a dedicated patient-safety nurse position with duties such as anonymous adverse event reporting.

▸ Appraisal of teamwork using a safety-attitude questionnaire.

▸ Protocol-based standardization of 34 common procedures, such as administration of oxytocin.

▸ Mandatory team training for all staff.

▸ Adoption of National Institute of Child Health and Human Development terminology for interpretation of fetal heart-rate monitoring, culminating in a national certification exam.

▸ Multidisciplinary oversight by a department-based patient safety committee on 14 individual outcomes such as 5-minute Apgar less than 7, fetal birth injury, and unexpected NICU admission.

Dr. Funai pointed out that adverse events occur in roughly 3% of all hospital admissions, with 50% thought to be preventable errors and 10%–14% of errors resulting in death.

Institutions put barriers in place to prevent these errors, but inevitably holes in the system occur.

“When an adverse event occurs, it is rarely the fault of the individual, but a breakdown of the system, and this is why it is crucial to move from a culture of blame to a culture of safety,” he said.

Audience reaction to the presentation was strong, with some members lauding the results and others questioning whether the findings of the observational study are generalizable. Some questioned whether the findings could be attributed to greater attention to quality rather than to the patient-safety strategy.

“I do agree there is certainly a Hawthorne effect because we were focused on quality and talking about it,” said Dr. Funai, who reported that he had no financial conflicts of interest or funding sources for the study.

He acknowledged there might be issues of generalizability.

Yale University is a large academic institution with substantial resources that were able to support the cost of the patient-safety nurse at a yearly salary of $125,000 plus fringe benefits, the safety-attitude questionnaire, and the fetal monitoring certification process, and other institutions might not have such resources available to them, he said.

The study was limited by its uncontrolled observational design—raising questions of causation versus association, the inability to assess the effect of individual interventions, and the possibility that undocumented improvements in communication and oversight as well as outside factors might have affected outcomes, Dr. Funai said.

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DALLAS — A comprehensive patient-safety strategy cut obstetric adverse events in half and lowered malpractice costs by nearly 40% at the Yale-New Haven Hospital.

The composite rate of adverse events in the obstetrics and gynecology department was 3% in October 2004 when the project started but decreased to 1.5% by February 2007, Dr. Edmund Funai said at the annual meeting of the Society for Maternal-Fetal Medicine. The difference was significant.

In the summer of 2004, only 15% of nurses and 40% of physicians reported that teamwork was high in the department, whereas 75% of both groups felt that teamwork was high in the department in the fall of 2006.

Malpractice premiums dropped significantly from a high of $95,000 per year in 2003 to a low of $53,000 in 2007.

“Granted this is a very complex marker, which is subject to the vagaries of the local legal climate; however, if I showed you a similar slide that reported new [malpractice] cases in each year, you'd see a similar trend,” said Dr. Funai of the department of obstetrics, gynecology, and reproductive services, Yale University, New Haven, Conn.

The initiative included these primary components:

▸ An independent review of the service.

▸ Creation of a dedicated patient-safety nurse position with duties such as anonymous adverse event reporting.

▸ Appraisal of teamwork using a safety-attitude questionnaire.

▸ Protocol-based standardization of 34 common procedures, such as administration of oxytocin.

▸ Mandatory team training for all staff.

▸ Adoption of National Institute of Child Health and Human Development terminology for interpretation of fetal heart-rate monitoring, culminating in a national certification exam.

▸ Multidisciplinary oversight by a department-based patient safety committee on 14 individual outcomes such as 5-minute Apgar less than 7, fetal birth injury, and unexpected NICU admission.

Dr. Funai pointed out that adverse events occur in roughly 3% of all hospital admissions, with 50% thought to be preventable errors and 10%–14% of errors resulting in death.

Institutions put barriers in place to prevent these errors, but inevitably holes in the system occur.

“When an adverse event occurs, it is rarely the fault of the individual, but a breakdown of the system, and this is why it is crucial to move from a culture of blame to a culture of safety,” he said.

Audience reaction to the presentation was strong, with some members lauding the results and others questioning whether the findings of the observational study are generalizable. Some questioned whether the findings could be attributed to greater attention to quality rather than to the patient-safety strategy.

“I do agree there is certainly a Hawthorne effect because we were focused on quality and talking about it,” said Dr. Funai, who reported that he had no financial conflicts of interest or funding sources for the study.

He acknowledged there might be issues of generalizability.

Yale University is a large academic institution with substantial resources that were able to support the cost of the patient-safety nurse at a yearly salary of $125,000 plus fringe benefits, the safety-attitude questionnaire, and the fetal monitoring certification process, and other institutions might not have such resources available to them, he said.

The study was limited by its uncontrolled observational design—raising questions of causation versus association, the inability to assess the effect of individual interventions, and the possibility that undocumented improvements in communication and oversight as well as outside factors might have affected outcomes, Dr. Funai said.

DALLAS — A comprehensive patient-safety strategy cut obstetric adverse events in half and lowered malpractice costs by nearly 40% at the Yale-New Haven Hospital.

The composite rate of adverse events in the obstetrics and gynecology department was 3% in October 2004 when the project started but decreased to 1.5% by February 2007, Dr. Edmund Funai said at the annual meeting of the Society for Maternal-Fetal Medicine. The difference was significant.

In the summer of 2004, only 15% of nurses and 40% of physicians reported that teamwork was high in the department, whereas 75% of both groups felt that teamwork was high in the department in the fall of 2006.

Malpractice premiums dropped significantly from a high of $95,000 per year in 2003 to a low of $53,000 in 2007.

“Granted this is a very complex marker, which is subject to the vagaries of the local legal climate; however, if I showed you a similar slide that reported new [malpractice] cases in each year, you'd see a similar trend,” said Dr. Funai of the department of obstetrics, gynecology, and reproductive services, Yale University, New Haven, Conn.

The initiative included these primary components:

▸ An independent review of the service.

▸ Creation of a dedicated patient-safety nurse position with duties such as anonymous adverse event reporting.

▸ Appraisal of teamwork using a safety-attitude questionnaire.

▸ Protocol-based standardization of 34 common procedures, such as administration of oxytocin.

▸ Mandatory team training for all staff.

▸ Adoption of National Institute of Child Health and Human Development terminology for interpretation of fetal heart-rate monitoring, culminating in a national certification exam.

▸ Multidisciplinary oversight by a department-based patient safety committee on 14 individual outcomes such as 5-minute Apgar less than 7, fetal birth injury, and unexpected NICU admission.

Dr. Funai pointed out that adverse events occur in roughly 3% of all hospital admissions, with 50% thought to be preventable errors and 10%–14% of errors resulting in death.

Institutions put barriers in place to prevent these errors, but inevitably holes in the system occur.

“When an adverse event occurs, it is rarely the fault of the individual, but a breakdown of the system, and this is why it is crucial to move from a culture of blame to a culture of safety,” he said.

Audience reaction to the presentation was strong, with some members lauding the results and others questioning whether the findings of the observational study are generalizable. Some questioned whether the findings could be attributed to greater attention to quality rather than to the patient-safety strategy.

“I do agree there is certainly a Hawthorne effect because we were focused on quality and talking about it,” said Dr. Funai, who reported that he had no financial conflicts of interest or funding sources for the study.

He acknowledged there might be issues of generalizability.

Yale University is a large academic institution with substantial resources that were able to support the cost of the patient-safety nurse at a yearly salary of $125,000 plus fringe benefits, the safety-attitude questionnaire, and the fetal monitoring certification process, and other institutions might not have such resources available to them, he said.

The study was limited by its uncontrolled observational design—raising questions of causation versus association, the inability to assess the effect of individual interventions, and the possibility that undocumented improvements in communication and oversight as well as outside factors might have affected outcomes, Dr. Funai said.

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Combined Tests Improve Delivery Timing in IUGR

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DALLAS — The combination of biophysical and venous Doppler ultrasound parameters provided better timing of deliveries than did either test alone in a study of 584 fetuses with fetal growth restriction.

The prospective, multicenter observational study evaluated umbilical artery, ductus venosus and umbilical vein Doppler flows, and biophysical parameters as predictors of stillbirth, acidemia (cord artery pH less than 7.0 and/or a base deficit of more than 12), neonatal morbidity (intraventricular hemorrhage above grade 2, bronchopulmonary dysplasia, and necrotizing colitis), and neonatal mortality.

All outcomes increased significantly with umbilical artery reversal, abnormal ductus venosus and umbilical vein Doppler, and abnormal biophysical parameters, Dr. Ahmet Baschat and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

For all outcomes, combining the two testing modalities improved prediction. The sensitivity to predict stillbirth was 81% for an abnormal Doppler, 70% for abnormal biophysical parameters, and 89% when both tests were used.

Similar improvements in sensitivity were observed with combined testing for acidemia (71% for abnormal Doppler, 63% for abnormal biophysical parameters, 88% for both); neonatal morbidity (53% for abnormal Doppler, 42% for abnormal biophysical parameters, 73% for both); and neonatal death within the first 28 days of life (74% for abnormal Doppler, 55% for abnormal biophysical parameters, 94% for both).

A total of 1,722 exams were performed on 584 fetuses at six centers in the United States, United Kingdom, and Germany. Fetal growth restriction was defined by a combination of abdominal circumference below the 5th percentile and more than a 2-standard-deviation elevation of the umbilical artery pulsatility index. Biophysical risk factors included gestational age, fetal movement, tone, breathing activity, heart rate, and amniotic fluid volume.

The average gestational age at birth was 32 weeks (range 24–41 weeks), the average birth weight was 1,190 g (390–2,100 g), and 452 babies were delivered by cesarean section. There were 38 stillbirths, 48 cases of acidemia, 97 neonatal morbidities, and 32 deaths.

The addition of Doppler correctly predicted 10 of 10 unexpected stillbirths that occurred within 1 week of being identified as normal by biophysical risk factors, and 23 of 97 neonatal morbidities after equivocal or abnormal biophysical findings, said Dr. Baschat of the University of Maryland, Baltimore. The addition of Doppler predicted 11 additional cases of acidemia, and 12 additional neonatal deaths.

Using abnormal biophysical parameters alone, 19 stillbirths and 18 cases of acidemia were prevented.

Absent ductus venosus atrial systole (a-wave), umbilical vein pulsations, loss of movement, and oligohydramnios were the strongest predictors of stillbirth and acidemia. When these biophysical variables were absent, Doppler changes had no further impact.

Doppler and biophysical parameters did not completely predict neonatal mortality and morbidity risks, as these depend on gestational age, said Dr. Baschat, who received no funding for the study and disclosed no conflicts of interest.

It is too early to say if integrated fetal testing should become the standard for determining delivery timing in intrauterine growth restriction (IUGR), although the University of Maryland Medical Center has been using the method for the past 7 years, Dr. Baschat said in an interview.

“These observational data lay the foundation for a randomized trial of delivery timing in IUGR,” he said, adding that an IUGR research consortium, coordinated through the University of Maryland, is developing a protocol for a management trial.

'These observational data lay the foundation for a randomized trial of delivery timing in IUGR.' DR. BASCHAT

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DALLAS — The combination of biophysical and venous Doppler ultrasound parameters provided better timing of deliveries than did either test alone in a study of 584 fetuses with fetal growth restriction.

The prospective, multicenter observational study evaluated umbilical artery, ductus venosus and umbilical vein Doppler flows, and biophysical parameters as predictors of stillbirth, acidemia (cord artery pH less than 7.0 and/or a base deficit of more than 12), neonatal morbidity (intraventricular hemorrhage above grade 2, bronchopulmonary dysplasia, and necrotizing colitis), and neonatal mortality.

All outcomes increased significantly with umbilical artery reversal, abnormal ductus venosus and umbilical vein Doppler, and abnormal biophysical parameters, Dr. Ahmet Baschat and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

For all outcomes, combining the two testing modalities improved prediction. The sensitivity to predict stillbirth was 81% for an abnormal Doppler, 70% for abnormal biophysical parameters, and 89% when both tests were used.

Similar improvements in sensitivity were observed with combined testing for acidemia (71% for abnormal Doppler, 63% for abnormal biophysical parameters, 88% for both); neonatal morbidity (53% for abnormal Doppler, 42% for abnormal biophysical parameters, 73% for both); and neonatal death within the first 28 days of life (74% for abnormal Doppler, 55% for abnormal biophysical parameters, 94% for both).

A total of 1,722 exams were performed on 584 fetuses at six centers in the United States, United Kingdom, and Germany. Fetal growth restriction was defined by a combination of abdominal circumference below the 5th percentile and more than a 2-standard-deviation elevation of the umbilical artery pulsatility index. Biophysical risk factors included gestational age, fetal movement, tone, breathing activity, heart rate, and amniotic fluid volume.

The average gestational age at birth was 32 weeks (range 24–41 weeks), the average birth weight was 1,190 g (390–2,100 g), and 452 babies were delivered by cesarean section. There were 38 stillbirths, 48 cases of acidemia, 97 neonatal morbidities, and 32 deaths.

The addition of Doppler correctly predicted 10 of 10 unexpected stillbirths that occurred within 1 week of being identified as normal by biophysical risk factors, and 23 of 97 neonatal morbidities after equivocal or abnormal biophysical findings, said Dr. Baschat of the University of Maryland, Baltimore. The addition of Doppler predicted 11 additional cases of acidemia, and 12 additional neonatal deaths.

Using abnormal biophysical parameters alone, 19 stillbirths and 18 cases of acidemia were prevented.

Absent ductus venosus atrial systole (a-wave), umbilical vein pulsations, loss of movement, and oligohydramnios were the strongest predictors of stillbirth and acidemia. When these biophysical variables were absent, Doppler changes had no further impact.

Doppler and biophysical parameters did not completely predict neonatal mortality and morbidity risks, as these depend on gestational age, said Dr. Baschat, who received no funding for the study and disclosed no conflicts of interest.

It is too early to say if integrated fetal testing should become the standard for determining delivery timing in intrauterine growth restriction (IUGR), although the University of Maryland Medical Center has been using the method for the past 7 years, Dr. Baschat said in an interview.

“These observational data lay the foundation for a randomized trial of delivery timing in IUGR,” he said, adding that an IUGR research consortium, coordinated through the University of Maryland, is developing a protocol for a management trial.

'These observational data lay the foundation for a randomized trial of delivery timing in IUGR.' DR. BASCHAT

DALLAS — The combination of biophysical and venous Doppler ultrasound parameters provided better timing of deliveries than did either test alone in a study of 584 fetuses with fetal growth restriction.

The prospective, multicenter observational study evaluated umbilical artery, ductus venosus and umbilical vein Doppler flows, and biophysical parameters as predictors of stillbirth, acidemia (cord artery pH less than 7.0 and/or a base deficit of more than 12), neonatal morbidity (intraventricular hemorrhage above grade 2, bronchopulmonary dysplasia, and necrotizing colitis), and neonatal mortality.

All outcomes increased significantly with umbilical artery reversal, abnormal ductus venosus and umbilical vein Doppler, and abnormal biophysical parameters, Dr. Ahmet Baschat and associates reported at the annual meeting of the Society for Maternal-Fetal Medicine.

For all outcomes, combining the two testing modalities improved prediction. The sensitivity to predict stillbirth was 81% for an abnormal Doppler, 70% for abnormal biophysical parameters, and 89% when both tests were used.

Similar improvements in sensitivity were observed with combined testing for acidemia (71% for abnormal Doppler, 63% for abnormal biophysical parameters, 88% for both); neonatal morbidity (53% for abnormal Doppler, 42% for abnormal biophysical parameters, 73% for both); and neonatal death within the first 28 days of life (74% for abnormal Doppler, 55% for abnormal biophysical parameters, 94% for both).

A total of 1,722 exams were performed on 584 fetuses at six centers in the United States, United Kingdom, and Germany. Fetal growth restriction was defined by a combination of abdominal circumference below the 5th percentile and more than a 2-standard-deviation elevation of the umbilical artery pulsatility index. Biophysical risk factors included gestational age, fetal movement, tone, breathing activity, heart rate, and amniotic fluid volume.

The average gestational age at birth was 32 weeks (range 24–41 weeks), the average birth weight was 1,190 g (390–2,100 g), and 452 babies were delivered by cesarean section. There were 38 stillbirths, 48 cases of acidemia, 97 neonatal morbidities, and 32 deaths.

The addition of Doppler correctly predicted 10 of 10 unexpected stillbirths that occurred within 1 week of being identified as normal by biophysical risk factors, and 23 of 97 neonatal morbidities after equivocal or abnormal biophysical findings, said Dr. Baschat of the University of Maryland, Baltimore. The addition of Doppler predicted 11 additional cases of acidemia, and 12 additional neonatal deaths.

Using abnormal biophysical parameters alone, 19 stillbirths and 18 cases of acidemia were prevented.

Absent ductus venosus atrial systole (a-wave), umbilical vein pulsations, loss of movement, and oligohydramnios were the strongest predictors of stillbirth and acidemia. When these biophysical variables were absent, Doppler changes had no further impact.

Doppler and biophysical parameters did not completely predict neonatal mortality and morbidity risks, as these depend on gestational age, said Dr. Baschat, who received no funding for the study and disclosed no conflicts of interest.

It is too early to say if integrated fetal testing should become the standard for determining delivery timing in intrauterine growth restriction (IUGR), although the University of Maryland Medical Center has been using the method for the past 7 years, Dr. Baschat said in an interview.

“These observational data lay the foundation for a randomized trial of delivery timing in IUGR,” he said, adding that an IUGR research consortium, coordinated through the University of Maryland, is developing a protocol for a management trial.

'These observational data lay the foundation for a randomized trial of delivery timing in IUGR.' DR. BASCHAT

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Reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, (800) 298-6288.

Oversedated, Unresponsive After Aneurysm Surgery
A 73-year-old man went to a hospital emergency department (ED) with complaints of chest pain, bloating, and blood in his stools. CT revealed an aortic aneurysm, and surgery was performed three days later. In the recovery room, the patient became confused and agitated. He managed to leave the building before several nurses were able to restrain him and return him to his room.

It was determined that the man was experiencing symptoms of alcohol withdrawal, making him uncooperative and potentially violent. He was started on a detoxification protocol, which included lorazepam and haloperidol.

Over the next several days, the patient appeared oversedated and unresponsive, and his lorazepam dosage was reduced. When he developed a rattle in his chest and began to have trouble breathing, no action was taken. He went into respiratory arrest and was intubated; during this procedure, he sustained a punctured lung. Although the man was resuscitated, he was left with anoxic brain injury. He remained in a deep coma until his ventilator was turned off.

Plaintiffs for the decedent claimed that he was oversedated. He developed a mucous plug that he was unable to clear because of physical restraints and a decreased level of consciousness.

According to a published account, a settlement of $107,500 was reached.

Discontinued Monitoring for Abdominal Cyst
The plaintiff child, an infant girl, was delivered in September by an Ob-Gyn from a women's health practice. Her mother had undergone serial fetal ultrasonography to monitor an abdominal cyst that was detected in the unborn child early in the woman's pregnancy.

During the eight weeks following hospital discharge, the child was seen numerous times by physicians at a pediatrics/adolescent medicine group for digestive issues, including nausea, vomiting, diarrhea, and pale-colored stools. In late October, the mother asked one of the pediatricians whether the infant's problems could be related to the cyst; she questioned whether the prenatal ultrasounds had been faxed to the pediatrician's office.

When no follow-up testing was ordered, the parents took the infant to another doctor, who had her admitted. She was diagnosed with a choledochal cyst (a congenital bile duct anomaly) and liver failure. During surgery, associated biliary atresia was also discovered.

In February, the infant underwent a liver transplant. She suffered one episode of liver rejection and will require a lifelong regimen of antirejection medications.

According to the plaintiff, an Ob-Gyn had assured the mother that an order for postpartum ultrasonography would be placed in the chart to ensure follow-up on the infant's cyst, but the test was never ordered. The plaintiffs also claimed that the Ob-Gyn never informed the pediatrics/adolescent medicine group about the cyst and that no information about the cyst was placed in the newborn's charts by hospital nurses. The plaintiff claimed that proper monitoring would have led to early intervention at a time when the infant's liver was salvageable.

The defendants contended that they had communicated properly and that the child would still have needed a liver transplant, even if testing had been conducted earlier.

During the trial, a confidential settlement was reached with the hospital and the pediatrics group. According to a published report, a $16.5 million verdict was returned against the women's health practice.

Abscess Develops Following a Fall
One day at work, a 54-year-old man fell off his chair and landed on his right hip. He did not seek immediate medical attention but was in considerable pain by the time he arrived home. During the night, his pain worsened, and his wife called an ambulance.

When the patient arrived at the ED, he was barely able to walk and reported a 9 on the 10-point pain scale. His skin moistness, color, and temperature were all normal. An IV was started, and the man was given morphine. When his pain persisted, he was given ketorolac tromethamine, meperidine, and hydroxyzine pamoate.

The ED physician made a diagnosis of acute lumbosacral strain and released the man with prescriptions and instructions for hydrocodone/acetaminophen and cyclobenzaprine. He was to be on bed rest for two days, remain home from work for two more days, and see his primary care provider in seven to 10 days if his condition had not resolved.

The man's pain became increasingly severe. He could not walk unaided, and after four days, he was pale or grayish in color, clammy, sweaty, and short of breath. On the fifth day, this US Army veteran kept an appointment at a US Air Force/university hospital–based clinic, where a second-year resident examined him, diagnosed muscle sprain, and prescribed a few more days of rest. The patient was not seen by the supervising physician.

 

 

The next day, the man was unable to urinate; the following day, he began to hallucinate. He was transported to an ED, where he was placed on life support. The day after his admission, CT confirmed the presence of a retroperitoneal (psoas) abscess and showed that the abscess was encroaching into the epidural space. By this time, his body had swelled to the point that his skin could no longer expand to accommodate it and had begun to crack.

A surgeon who was consulted diagnosed overwhelming sepsis, making the patient too unstable for surgery. By the time the decision was made to airlift him to the university hospital, the man was technically too heavy for the helicopter guidelines. He died one week later.

The case centered around a dispute regarding what the clinic's second-year resident had told the supervising physician regarding the decedent's symptoms. The court ultimately concluded that there was negligence on the part of both physicians, which led to the patient's death. According to a published report, a bench verdict of $8,265,009 was returned.

Infectious Mononucleosis Misdiagnosed as URI
A 19-year-old college student was treated by the defendant family practitioner, Dr. F., during repeated bouts of sinus infection and upper respiratory infection (URI). When the student's illness recurred in November while he was away at school, he was seen twice by an otolaryngologist. The student received a diagnosis of URI, for which he was given antibiotics and a steroid injection.

During the patient's winter break from school, he was still unwell. He called Dr. F.'s office for an appointment and was seen three days later. No lab work or tests were ordered, but Dr. F. made a diagnosis of strep throat and prescribed antibiotics. The student was also instructed that if his condition persisted or worsened, he should call Dr. F.

Two days later, the patient's mother phoned Dr. F.'s office to report that her son was experiencing severe abdominal pain. Because it was the weekend, the mother spoke with an on-call physician, who ordered a change in antibiotics. The patient's condition improved somewhat, but by the next afternoon, the pain had returned, and he was nauseated and vomiting.

He was taken to an ED, where a diagnosis of infectious mononucleosis was made. Less than an hour later, the patient went into cardiac arrest and died.

An autopsy revealed that the decedent's spleen had become enlarged to 10 times its normal size and ruptured, leading to massive internal bleeding and death.

The plaintiff alleged negligence in Dr. F.'s failure to diagnose infectious mononucleosis, claiming that the physician had not examined the decedent's abdomen during the office visit; had this examination been performed, the decedent's enlarged spleen would have been easily detected. The plaintiff further claimed that Dr. F.'s erroneous diagnosis had discouraged the decedent from seeking ED treatment when his condition first worsened.

The defendant denied any negligence, arguing that the decedent's death was an extremely rare complication of infectious mononucleosis and that the outcome would have been the same, even if the decedent had gone to the ED when his worsening symptoms began.

A defense verdict was returned.

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Oversedated, Unresponsive After Aneurysm Surgery
A 73-year-old man went to a hospital emergency department (ED) with complaints of chest pain, bloating, and blood in his stools. CT revealed an aortic aneurysm, and surgery was performed three days later. In the recovery room, the patient became confused and agitated. He managed to leave the building before several nurses were able to restrain him and return him to his room.

It was determined that the man was experiencing symptoms of alcohol withdrawal, making him uncooperative and potentially violent. He was started on a detoxification protocol, which included lorazepam and haloperidol.

Over the next several days, the patient appeared oversedated and unresponsive, and his lorazepam dosage was reduced. When he developed a rattle in his chest and began to have trouble breathing, no action was taken. He went into respiratory arrest and was intubated; during this procedure, he sustained a punctured lung. Although the man was resuscitated, he was left with anoxic brain injury. He remained in a deep coma until his ventilator was turned off.

Plaintiffs for the decedent claimed that he was oversedated. He developed a mucous plug that he was unable to clear because of physical restraints and a decreased level of consciousness.

According to a published account, a settlement of $107,500 was reached.

Discontinued Monitoring for Abdominal Cyst
The plaintiff child, an infant girl, was delivered in September by an Ob-Gyn from a women's health practice. Her mother had undergone serial fetal ultrasonography to monitor an abdominal cyst that was detected in the unborn child early in the woman's pregnancy.

During the eight weeks following hospital discharge, the child was seen numerous times by physicians at a pediatrics/adolescent medicine group for digestive issues, including nausea, vomiting, diarrhea, and pale-colored stools. In late October, the mother asked one of the pediatricians whether the infant's problems could be related to the cyst; she questioned whether the prenatal ultrasounds had been faxed to the pediatrician's office.

When no follow-up testing was ordered, the parents took the infant to another doctor, who had her admitted. She was diagnosed with a choledochal cyst (a congenital bile duct anomaly) and liver failure. During surgery, associated biliary atresia was also discovered.

In February, the infant underwent a liver transplant. She suffered one episode of liver rejection and will require a lifelong regimen of antirejection medications.

According to the plaintiff, an Ob-Gyn had assured the mother that an order for postpartum ultrasonography would be placed in the chart to ensure follow-up on the infant's cyst, but the test was never ordered. The plaintiffs also claimed that the Ob-Gyn never informed the pediatrics/adolescent medicine group about the cyst and that no information about the cyst was placed in the newborn's charts by hospital nurses. The plaintiff claimed that proper monitoring would have led to early intervention at a time when the infant's liver was salvageable.

The defendants contended that they had communicated properly and that the child would still have needed a liver transplant, even if testing had been conducted earlier.

During the trial, a confidential settlement was reached with the hospital and the pediatrics group. According to a published report, a $16.5 million verdict was returned against the women's health practice.

Abscess Develops Following a Fall
One day at work, a 54-year-old man fell off his chair and landed on his right hip. He did not seek immediate medical attention but was in considerable pain by the time he arrived home. During the night, his pain worsened, and his wife called an ambulance.

When the patient arrived at the ED, he was barely able to walk and reported a 9 on the 10-point pain scale. His skin moistness, color, and temperature were all normal. An IV was started, and the man was given morphine. When his pain persisted, he was given ketorolac tromethamine, meperidine, and hydroxyzine pamoate.

The ED physician made a diagnosis of acute lumbosacral strain and released the man with prescriptions and instructions for hydrocodone/acetaminophen and cyclobenzaprine. He was to be on bed rest for two days, remain home from work for two more days, and see his primary care provider in seven to 10 days if his condition had not resolved.

The man's pain became increasingly severe. He could not walk unaided, and after four days, he was pale or grayish in color, clammy, sweaty, and short of breath. On the fifth day, this US Army veteran kept an appointment at a US Air Force/university hospital–based clinic, where a second-year resident examined him, diagnosed muscle sprain, and prescribed a few more days of rest. The patient was not seen by the supervising physician.

 

 

The next day, the man was unable to urinate; the following day, he began to hallucinate. He was transported to an ED, where he was placed on life support. The day after his admission, CT confirmed the presence of a retroperitoneal (psoas) abscess and showed that the abscess was encroaching into the epidural space. By this time, his body had swelled to the point that his skin could no longer expand to accommodate it and had begun to crack.

A surgeon who was consulted diagnosed overwhelming sepsis, making the patient too unstable for surgery. By the time the decision was made to airlift him to the university hospital, the man was technically too heavy for the helicopter guidelines. He died one week later.

The case centered around a dispute regarding what the clinic's second-year resident had told the supervising physician regarding the decedent's symptoms. The court ultimately concluded that there was negligence on the part of both physicians, which led to the patient's death. According to a published report, a bench verdict of $8,265,009 was returned.

Infectious Mononucleosis Misdiagnosed as URI
A 19-year-old college student was treated by the defendant family practitioner, Dr. F., during repeated bouts of sinus infection and upper respiratory infection (URI). When the student's illness recurred in November while he was away at school, he was seen twice by an otolaryngologist. The student received a diagnosis of URI, for which he was given antibiotics and a steroid injection.

During the patient's winter break from school, he was still unwell. He called Dr. F.'s office for an appointment and was seen three days later. No lab work or tests were ordered, but Dr. F. made a diagnosis of strep throat and prescribed antibiotics. The student was also instructed that if his condition persisted or worsened, he should call Dr. F.

Two days later, the patient's mother phoned Dr. F.'s office to report that her son was experiencing severe abdominal pain. Because it was the weekend, the mother spoke with an on-call physician, who ordered a change in antibiotics. The patient's condition improved somewhat, but by the next afternoon, the pain had returned, and he was nauseated and vomiting.

He was taken to an ED, where a diagnosis of infectious mononucleosis was made. Less than an hour later, the patient went into cardiac arrest and died.

An autopsy revealed that the decedent's spleen had become enlarged to 10 times its normal size and ruptured, leading to massive internal bleeding and death.

The plaintiff alleged negligence in Dr. F.'s failure to diagnose infectious mononucleosis, claiming that the physician had not examined the decedent's abdomen during the office visit; had this examination been performed, the decedent's enlarged spleen would have been easily detected. The plaintiff further claimed that Dr. F.'s erroneous diagnosis had discouraged the decedent from seeking ED treatment when his condition first worsened.

The defendant denied any negligence, arguing that the decedent's death was an extremely rare complication of infectious mononucleosis and that the outcome would have been the same, even if the decedent had gone to the ED when his worsening symptoms began.

A defense verdict was returned.

Reprinted with permission from Medical Malpractice Verdicts, Settlements and Experts, Lewis Laska, Editor, (800) 298-6288.

Oversedated, Unresponsive After Aneurysm Surgery
A 73-year-old man went to a hospital emergency department (ED) with complaints of chest pain, bloating, and blood in his stools. CT revealed an aortic aneurysm, and surgery was performed three days later. In the recovery room, the patient became confused and agitated. He managed to leave the building before several nurses were able to restrain him and return him to his room.

It was determined that the man was experiencing symptoms of alcohol withdrawal, making him uncooperative and potentially violent. He was started on a detoxification protocol, which included lorazepam and haloperidol.

Over the next several days, the patient appeared oversedated and unresponsive, and his lorazepam dosage was reduced. When he developed a rattle in his chest and began to have trouble breathing, no action was taken. He went into respiratory arrest and was intubated; during this procedure, he sustained a punctured lung. Although the man was resuscitated, he was left with anoxic brain injury. He remained in a deep coma until his ventilator was turned off.

Plaintiffs for the decedent claimed that he was oversedated. He developed a mucous plug that he was unable to clear because of physical restraints and a decreased level of consciousness.

According to a published account, a settlement of $107,500 was reached.

Discontinued Monitoring for Abdominal Cyst
The plaintiff child, an infant girl, was delivered in September by an Ob-Gyn from a women's health practice. Her mother had undergone serial fetal ultrasonography to monitor an abdominal cyst that was detected in the unborn child early in the woman's pregnancy.

During the eight weeks following hospital discharge, the child was seen numerous times by physicians at a pediatrics/adolescent medicine group for digestive issues, including nausea, vomiting, diarrhea, and pale-colored stools. In late October, the mother asked one of the pediatricians whether the infant's problems could be related to the cyst; she questioned whether the prenatal ultrasounds had been faxed to the pediatrician's office.

When no follow-up testing was ordered, the parents took the infant to another doctor, who had her admitted. She was diagnosed with a choledochal cyst (a congenital bile duct anomaly) and liver failure. During surgery, associated biliary atresia was also discovered.

In February, the infant underwent a liver transplant. She suffered one episode of liver rejection and will require a lifelong regimen of antirejection medications.

According to the plaintiff, an Ob-Gyn had assured the mother that an order for postpartum ultrasonography would be placed in the chart to ensure follow-up on the infant's cyst, but the test was never ordered. The plaintiffs also claimed that the Ob-Gyn never informed the pediatrics/adolescent medicine group about the cyst and that no information about the cyst was placed in the newborn's charts by hospital nurses. The plaintiff claimed that proper monitoring would have led to early intervention at a time when the infant's liver was salvageable.

The defendants contended that they had communicated properly and that the child would still have needed a liver transplant, even if testing had been conducted earlier.

During the trial, a confidential settlement was reached with the hospital and the pediatrics group. According to a published report, a $16.5 million verdict was returned against the women's health practice.

Abscess Develops Following a Fall
One day at work, a 54-year-old man fell off his chair and landed on his right hip. He did not seek immediate medical attention but was in considerable pain by the time he arrived home. During the night, his pain worsened, and his wife called an ambulance.

When the patient arrived at the ED, he was barely able to walk and reported a 9 on the 10-point pain scale. His skin moistness, color, and temperature were all normal. An IV was started, and the man was given morphine. When his pain persisted, he was given ketorolac tromethamine, meperidine, and hydroxyzine pamoate.

The ED physician made a diagnosis of acute lumbosacral strain and released the man with prescriptions and instructions for hydrocodone/acetaminophen and cyclobenzaprine. He was to be on bed rest for two days, remain home from work for two more days, and see his primary care provider in seven to 10 days if his condition had not resolved.

The man's pain became increasingly severe. He could not walk unaided, and after four days, he was pale or grayish in color, clammy, sweaty, and short of breath. On the fifth day, this US Army veteran kept an appointment at a US Air Force/university hospital–based clinic, where a second-year resident examined him, diagnosed muscle sprain, and prescribed a few more days of rest. The patient was not seen by the supervising physician.

 

 

The next day, the man was unable to urinate; the following day, he began to hallucinate. He was transported to an ED, where he was placed on life support. The day after his admission, CT confirmed the presence of a retroperitoneal (psoas) abscess and showed that the abscess was encroaching into the epidural space. By this time, his body had swelled to the point that his skin could no longer expand to accommodate it and had begun to crack.

A surgeon who was consulted diagnosed overwhelming sepsis, making the patient too unstable for surgery. By the time the decision was made to airlift him to the university hospital, the man was technically too heavy for the helicopter guidelines. He died one week later.

The case centered around a dispute regarding what the clinic's second-year resident had told the supervising physician regarding the decedent's symptoms. The court ultimately concluded that there was negligence on the part of both physicians, which led to the patient's death. According to a published report, a bench verdict of $8,265,009 was returned.

Infectious Mononucleosis Misdiagnosed as URI
A 19-year-old college student was treated by the defendant family practitioner, Dr. F., during repeated bouts of sinus infection and upper respiratory infection (URI). When the student's illness recurred in November while he was away at school, he was seen twice by an otolaryngologist. The student received a diagnosis of URI, for which he was given antibiotics and a steroid injection.

During the patient's winter break from school, he was still unwell. He called Dr. F.'s office for an appointment and was seen three days later. No lab work or tests were ordered, but Dr. F. made a diagnosis of strep throat and prescribed antibiotics. The student was also instructed that if his condition persisted or worsened, he should call Dr. F.

Two days later, the patient's mother phoned Dr. F.'s office to report that her son was experiencing severe abdominal pain. Because it was the weekend, the mother spoke with an on-call physician, who ordered a change in antibiotics. The patient's condition improved somewhat, but by the next afternoon, the pain had returned, and he was nauseated and vomiting.

He was taken to an ED, where a diagnosis of infectious mononucleosis was made. Less than an hour later, the patient went into cardiac arrest and died.

An autopsy revealed that the decedent's spleen had become enlarged to 10 times its normal size and ruptured, leading to massive internal bleeding and death.

The plaintiff alleged negligence in Dr. F.'s failure to diagnose infectious mononucleosis, claiming that the physician had not examined the decedent's abdomen during the office visit; had this examination been performed, the decedent's enlarged spleen would have been easily detected. The plaintiff further claimed that Dr. F.'s erroneous diagnosis had discouraged the decedent from seeking ED treatment when his condition first worsened.

The defendant denied any negligence, arguing that the decedent's death was an extremely rare complication of infectious mononucleosis and that the outcome would have been the same, even if the decedent had gone to the ED when his worsening symptoms began.

A defense verdict was returned.

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Clinician Reviews - 18(4)
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Clinician Reviews - 18(4)
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30-32
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malpractice, alcohol withdrawal, aneurysm, oversedation, abdominal cyst, fetal ultrasound, choledochal cyst, liver transplant, fall, abscess, acute lumbosacral strain, upper respiratory infection, mononucleosis, spleen malpractice, alcohol withdrawal, aneurysm, oversedation, abdominal cyst, fetal ultrasound, choledochal cyst, liver transplant, fall, abscess, acute lumbosacral strain, upper respiratory infection, mononucleosis, spleen
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malpractice, alcohol withdrawal, aneurysm, oversedation, abdominal cyst, fetal ultrasound, choledochal cyst, liver transplant, fall, abscess, acute lumbosacral strain, upper respiratory infection, mononucleosis, spleen malpractice, alcohol withdrawal, aneurysm, oversedation, abdominal cyst, fetal ultrasound, choledochal cyst, liver transplant, fall, abscess, acute lumbosacral strain, upper respiratory infection, mononucleosis, spleen
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