Obstetrics

The risk of having a stroke during pregnancy is 15 times higher among women with active migraines, and the association is independent of preeclampsia, according to a large, population-based case-control study that analyzed national hospital-discharge data.

The study also identified significant associations between migraines during pregnancy and other vascular events, including myocardial infarctions, and vascular risk factors, such as smoking. The association between stroke and migraines was the strongest in the study and is consistent with previous findings that a migraine diagnosis is 17-fold greater among women who have a stroke during pregnancy (BMJ 2009;338:b664 [doi:10.1136/bmj.b664P]).

“Obstetricians, general practitioners, and neurologists should all realize that these results do not apply to every woman with migraine during pregnancy,” wrote study investigators Dr. Cheryl Bushnell of the department of neurology, Wake Forest University Health Sciences, Winston-Salem, N.C., and her associates. Still, “for pregnant women admitted to hospital with active migraines, modifiable cardiovascular risk factors and complications of pregnancy such as preeclampsia, should be recognized and treated,” they advised.

The researchers used ICD-9 diagnosis codes from a nationwide sample of inpatients that was culled from a database of 1,000 U.S. hospitals from 2000–2003. Almost 34,000 of the pregnancy-related discharges during this time also had a migraine diagnosis code, a migraine diagnosis rate of 185 per 100,000 deliveries. The researchers noted that this rate was lower than expected, probably because only women with active migraines during hospitalization were included in the analysis.

Migraines increased with maternal age; women 40 years and older had a 2.4-fold greater risk of having a migraine diagnosis at discharge than did women younger than 20 years. White women were more likely to have a migraine diagnosis than were women of other ethnicities and races.

Among women with a migraine diagnosis, the overall risk for all types of stroke was increased by nearly 16-fold. For individual types of strokes, the risk was highest for ischemic stroke, which was increased by nearly 31-fold among those women with a migraine diagnosis at discharge. There was no association between migraine and a diagnostic code of cerebral venous thrombosis or subarachnoid hemorrhage.

Migraine diagnostic codes were also significantly associated with codes for other vascular events: Among women with a migraine during pregnancy, a diagnosis of an MI was five times more likely, a heart disease diagnosis was about twice as likely, a diagnosis of a pulmonary embolism was about three times as likely, and a diagnosis of thrombophilia was almost four times as likely.

“The most logical explanation for the relation between migraine and vascular disease during pregnancy is the existence of overlapping pathophysiological mechanisms in both conditions, compounded by the physiological changes during pregnancy,” Dr. Bushnell and associates wrote. They added that the increases in blood volume and other physiological changes during pregnancy “favor thrombosis,” which may “compound the interactions between migraine and vascular complications.”

Women with a migraine diagnosis code were also almost nine times more likely to have a diagnosis of hypertension, about twice as likely to have a diagnosis of preeclampsia/gestational hypertension, and were nearly three times more likely to smoke cigarettes. A statistical analysis that adjusted the associations for age and removed the effect of preeclampsia indicated that stroke was independently associated with a migraine diagnosis, at a 15-fold greater risk.

The researchers noted that a strength of the study was its size: It is probably the largest study to date on the characteristics of migraine headaches during pregnancy, they said.

The investigators reported that they had no financial conflicts of interest.

The risk of having a stroke during pregnancy is 15 times higher among women with active migraines, and the association is independent of preeclampsia, according to a large, population-based case-control study that analyzed national hospital-discharge data.

The study also identified significant associations between migraines during pregnancy and other vascular events, including myocardial infarctions, and vascular risk factors, such as smoking. The association between stroke and migraines was the strongest in the study and is consistent with previous findings that a migraine diagnosis is 17-fold greater among women who have a stroke during pregnancy (BMJ 2009;338:b664 [doi:10.1136/bmj.b664P]).

“Obstetricians, general practitioners, and neurologists should all realize that these results do not apply to every woman with migraine during pregnancy,” wrote study investigators Dr. Cheryl Bushnell of the department of neurology, Wake Forest University Health Sciences, Winston-Salem, N.C., and her associates. Still, “for pregnant women admitted to hospital with active migraines, modifiable cardiovascular risk factors and complications of pregnancy such as preeclampsia, should be recognized and treated,” they advised.

The researchers used ICD-9 diagnosis codes from a nationwide sample of inpatients that was culled from a database of 1,000 U.S. hospitals from 2000–2003. Almost 34,000 of the pregnancy-related discharges during this time also had a migraine diagnosis code, a migraine diagnosis rate of 185 per 100,000 deliveries. The researchers noted that this rate was lower than expected, probably because only women with active migraines during hospitalization were included in the analysis.

Migraines increased with maternal age; women 40 years and older had a 2.4-fold greater risk of having a migraine diagnosis at discharge than did women younger than 20 years. White women were more likely to have a migraine diagnosis than were women of other ethnicities and races.

Among women with a migraine diagnosis, the overall risk for all types of stroke was increased by nearly 16-fold. For individual types of strokes, the risk was highest for ischemic stroke, which was increased by nearly 31-fold among those women with a migraine diagnosis at discharge. There was no association between migraine and a diagnostic code of cerebral venous thrombosis or subarachnoid hemorrhage.

Migraine diagnostic codes were also significantly associated with codes for other vascular events: Among women with a migraine during pregnancy, a diagnosis of an MI was five times more likely, a heart disease diagnosis was about twice as likely, a diagnosis of a pulmonary embolism was about three times as likely, and a diagnosis of thrombophilia was almost four times as likely.

“The most logical explanation for the relation between migraine and vascular disease during pregnancy is the existence of overlapping pathophysiological mechanisms in both conditions, compounded by the physiological changes during pregnancy,” Dr. Bushnell and associates wrote. They added that the increases in blood volume and other physiological changes during pregnancy “favor thrombosis,” which may “compound the interactions between migraine and vascular complications.”

Women with a migraine diagnosis code were also almost nine times more likely to have a diagnosis of hypertension, about twice as likely to have a diagnosis of preeclampsia/gestational hypertension, and were nearly three times more likely to smoke cigarettes. A statistical analysis that adjusted the associations for age and removed the effect of preeclampsia indicated that stroke was independently associated with a migraine diagnosis, at a 15-fold greater risk.

The researchers noted that a strength of the study was its size: It is probably the largest study to date on the characteristics of migraine headaches during pregnancy, they said.

The investigators reported that they had no financial conflicts of interest.

The risk of having a stroke during pregnancy is 15 times higher among women with active migraines, and the association is independent of preeclampsia, according to a large, population-based case-control study that analyzed national hospital-discharge data.

The study also identified significant associations between migraines during pregnancy and other vascular events, including myocardial infarctions, and vascular risk factors, such as smoking. The association between stroke and migraines was the strongest in the study and is consistent with previous findings that a migraine diagnosis is 17-fold greater among women who have a stroke during pregnancy (BMJ 2009;338:b664 [doi:10.1136/bmj.b664P]).

“Obstetricians, general practitioners, and neurologists should all realize that these results do not apply to every woman with migraine during pregnancy,” wrote study investigators Dr. Cheryl Bushnell of the department of neurology, Wake Forest University Health Sciences, Winston-Salem, N.C., and her associates. Still, “for pregnant women admitted to hospital with active migraines, modifiable cardiovascular risk factors and complications of pregnancy such as preeclampsia, should be recognized and treated,” they advised.

The researchers used ICD-9 diagnosis codes from a nationwide sample of inpatients that was culled from a database of 1,000 U.S. hospitals from 2000–2003. Almost 34,000 of the pregnancy-related discharges during this time also had a migraine diagnosis code, a migraine diagnosis rate of 185 per 100,000 deliveries. The researchers noted that this rate was lower than expected, probably because only women with active migraines during hospitalization were included in the analysis.

Migraines increased with maternal age; women 40 years and older had a 2.4-fold greater risk of having a migraine diagnosis at discharge than did women younger than 20 years. White women were more likely to have a migraine diagnosis than were women of other ethnicities and races.

Among women with a migraine diagnosis, the overall risk for all types of stroke was increased by nearly 16-fold. For individual types of strokes, the risk was highest for ischemic stroke, which was increased by nearly 31-fold among those women with a migraine diagnosis at discharge. There was no association between migraine and a diagnostic code of cerebral venous thrombosis or subarachnoid hemorrhage.

Migraine diagnostic codes were also significantly associated with codes for other vascular events: Among women with a migraine during pregnancy, a diagnosis of an MI was five times more likely, a heart disease diagnosis was about twice as likely, a diagnosis of a pulmonary embolism was about three times as likely, and a diagnosis of thrombophilia was almost four times as likely.

“The most logical explanation for the relation between migraine and vascular disease during pregnancy is the existence of overlapping pathophysiological mechanisms in both conditions, compounded by the physiological changes during pregnancy,” Dr. Bushnell and associates wrote. They added that the increases in blood volume and other physiological changes during pregnancy “favor thrombosis,” which may “compound the interactions between migraine and vascular complications.”

Women with a migraine diagnosis code were also almost nine times more likely to have a diagnosis of hypertension, about twice as likely to have a diagnosis of preeclampsia/gestational hypertension, and were nearly three times more likely to smoke cigarettes. A statistical analysis that adjusted the associations for age and removed the effect of preeclampsia indicated that stroke was independently associated with a migraine diagnosis, at a 15-fold greater risk.

The researchers noted that a strength of the study was its size: It is probably the largest study to date on the characteristics of migraine headaches during pregnancy, they said.

The investigators reported that they had no financial conflicts of interest.

SAN DIEGO — Antioxidant vitamins C and E given prior to 17 weeks' gestation in nulliparous, low-risk women do not reduce the frequency of serious maternal and perinatal complications associated with pregnancy-related hypertension.

Nor do the vitamins reduce the diagnosis of preeclampsia, according to findings from a 5-year study of more than 10,000 women conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Md.

In the randomized, placebo-controlled, double-blinded trial of low-risk nulliparous women, Dr. James M. Roberts and his colleagues at 16 centers in the United States allocated 10,154 women to daily treatment with 1,000 mg vitamin C and 400 IU vitamin E or placebo at 9–16 weeks' gestation.

The primary outcome was severe pregnancy-related hypertension (defined as a systolic blood pressure greater than 160 mm Hg or a diastolic pressure greater than 110 mm Hg), or mild pregnancy-related hypertension (defined as a blood pressure reading of greater than 140/90 mm Hg), with at least one of the following: renal or hepatic dysfunction, thrombocytopenia, eclampsia, indicated preterm delivery prior to 32 weeks' gestation, small for gestational age infant, stillbirth, or neonatal death up to discharge, Dr. Roberts explained at the annual meeting of the Society for Maternal-Fetal Medicine.

Dr. Roberts, professor of obstetrics, gynecology, and reproductive sciences at the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine, reported that the women had a mean age of 24 years, their mean prepregnancy body mass index was 25 kg/m₂, 16% were smokers, 44% entered the trial by 13 weeks' gestation, and 77% entered the trial taking multivitamins.

Pregnancy outcome data were available on 9,969 women (4,993 in the vitamin treatment group and 4,976 in the placebo group). There were no significant differences between the treatment and control groups in terms of hypertension as a composite outcome (6.1% vs. 5.8%, respectively) or in the incidence of preeclampsia (7.2% vs. 6.7%).

The only difference in outcomes between the two groups was observed in the rate of gestational hypertension, which was 2.6% higher in the treatment group, compared with controls, though this difference was not statistically significant. Failing that, “everything was identical between the two groups,” including rates of admission to the neonatal intensive care unit, respiratory distress syndrome, and sepsis, Dr. Roberts said.

“Why doesn't antioxidant therapy reduce the frequency of preeclampsia or adverse outcomes?” he asked. One possibility is that not all women develop preeclampsia due to the same linkage between reduced placental perfusion and abnormal implantation. It may be that only a subset of women benefit from treatment to reduce oxidative stress. “This is an important possibility that we will be testing in another part of this study.” Dr. Roberts reported having no conflicts of interest to disclose.

Vitamins C and E did not reduce complications associated with pregnancy-related hypertension. DR. ROBERTS

SAN DIEGO — Antioxidant vitamins C and E given prior to 17 weeks' gestation in nulliparous, low-risk women do not reduce the frequency of serious maternal and perinatal complications associated with pregnancy-related hypertension.

Nor do the vitamins reduce the diagnosis of preeclampsia, according to findings from a 5-year study of more than 10,000 women conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Md.

In the randomized, placebo-controlled, double-blinded trial of low-risk nulliparous women, Dr. James M. Roberts and his colleagues at 16 centers in the United States allocated 10,154 women to daily treatment with 1,000 mg vitamin C and 400 IU vitamin E or placebo at 9–16 weeks' gestation.

The primary outcome was severe pregnancy-related hypertension (defined as a systolic blood pressure greater than 160 mm Hg or a diastolic pressure greater than 110 mm Hg), or mild pregnancy-related hypertension (defined as a blood pressure reading of greater than 140/90 mm Hg), with at least one of the following: renal or hepatic dysfunction, thrombocytopenia, eclampsia, indicated preterm delivery prior to 32 weeks' gestation, small for gestational age infant, stillbirth, or neonatal death up to discharge, Dr. Roberts explained at the annual meeting of the Society for Maternal-Fetal Medicine.

Dr. Roberts, professor of obstetrics, gynecology, and reproductive sciences at the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine, reported that the women had a mean age of 24 years, their mean prepregnancy body mass index was 25 kg/m₂, 16% were smokers, 44% entered the trial by 13 weeks' gestation, and 77% entered the trial taking multivitamins.

Pregnancy outcome data were available on 9,969 women (4,993 in the vitamin treatment group and 4,976 in the placebo group). There were no significant differences between the treatment and control groups in terms of hypertension as a composite outcome (6.1% vs. 5.8%, respectively) or in the incidence of preeclampsia (7.2% vs. 6.7%).

The only difference in outcomes between the two groups was observed in the rate of gestational hypertension, which was 2.6% higher in the treatment group, compared with controls, though this difference was not statistically significant. Failing that, “everything was identical between the two groups,” including rates of admission to the neonatal intensive care unit, respiratory distress syndrome, and sepsis, Dr. Roberts said.

“Why doesn't antioxidant therapy reduce the frequency of preeclampsia or adverse outcomes?” he asked. One possibility is that not all women develop preeclampsia due to the same linkage between reduced placental perfusion and abnormal implantation. It may be that only a subset of women benefit from treatment to reduce oxidative stress. “This is an important possibility that we will be testing in another part of this study.” Dr. Roberts reported having no conflicts of interest to disclose.

Vitamins C and E did not reduce complications associated with pregnancy-related hypertension. DR. ROBERTS

SAN DIEGO — Antioxidant vitamins C and E given prior to 17 weeks' gestation in nulliparous, low-risk women do not reduce the frequency of serious maternal and perinatal complications associated with pregnancy-related hypertension.

Nor do the vitamins reduce the diagnosis of preeclampsia, according to findings from a 5-year study of more than 10,000 women conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Md.

In the randomized, placebo-controlled, double-blinded trial of low-risk nulliparous women, Dr. James M. Roberts and his colleagues at 16 centers in the United States allocated 10,154 women to daily treatment with 1,000 mg vitamin C and 400 IU vitamin E or placebo at 9–16 weeks' gestation.

The primary outcome was severe pregnancy-related hypertension (defined as a systolic blood pressure greater than 160 mm Hg or a diastolic pressure greater than 110 mm Hg), or mild pregnancy-related hypertension (defined as a blood pressure reading of greater than 140/90 mm Hg), with at least one of the following: renal or hepatic dysfunction, thrombocytopenia, eclampsia, indicated preterm delivery prior to 32 weeks' gestation, small for gestational age infant, stillbirth, or neonatal death up to discharge, Dr. Roberts explained at the annual meeting of the Society for Maternal-Fetal Medicine.

Dr. Roberts, professor of obstetrics, gynecology, and reproductive sciences at the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine, reported that the women had a mean age of 24 years, their mean prepregnancy body mass index was 25 kg/m₂, 16% were smokers, 44% entered the trial by 13 weeks' gestation, and 77% entered the trial taking multivitamins.

Pregnancy outcome data were available on 9,969 women (4,993 in the vitamin treatment group and 4,976 in the placebo group). There were no significant differences between the treatment and control groups in terms of hypertension as a composite outcome (6.1% vs. 5.8%, respectively) or in the incidence of preeclampsia (7.2% vs. 6.7%).

The only difference in outcomes between the two groups was observed in the rate of gestational hypertension, which was 2.6% higher in the treatment group, compared with controls, though this difference was not statistically significant. Failing that, “everything was identical between the two groups,” including rates of admission to the neonatal intensive care unit, respiratory distress syndrome, and sepsis, Dr. Roberts said.

“Why doesn't antioxidant therapy reduce the frequency of preeclampsia or adverse outcomes?” he asked. One possibility is that not all women develop preeclampsia due to the same linkage between reduced placental perfusion and abnormal implantation. It may be that only a subset of women benefit from treatment to reduce oxidative stress. “This is an important possibility that we will be testing in another part of this study.” Dr. Roberts reported having no conflicts of interest to disclose.

Vitamins C and E did not reduce complications associated with pregnancy-related hypertension. DR. ROBERTS

A low vitamin B₁₂ blood level was an independent and significant risk factor for having a pregnancy affected by a neural tube defect in a study of Irish women, in what the authors say is the first study to examine the risk of the birth defect associated with maternal B₁₂ concentration.

Their results have public health implications in terms of possible fortification of grains with B₁₂, although more studies are needed to learn more about the safety of this approach and the optimal protective dose of B₁₂ in food, according to Anne M. Molloy, Ph.D., of Trinity College, Dublin and her associates.

The data indicated that most of the neural tube defect (NTD) risk was limited to maternal B₁₂ levels at approximately 250 ng/L or less, although the data suggested that the risk could be further lowered if the B₁₂ level was above 320–350 ng/L. Based on this, they recommended that women have a vitamin B₁₂ level above 300 ng/L before conceiving.

The other authors were from the Child Health Epidemiology Unit at the Health Research Board in Dublin; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health and the National Human Genome Institute at NIH (Pediatrics 2009;123:917–23). Because the neural tube defect rate in Ireland is high, NIH and Irish researchers have worked together on NTD studies.

The study compared B₁₂ levels in stored blood samples of three groups of Irish women, at a median 15 weeks' gestation, obtained between 1983 and 1990, before food was fortified with folic acid and when vitamin supplementation during pregnancy in Ireland was not common. Mandatory folic acid fortification of grains in the United States has been reported to have reduced the incidence of NTDs by as much as 78%. But folic acid cannot prevent all NTDs and low maternal B₁₂ has previously been associated with a risk of NTDs, the authors wrote.

The three groups were composed as follows: 95 women with a pregnancy affected by a NTD (mean age 27 years) and 265 controls with a normal pregnancy (mean age 28 years); 107 women who had had a previous pregnancy affected by an NTD but were pregnant again with an unaffected pregnancy (mean age 32 years) and 414 controls (mean age 28 years); 76 women during an affected pregnancy (mean age 27 years); and 222 controls (mean age 28 years).

When compared with controls, the B₁₂ levels were significantly lower among the women who had a pregnancy affected by a NTD, with levels below 250 ng/L associated with the greatest risk. The risk of having a pregnancy affected by an NTD was three times greater among women with B₁₂ concentrations below 200 ng/L, compared with those whose levels were above 400 ng/L. The median B₁₂ concentrations among the affected women in all three groups were 13%-19% lower than those with unaffected pregnancies, a significant difference.

Since B₁₂ values were obtained at a median 15 weeks' gestation, at which time the level naturally would have dropped by about 20%-25%, “our data indicate that women should aim to enter pregnancy” with serum B₁₂ concentrations above 300 ng/L,” the authors concluded, adding that concentrations above 400 ng/L “might be desirable, although we found no statistically significant benefit,” for that value.

The researchers did an analysis to determine if the effects of B₁₂ and folate on NTD risk were independent, which found “little interaction between B₁₂ and folate,” they said. Mandatory fortification of grain products in the United States with folic acid, the synthetic version of the vitamin folate, has been reported to reduce NTD incidence by as much as 78%. But, “it is generally agreed that not all NTDs are preventable by folic acid.”

In a statement issued by NICHD, Dr. James Mills, one of the authors and a senior investigator in the NICHD's division of epidemiology, statistics, and prevention research, pointed out that since dietary B₁₂ is contained in milk, poultry, and other animal sources, women who are on a strict vegan diet may be at an increased risk of an NTD. He also advised that women with intestinal disorders who may not absorb an adequate amount of B₁₂ should consult with physicians before pregnancy, to ensure that they are getting enough of this vitamin.

The authors had no relevant disclosures.

A low vitamin B₁₂ blood level was an independent and significant risk factor for having a pregnancy affected by a neural tube defect in a study of Irish women, in what the authors say is the first study to examine the risk of the birth defect associated with maternal B₁₂ concentration.

Their results have public health implications in terms of possible fortification of grains with B₁₂, although more studies are needed to learn more about the safety of this approach and the optimal protective dose of B₁₂ in food, according to Anne M. Molloy, Ph.D., of Trinity College, Dublin and her associates.

The data indicated that most of the neural tube defect (NTD) risk was limited to maternal B₁₂ levels at approximately 250 ng/L or less, although the data suggested that the risk could be further lowered if the B₁₂ level was above 320–350 ng/L. Based on this, they recommended that women have a vitamin B₁₂ level above 300 ng/L before conceiving.

The other authors were from the Child Health Epidemiology Unit at the Health Research Board in Dublin; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health and the National Human Genome Institute at NIH (Pediatrics 2009;123:917–23). Because the neural tube defect rate in Ireland is high, NIH and Irish researchers have worked together on NTD studies.

The study compared B₁₂ levels in stored blood samples of three groups of Irish women, at a median 15 weeks' gestation, obtained between 1983 and 1990, before food was fortified with folic acid and when vitamin supplementation during pregnancy in Ireland was not common. Mandatory folic acid fortification of grains in the United States has been reported to have reduced the incidence of NTDs by as much as 78%. But folic acid cannot prevent all NTDs and low maternal B₁₂ has previously been associated with a risk of NTDs, the authors wrote.

The three groups were composed as follows: 95 women with a pregnancy affected by a NTD (mean age 27 years) and 265 controls with a normal pregnancy (mean age 28 years); 107 women who had had a previous pregnancy affected by an NTD but were pregnant again with an unaffected pregnancy (mean age 32 years) and 414 controls (mean age 28 years); 76 women during an affected pregnancy (mean age 27 years); and 222 controls (mean age 28 years).

When compared with controls, the B₁₂ levels were significantly lower among the women who had a pregnancy affected by a NTD, with levels below 250 ng/L associated with the greatest risk. The risk of having a pregnancy affected by an NTD was three times greater among women with B₁₂ concentrations below 200 ng/L, compared with those whose levels were above 400 ng/L. The median B₁₂ concentrations among the affected women in all three groups were 13%-19% lower than those with unaffected pregnancies, a significant difference.

Since B₁₂ values were obtained at a median 15 weeks' gestation, at which time the level naturally would have dropped by about 20%-25%, “our data indicate that women should aim to enter pregnancy” with serum B₁₂ concentrations above 300 ng/L,” the authors concluded, adding that concentrations above 400 ng/L “might be desirable, although we found no statistically significant benefit,” for that value.

The researchers did an analysis to determine if the effects of B₁₂ and folate on NTD risk were independent, which found “little interaction between B₁₂ and folate,” they said. Mandatory fortification of grain products in the United States with folic acid, the synthetic version of the vitamin folate, has been reported to reduce NTD incidence by as much as 78%. But, “it is generally agreed that not all NTDs are preventable by folic acid.”

In a statement issued by NICHD, Dr. James Mills, one of the authors and a senior investigator in the NICHD's division of epidemiology, statistics, and prevention research, pointed out that since dietary B₁₂ is contained in milk, poultry, and other animal sources, women who are on a strict vegan diet may be at an increased risk of an NTD. He also advised that women with intestinal disorders who may not absorb an adequate amount of B₁₂ should consult with physicians before pregnancy, to ensure that they are getting enough of this vitamin.

The authors had no relevant disclosures.

A low vitamin B₁₂ blood level was an independent and significant risk factor for having a pregnancy affected by a neural tube defect in a study of Irish women, in what the authors say is the first study to examine the risk of the birth defect associated with maternal B₁₂ concentration.

Their results have public health implications in terms of possible fortification of grains with B₁₂, although more studies are needed to learn more about the safety of this approach and the optimal protective dose of B₁₂ in food, according to Anne M. Molloy, Ph.D., of Trinity College, Dublin and her associates.

The data indicated that most of the neural tube defect (NTD) risk was limited to maternal B₁₂ levels at approximately 250 ng/L or less, although the data suggested that the risk could be further lowered if the B₁₂ level was above 320–350 ng/L. Based on this, they recommended that women have a vitamin B₁₂ level above 300 ng/L before conceiving.

The other authors were from the Child Health Epidemiology Unit at the Health Research Board in Dublin; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health and the National Human Genome Institute at NIH (Pediatrics 2009;123:917–23). Because the neural tube defect rate in Ireland is high, NIH and Irish researchers have worked together on NTD studies.

The study compared B₁₂ levels in stored blood samples of three groups of Irish women, at a median 15 weeks' gestation, obtained between 1983 and 1990, before food was fortified with folic acid and when vitamin supplementation during pregnancy in Ireland was not common. Mandatory folic acid fortification of grains in the United States has been reported to have reduced the incidence of NTDs by as much as 78%. But folic acid cannot prevent all NTDs and low maternal B₁₂ has previously been associated with a risk of NTDs, the authors wrote.

The three groups were composed as follows: 95 women with a pregnancy affected by a NTD (mean age 27 years) and 265 controls with a normal pregnancy (mean age 28 years); 107 women who had had a previous pregnancy affected by an NTD but were pregnant again with an unaffected pregnancy (mean age 32 years) and 414 controls (mean age 28 years); 76 women during an affected pregnancy (mean age 27 years); and 222 controls (mean age 28 years).

When compared with controls, the B₁₂ levels were significantly lower among the women who had a pregnancy affected by a NTD, with levels below 250 ng/L associated with the greatest risk. The risk of having a pregnancy affected by an NTD was three times greater among women with B₁₂ concentrations below 200 ng/L, compared with those whose levels were above 400 ng/L. The median B₁₂ concentrations among the affected women in all three groups were 13%-19% lower than those with unaffected pregnancies, a significant difference.

Since B₁₂ values were obtained at a median 15 weeks' gestation, at which time the level naturally would have dropped by about 20%-25%, “our data indicate that women should aim to enter pregnancy” with serum B₁₂ concentrations above 300 ng/L,” the authors concluded, adding that concentrations above 400 ng/L “might be desirable, although we found no statistically significant benefit,” for that value.

The researchers did an analysis to determine if the effects of B₁₂ and folate on NTD risk were independent, which found “little interaction between B₁₂ and folate,” they said. Mandatory fortification of grain products in the United States with folic acid, the synthetic version of the vitamin folate, has been reported to reduce NTD incidence by as much as 78%. But, “it is generally agreed that not all NTDs are preventable by folic acid.”

In a statement issued by NICHD, Dr. James Mills, one of the authors and a senior investigator in the NICHD's division of epidemiology, statistics, and prevention research, pointed out that since dietary B₁₂ is contained in milk, poultry, and other animal sources, women who are on a strict vegan diet may be at an increased risk of an NTD. He also advised that women with intestinal disorders who may not absorb an adequate amount of B₁₂ should consult with physicians before pregnancy, to ensure that they are getting enough of this vitamin.

The authors had no relevant disclosures.

SAN DIEGO — A single dose of intramuscular oxytocin achieved a significant reduction in the rate of placental retention in second-trimester medical termination, and was associated with a significant reduction in postpartum blood loss, results from a randomized, single-center study showed.

“Intramuscular oxytocin is a reasonable choice as a prophylactic ecbolic for the third stage [of labor] following second-trimester medical pregnancy termination,” Dr. Jan E. Dickinson said at the annual meeting of the Society for Maternal-Fetal Medicine.

Placental retention is a frequent complication of prostaglandin pregnancy termination, occurring 30%-40% of the time, said Dr. Dickinson, associate professor of maternal-fetal medicine at the University of Western Australia School of Women's and Infants' Health, Crawley. Potential complications of placental retention include increased blood loss, infectious morbidity, operative complications, and increased requirement for blood transfusion.

However, current protocols for third-stage management vary, so she and her associates conducted a study intended to develop a third-stage management protocol that would minimize the incidence of placental retention and associated complications among 251 women undergoing pregnancy termination at the university with intravaginal misoprostol at 14–24 weeks. They randomized the women to one of three management strategies: 83 women to receive 10 units of intramuscular oxytocin after delivery of the fetus (group 1); 83 women to receive 600 mcg oral misoprostol after delivery of the fetus (group 2); and 85 women to receive no additional medication after delivery of the fetus (group 3).

The primary outcome was incidence of failure of placental expulsion within 60 minutes of fetal delivery, with the need for operative removal.

Dr. Dickinson, who had no conflicts to disclose, reported that there were no significant differences between the three groups in terms of maternal age (mean, 31 years), race (93% white), parity (mean, one), prior uterine surgery (mean, 20%), median gestational age at study recruitment (19 weeks), or duration of termination (mean, 17 hours). The researchers did observe a significant difference between the groups in the incidence of placental retention (10% in group 1, 29% in group 2, and 31% in group 3). Logistic regression analysis of placental retention rates revealed that the odds ratio between groups 1 and 3 was significant (OR, 0.24), but between groups 2 and 3 it was not (OR, 0.92). Calculated blood loss was significantly lower in group 1 compared with the other groups (100 mL vs. 200 mL in groups 2 and 3). There were no significant differences among groups 1, 2, and 3 in terms of duration of hospital stay (30 hours, 33 hours, and 29 hours, respectively), readmission (7%, 4%, and 9%), or need for curettage (4%, 2%, and 6%).

In a later interview, Dr. Dickinson said that for centers and countries with limited access to hospital facilities, this protocol “potentially offers a simple and effective means to management of the third stage and improved safety for women with pregnancy loss in the second trimester.”

SAN DIEGO — A single dose of intramuscular oxytocin achieved a significant reduction in the rate of placental retention in second-trimester medical termination, and was associated with a significant reduction in postpartum blood loss, results from a randomized, single-center study showed.

“Intramuscular oxytocin is a reasonable choice as a prophylactic ecbolic for the third stage [of labor] following second-trimester medical pregnancy termination,” Dr. Jan E. Dickinson said at the annual meeting of the Society for Maternal-Fetal Medicine.

Placental retention is a frequent complication of prostaglandin pregnancy termination, occurring 30%-40% of the time, said Dr. Dickinson, associate professor of maternal-fetal medicine at the University of Western Australia School of Women's and Infants' Health, Crawley. Potential complications of placental retention include increased blood loss, infectious morbidity, operative complications, and increased requirement for blood transfusion.

However, current protocols for third-stage management vary, so she and her associates conducted a study intended to develop a third-stage management protocol that would minimize the incidence of placental retention and associated complications among 251 women undergoing pregnancy termination at the university with intravaginal misoprostol at 14–24 weeks. They randomized the women to one of three management strategies: 83 women to receive 10 units of intramuscular oxytocin after delivery of the fetus (group 1); 83 women to receive 600 mcg oral misoprostol after delivery of the fetus (group 2); and 85 women to receive no additional medication after delivery of the fetus (group 3).

The primary outcome was incidence of failure of placental expulsion within 60 minutes of fetal delivery, with the need for operative removal.

Dr. Dickinson, who had no conflicts to disclose, reported that there were no significant differences between the three groups in terms of maternal age (mean, 31 years), race (93% white), parity (mean, one), prior uterine surgery (mean, 20%), median gestational age at study recruitment (19 weeks), or duration of termination (mean, 17 hours). The researchers did observe a significant difference between the groups in the incidence of placental retention (10% in group 1, 29% in group 2, and 31% in group 3). Logistic regression analysis of placental retention rates revealed that the odds ratio between groups 1 and 3 was significant (OR, 0.24), but between groups 2 and 3 it was not (OR, 0.92). Calculated blood loss was significantly lower in group 1 compared with the other groups (100 mL vs. 200 mL in groups 2 and 3). There were no significant differences among groups 1, 2, and 3 in terms of duration of hospital stay (30 hours, 33 hours, and 29 hours, respectively), readmission (7%, 4%, and 9%), or need for curettage (4%, 2%, and 6%).

In a later interview, Dr. Dickinson said that for centers and countries with limited access to hospital facilities, this protocol “potentially offers a simple and effective means to management of the third stage and improved safety for women with pregnancy loss in the second trimester.”

SAN DIEGO — A single dose of intramuscular oxytocin achieved a significant reduction in the rate of placental retention in second-trimester medical termination, and was associated with a significant reduction in postpartum blood loss, results from a randomized, single-center study showed.

“Intramuscular oxytocin is a reasonable choice as a prophylactic ecbolic for the third stage [of labor] following second-trimester medical pregnancy termination,” Dr. Jan E. Dickinson said at the annual meeting of the Society for Maternal-Fetal Medicine.

Placental retention is a frequent complication of prostaglandin pregnancy termination, occurring 30%-40% of the time, said Dr. Dickinson, associate professor of maternal-fetal medicine at the University of Western Australia School of Women's and Infants' Health, Crawley. Potential complications of placental retention include increased blood loss, infectious morbidity, operative complications, and increased requirement for blood transfusion.

However, current protocols for third-stage management vary, so she and her associates conducted a study intended to develop a third-stage management protocol that would minimize the incidence of placental retention and associated complications among 251 women undergoing pregnancy termination at the university with intravaginal misoprostol at 14–24 weeks. They randomized the women to one of three management strategies: 83 women to receive 10 units of intramuscular oxytocin after delivery of the fetus (group 1); 83 women to receive 600 mcg oral misoprostol after delivery of the fetus (group 2); and 85 women to receive no additional medication after delivery of the fetus (group 3).

The primary outcome was incidence of failure of placental expulsion within 60 minutes of fetal delivery, with the need for operative removal.

Dr. Dickinson, who had no conflicts to disclose, reported that there were no significant differences between the three groups in terms of maternal age (mean, 31 years), race (93% white), parity (mean, one), prior uterine surgery (mean, 20%), median gestational age at study recruitment (19 weeks), or duration of termination (mean, 17 hours). The researchers did observe a significant difference between the groups in the incidence of placental retention (10% in group 1, 29% in group 2, and 31% in group 3). Logistic regression analysis of placental retention rates revealed that the odds ratio between groups 1 and 3 was significant (OR, 0.24), but between groups 2 and 3 it was not (OR, 0.92). Calculated blood loss was significantly lower in group 1 compared with the other groups (100 mL vs. 200 mL in groups 2 and 3). There were no significant differences among groups 1, 2, and 3 in terms of duration of hospital stay (30 hours, 33 hours, and 29 hours, respectively), readmission (7%, 4%, and 9%), or need for curettage (4%, 2%, and 6%).

In a later interview, Dr. Dickinson said that for centers and countries with limited access to hospital facilities, this protocol “potentially offers a simple and effective means to management of the third stage and improved safety for women with pregnancy loss in the second trimester.”

SAN DIEGO — Women who acquire HIV perinatally have pregnancy outcomes that are on a par with those who acquire HIV later in life, results from a small single-center study suggest.

“This is a relatively new group of young mothers, and not much is known about how they do in pregnancy,” Dr. Tania Kasdaglis said in an interview during a poster session at the annual meeting of the Society for Maternal-Fetal Medicine. Many may assume “that perinatally infected HIV patients might have poorer pregnancy outcomes because they have had HIV longer or because their immune systems have been tried since they were born, but in fact they do very well.”

She and her colleagues in the department of obstetrics, gynecology, and reproductive sciences at the University of Maryland, Baltimore, studied women receiving prenatal care at the university's HIV clinic between 1997 and 2008. On a 1:1 basis they matched perinatally infected women with those who acquired the disease after childhood for age, race, and prepregnancy body mass index. Both groups had access to prenatal care, were on highly active antiretroviral therapy, had their CD4 counts and viral loads monitored, and were delivered at the university's medical center.

Among these women, 11 perinatally infected patients with 13 continuing pregnancies were studied. Cases were similar to controls in terms of mean age (18.7 years vs. 19 years), prepregnancy body mass index (27.7 kg/m₂ vs. 27.3 kg/m₂); third-trimester viral load (1,688 copies/mL vs. 10,548 copies/mL); third-trimester CD4 counts (391 vs. 410 cells/mcL); gestational age at delivery (38.3 weeks vs. 39 weeks), and birth weight percentile (32.1% vs. 39.4%). Although the viral load was not significantly different between the two groups, it was lower among perinatally infected women, suggesting that this group of women may be more compliant with highly active antiretroviral therapy (HAART) compared with controls, said Dr. Kasdaglis, a first-year maternal-fetal medicine fellow at the university.

The study findings show that “perinatally infected HIV patients have good pregnancy outcomes that do not differ from [those of] women who acquire HIV later in life and have access to the same level of prenatal care,” concluded Dr. Kasdaglis, who reported having no conflicts of interest.

'Perinatally infected HIV pregnant patients have good pregnancy outcomes' in this small study. DR. KASDAGLIS

SAN DIEGO — Women who acquire HIV perinatally have pregnancy outcomes that are on a par with those who acquire HIV later in life, results from a small single-center study suggest.

“This is a relatively new group of young mothers, and not much is known about how they do in pregnancy,” Dr. Tania Kasdaglis said in an interview during a poster session at the annual meeting of the Society for Maternal-Fetal Medicine. Many may assume “that perinatally infected HIV patients might have poorer pregnancy outcomes because they have had HIV longer or because their immune systems have been tried since they were born, but in fact they do very well.”

She and her colleagues in the department of obstetrics, gynecology, and reproductive sciences at the University of Maryland, Baltimore, studied women receiving prenatal care at the university's HIV clinic between 1997 and 2008. On a 1:1 basis they matched perinatally infected women with those who acquired the disease after childhood for age, race, and prepregnancy body mass index. Both groups had access to prenatal care, were on highly active antiretroviral therapy, had their CD4 counts and viral loads monitored, and were delivered at the university's medical center.

Among these women, 11 perinatally infected patients with 13 continuing pregnancies were studied. Cases were similar to controls in terms of mean age (18.7 years vs. 19 years), prepregnancy body mass index (27.7 kg/m₂ vs. 27.3 kg/m₂); third-trimester viral load (1,688 copies/mL vs. 10,548 copies/mL); third-trimester CD4 counts (391 vs. 410 cells/mcL); gestational age at delivery (38.3 weeks vs. 39 weeks), and birth weight percentile (32.1% vs. 39.4%). Although the viral load was not significantly different between the two groups, it was lower among perinatally infected women, suggesting that this group of women may be more compliant with highly active antiretroviral therapy (HAART) compared with controls, said Dr. Kasdaglis, a first-year maternal-fetal medicine fellow at the university.

The study findings show that “perinatally infected HIV patients have good pregnancy outcomes that do not differ from [those of] women who acquire HIV later in life and have access to the same level of prenatal care,” concluded Dr. Kasdaglis, who reported having no conflicts of interest.

'Perinatally infected HIV pregnant patients have good pregnancy outcomes' in this small study. DR. KASDAGLIS

SAN DIEGO — Women who acquire HIV perinatally have pregnancy outcomes that are on a par with those who acquire HIV later in life, results from a small single-center study suggest.

“This is a relatively new group of young mothers, and not much is known about how they do in pregnancy,” Dr. Tania Kasdaglis said in an interview during a poster session at the annual meeting of the Society for Maternal-Fetal Medicine. Many may assume “that perinatally infected HIV patients might have poorer pregnancy outcomes because they have had HIV longer or because their immune systems have been tried since they were born, but in fact they do very well.”

She and her colleagues in the department of obstetrics, gynecology, and reproductive sciences at the University of Maryland, Baltimore, studied women receiving prenatal care at the university's HIV clinic between 1997 and 2008. On a 1:1 basis they matched perinatally infected women with those who acquired the disease after childhood for age, race, and prepregnancy body mass index. Both groups had access to prenatal care, were on highly active antiretroviral therapy, had their CD4 counts and viral loads monitored, and were delivered at the university's medical center.

Among these women, 11 perinatally infected patients with 13 continuing pregnancies were studied. Cases were similar to controls in terms of mean age (18.7 years vs. 19 years), prepregnancy body mass index (27.7 kg/m₂ vs. 27.3 kg/m₂); third-trimester viral load (1,688 copies/mL vs. 10,548 copies/mL); third-trimester CD4 counts (391 vs. 410 cells/mcL); gestational age at delivery (38.3 weeks vs. 39 weeks), and birth weight percentile (32.1% vs. 39.4%). Although the viral load was not significantly different between the two groups, it was lower among perinatally infected women, suggesting that this group of women may be more compliant with highly active antiretroviral therapy (HAART) compared with controls, said Dr. Kasdaglis, a first-year maternal-fetal medicine fellow at the university.

The study findings show that “perinatally infected HIV patients have good pregnancy outcomes that do not differ from [those of] women who acquire HIV later in life and have access to the same level of prenatal care,” concluded Dr. Kasdaglis, who reported having no conflicts of interest.

'Perinatally infected HIV pregnant patients have good pregnancy outcomes' in this small study. DR. KASDAGLIS

By now, the story of Nadya Suleman is well known. The 33-year-old California woman gave birth to octuplets—only the second set born in the United States—on January 26. Within a few weeks, what was initially reported as a heartwarming story of medicine’s finest hour had ignited a nationwide backlash as details of Suleman’s situation became known. The divorced single mom already had six children younger than 8 when she underwent the fertility treatments that led to an eight-baby bonanza.

Should Suleman have been allowed to undergo the additional treatments? Did her medical team violate guidelines by implanting more than the generally accepted number of embryos? Is it fair to burden taxpayers with the costs of raising her large family—particularly in the current economic climate?

Clinician Reviews does not profess to have the answers to these questions. But we did ask a panel of editorial board members and other experts for their take on the thorny ethical questions Suleman’s case has raised.

How do you feel about a woman with six children younger than 8 receiving fertility treatments and delivering another eight babies?

Stephen Nunn, MPAS, PA-C, a founding member of the Association of PAs in Ob-Gyn, who worked with the first successful in vitro fertilization program in Arizona for 18 years: The issue for me isn’t so much that she already has six children, but the real and serious risks to both the mother and fetuses with multiple gestation. The American Society of Reproductive Medicine has established guidelines for the number of embryos to be transferred, which for this patient would be three. It appears these guidelines were not used in this case. This would not have generated the same response had Ms. Suleman received fertility treatment in an effort to achieve a singleton or, at most, twin gestation.

Obviously, we do not know all the details; however, I wonder why so many embryos were placed. If there were a total of seven, as the press has stated, then there would have been more than one opportunity to achieve a single pregnancy. Even if the mother did not want the other embryos destroyed, she could have donated them to another woman.

Rebecca Scott, PhD, PA-C, Clinical Coordinator in the Physician Assistant Program at Northeastern University, Boston, and an elected member of the Board of Health in Sandwich, Massachusetts: I have been thinking about how this really illustrates a tension that we’ve had in our history of the rights of the individual versus the rights of the whole community. We have this long tradition of saying, “Everybody ought to be able to have children.” This seems to fit into that continuum of the individual’s right being very strongly upheld in this country over, perhaps, what is best for the good of society.

This is so interesting because other societies are quite up-front about their goals for their population. I remember traveling in Hungary at one point, where the people were not reproducing enough to replace the population. So the government said, “It’s in our best interests to have enough people to support the society,” and they actually subsidized moms with the equivalent of a factory worker’s wage to stay home with children for three years, up to three children’s worth.

The big thing that troubles me about this is where do the rights of the group get accounted for? Should we be paying tax dollars to subsidize people who want to have children?

Austin D. Potenza II, JD, a Phoenix-based attorney and Adjunct Professor at the Arizona School of Health Sciences, where he has taught a course on medical ethics for 10 years: I think in our society everything has to be open for discussion, but we have to realize that at some point it’s just discussion. Under current ethical thinking, the most important perspective is that of a competent patient. We as a society don’t make these kinds of decisions—whether it is getting fertility treatment or having multiple births—for people.

A close second is the perspective of the infants, but it is problematic to base a societal response on what is right for children when it comes to fertility and multiple birth. Is being born into a family of 14 somehow worse than not being born at all? If we’re trying to save children, what exactly are we saving them from? And why look at just these children? If we try to have a responsible answer to these questions, it is myopic to look only at this family.

Think about the thousands of children who are born into horrible poverty, hunger, abuse, and neglect. We don’t regulate their parents’ reproductive decisions. And that’s just considering our own country; if we really want to be concerned about children, think about places like Sierra Leone, where the infant mortality rate is about 25%. Although the consideration of the children is compelling, it is much more important to consider how to help them once they are born, rather than thinking of the solution in terms of fertility and multiple births.     

The next important ethical perspective is that of the caregiver [discussed in depth later]. 

Finally, society is a stakeholder, and this seems to be the perspective from which most people are approaching the issue. The typical questions you’re going to hear are, “Is the cost of care for this mother and these children going to fall on the rest of us as taxpayers? Is this part of what’s straining the health care and social support systems?” These are all valid questions, but they beg an awful lot of other questions that we have to answer first. For example, what should we spend our collective money on? Who decides?  

While it is understandable why the public is upset by this story, at the same time, does anyone have the right to impose restrictions on someone’s procreation? Where, if at all, do we draw a line in the sand? 

Marie-Eileen Onieal, PhD, CPNP, FAANP, Director of Medical Services for the Massachusetts Department of Youth Services and Clinician Reviews NP Editor-in-Chief: I think the line between moral soundness and legal rights was crossed when the woman put her desires to have more children above the needs of the children she already bore. Before the octup-let pregnancy, she needed more than minimal assistance to care for the six children she already had; at least two have special needs requiring more attention and care.  

I think, especially in the face of the fact that she is almost totally dependent on others to help her provide for her family, we as a society have a moral and legal obligation to impose restrictions on procreation (especially when one’s procreating consumes as many resources as this woman consumed).

Rebecca Scott: I don’t think sending hate mail and death threats is any way to respond in a civil society. But I think we do need to say, “No, it is not all right for somebody to be using taxpayer dollars to subsidize,” you know, whatever it is that the individual wants to do that is way above and beyond what most of us would consider reasonable. 

If we look at the welfare-to-work initiatives that took place under the Clinton administration, that’s a start on an answer. We made the decision at that point that it was OK to say to people, “You have to get off welfare. You must go to work.” But we also enabled people to do that by saying, “We will subsidize Medicaid so that you can continue to get coverage at these low-paying jobs where you don’t earn enough money to be able to pay for health care.”

Stephen Nunn: To me, the principle here is Primum non nocere or “First, do no harm.” A twin pregnancy is considered high risk just because it’s a twin pregnancy. Those risks skyrocket with each additional fetus. The main risk here is to the fetuses, their individual and collective survival, and the potential for future problems after birth, such as cerebral palsy, blindness, and learning disabilities. So, the risks and benefits have to be weighed on an individual basis.

Personally, I can see no circumstance to justify transferring more than four embryos—ever! Holding to this guideline is not restricting a woman’s right to procreation. It’s not saying “No,” it’s saying, “Not this many.”

Although the obstetrician’s patient is the mother, not the fetus, I believe the fertility specialist can’t take such a narrow view of his or her responsibilities. Ordinarily, an obstetrician becomes involved after pregnancy has occurred, while the fertility specialist is involved prior and thus has a greater duty in regard to the potential eventual outcome. Too much success can lead ultimately to failure.

Moving forward, where do we go from here? How might these issues be addressed?

Rebecca Scott: What I’m afraid is going to happen is that we’re going to react in a heavy-handed way and set up all kinds of oversight and come at it with a legislative approach—you know, somebody in the state legislature’s going to say, “Well, we’re going to make a rule about this.”

What I hope will happen is that we’ll have a good deal of dialogue about what’s appropriate and that that dialogue will include fertility specialists, public health experts, citizens in general, and government/public health departments and that the dialogue will try to come out with some policies and procedures to guide thinking in this kind of situation.

Austin Potenza: It’s very difficult for me to imagine any legislature taking on this issue. It would be politically impossible to attempt to regulate who can have children, and how many. Think back to the Terri Schiavo case, which was such a travesty in Congress. Everybody was trying to get involved, and it was obviously completely beyond the scope of their expertise and their ability. It was just a political nightmare. This is similar because it is government involvement in an intensely personal decision, in a country dedicated to personal freedoms. If we get involved in birth regulation, we’re repeating China’s mistakes and going against the fundamentally individual-rights focus of our society.

The next most likely—but still unlikely—step would be federal or state Medicare/Medicaid programs trying to regulate what kind of services they’ll pay for, in an effort to prevent these multiple births. In most cases, I don’t believe public or private money is available for fertility treatment, but I’m not expert in that area. Certainly, private insurers can decide, by contract, what they will and won’t cover, but when the government gets involved, it becomes more problematic. That could be seen as the state mandating forced embryo reductions. 

The only place that this could be regulated with any type of efficiency would be in the professional responsibility codes and the licensing boards of the various health care specialties.

What role can and should health care providers play in situations such as this? Where do their responsibilities end?

Randy D. Danielsen, PhD, PA-C, DFAAPA, Dean of the Arizona School of Health Sciences at A. T. Still University and Clinician Reviews PA Editor-in-Chief: We as clinicians must first require patients to be competent in their decision making, indicating the ability to make choices based on an understanding of the relevant consequences of their action. For the most part, this is subjective and relies on the skills of the clinician in recognizing the ability of the patient to understand and give consent.   

All clinicians have an obligation to be patient advocates in their area of expertise, but this does not give them the authority to overrule patients (except in certain situations).

Marie-Eileen Onieal: Given that this patient already had six young children, at least two with special needs, I think the role of the provider is to counsel the woman against trying to have more children. Providing for a large family takes energy, patience, and finances. I do not doubt that she loves the children; I just doubt that she is able to provide for their developmental needs—even the most basic physiological and safety needs. Clearer heads must prevail in situations where the person may not have sound judgment or may not have fully considered the consequences of his or her decision. 

I think that those professionals whose specialty is infertility and assisting women in getting pregnant must have a moral code, a gauge if you will, that not only puts a stop to repeated failed attempts but also repeated successful births, especially if a pregnancy has resulted in multiple births. I think the responsibility is to have the ability to say “no,” and that responsibility doesn’t end.

Stephen Nunn: The role of the provider is an active and interactive one. The mother should undergo a psychologic or psychiatric evaluation. Risks and benefits need to be clearly explained and explored in an unbiased atmosphere. The provider has, in my opinion, the right to put limits on their involvement, such as adhering to established guidelines, protecting the potential fetuses’ health, insisting on a mental health evaluation, and refusing to be a party, if necessary.

Austin Potenza: Our medical system has gone, in the past 50 years, from one of paternalistic physicians and caregivers who really controlled all of the major decision-making in health care to one where it’s the patient who now is the king, makes all the major decisions, and is involved in his or her care. The health care provider is there to facilitate, maybe guide, those decisions, but not to interfere in them, unless they involve illegality (ie, assisted suicide) or overriding personal ethical beliefs (ie, abortion). But the decisions are ultimately the responsibility of the patient, if the patient is competent.

The point at which the caregiver’s responsibility becomes heightened is the point at which damage is being done to the patient—or, in cases such as this, to the fetuses, and that damage is foreseeable and preventable. Short of that, the caregiver’s role is generally secondary to the patient’s when it comes to medical decision-making.

What, if any, impact do you think the scientific/medical achievement in this case—which culminated in the successful delivery of octuplets —had on the clinicians’ judgment?

Marie-Eileen Onieal: I think that this event has placed the fertility specialty in jeopardy of being regulated for the wrong reasons. I think the physician took advantage of the science available.

Randy Danielsen: The technology in this case seems to have overridden the social implications. I am sure this case will be added to many others where the rights of the individual counter the ethical obligations of the provider in an absence of legal intervention.

Rebecca Scott: The way it comes across to me is that there’s a certain kind of arrogance in doing that kind of thing. And it’s the same kind of arrogance that we had a century ago, saying, “You’re mentally retarded; you should not be having children, therefore I am sterilizing you whether you want to be sterilized or not.” It’s kind of the flip side of that attitude.

At the same time, I really have a horror of setting up a situation where individual health care providers refuse to provide appropriate care because of individual beliefs. I think if we start going down that road, we’re really asking for trouble…. Medical decision-making is rarely clear-cut. The interaction between patient and provider is so much of a negotiation, tinged with so many “shades of gray,” that I believe we really have to think very carefully about whether making decisions for patients is appropriate.

Stephen Nunn: I doubt the notoriety of an octuplet birth held any sway over the decision. In fact, it probably was a negative factor. I am aware of a professed fertility specialist who became famous—or rather infamous—for being responsible for the largest number of quad births in the nation. For various reasons, the state medical board investigated, and the doctor agreed to stop the practices that led to this.

The remarkable thing seems to be that multiple gestations survive, not that they happen. I suspect that in the coming years, we will start hearing more about various learning and other disabilities as these children enter the school system.

Austin Potenza: It’s a very relevant question, and it really goes to the heart of ethical thinking. Whose interests is the caregiver really serving? The caregiver’s, by making a medical breakthrough, or the patient’s? I certainly can’t define whether such considerations had an influence in this case, but they clearly shouldn’t….

The truth is our medical abilities are advancing at just an amazing rate, and I think it’s sometimes hard to tell the difference between doing something because we can do it and doing something because it’s the right thing to do for a particular patient in a particular circumstance. Medical ethics is fighting to catch up with the medical advances that are being made, and we always have to be thinking about these things.

By now, the story of Nadya Suleman is well known. The 33-year-old California woman gave birth to octuplets—only the second set born in the United States—on January 26. Within a few weeks, what was initially reported as a heartwarming story of medicine’s finest hour had ignited a nationwide backlash as details of Suleman’s situation became known. The divorced single mom already had six children younger than 8 when she underwent the fertility treatments that led to an eight-baby bonanza.

Should Suleman have been allowed to undergo the additional treatments? Did her medical team violate guidelines by implanting more than the generally accepted number of embryos? Is it fair to burden taxpayers with the costs of raising her large family—particularly in the current economic climate?

Clinician Reviews does not profess to have the answers to these questions. But we did ask a panel of editorial board members and other experts for their take on the thorny ethical questions Suleman’s case has raised.

How do you feel about a woman with six children younger than 8 receiving fertility treatments and delivering another eight babies?

Stephen Nunn, MPAS, PA-C, a founding member of the Association of PAs in Ob-Gyn, who worked with the first successful in vitro fertilization program in Arizona for 18 years: The issue for me isn’t so much that she already has six children, but the real and serious risks to both the mother and fetuses with multiple gestation. The American Society of Reproductive Medicine has established guidelines for the number of embryos to be transferred, which for this patient would be three. It appears these guidelines were not used in this case. This would not have generated the same response had Ms. Suleman received fertility treatment in an effort to achieve a singleton or, at most, twin gestation.

Obviously, we do not know all the details; however, I wonder why so many embryos were placed. If there were a total of seven, as the press has stated, then there would have been more than one opportunity to achieve a single pregnancy. Even if the mother did not want the other embryos destroyed, she could have donated them to another woman.

Rebecca Scott, PhD, PA-C, Clinical Coordinator in the Physician Assistant Program at Northeastern University, Boston, and an elected member of the Board of Health in Sandwich, Massachusetts: I have been thinking about how this really illustrates a tension that we’ve had in our history of the rights of the individual versus the rights of the whole community. We have this long tradition of saying, “Everybody ought to be able to have children.” This seems to fit into that continuum of the individual’s right being very strongly upheld in this country over, perhaps, what is best for the good of society.

This is so interesting because other societies are quite up-front about their goals for their population. I remember traveling in Hungary at one point, where the people were not reproducing enough to replace the population. So the government said, “It’s in our best interests to have enough people to support the society,” and they actually subsidized moms with the equivalent of a factory worker’s wage to stay home with children for three years, up to three children’s worth.

The big thing that troubles me about this is where do the rights of the group get accounted for? Should we be paying tax dollars to subsidize people who want to have children?

Austin D. Potenza II, JD, a Phoenix-based attorney and Adjunct Professor at the Arizona School of Health Sciences, where he has taught a course on medical ethics for 10 years: I think in our society everything has to be open for discussion, but we have to realize that at some point it’s just discussion. Under current ethical thinking, the most important perspective is that of a competent patient. We as a society don’t make these kinds of decisions—whether it is getting fertility treatment or having multiple births—for people.

A close second is the perspective of the infants, but it is problematic to base a societal response on what is right for children when it comes to fertility and multiple birth. Is being born into a family of 14 somehow worse than not being born at all? If we’re trying to save children, what exactly are we saving them from? And why look at just these children? If we try to have a responsible answer to these questions, it is myopic to look only at this family.

Think about the thousands of children who are born into horrible poverty, hunger, abuse, and neglect. We don’t regulate their parents’ reproductive decisions. And that’s just considering our own country; if we really want to be concerned about children, think about places like Sierra Leone, where the infant mortality rate is about 25%. Although the consideration of the children is compelling, it is much more important to consider how to help them once they are born, rather than thinking of the solution in terms of fertility and multiple births.     

The next important ethical perspective is that of the caregiver [discussed in depth later]. 

Finally, society is a stakeholder, and this seems to be the perspective from which most people are approaching the issue. The typical questions you’re going to hear are, “Is the cost of care for this mother and these children going to fall on the rest of us as taxpayers? Is this part of what’s straining the health care and social support systems?” These are all valid questions, but they beg an awful lot of other questions that we have to answer first. For example, what should we spend our collective money on? Who decides?  

While it is understandable why the public is upset by this story, at the same time, does anyone have the right to impose restrictions on someone’s procreation? Where, if at all, do we draw a line in the sand? 

Marie-Eileen Onieal, PhD, CPNP, FAANP, Director of Medical Services for the Massachusetts Department of Youth Services and Clinician Reviews NP Editor-in-Chief: I think the line between moral soundness and legal rights was crossed when the woman put her desires to have more children above the needs of the children she already bore. Before the octup-let pregnancy, she needed more than minimal assistance to care for the six children she already had; at least two have special needs requiring more attention and care.  

I think, especially in the face of the fact that she is almost totally dependent on others to help her provide for her family, we as a society have a moral and legal obligation to impose restrictions on procreation (especially when one’s procreating consumes as many resources as this woman consumed).

Rebecca Scott: I don’t think sending hate mail and death threats is any way to respond in a civil society. But I think we do need to say, “No, it is not all right for somebody to be using taxpayer dollars to subsidize,” you know, whatever it is that the individual wants to do that is way above and beyond what most of us would consider reasonable. 

If we look at the welfare-to-work initiatives that took place under the Clinton administration, that’s a start on an answer. We made the decision at that point that it was OK to say to people, “You have to get off welfare. You must go to work.” But we also enabled people to do that by saying, “We will subsidize Medicaid so that you can continue to get coverage at these low-paying jobs where you don’t earn enough money to be able to pay for health care.”

Stephen Nunn: To me, the principle here is Primum non nocere or “First, do no harm.” A twin pregnancy is considered high risk just because it’s a twin pregnancy. Those risks skyrocket with each additional fetus. The main risk here is to the fetuses, their individual and collective survival, and the potential for future problems after birth, such as cerebral palsy, blindness, and learning disabilities. So, the risks and benefits have to be weighed on an individual basis.

Personally, I can see no circumstance to justify transferring more than four embryos—ever! Holding to this guideline is not restricting a woman’s right to procreation. It’s not saying “No,” it’s saying, “Not this many.”

Although the obstetrician’s patient is the mother, not the fetus, I believe the fertility specialist can’t take such a narrow view of his or her responsibilities. Ordinarily, an obstetrician becomes involved after pregnancy has occurred, while the fertility specialist is involved prior and thus has a greater duty in regard to the potential eventual outcome. Too much success can lead ultimately to failure.

Moving forward, where do we go from here? How might these issues be addressed?

Rebecca Scott: What I’m afraid is going to happen is that we’re going to react in a heavy-handed way and set up all kinds of oversight and come at it with a legislative approach—you know, somebody in the state legislature’s going to say, “Well, we’re going to make a rule about this.”

What I hope will happen is that we’ll have a good deal of dialogue about what’s appropriate and that that dialogue will include fertility specialists, public health experts, citizens in general, and government/public health departments and that the dialogue will try to come out with some policies and procedures to guide thinking in this kind of situation.

Austin Potenza: It’s very difficult for me to imagine any legislature taking on this issue. It would be politically impossible to attempt to regulate who can have children, and how many. Think back to the Terri Schiavo case, which was such a travesty in Congress. Everybody was trying to get involved, and it was obviously completely beyond the scope of their expertise and their ability. It was just a political nightmare. This is similar because it is government involvement in an intensely personal decision, in a country dedicated to personal freedoms. If we get involved in birth regulation, we’re repeating China’s mistakes and going against the fundamentally individual-rights focus of our society.

The next most likely—but still unlikely—step would be federal or state Medicare/Medicaid programs trying to regulate what kind of services they’ll pay for, in an effort to prevent these multiple births. In most cases, I don’t believe public or private money is available for fertility treatment, but I’m not expert in that area. Certainly, private insurers can decide, by contract, what they will and won’t cover, but when the government gets involved, it becomes more problematic. That could be seen as the state mandating forced embryo reductions. 

The only place that this could be regulated with any type of efficiency would be in the professional responsibility codes and the licensing boards of the various health care specialties.

What role can and should health care providers play in situations such as this? Where do their responsibilities end?

Randy D. Danielsen, PhD, PA-C, DFAAPA, Dean of the Arizona School of Health Sciences at A. T. Still University and Clinician Reviews PA Editor-in-Chief: We as clinicians must first require patients to be competent in their decision making, indicating the ability to make choices based on an understanding of the relevant consequences of their action. For the most part, this is subjective and relies on the skills of the clinician in recognizing the ability of the patient to understand and give consent.   

All clinicians have an obligation to be patient advocates in their area of expertise, but this does not give them the authority to overrule patients (except in certain situations).

Marie-Eileen Onieal: Given that this patient already had six young children, at least two with special needs, I think the role of the provider is to counsel the woman against trying to have more children. Providing for a large family takes energy, patience, and finances. I do not doubt that she loves the children; I just doubt that she is able to provide for their developmental needs—even the most basic physiological and safety needs. Clearer heads must prevail in situations where the person may not have sound judgment or may not have fully considered the consequences of his or her decision. 

I think that those professionals whose specialty is infertility and assisting women in getting pregnant must have a moral code, a gauge if you will, that not only puts a stop to repeated failed attempts but also repeated successful births, especially if a pregnancy has resulted in multiple births. I think the responsibility is to have the ability to say “no,” and that responsibility doesn’t end.

Stephen Nunn: The role of the provider is an active and interactive one. The mother should undergo a psychologic or psychiatric evaluation. Risks and benefits need to be clearly explained and explored in an unbiased atmosphere. The provider has, in my opinion, the right to put limits on their involvement, such as adhering to established guidelines, protecting the potential fetuses’ health, insisting on a mental health evaluation, and refusing to be a party, if necessary.

Austin Potenza: Our medical system has gone, in the past 50 years, from one of paternalistic physicians and caregivers who really controlled all of the major decision-making in health care to one where it’s the patient who now is the king, makes all the major decisions, and is involved in his or her care. The health care provider is there to facilitate, maybe guide, those decisions, but not to interfere in them, unless they involve illegality (ie, assisted suicide) or overriding personal ethical beliefs (ie, abortion). But the decisions are ultimately the responsibility of the patient, if the patient is competent.

The point at which the caregiver’s responsibility becomes heightened is the point at which damage is being done to the patient—or, in cases such as this, to the fetuses, and that damage is foreseeable and preventable. Short of that, the caregiver’s role is generally secondary to the patient’s when it comes to medical decision-making.

What, if any, impact do you think the scientific/medical achievement in this case—which culminated in the successful delivery of octuplets —had on the clinicians’ judgment?

Marie-Eileen Onieal: I think that this event has placed the fertility specialty in jeopardy of being regulated for the wrong reasons. I think the physician took advantage of the science available.

Randy Danielsen: The technology in this case seems to have overridden the social implications. I am sure this case will be added to many others where the rights of the individual counter the ethical obligations of the provider in an absence of legal intervention.

Rebecca Scott: The way it comes across to me is that there’s a certain kind of arrogance in doing that kind of thing. And it’s the same kind of arrogance that we had a century ago, saying, “You’re mentally retarded; you should not be having children, therefore I am sterilizing you whether you want to be sterilized or not.” It’s kind of the flip side of that attitude.

At the same time, I really have a horror of setting up a situation where individual health care providers refuse to provide appropriate care because of individual beliefs. I think if we start going down that road, we’re really asking for trouble…. Medical decision-making is rarely clear-cut. The interaction between patient and provider is so much of a negotiation, tinged with so many “shades of gray,” that I believe we really have to think very carefully about whether making decisions for patients is appropriate.

Stephen Nunn: I doubt the notoriety of an octuplet birth held any sway over the decision. In fact, it probably was a negative factor. I am aware of a professed fertility specialist who became famous—or rather infamous—for being responsible for the largest number of quad births in the nation. For various reasons, the state medical board investigated, and the doctor agreed to stop the practices that led to this.

The remarkable thing seems to be that multiple gestations survive, not that they happen. I suspect that in the coming years, we will start hearing more about various learning and other disabilities as these children enter the school system.

Austin Potenza: It’s a very relevant question, and it really goes to the heart of ethical thinking. Whose interests is the caregiver really serving? The caregiver’s, by making a medical breakthrough, or the patient’s? I certainly can’t define whether such considerations had an influence in this case, but they clearly shouldn’t….

The truth is our medical abilities are advancing at just an amazing rate, and I think it’s sometimes hard to tell the difference between doing something because we can do it and doing something because it’s the right thing to do for a particular patient in a particular circumstance. Medical ethics is fighting to catch up with the medical advances that are being made, and we always have to be thinking about these things.

By now, the story of Nadya Suleman is well known. The 33-year-old California woman gave birth to octuplets—only the second set born in the United States—on January 26. Within a few weeks, what was initially reported as a heartwarming story of medicine’s finest hour had ignited a nationwide backlash as details of Suleman’s situation became known. The divorced single mom already had six children younger than 8 when she underwent the fertility treatments that led to an eight-baby bonanza.

Should Suleman have been allowed to undergo the additional treatments? Did her medical team violate guidelines by implanting more than the generally accepted number of embryos? Is it fair to burden taxpayers with the costs of raising her large family—particularly in the current economic climate?

Clinician Reviews does not profess to have the answers to these questions. But we did ask a panel of editorial board members and other experts for their take on the thorny ethical questions Suleman’s case has raised.

How do you feel about a woman with six children younger than 8 receiving fertility treatments and delivering another eight babies?

Stephen Nunn, MPAS, PA-C, a founding member of the Association of PAs in Ob-Gyn, who worked with the first successful in vitro fertilization program in Arizona for 18 years: The issue for me isn’t so much that she already has six children, but the real and serious risks to both the mother and fetuses with multiple gestation. The American Society of Reproductive Medicine has established guidelines for the number of embryos to be transferred, which for this patient would be three. It appears these guidelines were not used in this case. This would not have generated the same response had Ms. Suleman received fertility treatment in an effort to achieve a singleton or, at most, twin gestation.

Obviously, we do not know all the details; however, I wonder why so many embryos were placed. If there were a total of seven, as the press has stated, then there would have been more than one opportunity to achieve a single pregnancy. Even if the mother did not want the other embryos destroyed, she could have donated them to another woman.

Rebecca Scott, PhD, PA-C, Clinical Coordinator in the Physician Assistant Program at Northeastern University, Boston, and an elected member of the Board of Health in Sandwich, Massachusetts: I have been thinking about how this really illustrates a tension that we’ve had in our history of the rights of the individual versus the rights of the whole community. We have this long tradition of saying, “Everybody ought to be able to have children.” This seems to fit into that continuum of the individual’s right being very strongly upheld in this country over, perhaps, what is best for the good of society.

This is so interesting because other societies are quite up-front about their goals for their population. I remember traveling in Hungary at one point, where the people were not reproducing enough to replace the population. So the government said, “It’s in our best interests to have enough people to support the society,” and they actually subsidized moms with the equivalent of a factory worker’s wage to stay home with children for three years, up to three children’s worth.

The big thing that troubles me about this is where do the rights of the group get accounted for? Should we be paying tax dollars to subsidize people who want to have children?

Austin D. Potenza II, JD, a Phoenix-based attorney and Adjunct Professor at the Arizona School of Health Sciences, where he has taught a course on medical ethics for 10 years: I think in our society everything has to be open for discussion, but we have to realize that at some point it’s just discussion. Under current ethical thinking, the most important perspective is that of a competent patient. We as a society don’t make these kinds of decisions—whether it is getting fertility treatment or having multiple births—for people.

A close second is the perspective of the infants, but it is problematic to base a societal response on what is right for children when it comes to fertility and multiple birth. Is being born into a family of 14 somehow worse than not being born at all? If we’re trying to save children, what exactly are we saving them from? And why look at just these children? If we try to have a responsible answer to these questions, it is myopic to look only at this family.

Think about the thousands of children who are born into horrible poverty, hunger, abuse, and neglect. We don’t regulate their parents’ reproductive decisions. And that’s just considering our own country; if we really want to be concerned about children, think about places like Sierra Leone, where the infant mortality rate is about 25%. Although the consideration of the children is compelling, it is much more important to consider how to help them once they are born, rather than thinking of the solution in terms of fertility and multiple births.     

The next important ethical perspective is that of the caregiver [discussed in depth later]. 

Finally, society is a stakeholder, and this seems to be the perspective from which most people are approaching the issue. The typical questions you’re going to hear are, “Is the cost of care for this mother and these children going to fall on the rest of us as taxpayers? Is this part of what’s straining the health care and social support systems?” These are all valid questions, but they beg an awful lot of other questions that we have to answer first. For example, what should we spend our collective money on? Who decides?  

While it is understandable why the public is upset by this story, at the same time, does anyone have the right to impose restrictions on someone’s procreation? Where, if at all, do we draw a line in the sand? 

Marie-Eileen Onieal, PhD, CPNP, FAANP, Director of Medical Services for the Massachusetts Department of Youth Services and Clinician Reviews NP Editor-in-Chief: I think the line between moral soundness and legal rights was crossed when the woman put her desires to have more children above the needs of the children she already bore. Before the octup-let pregnancy, she needed more than minimal assistance to care for the six children she already had; at least two have special needs requiring more attention and care.  

I think, especially in the face of the fact that she is almost totally dependent on others to help her provide for her family, we as a society have a moral and legal obligation to impose restrictions on procreation (especially when one’s procreating consumes as many resources as this woman consumed).

Rebecca Scott: I don’t think sending hate mail and death threats is any way to respond in a civil society. But I think we do need to say, “No, it is not all right for somebody to be using taxpayer dollars to subsidize,” you know, whatever it is that the individual wants to do that is way above and beyond what most of us would consider reasonable. 

If we look at the welfare-to-work initiatives that took place under the Clinton administration, that’s a start on an answer. We made the decision at that point that it was OK to say to people, “You have to get off welfare. You must go to work.” But we also enabled people to do that by saying, “We will subsidize Medicaid so that you can continue to get coverage at these low-paying jobs where you don’t earn enough money to be able to pay for health care.”

Stephen Nunn: To me, the principle here is Primum non nocere or “First, do no harm.” A twin pregnancy is considered high risk just because it’s a twin pregnancy. Those risks skyrocket with each additional fetus. The main risk here is to the fetuses, their individual and collective survival, and the potential for future problems after birth, such as cerebral palsy, blindness, and learning disabilities. So, the risks and benefits have to be weighed on an individual basis.

Personally, I can see no circumstance to justify transferring more than four embryos—ever! Holding to this guideline is not restricting a woman’s right to procreation. It’s not saying “No,” it’s saying, “Not this many.”

Although the obstetrician’s patient is the mother, not the fetus, I believe the fertility specialist can’t take such a narrow view of his or her responsibilities. Ordinarily, an obstetrician becomes involved after pregnancy has occurred, while the fertility specialist is involved prior and thus has a greater duty in regard to the potential eventual outcome. Too much success can lead ultimately to failure.

Moving forward, where do we go from here? How might these issues be addressed?

Rebecca Scott: What I’m afraid is going to happen is that we’re going to react in a heavy-handed way and set up all kinds of oversight and come at it with a legislative approach—you know, somebody in the state legislature’s going to say, “Well, we’re going to make a rule about this.”

What I hope will happen is that we’ll have a good deal of dialogue about what’s appropriate and that that dialogue will include fertility specialists, public health experts, citizens in general, and government/public health departments and that the dialogue will try to come out with some policies and procedures to guide thinking in this kind of situation.

Austin Potenza: It’s very difficult for me to imagine any legislature taking on this issue. It would be politically impossible to attempt to regulate who can have children, and how many. Think back to the Terri Schiavo case, which was such a travesty in Congress. Everybody was trying to get involved, and it was obviously completely beyond the scope of their expertise and their ability. It was just a political nightmare. This is similar because it is government involvement in an intensely personal decision, in a country dedicated to personal freedoms. If we get involved in birth regulation, we’re repeating China’s mistakes and going against the fundamentally individual-rights focus of our society.

The next most likely—but still unlikely—step would be federal or state Medicare/Medicaid programs trying to regulate what kind of services they’ll pay for, in an effort to prevent these multiple births. In most cases, I don’t believe public or private money is available for fertility treatment, but I’m not expert in that area. Certainly, private insurers can decide, by contract, what they will and won’t cover, but when the government gets involved, it becomes more problematic. That could be seen as the state mandating forced embryo reductions. 

The only place that this could be regulated with any type of efficiency would be in the professional responsibility codes and the licensing boards of the various health care specialties.

What role can and should health care providers play in situations such as this? Where do their responsibilities end?

Randy D. Danielsen, PhD, PA-C, DFAAPA, Dean of the Arizona School of Health Sciences at A. T. Still University and Clinician Reviews PA Editor-in-Chief: We as clinicians must first require patients to be competent in their decision making, indicating the ability to make choices based on an understanding of the relevant consequences of their action. For the most part, this is subjective and relies on the skills of the clinician in recognizing the ability of the patient to understand and give consent.   

All clinicians have an obligation to be patient advocates in their area of expertise, but this does not give them the authority to overrule patients (except in certain situations).

Marie-Eileen Onieal: Given that this patient already had six young children, at least two with special needs, I think the role of the provider is to counsel the woman against trying to have more children. Providing for a large family takes energy, patience, and finances. I do not doubt that she loves the children; I just doubt that she is able to provide for their developmental needs—even the most basic physiological and safety needs. Clearer heads must prevail in situations where the person may not have sound judgment or may not have fully considered the consequences of his or her decision. 

I think that those professionals whose specialty is infertility and assisting women in getting pregnant must have a moral code, a gauge if you will, that not only puts a stop to repeated failed attempts but also repeated successful births, especially if a pregnancy has resulted in multiple births. I think the responsibility is to have the ability to say “no,” and that responsibility doesn’t end.

Stephen Nunn: The role of the provider is an active and interactive one. The mother should undergo a psychologic or psychiatric evaluation. Risks and benefits need to be clearly explained and explored in an unbiased atmosphere. The provider has, in my opinion, the right to put limits on their involvement, such as adhering to established guidelines, protecting the potential fetuses’ health, insisting on a mental health evaluation, and refusing to be a party, if necessary.

Austin Potenza: Our medical system has gone, in the past 50 years, from one of paternalistic physicians and caregivers who really controlled all of the major decision-making in health care to one where it’s the patient who now is the king, makes all the major decisions, and is involved in his or her care. The health care provider is there to facilitate, maybe guide, those decisions, but not to interfere in them, unless they involve illegality (ie, assisted suicide) or overriding personal ethical beliefs (ie, abortion). But the decisions are ultimately the responsibility of the patient, if the patient is competent.

The point at which the caregiver’s responsibility becomes heightened is the point at which damage is being done to the patient—or, in cases such as this, to the fetuses, and that damage is foreseeable and preventable. Short of that, the caregiver’s role is generally secondary to the patient’s when it comes to medical decision-making.

What, if any, impact do you think the scientific/medical achievement in this case—which culminated in the successful delivery of octuplets —had on the clinicians’ judgment?

Marie-Eileen Onieal: I think that this event has placed the fertility specialty in jeopardy of being regulated for the wrong reasons. I think the physician took advantage of the science available.

Randy Danielsen: The technology in this case seems to have overridden the social implications. I am sure this case will be added to many others where the rights of the individual counter the ethical obligations of the provider in an absence of legal intervention.

Rebecca Scott: The way it comes across to me is that there’s a certain kind of arrogance in doing that kind of thing. And it’s the same kind of arrogance that we had a century ago, saying, “You’re mentally retarded; you should not be having children, therefore I am sterilizing you whether you want to be sterilized or not.” It’s kind of the flip side of that attitude.

At the same time, I really have a horror of setting up a situation where individual health care providers refuse to provide appropriate care because of individual beliefs. I think if we start going down that road, we’re really asking for trouble…. Medical decision-making is rarely clear-cut. The interaction between patient and provider is so much of a negotiation, tinged with so many “shades of gray,” that I believe we really have to think very carefully about whether making decisions for patients is appropriate.

Stephen Nunn: I doubt the notoriety of an octuplet birth held any sway over the decision. In fact, it probably was a negative factor. I am aware of a professed fertility specialist who became famous—or rather infamous—for being responsible for the largest number of quad births in the nation. For various reasons, the state medical board investigated, and the doctor agreed to stop the practices that led to this.

The remarkable thing seems to be that multiple gestations survive, not that they happen. I suspect that in the coming years, we will start hearing more about various learning and other disabilities as these children enter the school system.

Austin Potenza: It’s a very relevant question, and it really goes to the heart of ethical thinking. Whose interests is the caregiver really serving? The caregiver’s, by making a medical breakthrough, or the patient’s? I certainly can’t define whether such considerations had an influence in this case, but they clearly shouldn’t….

The truth is our medical abilities are advancing at just an amazing rate, and I think it’s sometimes hard to tell the difference between doing something because we can do it and doing something because it’s the right thing to do for a particular patient in a particular circumstance. Medical ethics is fighting to catch up with the medical advances that are being made, and we always have to be thinking about these things.

SAN FRANCISCO — There is no reason to be hesitant in prescribing topical retinoids to women with acne, according to Dr. Hilary E. Baldwin.

While the teratogenic potential of oral isotretinoin is well known, topical retinoids appear to be safe for use in women of childbearing potential, said Dr. Baldwin of the State University of New York, Brooklyn.

According to data from Allergan Inc., which makes Tazorac (tazarotene gel), the normal, endogenous plasma level of retinoids is 6.6 ng/mL. These retinoids come from food sources such as carrots, red peppers, sweet potatoes, and fish, she said at a meeting sponsored by Skin Disease Education Foundation. Oral isotretinoin raises this level to 862 ng/mL, according to the Accutane package insert. In contrast, tretinoin 0.1% cream raises the endogenous plasma level by only 2.9 ng/mL, tazarotene 0.1% gel by 0.14 ng/mL, and adapalene 0.1% gel (Differin) by 0.04 ng/mL, she said.

Several studies looking at women who used topical retinoids during pregnancy found no increase in developmental anomalies among offspring, even though the Food and Drug Administration classifies tazarotene as category X. “My soapbox issue is that whether or not you decide to use it in women who are actively pregnant—and that's a completely different medical-legal concern—you can't ignore half of the world population with acne simply because they happen to have a uterus,” she said. Dr. Baldwin disclosed serving as a consultant to, and being on the speakers bureau of, Allergan and several other pharmaceutical companies. SDEF and this news organization are owned by Elsevier.

SAN FRANCISCO — There is no reason to be hesitant in prescribing topical retinoids to women with acne, according to Dr. Hilary E. Baldwin.

While the teratogenic potential of oral isotretinoin is well known, topical retinoids appear to be safe for use in women of childbearing potential, said Dr. Baldwin of the State University of New York, Brooklyn.

According to data from Allergan Inc., which makes Tazorac (tazarotene gel), the normal, endogenous plasma level of retinoids is 6.6 ng/mL. These retinoids come from food sources such as carrots, red peppers, sweet potatoes, and fish, she said at a meeting sponsored by Skin Disease Education Foundation. Oral isotretinoin raises this level to 862 ng/mL, according to the Accutane package insert. In contrast, tretinoin 0.1% cream raises the endogenous plasma level by only 2.9 ng/mL, tazarotene 0.1% gel by 0.14 ng/mL, and adapalene 0.1% gel (Differin) by 0.04 ng/mL, she said.

Several studies looking at women who used topical retinoids during pregnancy found no increase in developmental anomalies among offspring, even though the Food and Drug Administration classifies tazarotene as category X. “My soapbox issue is that whether or not you decide to use it in women who are actively pregnant—and that's a completely different medical-legal concern—you can't ignore half of the world population with acne simply because they happen to have a uterus,” she said. Dr. Baldwin disclosed serving as a consultant to, and being on the speakers bureau of, Allergan and several other pharmaceutical companies. SDEF and this news organization are owned by Elsevier.

SAN FRANCISCO — There is no reason to be hesitant in prescribing topical retinoids to women with acne, according to Dr. Hilary E. Baldwin.

While the teratogenic potential of oral isotretinoin is well known, topical retinoids appear to be safe for use in women of childbearing potential, said Dr. Baldwin of the State University of New York, Brooklyn.

According to data from Allergan Inc., which makes Tazorac (tazarotene gel), the normal, endogenous plasma level of retinoids is 6.6 ng/mL. These retinoids come from food sources such as carrots, red peppers, sweet potatoes, and fish, she said at a meeting sponsored by Skin Disease Education Foundation. Oral isotretinoin raises this level to 862 ng/mL, according to the Accutane package insert. In contrast, tretinoin 0.1% cream raises the endogenous plasma level by only 2.9 ng/mL, tazarotene 0.1% gel by 0.14 ng/mL, and adapalene 0.1% gel (Differin) by 0.04 ng/mL, she said.

Several studies looking at women who used topical retinoids during pregnancy found no increase in developmental anomalies among offspring, even though the Food and Drug Administration classifies tazarotene as category X. “My soapbox issue is that whether or not you decide to use it in women who are actively pregnant—and that's a completely different medical-legal concern—you can't ignore half of the world population with acne simply because they happen to have a uterus,” she said. Dr. Baldwin disclosed serving as a consultant to, and being on the speakers bureau of, Allergan and several other pharmaceutical companies. SDEF and this news organization are owned by Elsevier.

SAN DIEGO — Women with prior early spontaneous preterm birth and a midtrimester sonographic cervical length of less than 25 mm may benefit from cerclage, but the benefit is most pronounced when the cervical length is less than 15 mm, results from a large, multicenter, randomized study showed.

“Although clinicians have recommended cerclage for shortened cervical lengths, previous randomized trials have not supported this practice,” Dr. John Owen said at the annual meeting of the Society for Maternal-Fetal Medicine.

A recent meta-analysis of four randomized trials of cerclage for shortened cervical length uncovered a relationship between pregnancy history and cerclage effectiveness. Cerclage was helpful only in singletons—it was harmful in multiples—but it was especially helpful in women who'd had a prior preterm birth (Obstet. Gynecol. 2005;106:181–9).

“Our hypothesis was that in women with a prior early spontaneous preterm birth [gestational age less than 34 weeks] and cervical length less than 25 mm, cerclage would reduce the rate of preterm birth before 35 weeks' gestation,” said Dr. Owen of the department of obstetrics and gynecology at the University of Alabama at Birmingham.

To test the hypothesis, he and his colleagues at 15 centers in the United States, known as the Vaginal Ultrasound Trial Consortium, studied 1,014 women with a prior spontaneous birth at less than 34 weeks and a current singleton pregnancy who underwent serial ultrasound evaluation in the period beginning at 16 weeks and ending before 23 weeks (that is, no later than 22 weeks and 6 days). Of these, 301 women with a cervical length of less than 25 mm were randomized to either cerclage or no cerclage.

Vaginal ultrasound exams lasted a minimum of 5 minutes to allow the clinician to observe any spontaneous shortening, and included fundal pressure as a provocative measure to induce cervical shortening. The scans were scheduled every 2 weeks as long as the cervical length remained at least 30 mm. They were performed weekly if the cervical length shortened to 25–29 mm. The last scan was scheduled to occur just before the 23 weeks' gestational point.

Dr. Owen reported that the cerclage and no-cerclage groups were similar in terms of race/ethnicity, mean cervical length (18.7 vs. 19.5 mm, respectively), mean gestational age at randomization (19.4 vs. 19.5 weeks), and mean gestational age of earliest prior preterm birth (24.4 vs. 24.9 weeks).

Preterm birth before 35 weeks occurred in 42% of the no-cerclage group, compared with 32% of the cerclage group, a difference that revealed a statistical trend (P = .09).

However, further analysis revealed that women in the cerclage group maintained their pregnancies significantly better if their cervical length was less than 15 mm (odds ratio, 0.23), but there was no significantly positive effect if their cervical length was 15–24 mm (OR, 0.84).

Dr. Owen had no conflicts to disclose.

SAN DIEGO — Women with prior early spontaneous preterm birth and a midtrimester sonographic cervical length of less than 25 mm may benefit from cerclage, but the benefit is most pronounced when the cervical length is less than 15 mm, results from a large, multicenter, randomized study showed.

“Although clinicians have recommended cerclage for shortened cervical lengths, previous randomized trials have not supported this practice,” Dr. John Owen said at the annual meeting of the Society for Maternal-Fetal Medicine.

A recent meta-analysis of four randomized trials of cerclage for shortened cervical length uncovered a relationship between pregnancy history and cerclage effectiveness. Cerclage was helpful only in singletons—it was harmful in multiples—but it was especially helpful in women who'd had a prior preterm birth (Obstet. Gynecol. 2005;106:181–9).

“Our hypothesis was that in women with a prior early spontaneous preterm birth [gestational age less than 34 weeks] and cervical length less than 25 mm, cerclage would reduce the rate of preterm birth before 35 weeks' gestation,” said Dr. Owen of the department of obstetrics and gynecology at the University of Alabama at Birmingham.

To test the hypothesis, he and his colleagues at 15 centers in the United States, known as the Vaginal Ultrasound Trial Consortium, studied 1,014 women with a prior spontaneous birth at less than 34 weeks and a current singleton pregnancy who underwent serial ultrasound evaluation in the period beginning at 16 weeks and ending before 23 weeks (that is, no later than 22 weeks and 6 days). Of these, 301 women with a cervical length of less than 25 mm were randomized to either cerclage or no cerclage.

Vaginal ultrasound exams lasted a minimum of 5 minutes to allow the clinician to observe any spontaneous shortening, and included fundal pressure as a provocative measure to induce cervical shortening. The scans were scheduled every 2 weeks as long as the cervical length remained at least 30 mm. They were performed weekly if the cervical length shortened to 25–29 mm. The last scan was scheduled to occur just before the 23 weeks' gestational point.

Dr. Owen reported that the cerclage and no-cerclage groups were similar in terms of race/ethnicity, mean cervical length (18.7 vs. 19.5 mm, respectively), mean gestational age at randomization (19.4 vs. 19.5 weeks), and mean gestational age of earliest prior preterm birth (24.4 vs. 24.9 weeks).

Preterm birth before 35 weeks occurred in 42% of the no-cerclage group, compared with 32% of the cerclage group, a difference that revealed a statistical trend (P = .09).

However, further analysis revealed that women in the cerclage group maintained their pregnancies significantly better if their cervical length was less than 15 mm (odds ratio, 0.23), but there was no significantly positive effect if their cervical length was 15–24 mm (OR, 0.84).

Dr. Owen had no conflicts to disclose.

SAN DIEGO — Women with prior early spontaneous preterm birth and a midtrimester sonographic cervical length of less than 25 mm may benefit from cerclage, but the benefit is most pronounced when the cervical length is less than 15 mm, results from a large, multicenter, randomized study showed.

“Although clinicians have recommended cerclage for shortened cervical lengths, previous randomized trials have not supported this practice,” Dr. John Owen said at the annual meeting of the Society for Maternal-Fetal Medicine.

A recent meta-analysis of four randomized trials of cerclage for shortened cervical length uncovered a relationship between pregnancy history and cerclage effectiveness. Cerclage was helpful only in singletons—it was harmful in multiples—but it was especially helpful in women who'd had a prior preterm birth (Obstet. Gynecol. 2005;106:181–9).

“Our hypothesis was that in women with a prior early spontaneous preterm birth [gestational age less than 34 weeks] and cervical length less than 25 mm, cerclage would reduce the rate of preterm birth before 35 weeks' gestation,” said Dr. Owen of the department of obstetrics and gynecology at the University of Alabama at Birmingham.

To test the hypothesis, he and his colleagues at 15 centers in the United States, known as the Vaginal Ultrasound Trial Consortium, studied 1,014 women with a prior spontaneous birth at less than 34 weeks and a current singleton pregnancy who underwent serial ultrasound evaluation in the period beginning at 16 weeks and ending before 23 weeks (that is, no later than 22 weeks and 6 days). Of these, 301 women with a cervical length of less than 25 mm were randomized to either cerclage or no cerclage.

Vaginal ultrasound exams lasted a minimum of 5 minutes to allow the clinician to observe any spontaneous shortening, and included fundal pressure as a provocative measure to induce cervical shortening. The scans were scheduled every 2 weeks as long as the cervical length remained at least 30 mm. They were performed weekly if the cervical length shortened to 25–29 mm. The last scan was scheduled to occur just before the 23 weeks' gestational point.

Dr. Owen reported that the cerclage and no-cerclage groups were similar in terms of race/ethnicity, mean cervical length (18.7 vs. 19.5 mm, respectively), mean gestational age at randomization (19.4 vs. 19.5 weeks), and mean gestational age of earliest prior preterm birth (24.4 vs. 24.9 weeks).

Preterm birth before 35 weeks occurred in 42% of the no-cerclage group, compared with 32% of the cerclage group, a difference that revealed a statistical trend (P = .09).

However, further analysis revealed that women in the cerclage group maintained their pregnancies significantly better if their cervical length was less than 15 mm (odds ratio, 0.23), but there was no significantly positive effect if their cervical length was 15–24 mm (OR, 0.84).

Dr. Owen had no conflicts to disclose.

SAN DIEGO — Prepregnancy obesity is an independent risk factor for postpartum depression, a large analysis demonstrates.

Common pregnancy stressors such as divorce or separation or being involved in a physical fight also were found to increase the risk.

“While I advocate that we should screen all women for depression, I think there are subsets of women whose risk is so high that we should either be identifying ways to prevent depression in this group or carry out early targeted surveillance and treatment,” Dr. D. Yvette LaCoursiere said in an interview during a poster session at the annual meeting of the Society for Maternal-Fetal Medicine.

“So if a woman comes to pregnancy with a BMI of greater than 35 kg/m

Previous research has shown that women with a history of depression are at increased risk of developing postpartum depression, but the possible association between prepregnancy obesity and subsequent postpartum depression has not been sufficiently studied, said Dr. LaCoursiere of the department of obstetrics and gynecology at the University of California at San Diego.

She and her associate, Dr. Michael W. Varner of the division of maternal-fetal medicine at the University of Utah, Salt Lake City, followed 1,053 women who were delivered of a term, singleton, live-born infant at one of four hospitals in Utah between 2005 and 2007.

At intake, the researchers obtained demographic and anthropomorphic information and pregnancy stressors, in addition to a psychiatric, medical, obstetric, and family history. Participants were also asked to complete the Pregnancy Risk Assessment Monitoring System (PRAMS).

Self-reported prepregnancy body mass index was stratified by the World Health Organization classification system for underweight (less than 18.5 kg/m

At 6–8 weeks after delivery, the women were asked to complete the Edinburgh Postnatal Depression Scale. Postpartum depression was defined as a score of 12 or more.

Dr. LaCoursiere reported that the rate of postpartum depression was directly related to the extremes of body mass index. For example, the rates of postpartum depression among those in the underweight, normal weight, and preobese groups were 18%, 14%, and 19%, respectively, while the rates among those in the obese class I, class II, and class III groups were 19%, 32%, and 40%, respectively.

After the researchers controlled for demographic, psychological, medical, and obstetrical risk factors, the overall adjusted odds ratio of postpartum depression was 2.87 for obese class II women and 3.94 for obese class III women.

In the PRAMS stressors component of the study, Dr. LaCoursiere and Dr. Varner found that common pregnancy stressors increase the risk of postpartum depression. For example, the adjusted odds ratio for postpartum depression among women who reported partner-associated stressors such as divorce or arguing more than usual was 2.61, while the adjusted odds ratio for those who reported traumatic stressors such as being homeless or being involved in a physical fight was 1.66.

The adjusted odds ratio for those who reported both types of stressors was 8.48.

Fewer than half of the study participants (44%) reported that their clinician asked about their mood during pregnancy, while 54% reported that they were asked about their mood during the postpartum period.

Dr. LaCoursiere acknowledged certain limitations of the study, including the self-reported height and weight data and the fact that while women who were being actively treated for depression were excluded, the questionnaire was not administered antepartum or immediately post partum. Therefore, she said, “this cohort may represent women who were depressed antenatally and continued to have antenatal depression into the postpartum period.”

Dr. LaCoursiere reported that she had no conflicts to disclose.

SAN DIEGO — Prepregnancy obesity is an independent risk factor for postpartum depression, a large analysis demonstrates.

Common pregnancy stressors such as divorce or separation or being involved in a physical fight also were found to increase the risk.

“While I advocate that we should screen all women for depression, I think there are subsets of women whose risk is so high that we should either be identifying ways to prevent depression in this group or carry out early targeted surveillance and treatment,” Dr. D. Yvette LaCoursiere said in an interview during a poster session at the annual meeting of the Society for Maternal-Fetal Medicine.

“So if a woman comes to pregnancy with a BMI of greater than 35 kg/m

Previous research has shown that women with a history of depression are at increased risk of developing postpartum depression, but the possible association between prepregnancy obesity and subsequent postpartum depression has not been sufficiently studied, said Dr. LaCoursiere of the department of obstetrics and gynecology at the University of California at San Diego.

She and her associate, Dr. Michael W. Varner of the division of maternal-fetal medicine at the University of Utah, Salt Lake City, followed 1,053 women who were delivered of a term, singleton, live-born infant at one of four hospitals in Utah between 2005 and 2007.

At intake, the researchers obtained demographic and anthropomorphic information and pregnancy stressors, in addition to a psychiatric, medical, obstetric, and family history. Participants were also asked to complete the Pregnancy Risk Assessment Monitoring System (PRAMS).

Self-reported prepregnancy body mass index was stratified by the World Health Organization classification system for underweight (less than 18.5 kg/m

At 6–8 weeks after delivery, the women were asked to complete the Edinburgh Postnatal Depression Scale. Postpartum depression was defined as a score of 12 or more.

Dr. LaCoursiere reported that the rate of postpartum depression was directly related to the extremes of body mass index. For example, the rates of postpartum depression among those in the underweight, normal weight, and preobese groups were 18%, 14%, and 19%, respectively, while the rates among those in the obese class I, class II, and class III groups were 19%, 32%, and 40%, respectively.

After the researchers controlled for demographic, psychological, medical, and obstetrical risk factors, the overall adjusted odds ratio of postpartum depression was 2.87 for obese class II women and 3.94 for obese class III women.

In the PRAMS stressors component of the study, Dr. LaCoursiere and Dr. Varner found that common pregnancy stressors increase the risk of postpartum depression. For example, the adjusted odds ratio for postpartum depression among women who reported partner-associated stressors such as divorce or arguing more than usual was 2.61, while the adjusted odds ratio for those who reported traumatic stressors such as being homeless or being involved in a physical fight was 1.66.

The adjusted odds ratio for those who reported both types of stressors was 8.48.

Fewer than half of the study participants (44%) reported that their clinician asked about their mood during pregnancy, while 54% reported that they were asked about their mood during the postpartum period.

Dr. LaCoursiere acknowledged certain limitations of the study, including the self-reported height and weight data and the fact that while women who were being actively treated for depression were excluded, the questionnaire was not administered antepartum or immediately post partum. Therefore, she said, “this cohort may represent women who were depressed antenatally and continued to have antenatal depression into the postpartum period.”

Dr. LaCoursiere reported that she had no conflicts to disclose.

SAN DIEGO — Prepregnancy obesity is an independent risk factor for postpartum depression, a large analysis demonstrates.

Common pregnancy stressors such as divorce or separation or being involved in a physical fight also were found to increase the risk.

“While I advocate that we should screen all women for depression, I think there are subsets of women whose risk is so high that we should either be identifying ways to prevent depression in this group or carry out early targeted surveillance and treatment,” Dr. D. Yvette LaCoursiere said in an interview during a poster session at the annual meeting of the Society for Maternal-Fetal Medicine.

“So if a woman comes to pregnancy with a BMI of greater than 35 kg/m

Previous research has shown that women with a history of depression are at increased risk of developing postpartum depression, but the possible association between prepregnancy obesity and subsequent postpartum depression has not been sufficiently studied, said Dr. LaCoursiere of the department of obstetrics and gynecology at the University of California at San Diego.

She and her associate, Dr. Michael W. Varner of the division of maternal-fetal medicine at the University of Utah, Salt Lake City, followed 1,053 women who were delivered of a term, singleton, live-born infant at one of four hospitals in Utah between 2005 and 2007.

At intake, the researchers obtained demographic and anthropomorphic information and pregnancy stressors, in addition to a psychiatric, medical, obstetric, and family history. Participants were also asked to complete the Pregnancy Risk Assessment Monitoring System (PRAMS).

Self-reported prepregnancy body mass index was stratified by the World Health Organization classification system for underweight (less than 18.5 kg/m

At 6–8 weeks after delivery, the women were asked to complete the Edinburgh Postnatal Depression Scale. Postpartum depression was defined as a score of 12 or more.

Dr. LaCoursiere reported that the rate of postpartum depression was directly related to the extremes of body mass index. For example, the rates of postpartum depression among those in the underweight, normal weight, and preobese groups were 18%, 14%, and 19%, respectively, while the rates among those in the obese class I, class II, and class III groups were 19%, 32%, and 40%, respectively.

After the researchers controlled for demographic, psychological, medical, and obstetrical risk factors, the overall adjusted odds ratio of postpartum depression was 2.87 for obese class II women and 3.94 for obese class III women.

In the PRAMS stressors component of the study, Dr. LaCoursiere and Dr. Varner found that common pregnancy stressors increase the risk of postpartum depression. For example, the adjusted odds ratio for postpartum depression among women who reported partner-associated stressors such as divorce or arguing more than usual was 2.61, while the adjusted odds ratio for those who reported traumatic stressors such as being homeless or being involved in a physical fight was 1.66.

The adjusted odds ratio for those who reported both types of stressors was 8.48.

Fewer than half of the study participants (44%) reported that their clinician asked about their mood during pregnancy, while 54% reported that they were asked about their mood during the postpartum period.

Dr. LaCoursiere acknowledged certain limitations of the study, including the self-reported height and weight data and the fact that while women who were being actively treated for depression were excluded, the questionnaire was not administered antepartum or immediately post partum. Therefore, she said, “this cohort may represent women who were depressed antenatally and continued to have antenatal depression into the postpartum period.”

Dr. LaCoursiere reported that she had no conflicts to disclose.

Two forms of postnatal intervention—one with trained nurses or midwives, and another with a peer—significantly reduced the likelihood of postnatal depression, according to recent research.

The studies “add to the growing evidence that postnatal depression can be effectively treated and possibly prevented,” Dr. Cindy-Lee Dennis of the department of psychiatry at the University of Toronto and one of the lead investigators, wrote in an accompanying editorial (BMJ 2009:338:a3045 [doi:10.1136/bmj.a3064]).

The first study assessed the impact of a postnatal intervention conducted by trained “health visitors.” In the United Kingdom, health visitors are registered nurses or midwives who postnatally work with mothers on feeding, safety, physical and emotional development, and other aspects of health and child care, according to the National Health Service Web site.

The health visitors were “trained to identify depressive symptoms using the Edinburgh postnatal depression scale (EPDS) and to use clinical assessment skills to assess a mother's mood, including suicidal thoughts,” wrote Dr. C. Jane Morrell of the University of Huddersfield (England) and her colleagues (BMJ 2009;338:a3045 [doi:10.1136/bmj.a3045]).

The health visitors provided weekly 1-hour counseling sessions in the mother's home for up to 8 weeks, starting at 8 weeks postnatally. A control group was given usual care, without the in-home psychological sessions.

A total of 4,084 eligible women consented to participate, and 595 had a 6-week EPDS score greater than or equal to 12, which indicates the possibility of depression. The maximum score is 30.

Ultimately, 418 women who participated in the program had follow-up EPDS scores at 6 months and were analyzed.

At 6 months, the authors reported that the 271 women in the intervention group whose 6-week score had been greater than or equal to 12 were 40% less likely to have a score greater than or equal to 12, compared with the 147 women in the control group.

Furthermore, wrote Dr. Morrell and her associates, “the differences in the mean EPDS scores at 6 months … were sustained at 12 months.”

The trial “provides new evidence of the effectiveness of a package of training for health visitors to identify symptoms of depression postnatally and to provide psychologically informed sessions,” wrote the authors. They declared no competing interests and wrote that the study was funded entirely by the NHS.

The second randomized, controlled trial looked at the impact of a telephone-based intervention with nonmedical professional peers for postnatal women with an EPDS greater than 12.

A total of 315 women received usual care with follow-up information available at 12 weeks. Usual care “could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources.”

In contrast, the 297 women who were randomized to the intervention group and had follow-up data at 12 weeks received usual care plus telephone access to a peer volunteer—a mother who had personally experienced postnatal depression.

The volunteers were trained in providing telephone-based support and made referrals to health care professionals, if necessary, and in role playing.

A minimum of four contacts between the mother and peer volunteer were made.

“Women in the intervention group were significantly less likely to have symptoms of postnatal depression at the 12-week assessment than [were] those in the control group (odds ratio 2.1),” wrote the authors, led by Dr. Dennis.

“Specifically, 14% (40/297) of women in the intervention group had a score greater than 12, compared with 25% (78/315) in the control group.”

More than 80% of the 221 women who received peer counseling and evaluated their experience said that they would recommend the support to a friend and that they were satisfied with the experience.

Dr. Dennis disclosed having no individual competing interests.

Her study was supported by the Canadian Institutes of Health.

Two forms of postnatal intervention—one with trained nurses or midwives, and another with a peer—significantly reduced the likelihood of postnatal depression, according to recent research.

The studies “add to the growing evidence that postnatal depression can be effectively treated and possibly prevented,” Dr. Cindy-Lee Dennis of the department of psychiatry at the University of Toronto and one of the lead investigators, wrote in an accompanying editorial (BMJ 2009:338:a3045 [doi:10.1136/bmj.a3064]).

The first study assessed the impact of a postnatal intervention conducted by trained “health visitors.” In the United Kingdom, health visitors are registered nurses or midwives who postnatally work with mothers on feeding, safety, physical and emotional development, and other aspects of health and child care, according to the National Health Service Web site.

The health visitors were “trained to identify depressive symptoms using the Edinburgh postnatal depression scale (EPDS) and to use clinical assessment skills to assess a mother's mood, including suicidal thoughts,” wrote Dr. C. Jane Morrell of the University of Huddersfield (England) and her colleagues (BMJ 2009;338:a3045 [doi:10.1136/bmj.a3045]).

The health visitors provided weekly 1-hour counseling sessions in the mother's home for up to 8 weeks, starting at 8 weeks postnatally. A control group was given usual care, without the in-home psychological sessions.

A total of 4,084 eligible women consented to participate, and 595 had a 6-week EPDS score greater than or equal to 12, which indicates the possibility of depression. The maximum score is 30.

Ultimately, 418 women who participated in the program had follow-up EPDS scores at 6 months and were analyzed.

At 6 months, the authors reported that the 271 women in the intervention group whose 6-week score had been greater than or equal to 12 were 40% less likely to have a score greater than or equal to 12, compared with the 147 women in the control group.

Furthermore, wrote Dr. Morrell and her associates, “the differences in the mean EPDS scores at 6 months … were sustained at 12 months.”

The trial “provides new evidence of the effectiveness of a package of training for health visitors to identify symptoms of depression postnatally and to provide psychologically informed sessions,” wrote the authors. They declared no competing interests and wrote that the study was funded entirely by the NHS.

The second randomized, controlled trial looked at the impact of a telephone-based intervention with nonmedical professional peers for postnatal women with an EPDS greater than 12.

A total of 315 women received usual care with follow-up information available at 12 weeks. Usual care “could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources.”

In contrast, the 297 women who were randomized to the intervention group and had follow-up data at 12 weeks received usual care plus telephone access to a peer volunteer—a mother who had personally experienced postnatal depression.

The volunteers were trained in providing telephone-based support and made referrals to health care professionals, if necessary, and in role playing.

A minimum of four contacts between the mother and peer volunteer were made.

“Women in the intervention group were significantly less likely to have symptoms of postnatal depression at the 12-week assessment than [were] those in the control group (odds ratio 2.1),” wrote the authors, led by Dr. Dennis.

“Specifically, 14% (40/297) of women in the intervention group had a score greater than 12, compared with 25% (78/315) in the control group.”

More than 80% of the 221 women who received peer counseling and evaluated their experience said that they would recommend the support to a friend and that they were satisfied with the experience.

Dr. Dennis disclosed having no individual competing interests.

Her study was supported by the Canadian Institutes of Health.

Two forms of postnatal intervention—one with trained nurses or midwives, and another with a peer—significantly reduced the likelihood of postnatal depression, according to recent research.

The studies “add to the growing evidence that postnatal depression can be effectively treated and possibly prevented,” Dr. Cindy-Lee Dennis of the department of psychiatry at the University of Toronto and one of the lead investigators, wrote in an accompanying editorial (BMJ 2009:338:a3045 [doi:10.1136/bmj.a3064]).

The first study assessed the impact of a postnatal intervention conducted by trained “health visitors.” In the United Kingdom, health visitors are registered nurses or midwives who postnatally work with mothers on feeding, safety, physical and emotional development, and other aspects of health and child care, according to the National Health Service Web site.

The health visitors were “trained to identify depressive symptoms using the Edinburgh postnatal depression scale (EPDS) and to use clinical assessment skills to assess a mother's mood, including suicidal thoughts,” wrote Dr. C. Jane Morrell of the University of Huddersfield (England) and her colleagues (BMJ 2009;338:a3045 [doi:10.1136/bmj.a3045]).

The health visitors provided weekly 1-hour counseling sessions in the mother's home for up to 8 weeks, starting at 8 weeks postnatally. A control group was given usual care, without the in-home psychological sessions.

A total of 4,084 eligible women consented to participate, and 595 had a 6-week EPDS score greater than or equal to 12, which indicates the possibility of depression. The maximum score is 30.

Ultimately, 418 women who participated in the program had follow-up EPDS scores at 6 months and were analyzed.

At 6 months, the authors reported that the 271 women in the intervention group whose 6-week score had been greater than or equal to 12 were 40% less likely to have a score greater than or equal to 12, compared with the 147 women in the control group.

Furthermore, wrote Dr. Morrell and her associates, “the differences in the mean EPDS scores at 6 months … were sustained at 12 months.”

The trial “provides new evidence of the effectiveness of a package of training for health visitors to identify symptoms of depression postnatally and to provide psychologically informed sessions,” wrote the authors. They declared no competing interests and wrote that the study was funded entirely by the NHS.

The second randomized, controlled trial looked at the impact of a telephone-based intervention with nonmedical professional peers for postnatal women with an EPDS greater than 12.

A total of 315 women received usual care with follow-up information available at 12 weeks. Usual care “could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources.”

In contrast, the 297 women who were randomized to the intervention group and had follow-up data at 12 weeks received usual care plus telephone access to a peer volunteer—a mother who had personally experienced postnatal depression.

The volunteers were trained in providing telephone-based support and made referrals to health care professionals, if necessary, and in role playing.

A minimum of four contacts between the mother and peer volunteer were made.

“Women in the intervention group were significantly less likely to have symptoms of postnatal depression at the 12-week assessment than [were] those in the control group (odds ratio 2.1),” wrote the authors, led by Dr. Dennis.

“Specifically, 14% (40/297) of women in the intervention group had a score greater than 12, compared with 25% (78/315) in the control group.”

More than 80% of the 221 women who received peer counseling and evaluated their experience said that they would recommend the support to a friend and that they were satisfied with the experience.

Dr. Dennis disclosed having no individual competing interests.

Her study was supported by the Canadian Institutes of Health.