Obstetrics

MONTEREY, CALIF. — Ingestion of flax oil by women during the second and third trimester of pregnancy is associated with almost a threefold increase in the rate of premature birth, according to the findings of a recent study.

The format of the study questionnaire did not allow investigators to estimate the dose of flax oil associated with preterm birth, study investigator Anick Bérard, Ph.D., of the University of Montreal said in an interview.

Dr. Bérard noted that the question about flax referred specifically to flax oil, which is often used for constipation during pregnancy, and not flax seed, a common foodstuff.

The investigators found no link between premature birth and ingestion of a number of other herbal products, including chamomile, peppermint, and green tea, wrote lead author Krystel Moussally, B.Sc., of the University of Montreal, and her colleagues in a poster presentation at the annual meeting of the Teratology Society.

The case-control study involved 3,354 women listed in the Quebec Pregnancy Registry who responded to a questionnaire. All gave birth to a live infant between 1998 and 2003 in Quebec hospitals and all were continuously insured by the Regie de l'assurance maladie du Québec drug plan for at least 12 months before and during pregnancy. In all, the investigators mailed 8,505 questionnaires, so the response rate was 39%.

Among the women who returned questionnaires, 22% had given birth before 37 weeks' gestation.

As expected, women who gave birth prematurely differed from the controls on a number of variables.

For example, they were more likely to have asthma, and they had fewer prenatal visits.

After controlling for health status, sociodemographic characteristics, lifestyle habits, medication use before and during pregnancy, pregnancy complications, and the baby's sex, the investigators found that women who used flax oil during their last two trimesters were 2.76 times more likely to give birth prematurely than were those who did not.

“Flax use should be avoided during pregnancy,” the investigators concluded. “Caution in the use of not-as-yet regulated [herbal products] during the last two trimesters of pregnancy is warranted.”

The investigators stated that they had no conflicts of interest to declare.

MONTEREY, CALIF. — Ingestion of flax oil by women during the second and third trimester of pregnancy is associated with almost a threefold increase in the rate of premature birth, according to the findings of a recent study.

The format of the study questionnaire did not allow investigators to estimate the dose of flax oil associated with preterm birth, study investigator Anick Bérard, Ph.D., of the University of Montreal said in an interview.

Dr. Bérard noted that the question about flax referred specifically to flax oil, which is often used for constipation during pregnancy, and not flax seed, a common foodstuff.

The investigators found no link between premature birth and ingestion of a number of other herbal products, including chamomile, peppermint, and green tea, wrote lead author Krystel Moussally, B.Sc., of the University of Montreal, and her colleagues in a poster presentation at the annual meeting of the Teratology Society.

The case-control study involved 3,354 women listed in the Quebec Pregnancy Registry who responded to a questionnaire. All gave birth to a live infant between 1998 and 2003 in Quebec hospitals and all were continuously insured by the Regie de l'assurance maladie du Québec drug plan for at least 12 months before and during pregnancy. In all, the investigators mailed 8,505 questionnaires, so the response rate was 39%.

Among the women who returned questionnaires, 22% had given birth before 37 weeks' gestation.

As expected, women who gave birth prematurely differed from the controls on a number of variables.

For example, they were more likely to have asthma, and they had fewer prenatal visits.

After controlling for health status, sociodemographic characteristics, lifestyle habits, medication use before and during pregnancy, pregnancy complications, and the baby's sex, the investigators found that women who used flax oil during their last two trimesters were 2.76 times more likely to give birth prematurely than were those who did not.

“Flax use should be avoided during pregnancy,” the investigators concluded. “Caution in the use of not-as-yet regulated [herbal products] during the last two trimesters of pregnancy is warranted.”

The investigators stated that they had no conflicts of interest to declare.

MONTEREY, CALIF. — Ingestion of flax oil by women during the second and third trimester of pregnancy is associated with almost a threefold increase in the rate of premature birth, according to the findings of a recent study.

The format of the study questionnaire did not allow investigators to estimate the dose of flax oil associated with preterm birth, study investigator Anick Bérard, Ph.D., of the University of Montreal said in an interview.

Dr. Bérard noted that the question about flax referred specifically to flax oil, which is often used for constipation during pregnancy, and not flax seed, a common foodstuff.

The investigators found no link between premature birth and ingestion of a number of other herbal products, including chamomile, peppermint, and green tea, wrote lead author Krystel Moussally, B.Sc., of the University of Montreal, and her colleagues in a poster presentation at the annual meeting of the Teratology Society.

The case-control study involved 3,354 women listed in the Quebec Pregnancy Registry who responded to a questionnaire. All gave birth to a live infant between 1998 and 2003 in Quebec hospitals and all were continuously insured by the Regie de l'assurance maladie du Québec drug plan for at least 12 months before and during pregnancy. In all, the investigators mailed 8,505 questionnaires, so the response rate was 39%.

Among the women who returned questionnaires, 22% had given birth before 37 weeks' gestation.

As expected, women who gave birth prematurely differed from the controls on a number of variables.

For example, they were more likely to have asthma, and they had fewer prenatal visits.

After controlling for health status, sociodemographic characteristics, lifestyle habits, medication use before and during pregnancy, pregnancy complications, and the baby's sex, the investigators found that women who used flax oil during their last two trimesters were 2.76 times more likely to give birth prematurely than were those who did not.

“Flax use should be avoided during pregnancy,” the investigators concluded. “Caution in the use of not-as-yet regulated [herbal products] during the last two trimesters of pregnancy is warranted.”

The investigators stated that they had no conflicts of interest to declare.

The risk of serious medical and social disabilities in adulthood increases sharply with decreasing gestational age at birth, according to a report in the New England Journal of Medicine.

Even young adults who were born preterm but have no lingering medical disabilities are at high risk of failing to complete high school, earning a low income, and failing to marry or have children, said Dr. Dag Moster of the University of Bergen (Norway) and his associates.

The researchers assessed the relationship between gestational age at birth and outcomes in adulthood because “the increased prevalence of medical disabilities, learning difficulties, and behavioral and psychological problems among surviving preterm infants has raised concerns that these infants may have difficulties in coping with adult life.”

They examined the issue using data from compulsory national registries of birth, education, job-related income, disability payments, and criminal records, tracking a cohort of 867,692 people born during 1967-1983 and followed until when they were aged 20-36 years.

The risk of serious medical disabilities such as cerebral palsy, blindness or severely impaired vision, hearing loss, and epilepsy increased markedly with decreasing gestational age, as did the risk of mental retardation and psychological, behavioral, and emotional disorders.

“At 19-35 years of age, nearly 1 of 9 persons who had been born at 23-27 weeks of gestation received a disability pension, as compared with 1 of 12 who had been born at 28-30 weeks, 1 of 24 born at 31-33 weeks, 1 of 42 born at 34-36 weeks, and 1 of 59 born at term,” Dr. Moster and his associates said (N. Engl. J. Med. 2008;359:262-73).

Even when people with residual medical disabilities were excluded from the analysis, a lower gestational age at birth was associated with a reduced likelihood of completing high school or higher education and of earning a high income. It also was linked to a low likelihood of finding a life partner and of having children.

“We also observed a significant association of autism spectrum disorders with very low gestational age,” but “caution is warranted interpreting this finding given the small number of cases in the very premature groups,” the researchers noted.

These results are consistent with those of other studies showing a link between preterm birth and “specific difficulties in the areas of motor, cognitive, behavioral, psychological, and social function among preschool and school-aged children,” Dr. Moster and his colleagues said.

The adverse outcomes in adulthood “may represent long-term effects of subtle brain dysfunction caused by preterm birth,” or they may be related to biologic and social factors underlying both the preterm birth and its later sequelae, they added.

Despite their study's findings on disability prevalence, the researchers wrote, “It should be recognized that a large proportion of the adults who were born prematurely and did not have severe medical disabilities completed higher education and seem to be functioning well.”

The risk of serious medical and social disabilities in adulthood increases sharply with decreasing gestational age at birth, according to a report in the New England Journal of Medicine.

Even young adults who were born preterm but have no lingering medical disabilities are at high risk of failing to complete high school, earning a low income, and failing to marry or have children, said Dr. Dag Moster of the University of Bergen (Norway) and his associates.

The researchers assessed the relationship between gestational age at birth and outcomes in adulthood because “the increased prevalence of medical disabilities, learning difficulties, and behavioral and psychological problems among surviving preterm infants has raised concerns that these infants may have difficulties in coping with adult life.”

They examined the issue using data from compulsory national registries of birth, education, job-related income, disability payments, and criminal records, tracking a cohort of 867,692 people born during 1967-1983 and followed until when they were aged 20-36 years.

The risk of serious medical disabilities such as cerebral palsy, blindness or severely impaired vision, hearing loss, and epilepsy increased markedly with decreasing gestational age, as did the risk of mental retardation and psychological, behavioral, and emotional disorders.

“At 19-35 years of age, nearly 1 of 9 persons who had been born at 23-27 weeks of gestation received a disability pension, as compared with 1 of 12 who had been born at 28-30 weeks, 1 of 24 born at 31-33 weeks, 1 of 42 born at 34-36 weeks, and 1 of 59 born at term,” Dr. Moster and his associates said (N. Engl. J. Med. 2008;359:262-73).

Even when people with residual medical disabilities were excluded from the analysis, a lower gestational age at birth was associated with a reduced likelihood of completing high school or higher education and of earning a high income. It also was linked to a low likelihood of finding a life partner and of having children.

“We also observed a significant association of autism spectrum disorders with very low gestational age,” but “caution is warranted interpreting this finding given the small number of cases in the very premature groups,” the researchers noted.

These results are consistent with those of other studies showing a link between preterm birth and “specific difficulties in the areas of motor, cognitive, behavioral, psychological, and social function among preschool and school-aged children,” Dr. Moster and his colleagues said.

The adverse outcomes in adulthood “may represent long-term effects of subtle brain dysfunction caused by preterm birth,” or they may be related to biologic and social factors underlying both the preterm birth and its later sequelae, they added.

Despite their study's findings on disability prevalence, the researchers wrote, “It should be recognized that a large proportion of the adults who were born prematurely and did not have severe medical disabilities completed higher education and seem to be functioning well.”

The risk of serious medical and social disabilities in adulthood increases sharply with decreasing gestational age at birth, according to a report in the New England Journal of Medicine.

Even young adults who were born preterm but have no lingering medical disabilities are at high risk of failing to complete high school, earning a low income, and failing to marry or have children, said Dr. Dag Moster of the University of Bergen (Norway) and his associates.

The researchers assessed the relationship between gestational age at birth and outcomes in adulthood because “the increased prevalence of medical disabilities, learning difficulties, and behavioral and psychological problems among surviving preterm infants has raised concerns that these infants may have difficulties in coping with adult life.”

They examined the issue using data from compulsory national registries of birth, education, job-related income, disability payments, and criminal records, tracking a cohort of 867,692 people born during 1967-1983 and followed until when they were aged 20-36 years.

The risk of serious medical disabilities such as cerebral palsy, blindness or severely impaired vision, hearing loss, and epilepsy increased markedly with decreasing gestational age, as did the risk of mental retardation and psychological, behavioral, and emotional disorders.

“At 19-35 years of age, nearly 1 of 9 persons who had been born at 23-27 weeks of gestation received a disability pension, as compared with 1 of 12 who had been born at 28-30 weeks, 1 of 24 born at 31-33 weeks, 1 of 42 born at 34-36 weeks, and 1 of 59 born at term,” Dr. Moster and his associates said (N. Engl. J. Med. 2008;359:262-73).

Even when people with residual medical disabilities were excluded from the analysis, a lower gestational age at birth was associated with a reduced likelihood of completing high school or higher education and of earning a high income. It also was linked to a low likelihood of finding a life partner and of having children.

“We also observed a significant association of autism spectrum disorders with very low gestational age,” but “caution is warranted interpreting this finding given the small number of cases in the very premature groups,” the researchers noted.

These results are consistent with those of other studies showing a link between preterm birth and “specific difficulties in the areas of motor, cognitive, behavioral, psychological, and social function among preschool and school-aged children,” Dr. Moster and his colleagues said.

The adverse outcomes in adulthood “may represent long-term effects of subtle brain dysfunction caused by preterm birth,” or they may be related to biologic and social factors underlying both the preterm birth and its later sequelae, they added.

Despite their study's findings on disability prevalence, the researchers wrote, “It should be recognized that a large proportion of the adults who were born prematurely and did not have severe medical disabilities completed higher education and seem to be functioning well.”

CHICAGO — A prospective study of 5,300 women has provided the first biological evidence of the mechanisms underlying the statistically established association between preterm delivery and the mother's future risk of heart disease and stroke.

Low HDL cholesterol and elevated homocysteine levels surfaced as key factors associated with spontaneous preterm birth, Dr. Michael S. Kramer of McGill University reported in a plenary session at the annual meeting of the Society for Pediatric and Perinatal Epidemiologic Research.

In addition, a significantly higher proportion of women with concentrations of homocysteine above the median showed signs of decidual vasculopathy (13.0% vs. 6.8%), Dr. Kramer said.

The study compared frozen plasma samples and fixed and stained placentas from 207 cases of spontaneous preterm birth with 444 term controls, approximately 2 per case.

Researchers analyzed homocysteine, folate, cholesterol (total, LDL, and HDL), and thrombin-antithrombin complexes and blindly assessed fixed and stained placentas for histologic evidence of infarction and decidual vasculopathy.

Both elevated homocysteine and low HDL cholesterol levels were significantly and independently associated with twice the risk of preterm birth, Dr. Kramer reported. “Similar vasculopathic risk factors may underlie preterm birth and adult coronary heart disease and stroke,” he said.

Women who delivered preterm had significantly higher plasma homocysteine (4.0 vs. 3.7 mmol/L; P = .001) and lower HDL cholesterol (1.6 vs. 1.8 mmol/L; P = .0001) levels, compared with women who delivered at term.

In addition, a higher proportion of women with high homocysteine concentrations (but not low HDL) had decidual vasculopathy (13.0% vs. 6.8%).

“The same factors that we know lead to stroke and heart disease were found to be elevated in the second trimester in mothers who subsequently gave birth preterm,” said Dr. Kramer in an interview.

The fact that their placentas showed evidence of vasculopathy on the mother's side was a major finding, because it provides a biological link with the vasculopathic plasma markers, he said.

However, “even if [these results] are robust, we still don't know whether homocysteine and HDL are pathologically involved in a biological sense with the preterm birth, or whether they're just markers of the mother's increased risk,” he said.

“In adults, when HDL and homocysteine damage blood vessels, they do it over decades,” he said. “With pregnancy, we're talking about months. How do [these factors] get translated biologically into an increased risk for preterm birth? It may be the homocysteine and HDL themselves that are acting on blood vessels in the placenta, or it may be something else that's causing the preterm birth.”

Dr. Kramer noted that the differences in HDL and homocysteine levels between the two groups were statistically significant but modest. For example, there was a less than 10% difference between the cases and controls in homocysteine (4.0 vs. 3.7 mmol/L). In addition, “the homocysteine concentrations were not high in terms of what is known or suspected to cause vascular damage, which is why we're underlining the fact that we don't know if it's the homocysteine,” he said. “These were not the sky-high levels associated with very high risks of coronary heart disease.”

The findings need to be replicated to determine whether they are robust, Dr. Kramer said. “However, I think it's unlikely that they were just a statistical fluke, because they were in the direction you'd expect,” he said.

Existing serum banks for large populations would offer a relatively easy and inexpensive method of linking pregnancy outcomes with HDL and homocysteine concentrations, he said.

CHICAGO — A prospective study of 5,300 women has provided the first biological evidence of the mechanisms underlying the statistically established association between preterm delivery and the mother's future risk of heart disease and stroke.

Low HDL cholesterol and elevated homocysteine levels surfaced as key factors associated with spontaneous preterm birth, Dr. Michael S. Kramer of McGill University reported in a plenary session at the annual meeting of the Society for Pediatric and Perinatal Epidemiologic Research.

In addition, a significantly higher proportion of women with concentrations of homocysteine above the median showed signs of decidual vasculopathy (13.0% vs. 6.8%), Dr. Kramer said.

The study compared frozen plasma samples and fixed and stained placentas from 207 cases of spontaneous preterm birth with 444 term controls, approximately 2 per case.

Researchers analyzed homocysteine, folate, cholesterol (total, LDL, and HDL), and thrombin-antithrombin complexes and blindly assessed fixed and stained placentas for histologic evidence of infarction and decidual vasculopathy.

Both elevated homocysteine and low HDL cholesterol levels were significantly and independently associated with twice the risk of preterm birth, Dr. Kramer reported. “Similar vasculopathic risk factors may underlie preterm birth and adult coronary heart disease and stroke,” he said.

Women who delivered preterm had significantly higher plasma homocysteine (4.0 vs. 3.7 mmol/L; P = .001) and lower HDL cholesterol (1.6 vs. 1.8 mmol/L; P = .0001) levels, compared with women who delivered at term.

In addition, a higher proportion of women with high homocysteine concentrations (but not low HDL) had decidual vasculopathy (13.0% vs. 6.8%).

“The same factors that we know lead to stroke and heart disease were found to be elevated in the second trimester in mothers who subsequently gave birth preterm,” said Dr. Kramer in an interview.

The fact that their placentas showed evidence of vasculopathy on the mother's side was a major finding, because it provides a biological link with the vasculopathic plasma markers, he said.

However, “even if [these results] are robust, we still don't know whether homocysteine and HDL are pathologically involved in a biological sense with the preterm birth, or whether they're just markers of the mother's increased risk,” he said.

“In adults, when HDL and homocysteine damage blood vessels, they do it over decades,” he said. “With pregnancy, we're talking about months. How do [these factors] get translated biologically into an increased risk for preterm birth? It may be the homocysteine and HDL themselves that are acting on blood vessels in the placenta, or it may be something else that's causing the preterm birth.”

Dr. Kramer noted that the differences in HDL and homocysteine levels between the two groups were statistically significant but modest. For example, there was a less than 10% difference between the cases and controls in homocysteine (4.0 vs. 3.7 mmol/L). In addition, “the homocysteine concentrations were not high in terms of what is known or suspected to cause vascular damage, which is why we're underlining the fact that we don't know if it's the homocysteine,” he said. “These were not the sky-high levels associated with very high risks of coronary heart disease.”

The findings need to be replicated to determine whether they are robust, Dr. Kramer said. “However, I think it's unlikely that they were just a statistical fluke, because they were in the direction you'd expect,” he said.

Existing serum banks for large populations would offer a relatively easy and inexpensive method of linking pregnancy outcomes with HDL and homocysteine concentrations, he said.

CHICAGO — A prospective study of 5,300 women has provided the first biological evidence of the mechanisms underlying the statistically established association between preterm delivery and the mother's future risk of heart disease and stroke.

Low HDL cholesterol and elevated homocysteine levels surfaced as key factors associated with spontaneous preterm birth, Dr. Michael S. Kramer of McGill University reported in a plenary session at the annual meeting of the Society for Pediatric and Perinatal Epidemiologic Research.

In addition, a significantly higher proportion of women with concentrations of homocysteine above the median showed signs of decidual vasculopathy (13.0% vs. 6.8%), Dr. Kramer said.

The study compared frozen plasma samples and fixed and stained placentas from 207 cases of spontaneous preterm birth with 444 term controls, approximately 2 per case.

Researchers analyzed homocysteine, folate, cholesterol (total, LDL, and HDL), and thrombin-antithrombin complexes and blindly assessed fixed and stained placentas for histologic evidence of infarction and decidual vasculopathy.

Both elevated homocysteine and low HDL cholesterol levels were significantly and independently associated with twice the risk of preterm birth, Dr. Kramer reported. “Similar vasculopathic risk factors may underlie preterm birth and adult coronary heart disease and stroke,” he said.

Women who delivered preterm had significantly higher plasma homocysteine (4.0 vs. 3.7 mmol/L; P = .001) and lower HDL cholesterol (1.6 vs. 1.8 mmol/L; P = .0001) levels, compared with women who delivered at term.

In addition, a higher proportion of women with high homocysteine concentrations (but not low HDL) had decidual vasculopathy (13.0% vs. 6.8%).

“The same factors that we know lead to stroke and heart disease were found to be elevated in the second trimester in mothers who subsequently gave birth preterm,” said Dr. Kramer in an interview.

The fact that their placentas showed evidence of vasculopathy on the mother's side was a major finding, because it provides a biological link with the vasculopathic plasma markers, he said.

However, “even if [these results] are robust, we still don't know whether homocysteine and HDL are pathologically involved in a biological sense with the preterm birth, or whether they're just markers of the mother's increased risk,” he said.

“In adults, when HDL and homocysteine damage blood vessels, they do it over decades,” he said. “With pregnancy, we're talking about months. How do [these factors] get translated biologically into an increased risk for preterm birth? It may be the homocysteine and HDL themselves that are acting on blood vessels in the placenta, or it may be something else that's causing the preterm birth.”

Dr. Kramer noted that the differences in HDL and homocysteine levels between the two groups were statistically significant but modest. For example, there was a less than 10% difference between the cases and controls in homocysteine (4.0 vs. 3.7 mmol/L). In addition, “the homocysteine concentrations were not high in terms of what is known or suspected to cause vascular damage, which is why we're underlining the fact that we don't know if it's the homocysteine,” he said. “These were not the sky-high levels associated with very high risks of coronary heart disease.”

The findings need to be replicated to determine whether they are robust, Dr. Kramer said. “However, I think it's unlikely that they were just a statistical fluke, because they were in the direction you'd expect,” he said.

Existing serum banks for large populations would offer a relatively easy and inexpensive method of linking pregnancy outcomes with HDL and homocysteine concentrations, he said.

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

Recommendation Unheeded for Endocrinology Referral
A middle-aged man was referred by his primary care physician to the defendant pulmonologist in October 2002 for a sleep apnea consult. The patient complained of snoring, gasping for air at night, and daytime drowsiness. The pulmonologist, noticing that the man had coarse facial features, asked him whether anyone had ever mentioned facial changes to him; the man replied, “No.” The pulmonologist ordered blood work, including a random growth hormone sampling to test for excessive growth hormone.

The pulmonologist advised the patient to see his primary care physician for a possible referral to an endocrinologist. The man was also sent for an overnight sleep study to be tested for sleep apnea. The pulmonologist communicated with the patient’s primary care physician, mentioning the possibility of acromegaly and recommending an endocrinology consult. The primary care physician did not provide the referral to an endocrinologist, however.

The plaintiff returned to the defendant two months later for results of his sleep study. During that visit, the defendant informed him that findings from the growth hormone test were inconclusive. He advised the patient to return to his primary care physician for an endocrinology referral. The plaintiff was also instructed to return to the defendant pulmonologist in one month. The plaintiff never returned to the defendant and did not return to his primary care physician for 17 months.

The man was ultimately diagnosed with acromegaly, the production of excess growth hormone by the pituitary gland. He lost 90% of his pituitary gland and complains of double vision, cranial nerve injuries, hypopituitarism, diabetes insipidus, and sexual dysfunction.

The plaintiff claimed that the defendant pulmonologist wrote an “ambiguous” letter to the primary care physician (also a defendant in the case) that failed to specifically direct that physician to order an endocrinology consult. The plaintiff also claimed that results of the growth hormone test should have been forwarded to the primary care physician. The plaintiff claimed that diagnosis of acromegaly and appropriate treatment in 2002 or 2003 would have led to a cure for the pituitary tumor.

The defendant argued that his correspondence was clear regarding the need for an endocrinology consult and that forwarding the laboratory report was not required because results were inconclusive. The defendant also claimed that even with earlier treatment, the plaintiff’s condition would have been unchanged.

According to a published account, a defense verdict was returned. The primary care physician settled for an undisclosed amount prior to trial.

Post–Cesarean Surgery Complaints Overlooked
A woman underwent a cesarean delivery, performed by the defendant obstetrician with the assistance of two surgical nurses. At the conclusion of the procedure, the nurses informed the obstetrician that the sponge count was correct, and the surgical wound was closed.

About five months later, the patient complained of pain and tenderness in her abdomen; two months later, she went to the emergency department (ED) and was instructed to consult with her primary care physician. At that time, the patient did not have any pain but said her abdomen was “hard.”

One week later, the patient was seen by a different obstetrician/gynecologist, who ordered an abdominal CT. The test revealed that a surgical sponge had been retained during the cesarean delivery. The woman underwent surgery at the original hospital for removal of the sponge. The hospital eventually wrote off the charges for this surgery.

The plaintiff charged the nurses with negligence in miscounting the sponges and the defendant obstetrician for failing to refer her to another provider to determine the cause of her pain. A $159,000 settlement was reached with the hospital and the nurses.

The matter proceeded against the obstetrician, with the plaintiff claiming that the obstetrician should not have relied solely on the nurses’ sponge count and that she should have been more diligent about responding to the plaintiff’s complaints after the surgery.

The defendant claimed that she had acted appropriately in relying on the nurses’ sponge count and maintained that the plaintiff had no signs of fever or infection when she saw her two months after the surgery. The defendant also claimed that she repeatedly referred the plaintiff to other health care providers, including a neurologist and her primary care physician. She argued that the plaintiff had gone to the ED at least twice and had undergone ultrasonographic tests that did not detect the presence of the sponge. Finally, the defendant maintained that the plaintiff had no residual complications following the removal of the sponge.

According to a published report, a $375,000 verdict was returned. The court then ruled that the defendant obstetrician was entitled to a set-off against the verdict for the earlier $159,000 settlement. This reduced the plaintiff’s verdict to $216,000.

Failure to Diagnose Colon Cancer in Clinical Trial Subject
In August 2000, a 56-year-old man with a five-year history of Crohn’s disease was referred to Dr. B. for enrollment in a clinical trial of recombinant human interleukin 11 for treatment of Crohn’s disease.

Before seeing Dr. B., the patient had undergone abdominal CT. This revealed a 1.0-cm lesion on the liver that a radiologist had pronounced benign. The CT report was given to Dr. B., who recommended a laparotomy as the best strategy for the patient’s condition. However, the patient chose not to have the surgery and instead opted to participate in the clinical study.

Several times during his treatment with Dr. B., the man complained of abdominal pain, diarrhea, and constipation. He continued to participate in the study until March 2001, when he went to a hospital with abdominal pain. At that time, Dr. B. withdrew the patient from the drug trial.

One month later, the man returned to Dr. B., who recommended surgery once again. In August, the patient went to a second hospital with worsening abdominal symptoms. He received a diagnosis of colon cancer with metastasis to the liver. He died one week later.

The plaintiff alleged negligence in the failure to diagnose and treat the decedent’s colon cancer. The matter was ultimately tried against Dr. B. alone. The plaintiff claimed that Dr. B. should have followed up on the decedent’s abdominal CT, including investigation and treatment of the liver lesion. The plaintiff also claimed that the decedent’s reported abdominal pain, diarrhea, and constipation were not properly treated; earlier diagnosis of the decedent’s colon cancer would have increased his chance of survival, it was argued.

Dr. B. denied any negligence, main-taining that the decedent had not followed his recommendation for a laparotomy at the first visit and had ignored subsequent recommendations for surgery. He also defended his reliance on the radiologist’s opinion that the liver lesion was benign. If the cancer had already metastasized by the time he first saw the decedent, then there was nothing he could have done to change the outcome, he argued.

According to a published account, a defense verdict was returned.

Vascular Compromise After Surgery for Complex Tibia Fracture
After a serious motorcycle crash, a 39-year-old man was taken to a hospital emergency department, where he was treated by the defendant orthopedist for a complex tibia fracture and dislocation. Because vascular compromise in the leg was a concern, regular circulatory checks were ordered. Surgery was performed two days later, and the plaintiff began rehabilitation on day 4 of his hospitalization.

Two days later, nurses identified vascular compromise in the man’s foot, which was attributed to a popliteal artery injury. Surgery was performed, but the patient’s condition necessitated an above-the-knee amputation.

The plaintiff claimed that the amputation was required because of failure to provide proper monitoring or to identify the arterial injury. The defendants argued that the man’s care and monitoring were proper and that the need for amputation resulted from the serious injury he sustained in the motorcycle crash.

According to a published report, the jury awarded $604,000 in damages, with 70% negligence assessed to the orthopedist and 30% to the hospital.           

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

Recommendation Unheeded for Endocrinology Referral
A middle-aged man was referred by his primary care physician to the defendant pulmonologist in October 2002 for a sleep apnea consult. The patient complained of snoring, gasping for air at night, and daytime drowsiness. The pulmonologist, noticing that the man had coarse facial features, asked him whether anyone had ever mentioned facial changes to him; the man replied, “No.” The pulmonologist ordered blood work, including a random growth hormone sampling to test for excessive growth hormone.

The pulmonologist advised the patient to see his primary care physician for a possible referral to an endocrinologist. The man was also sent for an overnight sleep study to be tested for sleep apnea. The pulmonologist communicated with the patient’s primary care physician, mentioning the possibility of acromegaly and recommending an endocrinology consult. The primary care physician did not provide the referral to an endocrinologist, however.

The plaintiff returned to the defendant two months later for results of his sleep study. During that visit, the defendant informed him that findings from the growth hormone test were inconclusive. He advised the patient to return to his primary care physician for an endocrinology referral. The plaintiff was also instructed to return to the defendant pulmonologist in one month. The plaintiff never returned to the defendant and did not return to his primary care physician for 17 months.

The man was ultimately diagnosed with acromegaly, the production of excess growth hormone by the pituitary gland. He lost 90% of his pituitary gland and complains of double vision, cranial nerve injuries, hypopituitarism, diabetes insipidus, and sexual dysfunction.

The plaintiff claimed that the defendant pulmonologist wrote an “ambiguous” letter to the primary care physician (also a defendant in the case) that failed to specifically direct that physician to order an endocrinology consult. The plaintiff also claimed that results of the growth hormone test should have been forwarded to the primary care physician. The plaintiff claimed that diagnosis of acromegaly and appropriate treatment in 2002 or 2003 would have led to a cure for the pituitary tumor.

The defendant argued that his correspondence was clear regarding the need for an endocrinology consult and that forwarding the laboratory report was not required because results were inconclusive. The defendant also claimed that even with earlier treatment, the plaintiff’s condition would have been unchanged.

According to a published account, a defense verdict was returned. The primary care physician settled for an undisclosed amount prior to trial.

Post–Cesarean Surgery Complaints Overlooked
A woman underwent a cesarean delivery, performed by the defendant obstetrician with the assistance of two surgical nurses. At the conclusion of the procedure, the nurses informed the obstetrician that the sponge count was correct, and the surgical wound was closed.

About five months later, the patient complained of pain and tenderness in her abdomen; two months later, she went to the emergency department (ED) and was instructed to consult with her primary care physician. At that time, the patient did not have any pain but said her abdomen was “hard.”

One week later, the patient was seen by a different obstetrician/gynecologist, who ordered an abdominal CT. The test revealed that a surgical sponge had been retained during the cesarean delivery. The woman underwent surgery at the original hospital for removal of the sponge. The hospital eventually wrote off the charges for this surgery.

The plaintiff charged the nurses with negligence in miscounting the sponges and the defendant obstetrician for failing to refer her to another provider to determine the cause of her pain. A $159,000 settlement was reached with the hospital and the nurses.

The matter proceeded against the obstetrician, with the plaintiff claiming that the obstetrician should not have relied solely on the nurses’ sponge count and that she should have been more diligent about responding to the plaintiff’s complaints after the surgery.

The defendant claimed that she had acted appropriately in relying on the nurses’ sponge count and maintained that the plaintiff had no signs of fever or infection when she saw her two months after the surgery. The defendant also claimed that she repeatedly referred the plaintiff to other health care providers, including a neurologist and her primary care physician. She argued that the plaintiff had gone to the ED at least twice and had undergone ultrasonographic tests that did not detect the presence of the sponge. Finally, the defendant maintained that the plaintiff had no residual complications following the removal of the sponge.

According to a published report, a $375,000 verdict was returned. The court then ruled that the defendant obstetrician was entitled to a set-off against the verdict for the earlier $159,000 settlement. This reduced the plaintiff’s verdict to $216,000.

Failure to Diagnose Colon Cancer in Clinical Trial Subject
In August 2000, a 56-year-old man with a five-year history of Crohn’s disease was referred to Dr. B. for enrollment in a clinical trial of recombinant human interleukin 11 for treatment of Crohn’s disease.

Before seeing Dr. B., the patient had undergone abdominal CT. This revealed a 1.0-cm lesion on the liver that a radiologist had pronounced benign. The CT report was given to Dr. B., who recommended a laparotomy as the best strategy for the patient’s condition. However, the patient chose not to have the surgery and instead opted to participate in the clinical study.

Several times during his treatment with Dr. B., the man complained of abdominal pain, diarrhea, and constipation. He continued to participate in the study until March 2001, when he went to a hospital with abdominal pain. At that time, Dr. B. withdrew the patient from the drug trial.

One month later, the man returned to Dr. B., who recommended surgery once again. In August, the patient went to a second hospital with worsening abdominal symptoms. He received a diagnosis of colon cancer with metastasis to the liver. He died one week later.

The plaintiff alleged negligence in the failure to diagnose and treat the decedent’s colon cancer. The matter was ultimately tried against Dr. B. alone. The plaintiff claimed that Dr. B. should have followed up on the decedent’s abdominal CT, including investigation and treatment of the liver lesion. The plaintiff also claimed that the decedent’s reported abdominal pain, diarrhea, and constipation were not properly treated; earlier diagnosis of the decedent’s colon cancer would have increased his chance of survival, it was argued.

Dr. B. denied any negligence, main-taining that the decedent had not followed his recommendation for a laparotomy at the first visit and had ignored subsequent recommendations for surgery. He also defended his reliance on the radiologist’s opinion that the liver lesion was benign. If the cancer had already metastasized by the time he first saw the decedent, then there was nothing he could have done to change the outcome, he argued.

According to a published account, a defense verdict was returned.

Vascular Compromise After Surgery for Complex Tibia Fracture
After a serious motorcycle crash, a 39-year-old man was taken to a hospital emergency department, where he was treated by the defendant orthopedist for a complex tibia fracture and dislocation. Because vascular compromise in the leg was a concern, regular circulatory checks were ordered. Surgery was performed two days later, and the plaintiff began rehabilitation on day 4 of his hospitalization.

Two days later, nurses identified vascular compromise in the man’s foot, which was attributed to a popliteal artery injury. Surgery was performed, but the patient’s condition necessitated an above-the-knee amputation.

The plaintiff claimed that the amputation was required because of failure to provide proper monitoring or to identify the arterial injury. The defendants argued that the man’s care and monitoring were proper and that the need for amputation resulted from the serious injury he sustained in the motorcycle crash.

According to a published report, the jury awarded $604,000 in damages, with 70% negligence assessed to the orthopedist and 30% to the hospital.           

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

Recommendation Unheeded for Endocrinology Referral
A middle-aged man was referred by his primary care physician to the defendant pulmonologist in October 2002 for a sleep apnea consult. The patient complained of snoring, gasping for air at night, and daytime drowsiness. The pulmonologist, noticing that the man had coarse facial features, asked him whether anyone had ever mentioned facial changes to him; the man replied, “No.” The pulmonologist ordered blood work, including a random growth hormone sampling to test for excessive growth hormone.

The pulmonologist advised the patient to see his primary care physician for a possible referral to an endocrinologist. The man was also sent for an overnight sleep study to be tested for sleep apnea. The pulmonologist communicated with the patient’s primary care physician, mentioning the possibility of acromegaly and recommending an endocrinology consult. The primary care physician did not provide the referral to an endocrinologist, however.

The plaintiff returned to the defendant two months later for results of his sleep study. During that visit, the defendant informed him that findings from the growth hormone test were inconclusive. He advised the patient to return to his primary care physician for an endocrinology referral. The plaintiff was also instructed to return to the defendant pulmonologist in one month. The plaintiff never returned to the defendant and did not return to his primary care physician for 17 months.

The man was ultimately diagnosed with acromegaly, the production of excess growth hormone by the pituitary gland. He lost 90% of his pituitary gland and complains of double vision, cranial nerve injuries, hypopituitarism, diabetes insipidus, and sexual dysfunction.

The plaintiff claimed that the defendant pulmonologist wrote an “ambiguous” letter to the primary care physician (also a defendant in the case) that failed to specifically direct that physician to order an endocrinology consult. The plaintiff also claimed that results of the growth hormone test should have been forwarded to the primary care physician. The plaintiff claimed that diagnosis of acromegaly and appropriate treatment in 2002 or 2003 would have led to a cure for the pituitary tumor.

The defendant argued that his correspondence was clear regarding the need for an endocrinology consult and that forwarding the laboratory report was not required because results were inconclusive. The defendant also claimed that even with earlier treatment, the plaintiff’s condition would have been unchanged.

According to a published account, a defense verdict was returned. The primary care physician settled for an undisclosed amount prior to trial.

Post–Cesarean Surgery Complaints Overlooked
A woman underwent a cesarean delivery, performed by the defendant obstetrician with the assistance of two surgical nurses. At the conclusion of the procedure, the nurses informed the obstetrician that the sponge count was correct, and the surgical wound was closed.

About five months later, the patient complained of pain and tenderness in her abdomen; two months later, she went to the emergency department (ED) and was instructed to consult with her primary care physician. At that time, the patient did not have any pain but said her abdomen was “hard.”

One week later, the patient was seen by a different obstetrician/gynecologist, who ordered an abdominal CT. The test revealed that a surgical sponge had been retained during the cesarean delivery. The woman underwent surgery at the original hospital for removal of the sponge. The hospital eventually wrote off the charges for this surgery.

The plaintiff charged the nurses with negligence in miscounting the sponges and the defendant obstetrician for failing to refer her to another provider to determine the cause of her pain. A $159,000 settlement was reached with the hospital and the nurses.

The matter proceeded against the obstetrician, with the plaintiff claiming that the obstetrician should not have relied solely on the nurses’ sponge count and that she should have been more diligent about responding to the plaintiff’s complaints after the surgery.

The defendant claimed that she had acted appropriately in relying on the nurses’ sponge count and maintained that the plaintiff had no signs of fever or infection when she saw her two months after the surgery. The defendant also claimed that she repeatedly referred the plaintiff to other health care providers, including a neurologist and her primary care physician. She argued that the plaintiff had gone to the ED at least twice and had undergone ultrasonographic tests that did not detect the presence of the sponge. Finally, the defendant maintained that the plaintiff had no residual complications following the removal of the sponge.

According to a published report, a $375,000 verdict was returned. The court then ruled that the defendant obstetrician was entitled to a set-off against the verdict for the earlier $159,000 settlement. This reduced the plaintiff’s verdict to $216,000.

Failure to Diagnose Colon Cancer in Clinical Trial Subject
In August 2000, a 56-year-old man with a five-year history of Crohn’s disease was referred to Dr. B. for enrollment in a clinical trial of recombinant human interleukin 11 for treatment of Crohn’s disease.

Before seeing Dr. B., the patient had undergone abdominal CT. This revealed a 1.0-cm lesion on the liver that a radiologist had pronounced benign. The CT report was given to Dr. B., who recommended a laparotomy as the best strategy for the patient’s condition. However, the patient chose not to have the surgery and instead opted to participate in the clinical study.

Several times during his treatment with Dr. B., the man complained of abdominal pain, diarrhea, and constipation. He continued to participate in the study until March 2001, when he went to a hospital with abdominal pain. At that time, Dr. B. withdrew the patient from the drug trial.

One month later, the man returned to Dr. B., who recommended surgery once again. In August, the patient went to a second hospital with worsening abdominal symptoms. He received a diagnosis of colon cancer with metastasis to the liver. He died one week later.

The plaintiff alleged negligence in the failure to diagnose and treat the decedent’s colon cancer. The matter was ultimately tried against Dr. B. alone. The plaintiff claimed that Dr. B. should have followed up on the decedent’s abdominal CT, including investigation and treatment of the liver lesion. The plaintiff also claimed that the decedent’s reported abdominal pain, diarrhea, and constipation were not properly treated; earlier diagnosis of the decedent’s colon cancer would have increased his chance of survival, it was argued.

Dr. B. denied any negligence, main-taining that the decedent had not followed his recommendation for a laparotomy at the first visit and had ignored subsequent recommendations for surgery. He also defended his reliance on the radiologist’s opinion that the liver lesion was benign. If the cancer had already metastasized by the time he first saw the decedent, then there was nothing he could have done to change the outcome, he argued.

According to a published account, a defense verdict was returned.

Vascular Compromise After Surgery for Complex Tibia Fracture
After a serious motorcycle crash, a 39-year-old man was taken to a hospital emergency department, where he was treated by the defendant orthopedist for a complex tibia fracture and dislocation. Because vascular compromise in the leg was a concern, regular circulatory checks were ordered. Surgery was performed two days later, and the plaintiff began rehabilitation on day 4 of his hospitalization.

Two days later, nurses identified vascular compromise in the man’s foot, which was attributed to a popliteal artery injury. Surgery was performed, but the patient’s condition necessitated an above-the-knee amputation.

The plaintiff claimed that the amputation was required because of failure to provide proper monitoring or to identify the arterial injury. The defendants argued that the man’s care and monitoring were proper and that the need for amputation resulted from the serious injury he sustained in the motorcycle crash.

According to a published report, the jury awarded $604,000 in damages, with 70% negligence assessed to the orthopedist and 30% to the hospital.           

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as from 1 month prior to pregnancy to the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use.

Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

The risk of a rectal atresia was significantly elevated when the mother used anti-inflammatories during the entire critical period from 1 month prior to conception to the end of the third month. They also found a dose-response relationship because the risk was higher in those who used the drugs throughout the critical period compared with those who used anti-inflammatory drugs infrequently.

The investigators concluded that using asthma medications during the critical period of pregnancy carried no increased risk of isolated neural tube defects, omphalocele, or limb reduction.

In an interview, Gerald Briggs, B.Pharm., a pharmacist clinical specialist at the Women's Pavilion, Miller Children's Hospital, Long Beach, Calif., commented on Dr. Lin's study. “While a dose-response relationship is important for determining causation, the timing of the exposure also is critical,” he said. “Saying that some subjects used the drugs 'infrequently' is very subjective. What if some of the 'infrequent' users avoided the critical time (weeks 6-7) for causing anorectal atresia? That would reduce or eliminate the argument for a dose response. Moreover, at least three different classes of anti-inflammatory drugs were grouped together.”

Given these concerns, Mr. Briggs said, “I completely agree with the investigators that the study could only raise a hypothesis that requires further study. I would be reluctant to recommend that physicians change the way they counsel women with asthma until more information is available.”

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as from 1 month prior to pregnancy to the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use.

Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

The risk of a rectal atresia was significantly elevated when the mother used anti-inflammatories during the entire critical period from 1 month prior to conception to the end of the third month. They also found a dose-response relationship because the risk was higher in those who used the drugs throughout the critical period compared with those who used anti-inflammatory drugs infrequently.

The investigators concluded that using asthma medications during the critical period of pregnancy carried no increased risk of isolated neural tube defects, omphalocele, or limb reduction.

In an interview, Gerald Briggs, B.Pharm., a pharmacist clinical specialist at the Women's Pavilion, Miller Children's Hospital, Long Beach, Calif., commented on Dr. Lin's study. “While a dose-response relationship is important for determining causation, the timing of the exposure also is critical,” he said. “Saying that some subjects used the drugs 'infrequently' is very subjective. What if some of the 'infrequent' users avoided the critical time (weeks 6-7) for causing anorectal atresia? That would reduce or eliminate the argument for a dose response. Moreover, at least three different classes of anti-inflammatory drugs were grouped together.”

Given these concerns, Mr. Briggs said, “I completely agree with the investigators that the study could only raise a hypothesis that requires further study. I would be reluctant to recommend that physicians change the way they counsel women with asthma until more information is available.”

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — Women who take anti-inflammatories for asthma during the first trimester of pregnancy have an elevated risk of giving birth to an infant with anorectal atresia, according to results of a multicenter, case-control study of more than 7,000 women.

Anti-inflammatory use was not associated with any other birth defects, nor was the use of bronchodilators, Shao Lin, Ph.D., and colleagues at the New York State Department of Health reported in a poster presentation at the annual meeting of the Teratology Society.

The multicenter case-control study was part of the National Birth Defects Prevention Study, which collects data from 10 regions in the United States.

The investigators included women exposed to asthma medications at least once during a critical period defined as from 1 month prior to pregnancy to the end of the third pregnancy month. They focused on babies born between 1997 and 2003 with one of seven birth defects: diaphragmatic hernia, esophageal atresia, intestinal atresia, anorectal atresia, neural tube defects, omphalocele, and limb reduction.

In all, the investigators identified 2,248 infants with birth defects born to mothers taking asthma medications. They compared them with 4,986 nonmalformed, live-born infants identified by birth certificates or birth hospitals.

After adjusting for age, body mass index, parity, race/ethnicity, education, alcohol use, smoking, gender, folic acid use, fever, cocaine use, and the use of seven different vasoactive medications, the investigators found no significantly increased risks of birth defects associated with maternal bronchodilator use.

Maternal anti-inflammatory use, on the other hand, was associated with a statistically significant 2.6-fold increase in the risk of anorectal atresia. There were no other statistically significant associations between anti-inflammatory use and birth defects.

The investigators acknowledged that their study could not determine whether it was the anti-inflammatories or the asthma itself that was the causal agent. The use of asthma medications during the entire critical period could be an indication of especially severe asthma. They wrote that further studies would be needed to separate the effects of asthma from the effects of asthma treatment.

The risk of a rectal atresia was significantly elevated when the mother used anti-inflammatories during the entire critical period from 1 month prior to conception to the end of the third month. They also found a dose-response relationship because the risk was higher in those who used the drugs throughout the critical period compared with those who used anti-inflammatory drugs infrequently.

The investigators concluded that using asthma medications during the critical period of pregnancy carried no increased risk of isolated neural tube defects, omphalocele, or limb reduction.

In an interview, Gerald Briggs, B.Pharm., a pharmacist clinical specialist at the Women's Pavilion, Miller Children's Hospital, Long Beach, Calif., commented on Dr. Lin's study. “While a dose-response relationship is important for determining causation, the timing of the exposure also is critical,” he said. “Saying that some subjects used the drugs 'infrequently' is very subjective. What if some of the 'infrequent' users avoided the critical time (weeks 6-7) for causing anorectal atresia? That would reduce or eliminate the argument for a dose response. Moreover, at least three different classes of anti-inflammatory drugs were grouped together.”

Given these concerns, Mr. Briggs said, “I completely agree with the investigators that the study could only raise a hypothesis that requires further study. I would be reluctant to recommend that physicians change the way they counsel women with asthma until more information is available.”

Dr. Lin disclosed no conflicts of interest associated with the study.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration, Health Canada, and its manufacturer referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society.

And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, several more studies have been published.

Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately.

The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women.

The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls.

The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators disclosed no conflicts of interest related to their presentation.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration, Health Canada, and its manufacturer referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society.

And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, several more studies have been published.

Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately.

The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women.

The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls.

The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators disclosed no conflicts of interest related to their presentation.

MONTEREY, CALIF. — There is no statistically significant association between paroxetine usage during the first trimester of pregnancy and an increased risk of cardiac malformations in the infants, according to a meta-analysis of nine studies.

A selective serotonin reuptake inhibitor frequently prescribed for depression and anxiety, paroxetine (Paxil) was the subject of a 2005 warning by the Food and Drug Administration, Health Canada, and its manufacturer referencing unpublished findings of cardiac malformations in infants exposed during the first trimester of pregnancy.

Several other studies appeared to confirm these findings, Lisa O'Brien reported in a poster session at the annual meeting of the Teratology Society.

And a meta-analysis published in 2007 that included all of the studies published up until that time found that first-trimester paroxetine presented a modest increased risk of cardiac malformations (Clin. Ther. 2007;29:918-26).

Since then, however, several more studies have been published.

Ms. O'Brien of the Hospital for Sick Children, Toronto, and her colleagues identified a total of nine studies that could be included in their analysis—six cohort studies and three case-control studies—which they analyzed separately.

The case-control studies together included 30,247 women and, with a summary odds ratio of 1.18, found no statistically significant association between paroxetine and cardiac malformations.

The cohort studies included 66,409 women.

The rate of cardiac malformation was 1.14% among the 3,428 infants exposed to paroxetine and 1.09% among the 62,981 controls.

The weighted average difference in cardiac malformation rates between the two groups was 0.3%, which the investigators described as small and nonsignificant.

“First-trimester exposure to paroxetine appears not to be associated with an increased risk of cardiac malformations,” the investigators concluded.

“This evidence-based information will assist women, together with their physicians and other health care providers, to make an informed decision regarding the use of paroxetine during pregnancy.”

The investigators disclosed no conflicts of interest related to their presentation.

NEWPORT BEACH, CALIF. — Like the rest of the U.S. population, pregnant adolescents have gotten heavier since 1990, but that hasn't resulted in fewer preterm or small-for-gestational-age babies born to teenage mothers, according to data gathered on 1,187 such first-time mothers.

“They're not benefiting the babies by adding the extra weight,” Jeanelle Sheeder said in a presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Ms. Sheeder of the University of Colorado, Denver, and her associates analyzed data on 1,187 primigravida participants who enrolled consecutively between 1990 and 2005 in the Colorado Adolescent Maternity Program (CAMP) at the university. All were 13-18 years old and of diverse racial and ethnic backgrounds.

In that 15-year time period, there were significant increases in maternal weight, body mass index, proportion of overweight or obese mothers, age, proportion of Hispanics, and rate of induced labors. “Oddly,” Ms. Sheeder noted, maternal height decreased significantly. There also were significant decreases in the rate of pregnancy-induced hypertension and in the proportion of those who were white.

No differences over time were seen, however, in any infant outcomes, including birth weight, gestational age, preterm birth rate, and proportions of infants who were small, average, or large for gestational age. On average, the babies born to this adolescent cohort were a bit smaller than babies typically born to adult women, Ms. Sheeder said.

After adjustment of the data for significant factors, including age and race or ethnicity, only the increase in maternal weight and the decrease in maternal height remained statistically significant. No other maternal or infant measures changed significantly over time. Average maternal weight increased from 124 pounds in the early 1990s to 132 pounds in 2005, an 8-pound gain. Average maternal height decreased from 5 feet 4 inches to 5 feet 3 inches. Average birth weights were 3,170 g in 1990 and 3,000 g in 2005; the difference is within a normal 200-g fluctuation seen from year to year in this population, she said.

Maternal body mass index increased from 22 kg/m

Maternal age increased from 16.1 years to 16.7 years on average. The increasing age of the primigravid adolescents in the program over time cheered the investigators. “We were happy to see that they were getting older,” she said.

When the investigators looked at the amount of weight the mothers gained during gestation, they initially were pleased that the mothers tended to gain more pounds during pregnancy as the years progressed; they hoped that this trend would translate into bigger, healthier babies.

Unlike trends in adults, however, in which both mothers and their infants have gotten bigger, in adolescents only the moms got bigger. “This leads us to believe that adolescents probably transfer less of the weight that they gain” to infants, she said, noting that studies on appropriate weight for adolescent mothers may be warranted.

NEWPORT BEACH, CALIF. — Like the rest of the U.S. population, pregnant adolescents have gotten heavier since 1990, but that hasn't resulted in fewer preterm or small-for-gestational-age babies born to teenage mothers, according to data gathered on 1,187 such first-time mothers.

“They're not benefiting the babies by adding the extra weight,” Jeanelle Sheeder said in a presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Ms. Sheeder of the University of Colorado, Denver, and her associates analyzed data on 1,187 primigravida participants who enrolled consecutively between 1990 and 2005 in the Colorado Adolescent Maternity Program (CAMP) at the university. All were 13-18 years old and of diverse racial and ethnic backgrounds.

In that 15-year time period, there were significant increases in maternal weight, body mass index, proportion of overweight or obese mothers, age, proportion of Hispanics, and rate of induced labors. “Oddly,” Ms. Sheeder noted, maternal height decreased significantly. There also were significant decreases in the rate of pregnancy-induced hypertension and in the proportion of those who were white.

No differences over time were seen, however, in any infant outcomes, including birth weight, gestational age, preterm birth rate, and proportions of infants who were small, average, or large for gestational age. On average, the babies born to this adolescent cohort were a bit smaller than babies typically born to adult women, Ms. Sheeder said.

After adjustment of the data for significant factors, including age and race or ethnicity, only the increase in maternal weight and the decrease in maternal height remained statistically significant. No other maternal or infant measures changed significantly over time. Average maternal weight increased from 124 pounds in the early 1990s to 132 pounds in 2005, an 8-pound gain. Average maternal height decreased from 5 feet 4 inches to 5 feet 3 inches. Average birth weights were 3,170 g in 1990 and 3,000 g in 2005; the difference is within a normal 200-g fluctuation seen from year to year in this population, she said.

Maternal body mass index increased from 22 kg/m

Maternal age increased from 16.1 years to 16.7 years on average. The increasing age of the primigravid adolescents in the program over time cheered the investigators. “We were happy to see that they were getting older,” she said.

When the investigators looked at the amount of weight the mothers gained during gestation, they initially were pleased that the mothers tended to gain more pounds during pregnancy as the years progressed; they hoped that this trend would translate into bigger, healthier babies.

Unlike trends in adults, however, in which both mothers and their infants have gotten bigger, in adolescents only the moms got bigger. “This leads us to believe that adolescents probably transfer less of the weight that they gain” to infants, she said, noting that studies on appropriate weight for adolescent mothers may be warranted.

NEWPORT BEACH, CALIF. — Like the rest of the U.S. population, pregnant adolescents have gotten heavier since 1990, but that hasn't resulted in fewer preterm or small-for-gestational-age babies born to teenage mothers, according to data gathered on 1,187 such first-time mothers.

“They're not benefiting the babies by adding the extra weight,” Jeanelle Sheeder said in a presentation at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Ms. Sheeder of the University of Colorado, Denver, and her associates analyzed data on 1,187 primigravida participants who enrolled consecutively between 1990 and 2005 in the Colorado Adolescent Maternity Program (CAMP) at the university. All were 13-18 years old and of diverse racial and ethnic backgrounds.

In that 15-year time period, there were significant increases in maternal weight, body mass index, proportion of overweight or obese mothers, age, proportion of Hispanics, and rate of induced labors. “Oddly,” Ms. Sheeder noted, maternal height decreased significantly. There also were significant decreases in the rate of pregnancy-induced hypertension and in the proportion of those who were white.

No differences over time were seen, however, in any infant outcomes, including birth weight, gestational age, preterm birth rate, and proportions of infants who were small, average, or large for gestational age. On average, the babies born to this adolescent cohort were a bit smaller than babies typically born to adult women, Ms. Sheeder said.

After adjustment of the data for significant factors, including age and race or ethnicity, only the increase in maternal weight and the decrease in maternal height remained statistically significant. No other maternal or infant measures changed significantly over time. Average maternal weight increased from 124 pounds in the early 1990s to 132 pounds in 2005, an 8-pound gain. Average maternal height decreased from 5 feet 4 inches to 5 feet 3 inches. Average birth weights were 3,170 g in 1990 and 3,000 g in 2005; the difference is within a normal 200-g fluctuation seen from year to year in this population, she said.

Maternal body mass index increased from 22 kg/m

Maternal age increased from 16.1 years to 16.7 years on average. The increasing age of the primigravid adolescents in the program over time cheered the investigators. “We were happy to see that they were getting older,” she said.

When the investigators looked at the amount of weight the mothers gained during gestation, they initially were pleased that the mothers tended to gain more pounds during pregnancy as the years progressed; they hoped that this trend would translate into bigger, healthier babies.

Unlike trends in adults, however, in which both mothers and their infants have gotten bigger, in adolescents only the moms got bigger. “This leads us to believe that adolescents probably transfer less of the weight that they gain” to infants, she said, noting that studies on appropriate weight for adolescent mothers may be warranted.

SAN FRANCISCO — Pregnancy outcomes for women with diabetes who maintain excellent glucose control during their pregnancy are very good, and are similar to those seen in the general population, according to the results of a retrospective study.

The study, conducted by the high-risk obstetrics/endocrinology clinic at the Nebraska Medical Center, Omaha, found a low rate of diabetes-related obstetric complications among a group of 100 women who attended the clinic during their pregnancies.

The clinic has used a team approach, incorporating intensive insulin and specific targets, since 1997. That approach “can result in excellent glucose control in at least half of patients, with overall maternal and fetal outcomes similar to” those in the general population, Dr. Kara Meinke Baehr said in a poster presented at the annual meeting of the Endocrine Society. The team includes perinatologists, endocrinologists, certified diabetes educators, registered dietitians, a social worker, and a translator.

Dr. Meinke Baehr of the Nebraska Medical Center and her colleagues reviewed the records of 100 women whose pregnancies were managed at the clinic from 1997 to 2006. Fetal outcomes were compared with the Nebraska 2004 Vital Statistics report.

The mean age at enrollment in the clinic was 29 years; the mean prepregnancy body mass index was 32 kg/m

More than a third of the women (36%) had type 1 diabetes; 26% had type 2 diabetes; 26% had gestational diabetes managed with insulin; and 12% had gestational diabetes managed by diet.

Women with types 1 and 2 diabetes significantly improved their blood glucose levels during the second and third trimesters of their pregnancies. At 8 weeks, only 25% had a hemoglobin A1c (HbA1c) value of less than 7%. That number rose to 80% by week 16 and to 90% by week 24; it then dropped back to 80% by week 32.

By the second half of pregnancy, about half of the cohort was meeting the goal of an HbA1c value of 6% or less, a significant improvement from the first trimester.

Maternal complications during pregnancy included retinopathy (6%), proteinuria (38%), and pre-eclampsia (17%). There were 104 hospitalizations, more than half of which were for glucose control. One woman was admitted 10 times.

Insulin regimens were used in 115 of the 127 pregnancies (90%). At the time of delivery, 43% were taking four injections per day; 2% were taking one insulin injection per day; 22% were taking two injections per day; and 3% were taking three injections per day. In all, 20% were using an insulin pump.

There were 127 pregnancies among these women over the study period, including 121 live births with two sets of twins. Most of the deliveries (71%) were by cesarean section; the rest were vaginal.

The mean gestational age was 37 weeks. Apgar scores were good, with a mean of 7.4 at 1 minute and 8.5 at 5 minutes. The mean birth weight was 3,479 grams; 28% of the infants were macrosomic. Overall, 35% of the infants required a stay in the neonatal intensive care unit (mean length of stay, 16 days).

The rate of birth trauma was 2%; traumas included Erb's palsy and shoulder dystocia. The rate of birth defects was 7%. Such defects included one schizencephaly, one tracheoesophageal fistula, one transposition of the great vessels, one polydactyly, and two cases of patent ductus arteriosus.

All rates were lower than those in the 2004 Nebraska state report, but comparisons can't be drawn because of the small study sample, Dr. Meinke Baehr noted.

SAN FRANCISCO — Pregnancy outcomes for women with diabetes who maintain excellent glucose control during their pregnancy are very good, and are similar to those seen in the general population, according to the results of a retrospective study.

The study, conducted by the high-risk obstetrics/endocrinology clinic at the Nebraska Medical Center, Omaha, found a low rate of diabetes-related obstetric complications among a group of 100 women who attended the clinic during their pregnancies.

The clinic has used a team approach, incorporating intensive insulin and specific targets, since 1997. That approach “can result in excellent glucose control in at least half of patients, with overall maternal and fetal outcomes similar to” those in the general population, Dr. Kara Meinke Baehr said in a poster presented at the annual meeting of the Endocrine Society. The team includes perinatologists, endocrinologists, certified diabetes educators, registered dietitians, a social worker, and a translator.

Dr. Meinke Baehr of the Nebraska Medical Center and her colleagues reviewed the records of 100 women whose pregnancies were managed at the clinic from 1997 to 2006. Fetal outcomes were compared with the Nebraska 2004 Vital Statistics report.

The mean age at enrollment in the clinic was 29 years; the mean prepregnancy body mass index was 32 kg/m

More than a third of the women (36%) had type 1 diabetes; 26% had type 2 diabetes; 26% had gestational diabetes managed with insulin; and 12% had gestational diabetes managed by diet.

Women with types 1 and 2 diabetes significantly improved their blood glucose levels during the second and third trimesters of their pregnancies. At 8 weeks, only 25% had a hemoglobin A1c (HbA1c) value of less than 7%. That number rose to 80% by week 16 and to 90% by week 24; it then dropped back to 80% by week 32.

By the second half of pregnancy, about half of the cohort was meeting the goal of an HbA1c value of 6% or less, a significant improvement from the first trimester.

Maternal complications during pregnancy included retinopathy (6%), proteinuria (38%), and pre-eclampsia (17%). There were 104 hospitalizations, more than half of which were for glucose control. One woman was admitted 10 times.

Insulin regimens were used in 115 of the 127 pregnancies (90%). At the time of delivery, 43% were taking four injections per day; 2% were taking one insulin injection per day; 22% were taking two injections per day; and 3% were taking three injections per day. In all, 20% were using an insulin pump.

There were 127 pregnancies among these women over the study period, including 121 live births with two sets of twins. Most of the deliveries (71%) were by cesarean section; the rest were vaginal.

The mean gestational age was 37 weeks. Apgar scores were good, with a mean of 7.4 at 1 minute and 8.5 at 5 minutes. The mean birth weight was 3,479 grams; 28% of the infants were macrosomic. Overall, 35% of the infants required a stay in the neonatal intensive care unit (mean length of stay, 16 days).

The rate of birth trauma was 2%; traumas included Erb's palsy and shoulder dystocia. The rate of birth defects was 7%. Such defects included one schizencephaly, one tracheoesophageal fistula, one transposition of the great vessels, one polydactyly, and two cases of patent ductus arteriosus.

All rates were lower than those in the 2004 Nebraska state report, but comparisons can't be drawn because of the small study sample, Dr. Meinke Baehr noted.

SAN FRANCISCO — Pregnancy outcomes for women with diabetes who maintain excellent glucose control during their pregnancy are very good, and are similar to those seen in the general population, according to the results of a retrospective study.

The study, conducted by the high-risk obstetrics/endocrinology clinic at the Nebraska Medical Center, Omaha, found a low rate of diabetes-related obstetric complications among a group of 100 women who attended the clinic during their pregnancies.

The clinic has used a team approach, incorporating intensive insulin and specific targets, since 1997. That approach “can result in excellent glucose control in at least half of patients, with overall maternal and fetal outcomes similar to” those in the general population, Dr. Kara Meinke Baehr said in a poster presented at the annual meeting of the Endocrine Society. The team includes perinatologists, endocrinologists, certified diabetes educators, registered dietitians, a social worker, and a translator.

Dr. Meinke Baehr of the Nebraska Medical Center and her colleagues reviewed the records of 100 women whose pregnancies were managed at the clinic from 1997 to 2006. Fetal outcomes were compared with the Nebraska 2004 Vital Statistics report.

The mean age at enrollment in the clinic was 29 years; the mean prepregnancy body mass index was 32 kg/m

More than a third of the women (36%) had type 1 diabetes; 26% had type 2 diabetes; 26% had gestational diabetes managed with insulin; and 12% had gestational diabetes managed by diet.

Women with types 1 and 2 diabetes significantly improved their blood glucose levels during the second and third trimesters of their pregnancies. At 8 weeks, only 25% had a hemoglobin A1c (HbA1c) value of less than 7%. That number rose to 80% by week 16 and to 90% by week 24; it then dropped back to 80% by week 32.

By the second half of pregnancy, about half of the cohort was meeting the goal of an HbA1c value of 6% or less, a significant improvement from the first trimester.

Maternal complications during pregnancy included retinopathy (6%), proteinuria (38%), and pre-eclampsia (17%). There were 104 hospitalizations, more than half of which were for glucose control. One woman was admitted 10 times.

Insulin regimens were used in 115 of the 127 pregnancies (90%). At the time of delivery, 43% were taking four injections per day; 2% were taking one insulin injection per day; 22% were taking two injections per day; and 3% were taking three injections per day. In all, 20% were using an insulin pump.

There were 127 pregnancies among these women over the study period, including 121 live births with two sets of twins. Most of the deliveries (71%) were by cesarean section; the rest were vaginal.

The mean gestational age was 37 weeks. Apgar scores were good, with a mean of 7.4 at 1 minute and 8.5 at 5 minutes. The mean birth weight was 3,479 grams; 28% of the infants were macrosomic. Overall, 35% of the infants required a stay in the neonatal intensive care unit (mean length of stay, 16 days).

The rate of birth trauma was 2%; traumas included Erb's palsy and shoulder dystocia. The rate of birth defects was 7%. Such defects included one schizencephaly, one tracheoesophageal fistula, one transposition of the great vessels, one polydactyly, and two cases of patent ductus arteriosus.

All rates were lower than those in the 2004 Nebraska state report, but comparisons can't be drawn because of the small study sample, Dr. Meinke Baehr noted.

Pregnancy does not raise the risk of developing any of the most prevalent mental disorders, with the notable exception of postpartum depression, according to a report in the July issue of the Archives of General Psychiatry.

“Pregnancy is traditionally viewed as a stressful period that may provoke mental illness. However, [except for] major depressive disorder among postpartum women, rates of the most prevalent psychiatric disorders are not significantly higher and, in some cases, are even lower in pregnant and postpartum women than in nonpregnant women of childbearing age,” said Dr. Oriana Vesga-López of the New York State Psychiatric Institute and her associates.

Pregnant and postpartum women are widely considered to be vulnerable to psychiatric disorders, but no study to date has used methods that permit accurate estimation of the prevalence of a wide range of such disorders among pregnant women in the general U.S. population.

“Furthermore, we know of no previous study that included nonpregnant women of comparable age drawn from the general population to identify the specific contribution of pregnancy or the postpartum period to the risk of psychiatric disorders,” Dr. Vesga-López and her associates noted.

They studied the issue using a nationally representative sample of 43,093 adults surveyed in person as part of the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions conducted by professional lay interviewers in the U.S. Census Bureau.

This included nearly 15,000 women of childbearing age, of whom 453 were pregnant at the time of the survey, 994 were postpartum, and 13,025 were neither (“nonpregnant”).

The survey included a diagnostic interview to screen for self-reported Axis I diagnoses, including substance use, mood disorders, and anxiety disorders.

To gauge possible psychotic disorders, respondents were asked whether they had ever been told by a physician or other health professional that they had schizophrenia or a psychotic disorder.

The 1-year prevalence of psychiatric disorders ranged from 0.4% (psychotic disorders) to 14.6% (substance use disorders) in pregnant and postpartum subjects, compared with 0.3%-19.9% for the same diagnoses in nonpregnant women, the researchers said (Arch. Gen. Psychiatry 2008;65:805-15).

The prevalence of substance use was actually lower in pregnant and postpartum women than in nonpregnant women, and the prevalence of social anxiety disorder was markedly lower.

Factors that heightened the risk of psychiatric disorder in pregnant women included younger age, single marital status, recent exposure to traumatic or stressful life events, pregnancy complications, and poor overall health.

The presence of any of these factors should alert clinicians who treat women and their children that targeted intervention might be necessary, Dr. Vesga-López and her associates said.

Despite the relatively high prevalence of psychiatric disorders in both pregnant and nonpregnant women in this study, the rate of treatment for psychiatric disorders was “very low” in both groups. This finding was particularly striking in pregnant women, given their usual access to health care during and immediately after pregnancy.

“Their failure to receive psychiatric treatment suggests the existence of important barriers to mental health care for this population,” including the failure of clinicians to recognize psychiatric symptoms or to consider them a normal response to the physiologic and psychosocial changes of pregnancy, the investigators noted.

The researchers wrote that considering the importance of this period of life for mothers and their offspring, “urgent action is needed to increase detection and treatment of psychiatric disorders among pregnant and postpartum women in the United States.”

The study was funded by National Institutes of Health grants, and grants from the American Foundation for Suicide Prevention and the New York State Psychiatric Institute.

Dr. Vesga-López stated that she had no conflicts of interest to disclose.

Pregnancy does not raise the risk of developing any of the most prevalent mental disorders, with the notable exception of postpartum depression, according to a report in the July issue of the Archives of General Psychiatry.

“Pregnancy is traditionally viewed as a stressful period that may provoke mental illness. However, [except for] major depressive disorder among postpartum women, rates of the most prevalent psychiatric disorders are not significantly higher and, in some cases, are even lower in pregnant and postpartum women than in nonpregnant women of childbearing age,” said Dr. Oriana Vesga-López of the New York State Psychiatric Institute and her associates.

Pregnant and postpartum women are widely considered to be vulnerable to psychiatric disorders, but no study to date has used methods that permit accurate estimation of the prevalence of a wide range of such disorders among pregnant women in the general U.S. population.

“Furthermore, we know of no previous study that included nonpregnant women of comparable age drawn from the general population to identify the specific contribution of pregnancy or the postpartum period to the risk of psychiatric disorders,” Dr. Vesga-López and her associates noted.

They studied the issue using a nationally representative sample of 43,093 adults surveyed in person as part of the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions conducted by professional lay interviewers in the U.S. Census Bureau.

This included nearly 15,000 women of childbearing age, of whom 453 were pregnant at the time of the survey, 994 were postpartum, and 13,025 were neither (“nonpregnant”).

The survey included a diagnostic interview to screen for self-reported Axis I diagnoses, including substance use, mood disorders, and anxiety disorders.

To gauge possible psychotic disorders, respondents were asked whether they had ever been told by a physician or other health professional that they had schizophrenia or a psychotic disorder.

The 1-year prevalence of psychiatric disorders ranged from 0.4% (psychotic disorders) to 14.6% (substance use disorders) in pregnant and postpartum subjects, compared with 0.3%-19.9% for the same diagnoses in nonpregnant women, the researchers said (Arch. Gen. Psychiatry 2008;65:805-15).

The prevalence of substance use was actually lower in pregnant and postpartum women than in nonpregnant women, and the prevalence of social anxiety disorder was markedly lower.

Factors that heightened the risk of psychiatric disorder in pregnant women included younger age, single marital status, recent exposure to traumatic or stressful life events, pregnancy complications, and poor overall health.

The presence of any of these factors should alert clinicians who treat women and their children that targeted intervention might be necessary, Dr. Vesga-López and her associates said.

Despite the relatively high prevalence of psychiatric disorders in both pregnant and nonpregnant women in this study, the rate of treatment for psychiatric disorders was “very low” in both groups. This finding was particularly striking in pregnant women, given their usual access to health care during and immediately after pregnancy.

“Their failure to receive psychiatric treatment suggests the existence of important barriers to mental health care for this population,” including the failure of clinicians to recognize psychiatric symptoms or to consider them a normal response to the physiologic and psychosocial changes of pregnancy, the investigators noted.

The researchers wrote that considering the importance of this period of life for mothers and their offspring, “urgent action is needed to increase detection and treatment of psychiatric disorders among pregnant and postpartum women in the United States.”

The study was funded by National Institutes of Health grants, and grants from the American Foundation for Suicide Prevention and the New York State Psychiatric Institute.

Dr. Vesga-López stated that she had no conflicts of interest to disclose.

Pregnancy does not raise the risk of developing any of the most prevalent mental disorders, with the notable exception of postpartum depression, according to a report in the July issue of the Archives of General Psychiatry.

“Pregnancy is traditionally viewed as a stressful period that may provoke mental illness. However, [except for] major depressive disorder among postpartum women, rates of the most prevalent psychiatric disorders are not significantly higher and, in some cases, are even lower in pregnant and postpartum women than in nonpregnant women of childbearing age,” said Dr. Oriana Vesga-López of the New York State Psychiatric Institute and her associates.

Pregnant and postpartum women are widely considered to be vulnerable to psychiatric disorders, but no study to date has used methods that permit accurate estimation of the prevalence of a wide range of such disorders among pregnant women in the general U.S. population.

“Furthermore, we know of no previous study that included nonpregnant women of comparable age drawn from the general population to identify the specific contribution of pregnancy or the postpartum period to the risk of psychiatric disorders,” Dr. Vesga-López and her associates noted.

They studied the issue using a nationally representative sample of 43,093 adults surveyed in person as part of the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions conducted by professional lay interviewers in the U.S. Census Bureau.

This included nearly 15,000 women of childbearing age, of whom 453 were pregnant at the time of the survey, 994 were postpartum, and 13,025 were neither (“nonpregnant”).

The survey included a diagnostic interview to screen for self-reported Axis I diagnoses, including substance use, mood disorders, and anxiety disorders.

To gauge possible psychotic disorders, respondents were asked whether they had ever been told by a physician or other health professional that they had schizophrenia or a psychotic disorder.

The 1-year prevalence of psychiatric disorders ranged from 0.4% (psychotic disorders) to 14.6% (substance use disorders) in pregnant and postpartum subjects, compared with 0.3%-19.9% for the same diagnoses in nonpregnant women, the researchers said (Arch. Gen. Psychiatry 2008;65:805-15).

The prevalence of substance use was actually lower in pregnant and postpartum women than in nonpregnant women, and the prevalence of social anxiety disorder was markedly lower.

Factors that heightened the risk of psychiatric disorder in pregnant women included younger age, single marital status, recent exposure to traumatic or stressful life events, pregnancy complications, and poor overall health.

The presence of any of these factors should alert clinicians who treat women and their children that targeted intervention might be necessary, Dr. Vesga-López and her associates said.

Despite the relatively high prevalence of psychiatric disorders in both pregnant and nonpregnant women in this study, the rate of treatment for psychiatric disorders was “very low” in both groups. This finding was particularly striking in pregnant women, given their usual access to health care during and immediately after pregnancy.

“Their failure to receive psychiatric treatment suggests the existence of important barriers to mental health care for this population,” including the failure of clinicians to recognize psychiatric symptoms or to consider them a normal response to the physiologic and psychosocial changes of pregnancy, the investigators noted.

The researchers wrote that considering the importance of this period of life for mothers and their offspring, “urgent action is needed to increase detection and treatment of psychiatric disorders among pregnant and postpartum women in the United States.”

The study was funded by National Institutes of Health grants, and grants from the American Foundation for Suicide Prevention and the New York State Psychiatric Institute.

Dr. Vesga-López stated that she had no conflicts of interest to disclose.

WASHINGTON — Even though the sleeping aid zolpidem does cross the placenta, use of the drug during pregnancy does not appear to significantly affect outcomes, a study of 45 women shows.

The study, presented as a poster at the annual meeting of the American Psychiatric Association, included pregnant women who were enrolled in a prospective study of the pharmacokinetics of psychotropic drugs during pregnancy and who were treated with zolpidem (Ambien) during pregnancy. Maternal diagnoses were determined using the Structured Clinical Interview for DSM-IV (SCID). Maternal and cord blood samples were obtained at delivery when possible.

The placental passage rate was calculated as the ratio of medication concentration in the umbilical cord plasma to that in maternal plasma. When umbilical cord concentrations were below the limit of detection (less than 4.0 ng/mL), this value was used for data analysis. This approach was thought to be conservative, erring toward overestimation of fetal exposure to zolpidem. When both maternal and umbilical plasma concentrations were less than the detection limit, the pair was excluded from the analysis.

Obstetric and neonatal outcomes among women who had given birth to a live infant after taking zolpidem during pregnancy were compared with outcomes among a group of 45 women who were matched for age, race, level of education, SCID diagnosis, and pregnancy exposure to the same classes of nonzolpidem psychotropic medications.

In additional analyses, the researchers looked at zolpidem use during the third trimester versus use during the first or second (but not third) trimesters, those taking a low (5 mg or less per day) zolpidem daily dose versus those receiving a greater daily dose, and those with extended (10 weeks or greater) zolpidem exposure versus those with shorter exposure.

For women who took zolpidem during pregnancy, exposure by trimester included 38% in the first trimester, 56% in the second trimester, and 38% in the third trimester. The average zolpidem exposure during pregnancy was 14 weeks, and the average dose was 9 mg.

There were no statistically significant differences between the two groups in terms of obstetric and neonatal outcomes. However, there was a trend toward preterm delivery and low-birth-weight infants among women on zolpidem during pregnancy. In the zolpidem group, 27% of the women had a preterm delivery and 16% had low-birth-weight infants, compared with 16% and 8%, respectively, for the nonzolpidem group.

“It is unclear if these outcomes were driven by zolpidem exposure and/or sleep disturbance or other pharmacological intervention in pregnancy,” wrote Sandra Juric and her colleagues at Emory University's Women's Mental Health Program in Atlanta.

Nine women reported taking zolpidem within 24 hours of delivery, but this could be confirmed for only six women. For these women, zolpidem concentrations at delivery were lower than expected for both maternal plasma (range of less than 4 ng/mL to 64 ng/mL) and umbilical plasma (range of less than 4 ng/mL to 15 ng/mL.

“These concentrations are lower than the peak plasma concentrations reported for healthy adults after a single 5- or 10-mg dose,” the researchers noted. “Zolpidem appears to rapidly clear the fetal circulation; however, if delivery occurs less than 11 hours after the last maternal dose, zolpidem may still be present in the neonatal circulation.”

Women who reported longer zolpidem use during pregnancy (10 weeks or longer) did not have a greater rate of complications. There also appeared to be no difference between drug use in a particular trimester versus use throughout the pregnancy in terms of complications.

Ms. Juric stated she had no conflicts of interest to report.

WASHINGTON — Even though the sleeping aid zolpidem does cross the placenta, use of the drug during pregnancy does not appear to significantly affect outcomes, a study of 45 women shows.

The study, presented as a poster at the annual meeting of the American Psychiatric Association, included pregnant women who were enrolled in a prospective study of the pharmacokinetics of psychotropic drugs during pregnancy and who were treated with zolpidem (Ambien) during pregnancy. Maternal diagnoses were determined using the Structured Clinical Interview for DSM-IV (SCID). Maternal and cord blood samples were obtained at delivery when possible.

The placental passage rate was calculated as the ratio of medication concentration in the umbilical cord plasma to that in maternal plasma. When umbilical cord concentrations were below the limit of detection (less than 4.0 ng/mL), this value was used for data analysis. This approach was thought to be conservative, erring toward overestimation of fetal exposure to zolpidem. When both maternal and umbilical plasma concentrations were less than the detection limit, the pair was excluded from the analysis.

Obstetric and neonatal outcomes among women who had given birth to a live infant after taking zolpidem during pregnancy were compared with outcomes among a group of 45 women who were matched for age, race, level of education, SCID diagnosis, and pregnancy exposure to the same classes of nonzolpidem psychotropic medications.

In additional analyses, the researchers looked at zolpidem use during the third trimester versus use during the first or second (but not third) trimesters, those taking a low (5 mg or less per day) zolpidem daily dose versus those receiving a greater daily dose, and those with extended (10 weeks or greater) zolpidem exposure versus those with shorter exposure.

For women who took zolpidem during pregnancy, exposure by trimester included 38% in the first trimester, 56% in the second trimester, and 38% in the third trimester. The average zolpidem exposure during pregnancy was 14 weeks, and the average dose was 9 mg.

There were no statistically significant differences between the two groups in terms of obstetric and neonatal outcomes. However, there was a trend toward preterm delivery and low-birth-weight infants among women on zolpidem during pregnancy. In the zolpidem group, 27% of the women had a preterm delivery and 16% had low-birth-weight infants, compared with 16% and 8%, respectively, for the nonzolpidem group.

“It is unclear if these outcomes were driven by zolpidem exposure and/or sleep disturbance or other pharmacological intervention in pregnancy,” wrote Sandra Juric and her colleagues at Emory University's Women's Mental Health Program in Atlanta.

Nine women reported taking zolpidem within 24 hours of delivery, but this could be confirmed for only six women. For these women, zolpidem concentrations at delivery were lower than expected for both maternal plasma (range of less than 4 ng/mL to 64 ng/mL) and umbilical plasma (range of less than 4 ng/mL to 15 ng/mL.

“These concentrations are lower than the peak plasma concentrations reported for healthy adults after a single 5- or 10-mg dose,” the researchers noted. “Zolpidem appears to rapidly clear the fetal circulation; however, if delivery occurs less than 11 hours after the last maternal dose, zolpidem may still be present in the neonatal circulation.”

Women who reported longer zolpidem use during pregnancy (10 weeks or longer) did not have a greater rate of complications. There also appeared to be no difference between drug use in a particular trimester versus use throughout the pregnancy in terms of complications.

Ms. Juric stated she had no conflicts of interest to report.

WASHINGTON — Even though the sleeping aid zolpidem does cross the placenta, use of the drug during pregnancy does not appear to significantly affect outcomes, a study of 45 women shows.

The study, presented as a poster at the annual meeting of the American Psychiatric Association, included pregnant women who were enrolled in a prospective study of the pharmacokinetics of psychotropic drugs during pregnancy and who were treated with zolpidem (Ambien) during pregnancy. Maternal diagnoses were determined using the Structured Clinical Interview for DSM-IV (SCID). Maternal and cord blood samples were obtained at delivery when possible.

The placental passage rate was calculated as the ratio of medication concentration in the umbilical cord plasma to that in maternal plasma. When umbilical cord concentrations were below the limit of detection (less than 4.0 ng/mL), this value was used for data analysis. This approach was thought to be conservative, erring toward overestimation of fetal exposure to zolpidem. When both maternal and umbilical plasma concentrations were less than the detection limit, the pair was excluded from the analysis.

Obstetric and neonatal outcomes among women who had given birth to a live infant after taking zolpidem during pregnancy were compared with outcomes among a group of 45 women who were matched for age, race, level of education, SCID diagnosis, and pregnancy exposure to the same classes of nonzolpidem psychotropic medications.

In additional analyses, the researchers looked at zolpidem use during the third trimester versus use during the first or second (but not third) trimesters, those taking a low (5 mg or less per day) zolpidem daily dose versus those receiving a greater daily dose, and those with extended (10 weeks or greater) zolpidem exposure versus those with shorter exposure.

For women who took zolpidem during pregnancy, exposure by trimester included 38% in the first trimester, 56% in the second trimester, and 38% in the third trimester. The average zolpidem exposure during pregnancy was 14 weeks, and the average dose was 9 mg.

There were no statistically significant differences between the two groups in terms of obstetric and neonatal outcomes. However, there was a trend toward preterm delivery and low-birth-weight infants among women on zolpidem during pregnancy. In the zolpidem group, 27% of the women had a preterm delivery and 16% had low-birth-weight infants, compared with 16% and 8%, respectively, for the nonzolpidem group.

“It is unclear if these outcomes were driven by zolpidem exposure and/or sleep disturbance or other pharmacological intervention in pregnancy,” wrote Sandra Juric and her colleagues at Emory University's Women's Mental Health Program in Atlanta.

Nine women reported taking zolpidem within 24 hours of delivery, but this could be confirmed for only six women. For these women, zolpidem concentrations at delivery were lower than expected for both maternal plasma (range of less than 4 ng/mL to 64 ng/mL) and umbilical plasma (range of less than 4 ng/mL to 15 ng/mL.

“These concentrations are lower than the peak plasma concentrations reported for healthy adults after a single 5- or 10-mg dose,” the researchers noted. “Zolpidem appears to rapidly clear the fetal circulation; however, if delivery occurs less than 11 hours after the last maternal dose, zolpidem may still be present in the neonatal circulation.”

Women who reported longer zolpidem use during pregnancy (10 weeks or longer) did not have a greater rate of complications. There also appeared to be no difference between drug use in a particular trimester versus use throughout the pregnancy in terms of complications.

Ms. Juric stated she had no conflicts of interest to report.