Obstetrics

Fetal exposure to ondansetron showed no association with adverse pregnancy outcomes in a nationwide Danish cohort study that included more than 608,000 pregnancies, according to a report published online Feb. 28 in the New England Journal of Medicine.

Ondansetron, an antiemetic often prescribed for nausea and vomiting during pregnancy, was not associated with an increased rate of spontaneous abortion, stillbirth, any major birth defect, preterm delivery, low-birth-weight (LBW) infants, or small-for-gestational-age (SGA) infants, reported Björn Pasternak, M.D., Ph.D., of the department of epidemiology research at Statens Serum Institut, Copenhagen, and his associates.

"Although these results cannot definitively rule out the possibility of adverse effects in association with ondansetron, the results do provide reassurance regarding the use of this agent for nausea and vomiting in pregnancy," the investigators noted.

To date, only two controlled studies have assessed the fetal safety of the drug, which nevertheless is the most frequently prescribed antiemetic in the United States.

Dr. Pasternak and his colleagues used data from Danish national registries to construct a nationwide historical cohort of all pregnancies that resulted in a singleton birth, stillbirth, or any abortive outcome between 2004 and March 31, 2011. (Ondansetron was rarely used during pregnancy before 2004 in Denmark.)

The investigators assessed outcomes in 608,385 pregnancies. Mothers took ondansetron in 1,970 of these pregnancies. The median number of doses dispensed was 30 per pregnancy.

In an initial unadjusted analysis, exposure to ondansetron did not increase the risk of stillbirth, major birth defects, LBW infants, or SGA infants.

The researchers then conducted several propensity-matched analyses for six possible adverse outcomes.

For the 1,233 pregnancies in this analysis in which the mother took ondansetron during the first trimester, 36 infants (2.9%) had a major birth defect. In comparison, 141 of 4,932 infants (also 2.9%) not exposed to the drug had a major birth defect. This study was not powered to assess the risks of individual birth defects.

The rate of preterm birth was 6.2% among women who took ondansetron and 5.2% among women who did not, a difference that was not significant. Similarly, the rates of stillbirth were 0.3% and 0.4%, respectively, also a nonsignificant difference.

The rates of LBW infants were 4.1% with exposure to ondansetron and 3.7% without exposure, also a nonsignificant difference. And the rates of SGA infants were 10.4% and 9.2%, another nonsignificant difference, Dr. Pasternak and his associates reported (New Engl. J. Med. 2013;368:814-23).

These results remained robust in several sensitivity analyses, including one that compared rates of adverse fetal outcomes between women who filled only one prescription for ondansetron and women who filled two or more such prescriptions.

Previously, a case-control study found an increase in the risk of cleft palate with in utero exposure to ondansetron. In this cohort, there were no cases of cleft palate, Dr. Pasternak and his associates said.

This study was funded by the Danish Medical Research Council. No financial conflicts of interest were reported.

[email protected]

Fetal exposure to ondansetron showed no association with adverse pregnancy outcomes in a nationwide Danish cohort study that included more than 608,000 pregnancies, according to a report published online Feb. 28 in the New England Journal of Medicine.

Ondansetron, an antiemetic often prescribed for nausea and vomiting during pregnancy, was not associated with an increased rate of spontaneous abortion, stillbirth, any major birth defect, preterm delivery, low-birth-weight (LBW) infants, or small-for-gestational-age (SGA) infants, reported Björn Pasternak, M.D., Ph.D., of the department of epidemiology research at Statens Serum Institut, Copenhagen, and his associates.

"Although these results cannot definitively rule out the possibility of adverse effects in association with ondansetron, the results do provide reassurance regarding the use of this agent for nausea and vomiting in pregnancy," the investigators noted.

To date, only two controlled studies have assessed the fetal safety of the drug, which nevertheless is the most frequently prescribed antiemetic in the United States.

Dr. Pasternak and his colleagues used data from Danish national registries to construct a nationwide historical cohort of all pregnancies that resulted in a singleton birth, stillbirth, or any abortive outcome between 2004 and March 31, 2011. (Ondansetron was rarely used during pregnancy before 2004 in Denmark.)

The investigators assessed outcomes in 608,385 pregnancies. Mothers took ondansetron in 1,970 of these pregnancies. The median number of doses dispensed was 30 per pregnancy.

In an initial unadjusted analysis, exposure to ondansetron did not increase the risk of stillbirth, major birth defects, LBW infants, or SGA infants.

The researchers then conducted several propensity-matched analyses for six possible adverse outcomes.

For the 1,233 pregnancies in this analysis in which the mother took ondansetron during the first trimester, 36 infants (2.9%) had a major birth defect. In comparison, 141 of 4,932 infants (also 2.9%) not exposed to the drug had a major birth defect. This study was not powered to assess the risks of individual birth defects.

The rate of preterm birth was 6.2% among women who took ondansetron and 5.2% among women who did not, a difference that was not significant. Similarly, the rates of stillbirth were 0.3% and 0.4%, respectively, also a nonsignificant difference.

The rates of LBW infants were 4.1% with exposure to ondansetron and 3.7% without exposure, also a nonsignificant difference. And the rates of SGA infants were 10.4% and 9.2%, another nonsignificant difference, Dr. Pasternak and his associates reported (New Engl. J. Med. 2013;368:814-23).

These results remained robust in several sensitivity analyses, including one that compared rates of adverse fetal outcomes between women who filled only one prescription for ondansetron and women who filled two or more such prescriptions.

Previously, a case-control study found an increase in the risk of cleft palate with in utero exposure to ondansetron. In this cohort, there were no cases of cleft palate, Dr. Pasternak and his associates said.

This study was funded by the Danish Medical Research Council. No financial conflicts of interest were reported.

[email protected]

Fetal exposure to ondansetron showed no association with adverse pregnancy outcomes in a nationwide Danish cohort study that included more than 608,000 pregnancies, according to a report published online Feb. 28 in the New England Journal of Medicine.

Ondansetron, an antiemetic often prescribed for nausea and vomiting during pregnancy, was not associated with an increased rate of spontaneous abortion, stillbirth, any major birth defect, preterm delivery, low-birth-weight (LBW) infants, or small-for-gestational-age (SGA) infants, reported Björn Pasternak, M.D., Ph.D., of the department of epidemiology research at Statens Serum Institut, Copenhagen, and his associates.

"Although these results cannot definitively rule out the possibility of adverse effects in association with ondansetron, the results do provide reassurance regarding the use of this agent for nausea and vomiting in pregnancy," the investigators noted.

To date, only two controlled studies have assessed the fetal safety of the drug, which nevertheless is the most frequently prescribed antiemetic in the United States.

Dr. Pasternak and his colleagues used data from Danish national registries to construct a nationwide historical cohort of all pregnancies that resulted in a singleton birth, stillbirth, or any abortive outcome between 2004 and March 31, 2011. (Ondansetron was rarely used during pregnancy before 2004 in Denmark.)

The investigators assessed outcomes in 608,385 pregnancies. Mothers took ondansetron in 1,970 of these pregnancies. The median number of doses dispensed was 30 per pregnancy.

In an initial unadjusted analysis, exposure to ondansetron did not increase the risk of stillbirth, major birth defects, LBW infants, or SGA infants.

The researchers then conducted several propensity-matched analyses for six possible adverse outcomes.

For the 1,233 pregnancies in this analysis in which the mother took ondansetron during the first trimester, 36 infants (2.9%) had a major birth defect. In comparison, 141 of 4,932 infants (also 2.9%) not exposed to the drug had a major birth defect. This study was not powered to assess the risks of individual birth defects.

The rate of preterm birth was 6.2% among women who took ondansetron and 5.2% among women who did not, a difference that was not significant. Similarly, the rates of stillbirth were 0.3% and 0.4%, respectively, also a nonsignificant difference.

The rates of LBW infants were 4.1% with exposure to ondansetron and 3.7% without exposure, also a nonsignificant difference. And the rates of SGA infants were 10.4% and 9.2%, another nonsignificant difference, Dr. Pasternak and his associates reported (New Engl. J. Med. 2013;368:814-23).

These results remained robust in several sensitivity analyses, including one that compared rates of adverse fetal outcomes between women who filled only one prescription for ondansetron and women who filled two or more such prescriptions.

Previously, a case-control study found an increase in the risk of cleft palate with in utero exposure to ondansetron. In this cohort, there were no cases of cleft palate, Dr. Pasternak and his associates said.

This study was funded by the Danish Medical Research Council. No financial conflicts of interest were reported.

[email protected]

With all the mobile technology available today, many patients pull out their phones, smartphones, or tablets while in waiting rooms or exam rooms, until the physician arrives.

You might be surprised to learn how many people are using these tools in ways related to pregnancy. Two new reports provide snapshots.

Courtesy of Wikimedia Commons/AngryJulieMonday/Creative Commons

On average, 47% of subscribers to mobile data plans who use at least one health-related application (app) on their smartphones or tablets use an app related to pregnancy. That’s more than the 39% of app-using subscribers who used fitness-specific apps, a 2013 report from Citrix ByteMobile found.

The data are based on real-world use. Citrix ByteMobile works with 130 mobile operators in 60 countries to help them understand what people are doing on their mobile phones and devices, in order to try and optimize the data and video services on the operators’ 3G and 4G networks, according to MobiHealthNews.

Sounds impressive, but how many people is that, really? Let’s do a quick calculation. There were more than 239 million U.S. adults in 2012, according to the U.S. Census Bureau. Approximately 9% of all U.S. adults have at least one health or medical app on a smartphone, according to the "Mobile Health 2012" report by the Pew Research Center. That’s more than 21 million people, so far.

The different kinds of apps get used in different ways, the Citrix ByteMobile analysis found. Even though a greater proportion of app-using mobile subscribers use pregnancy-related apps, the fitness app users generated a lot more data, accounting for 50% of all mobile health-related data traffic on wireless networks, compared with 9% of health-related data traffic from the pregnancy app users.

The apps get used at different times of day, too. The busiest time of day for apps that monitor women’s health (such as pregnancy or menstrual tracking apps) is 9 a.m. For fitness apps, 6 p.m. is the busy hour.

Other popular kinds of personal-health apps include calorie counters, apps that provide medical information, sleep cycle trackers, and relaxation tools, the report noted.

And it’s not just smartphones and iPads catching pregnant women’s attention. Fully 85% of U.S. adults own a cell phone, according to the Pew report, and many are using them in ways related to health.

My colleague Naseem Miller reported that the public-private partnership textforbaby had 260,000 pregnant women and new moms receiving free educational texts and health-related reminders on their phones in 2011, up from 150,000 in less than a year. A small preliminary study suggests that this tool is making a difference in promoting timely immunizations, prompting conversations between women and their doctors, and more.

So, the next time you walk into an exam room and find your female patient on her phone or tablet, don’t assume she’s just playing Angry Birds to pass the time. She might actually be doing something for her or her baby’s health.

–By Sherry Boschert

[email protected]

On Twitter @sherryboschert

With all the mobile technology available today, many patients pull out their phones, smartphones, or tablets while in waiting rooms or exam rooms, until the physician arrives.

You might be surprised to learn how many people are using these tools in ways related to pregnancy. Two new reports provide snapshots.

Courtesy of Wikimedia Commons/AngryJulieMonday/Creative Commons

On average, 47% of subscribers to mobile data plans who use at least one health-related application (app) on their smartphones or tablets use an app related to pregnancy. That’s more than the 39% of app-using subscribers who used fitness-specific apps, a 2013 report from Citrix ByteMobile found.

The data are based on real-world use. Citrix ByteMobile works with 130 mobile operators in 60 countries to help them understand what people are doing on their mobile phones and devices, in order to try and optimize the data and video services on the operators’ 3G and 4G networks, according to MobiHealthNews.

Sounds impressive, but how many people is that, really? Let’s do a quick calculation. There were more than 239 million U.S. adults in 2012, according to the U.S. Census Bureau. Approximately 9% of all U.S. adults have at least one health or medical app on a smartphone, according to the "Mobile Health 2012" report by the Pew Research Center. That’s more than 21 million people, so far.

The different kinds of apps get used in different ways, the Citrix ByteMobile analysis found. Even though a greater proportion of app-using mobile subscribers use pregnancy-related apps, the fitness app users generated a lot more data, accounting for 50% of all mobile health-related data traffic on wireless networks, compared with 9% of health-related data traffic from the pregnancy app users.

The apps get used at different times of day, too. The busiest time of day for apps that monitor women’s health (such as pregnancy or menstrual tracking apps) is 9 a.m. For fitness apps, 6 p.m. is the busy hour.

Other popular kinds of personal-health apps include calorie counters, apps that provide medical information, sleep cycle trackers, and relaxation tools, the report noted.

And it’s not just smartphones and iPads catching pregnant women’s attention. Fully 85% of U.S. adults own a cell phone, according to the Pew report, and many are using them in ways related to health.

My colleague Naseem Miller reported that the public-private partnership textforbaby had 260,000 pregnant women and new moms receiving free educational texts and health-related reminders on their phones in 2011, up from 150,000 in less than a year. A small preliminary study suggests that this tool is making a difference in promoting timely immunizations, prompting conversations between women and their doctors, and more.

So, the next time you walk into an exam room and find your female patient on her phone or tablet, don’t assume she’s just playing Angry Birds to pass the time. She might actually be doing something for her or her baby’s health.

–By Sherry Boschert

[email protected]

On Twitter @sherryboschert

With all the mobile technology available today, many patients pull out their phones, smartphones, or tablets while in waiting rooms or exam rooms, until the physician arrives.

You might be surprised to learn how many people are using these tools in ways related to pregnancy. Two new reports provide snapshots.

Courtesy of Wikimedia Commons/AngryJulieMonday/Creative Commons

On average, 47% of subscribers to mobile data plans who use at least one health-related application (app) on their smartphones or tablets use an app related to pregnancy. That’s more than the 39% of app-using subscribers who used fitness-specific apps, a 2013 report from Citrix ByteMobile found.

The data are based on real-world use. Citrix ByteMobile works with 130 mobile operators in 60 countries to help them understand what people are doing on their mobile phones and devices, in order to try and optimize the data and video services on the operators’ 3G and 4G networks, according to MobiHealthNews.

Sounds impressive, but how many people is that, really? Let’s do a quick calculation. There were more than 239 million U.S. adults in 2012, according to the U.S. Census Bureau. Approximately 9% of all U.S. adults have at least one health or medical app on a smartphone, according to the "Mobile Health 2012" report by the Pew Research Center. That’s more than 21 million people, so far.

The different kinds of apps get used in different ways, the Citrix ByteMobile analysis found. Even though a greater proportion of app-using mobile subscribers use pregnancy-related apps, the fitness app users generated a lot more data, accounting for 50% of all mobile health-related data traffic on wireless networks, compared with 9% of health-related data traffic from the pregnancy app users.

The apps get used at different times of day, too. The busiest time of day for apps that monitor women’s health (such as pregnancy or menstrual tracking apps) is 9 a.m. For fitness apps, 6 p.m. is the busy hour.

Other popular kinds of personal-health apps include calorie counters, apps that provide medical information, sleep cycle trackers, and relaxation tools, the report noted.

And it’s not just smartphones and iPads catching pregnant women’s attention. Fully 85% of U.S. adults own a cell phone, according to the Pew report, and many are using them in ways related to health.

My colleague Naseem Miller reported that the public-private partnership textforbaby had 260,000 pregnant women and new moms receiving free educational texts and health-related reminders on their phones in 2011, up from 150,000 in less than a year. A small preliminary study suggests that this tool is making a difference in promoting timely immunizations, prompting conversations between women and their doctors, and more.

So, the next time you walk into an exam room and find your female patient on her phone or tablet, don’t assume she’s just playing Angry Birds to pass the time. She might actually be doing something for her or her baby’s health.

–By Sherry Boschert

[email protected]

On Twitter @sherryboschert

Some women who have experienced a pregnancy loss can increase their odds of a live birth in the next pregnancy simply by taking aspirin, investigators reported at the Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine.

A team led by Enrique F. Schisterman, Ph.D., conducted a randomized trial of 1,228 healthy young women who had had up to two prior pregnancy losses, but did not have infertility and were attempting to conceive again.

©jimdeli/Fotolia.com

The women were assigned evenly to take low-dose aspirin (81 mg) or placebo daily, along with folic acid, for up to six menstrual cycles or, if they conceived, up to the 36th week of pregnancy.

Results showed that low-dose aspirin was associated with an absolute 9.2% increase in the rate of live birth among the subset of women who met restricted criteria for pregnancy loss, namely a single pregnancy loss before 20 weeks’ gestation in the past year, reported Dr. Schisterman, who is a senior investigator and chief of the epidemiology branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Rockville, Md.

The benefit was mainly due to early effects. "There was an effect on becoming pregnant and early pregnancy [maintenance], but there were no differences after that," he elaborated. "The implications of that are not only that aspirin will help women become pregnant, but if you start too late, then the effects of aspirin are not there any more."

Analyses in the group with restricted criteria suggested that only about 11 women would need to be treated with low-dose aspirin to achieve one additional live birth.

In contrast, there was no significant benefit of low-dose aspirin among the subset of women who met general criteria for pregnancy loss that required one or two pregnancy losses at any time in the past, but excluded those meeting restricted criteria.

Low-dose aspirin was associated with somewhat higher rates of minor vaginal bleeding and minor gastrointestinal upset, but the drug was not associated with pregnancy loss or with an increased risk of major fetal, neonatal, or maternal complications.

An attendee wondered about the difference between the two subsets of women having differing histories of pregnancy loss, saying, "You would expect more or less the same effect."

Dr. Schisterman maintained that the two groups were not all that similar. "I am not sure I would expect the same result, although when we did some analyses in which we compared those who had a single loss in the restricted stratum to those who had a single loss in the general stratum, we found attenuated but in a similar direction results in the general stratum," he commented. "So it seems that the number of losses is the driving force. But we are still analyzing that data."

Another attendee raised the issue of the timing of the previous pregnancy loss in the subset meeting restricted criteria. "Were you able to identify any influence of the gestational age of the previous loss on the effectiveness of aspirin in the next pregnancy, the randomized pregnancy?" he asked.

"Not yet," Dr. Schisterman replied, noting that all of the losses were fairly early. However, here too, analyses are still ongoing.

Giving some background to the trial, he noted, "We know that inflammation and abnormal blood flow, especially in the uterus, endometrium, ovaries, and placenta, ... are unifying features of outcomes like infertility, pregnancy loss, preeclampsia, preterm delivery, and small for gestational age. So clearly, an ideal therapy that would reduce inflammation and improve blood flow will be the one that we are looking for. Low-dose aspirin could be such a therapy."

The drug has seldom been studied when given in the preconceptional period, but there is a strong rationale for such use, he maintained.

"It impacts endometrial vascularization and placentation. It has very well documented anti-inflammatory effects. It has very few maternal and fetal side effects. It’s safe, widely available, and more importantly, it’s cheap – it costs $2 for the whole pregnancy to treat a woman," he elaborated.

Women enrolled in the trial, known as EAGeR (The Effects of Aspirin in Gestation and Reproduction), were aged 18-39 years. They were roughly evenly split between meeting the restricted criteria and the general criteria for previous pregnancy loss.

On average, the women were 29 years old and had a body mass index of about 27 kg/m². Most were married and white.

Overall, there was only a trend toward a higher rate of live births in the low-dose aspirin group compared with the placebo group (57.8% vs. 52.7%, P = .09), reported Dr. Schisterman.

In stratified analyses, there was a significant benefit of low-dose aspirin in the subset meeting the restricted pregnancy loss criteria (62.4% vs. 53.2%, P = .04) but not in the subset meeting the general pregnancy loss criteria (53.9% vs. 52.2%).

When the investigators more closely assessed the reason for benefit in the women meeting restricted criteria, they found a higher rate of achieving a positive pregnancy test with low-dose aspirin (70.5% vs. 61.7%, P = .03). Rates of progression thereafter to confirmed pregnancy by ultrasound at 6 weeks and ultimately to live birth were similar for the two treatment groups.

Dr. Schisterman disclosed no relevant conflicts of interest.

[email protected]

Some women who have experienced a pregnancy loss can increase their odds of a live birth in the next pregnancy simply by taking aspirin, investigators reported at the Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine.

A team led by Enrique F. Schisterman, Ph.D., conducted a randomized trial of 1,228 healthy young women who had had up to two prior pregnancy losses, but did not have infertility and were attempting to conceive again.

©jimdeli/Fotolia.com

The women were assigned evenly to take low-dose aspirin (81 mg) or placebo daily, along with folic acid, for up to six menstrual cycles or, if they conceived, up to the 36th week of pregnancy.

Results showed that low-dose aspirin was associated with an absolute 9.2% increase in the rate of live birth among the subset of women who met restricted criteria for pregnancy loss, namely a single pregnancy loss before 20 weeks’ gestation in the past year, reported Dr. Schisterman, who is a senior investigator and chief of the epidemiology branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Rockville, Md.

The benefit was mainly due to early effects. "There was an effect on becoming pregnant and early pregnancy [maintenance], but there were no differences after that," he elaborated. "The implications of that are not only that aspirin will help women become pregnant, but if you start too late, then the effects of aspirin are not there any more."

Analyses in the group with restricted criteria suggested that only about 11 women would need to be treated with low-dose aspirin to achieve one additional live birth.

In contrast, there was no significant benefit of low-dose aspirin among the subset of women who met general criteria for pregnancy loss that required one or two pregnancy losses at any time in the past, but excluded those meeting restricted criteria.

Low-dose aspirin was associated with somewhat higher rates of minor vaginal bleeding and minor gastrointestinal upset, but the drug was not associated with pregnancy loss or with an increased risk of major fetal, neonatal, or maternal complications.

An attendee wondered about the difference between the two subsets of women having differing histories of pregnancy loss, saying, "You would expect more or less the same effect."

Dr. Schisterman maintained that the two groups were not all that similar. "I am not sure I would expect the same result, although when we did some analyses in which we compared those who had a single loss in the restricted stratum to those who had a single loss in the general stratum, we found attenuated but in a similar direction results in the general stratum," he commented. "So it seems that the number of losses is the driving force. But we are still analyzing that data."

Another attendee raised the issue of the timing of the previous pregnancy loss in the subset meeting restricted criteria. "Were you able to identify any influence of the gestational age of the previous loss on the effectiveness of aspirin in the next pregnancy, the randomized pregnancy?" he asked.

"Not yet," Dr. Schisterman replied, noting that all of the losses were fairly early. However, here too, analyses are still ongoing.

Giving some background to the trial, he noted, "We know that inflammation and abnormal blood flow, especially in the uterus, endometrium, ovaries, and placenta, ... are unifying features of outcomes like infertility, pregnancy loss, preeclampsia, preterm delivery, and small for gestational age. So clearly, an ideal therapy that would reduce inflammation and improve blood flow will be the one that we are looking for. Low-dose aspirin could be such a therapy."

The drug has seldom been studied when given in the preconceptional period, but there is a strong rationale for such use, he maintained.

"It impacts endometrial vascularization and placentation. It has very well documented anti-inflammatory effects. It has very few maternal and fetal side effects. It’s safe, widely available, and more importantly, it’s cheap – it costs $2 for the whole pregnancy to treat a woman," he elaborated.

Women enrolled in the trial, known as EAGeR (The Effects of Aspirin in Gestation and Reproduction), were aged 18-39 years. They were roughly evenly split between meeting the restricted criteria and the general criteria for previous pregnancy loss.

On average, the women were 29 years old and had a body mass index of about 27 kg/m². Most were married and white.

Overall, there was only a trend toward a higher rate of live births in the low-dose aspirin group compared with the placebo group (57.8% vs. 52.7%, P = .09), reported Dr. Schisterman.

In stratified analyses, there was a significant benefit of low-dose aspirin in the subset meeting the restricted pregnancy loss criteria (62.4% vs. 53.2%, P = .04) but not in the subset meeting the general pregnancy loss criteria (53.9% vs. 52.2%).

When the investigators more closely assessed the reason for benefit in the women meeting restricted criteria, they found a higher rate of achieving a positive pregnancy test with low-dose aspirin (70.5% vs. 61.7%, P = .03). Rates of progression thereafter to confirmed pregnancy by ultrasound at 6 weeks and ultimately to live birth were similar for the two treatment groups.

Dr. Schisterman disclosed no relevant conflicts of interest.

[email protected]

Some women who have experienced a pregnancy loss can increase their odds of a live birth in the next pregnancy simply by taking aspirin, investigators reported at the Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine.

A team led by Enrique F. Schisterman, Ph.D., conducted a randomized trial of 1,228 healthy young women who had had up to two prior pregnancy losses, but did not have infertility and were attempting to conceive again.

©jimdeli/Fotolia.com

The women were assigned evenly to take low-dose aspirin (81 mg) or placebo daily, along with folic acid, for up to six menstrual cycles or, if they conceived, up to the 36th week of pregnancy.

Results showed that low-dose aspirin was associated with an absolute 9.2% increase in the rate of live birth among the subset of women who met restricted criteria for pregnancy loss, namely a single pregnancy loss before 20 weeks’ gestation in the past year, reported Dr. Schisterman, who is a senior investigator and chief of the epidemiology branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Rockville, Md.

The benefit was mainly due to early effects. "There was an effect on becoming pregnant and early pregnancy [maintenance], but there were no differences after that," he elaborated. "The implications of that are not only that aspirin will help women become pregnant, but if you start too late, then the effects of aspirin are not there any more."

Analyses in the group with restricted criteria suggested that only about 11 women would need to be treated with low-dose aspirin to achieve one additional live birth.

In contrast, there was no significant benefit of low-dose aspirin among the subset of women who met general criteria for pregnancy loss that required one or two pregnancy losses at any time in the past, but excluded those meeting restricted criteria.

Low-dose aspirin was associated with somewhat higher rates of minor vaginal bleeding and minor gastrointestinal upset, but the drug was not associated with pregnancy loss or with an increased risk of major fetal, neonatal, or maternal complications.

An attendee wondered about the difference between the two subsets of women having differing histories of pregnancy loss, saying, "You would expect more or less the same effect."

Dr. Schisterman maintained that the two groups were not all that similar. "I am not sure I would expect the same result, although when we did some analyses in which we compared those who had a single loss in the restricted stratum to those who had a single loss in the general stratum, we found attenuated but in a similar direction results in the general stratum," he commented. "So it seems that the number of losses is the driving force. But we are still analyzing that data."

Another attendee raised the issue of the timing of the previous pregnancy loss in the subset meeting restricted criteria. "Were you able to identify any influence of the gestational age of the previous loss on the effectiveness of aspirin in the next pregnancy, the randomized pregnancy?" he asked.

"Not yet," Dr. Schisterman replied, noting that all of the losses were fairly early. However, here too, analyses are still ongoing.

Giving some background to the trial, he noted, "We know that inflammation and abnormal blood flow, especially in the uterus, endometrium, ovaries, and placenta, ... are unifying features of outcomes like infertility, pregnancy loss, preeclampsia, preterm delivery, and small for gestational age. So clearly, an ideal therapy that would reduce inflammation and improve blood flow will be the one that we are looking for. Low-dose aspirin could be such a therapy."

The drug has seldom been studied when given in the preconceptional period, but there is a strong rationale for such use, he maintained.

"It impacts endometrial vascularization and placentation. It has very well documented anti-inflammatory effects. It has very few maternal and fetal side effects. It’s safe, widely available, and more importantly, it’s cheap – it costs $2 for the whole pregnancy to treat a woman," he elaborated.

Women enrolled in the trial, known as EAGeR (The Effects of Aspirin in Gestation and Reproduction), were aged 18-39 years. They were roughly evenly split between meeting the restricted criteria and the general criteria for previous pregnancy loss.

On average, the women were 29 years old and had a body mass index of about 27 kg/m². Most were married and white.

Overall, there was only a trend toward a higher rate of live births in the low-dose aspirin group compared with the placebo group (57.8% vs. 52.7%, P = .09), reported Dr. Schisterman.

In stratified analyses, there was a significant benefit of low-dose aspirin in the subset meeting the restricted pregnancy loss criteria (62.4% vs. 53.2%, P = .04) but not in the subset meeting the general pregnancy loss criteria (53.9% vs. 52.2%).

When the investigators more closely assessed the reason for benefit in the women meeting restricted criteria, they found a higher rate of achieving a positive pregnancy test with low-dose aspirin (70.5% vs. 61.7%, P = .03). Rates of progression thereafter to confirmed pregnancy by ultrasound at 6 weeks and ultimately to live birth were similar for the two treatment groups.

Dr. Schisterman disclosed no relevant conflicts of interest.

[email protected]

The postpartum period is often a time when women with moderate to severe psoriasis experience a significant disease flare – and if they’re breastfeeding, treatment options are limited, according to Dr. Alan Menter.

This postpartum major flare of psoriasis is an underappreciated phenomenon that catches many dermatologists and most ob.gyns. off guard, he said.

"Fifty to 60% of psoriasis patients have genital involvement. A woman with genital psoriasis in the postpartum period or during delivery really needs help, and I think we in dermatology should be addressing these issues because most of the obstetricians are not sure how to treat these patients," said Dr. Menter, chief of the division of dermatology at Baylor University Medical Center, Dallas, and chair of the American Academy of Dermatology psoriasis guidelines committee.

Psoriasis is equally common in men and women, and two-thirds of affected individuals present before age 40 – for women, the childbearing years. Thorny psoriasis management issues in pregnancy and postpartum are common.

Psoriasis slowly improves during pregnancy in roughly two-thirds of patients, as is true for other immune-mediated diseases. But for that other third, many of the mainstay therapies for tough psoriasis are off limits during pregnancy and/or post partum. UVB is a good, safe option, albeit inconvenient. Retinoids and cyclosporine are out because of teratogenicity.

Cyclosporine probably should be considered the go-to drug for significant disease during pregnancy. Its strengths are its fast onset of action and the safety reassurance provided by vast patient registries started back in the 1980s when the drug was first used in transplant recipients.

"We’re all comfortable using cyclosporine," Dr. Menter said. "Our AAD guidelines state it is appropriate for 1 year of continuous use. The European guidelines say, ‘2 years of continuous use.’ But I think most of us use it as an interventional therapy for 3-6 months. I actually think we should be using it a little more frequently as an interventional therapy."

Cyclosporine must be stopped in month 8 of pregnancy to allow the drug to clear from the patient’s system before delivery, since it is secreted in breast milk.

For the breastfeeding woman experiencing a major disease flare, the options are basically potent topical steroids, which physicians should feel comfortable in prescribing according to the standard dosing schedule used in nonpregnant patients, or – when topical therapy won’t get the job done – the biologic agents, listed by the Food and Drug Administration as category B.

The most forward-thinking approach to take with young women who require systemic therapy for psoriasis is to discuss pregnancy-related issues before pregnancy occurs. In particular, a prospective case-control study from the Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project concluded that women with psoriasis were significantly more likely to smoke, carry a diagnosis of depression, and be overweight or obese before pregnancy – factors that increase their risk for adverse pregnancy outcomes (Br. J. Dermatol. 2010;163:334-9).

Moreover, other studies have shown that psoriasis patients, men as well as women, have an increased prevalence of the metabolic syndrome, which increases their long-term risk of cardiovascular disease. Women with an adverse cardiovascular risk profile who are considering pregnancy and parenthood may be in a teachable moment where they are more amenable to lifestyle changes that reduce the risks both to their baby and themselves, Dr. Menter said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Of course, half of pregnancies in the United States are unplanned, so the potential for unintended first-trimester fetal exposure to a teratogenic drug is substantial. While methotrexate is rated by the FDA as category X in pregnancy, dermatologists can derive some comfort from a well-executed review of 101 methotrexate-exposed pregnancies in rheumatology patients (Clin. Exp. Rheumatol. 2009;27:678-84). The 23% miscarriage rate wasn’t significantly different from that seen in pregnant psoriasis patients not on systemic agents. The live birth rate was 66%, with a 5% rate of neonatal malformations, all minor.

"The outcomes were actually better than any of us would have anticipated," Dr. Menter commented.

Psoriasis appears to have an inherent adverse impact upon pregnancy, he continued, pointing to an Israeli study of 68 deliveries in 35 women with moderate to severe psoriasis and 237 deliveries in 236 controls without psoriasis matched for age, parity, and gestational age.

"I think this is something we have to very gently discuss with our female patients who are considering pregnancy. We should tell them to be cautious in pregnancy because of this link between psoriasis and a slightly increased risk of spontaneous abortions. And I also discuss it with our ob.gyn. colleagues, who really are not aware of this link," the dermatologist said.

Dr. Menter reported receiving research support and/or consultant or lecture fees from roughly 20 pharmaceutical companies. SDEF and this news organization are owned by the same parent company.

[email protected]

*This story was updated March 1, 2013.

The postpartum period is often a time when women with moderate to severe psoriasis experience a significant disease flare – and if they’re breastfeeding, treatment options are limited, according to Dr. Alan Menter.

This postpartum major flare of psoriasis is an underappreciated phenomenon that catches many dermatologists and most ob.gyns. off guard, he said.

"Fifty to 60% of psoriasis patients have genital involvement. A woman with genital psoriasis in the postpartum period or during delivery really needs help, and I think we in dermatology should be addressing these issues because most of the obstetricians are not sure how to treat these patients," said Dr. Menter, chief of the division of dermatology at Baylor University Medical Center, Dallas, and chair of the American Academy of Dermatology psoriasis guidelines committee.

Psoriasis is equally common in men and women, and two-thirds of affected individuals present before age 40 – for women, the childbearing years. Thorny psoriasis management issues in pregnancy and postpartum are common.

Psoriasis slowly improves during pregnancy in roughly two-thirds of patients, as is true for other immune-mediated diseases. But for that other third, many of the mainstay therapies for tough psoriasis are off limits during pregnancy and/or post partum. UVB is a good, safe option, albeit inconvenient. Retinoids and cyclosporine are out because of teratogenicity.

Cyclosporine probably should be considered the go-to drug for significant disease during pregnancy. Its strengths are its fast onset of action and the safety reassurance provided by vast patient registries started back in the 1980s when the drug was first used in transplant recipients.

"We’re all comfortable using cyclosporine," Dr. Menter said. "Our AAD guidelines state it is appropriate for 1 year of continuous use. The European guidelines say, ‘2 years of continuous use.’ But I think most of us use it as an interventional therapy for 3-6 months. I actually think we should be using it a little more frequently as an interventional therapy."

Cyclosporine must be stopped in month 8 of pregnancy to allow the drug to clear from the patient’s system before delivery, since it is secreted in breast milk.

For the breastfeeding woman experiencing a major disease flare, the options are basically potent topical steroids, which physicians should feel comfortable in prescribing according to the standard dosing schedule used in nonpregnant patients, or – when topical therapy won’t get the job done – the biologic agents, listed by the Food and Drug Administration as category B.

The most forward-thinking approach to take with young women who require systemic therapy for psoriasis is to discuss pregnancy-related issues before pregnancy occurs. In particular, a prospective case-control study from the Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project concluded that women with psoriasis were significantly more likely to smoke, carry a diagnosis of depression, and be overweight or obese before pregnancy – factors that increase their risk for adverse pregnancy outcomes (Br. J. Dermatol. 2010;163:334-9).

Moreover, other studies have shown that psoriasis patients, men as well as women, have an increased prevalence of the metabolic syndrome, which increases their long-term risk of cardiovascular disease. Women with an adverse cardiovascular risk profile who are considering pregnancy and parenthood may be in a teachable moment where they are more amenable to lifestyle changes that reduce the risks both to their baby and themselves, Dr. Menter said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Of course, half of pregnancies in the United States are unplanned, so the potential for unintended first-trimester fetal exposure to a teratogenic drug is substantial. While methotrexate is rated by the FDA as category X in pregnancy, dermatologists can derive some comfort from a well-executed review of 101 methotrexate-exposed pregnancies in rheumatology patients (Clin. Exp. Rheumatol. 2009;27:678-84). The 23% miscarriage rate wasn’t significantly different from that seen in pregnant psoriasis patients not on systemic agents. The live birth rate was 66%, with a 5% rate of neonatal malformations, all minor.

"The outcomes were actually better than any of us would have anticipated," Dr. Menter commented.

Psoriasis appears to have an inherent adverse impact upon pregnancy, he continued, pointing to an Israeli study of 68 deliveries in 35 women with moderate to severe psoriasis and 237 deliveries in 236 controls without psoriasis matched for age, parity, and gestational age.

"I think this is something we have to very gently discuss with our female patients who are considering pregnancy. We should tell them to be cautious in pregnancy because of this link between psoriasis and a slightly increased risk of spontaneous abortions. And I also discuss it with our ob.gyn. colleagues, who really are not aware of this link," the dermatologist said.

Dr. Menter reported receiving research support and/or consultant or lecture fees from roughly 20 pharmaceutical companies. SDEF and this news organization are owned by the same parent company.

[email protected]

*This story was updated March 1, 2013.

The postpartum period is often a time when women with moderate to severe psoriasis experience a significant disease flare – and if they’re breastfeeding, treatment options are limited, according to Dr. Alan Menter.

This postpartum major flare of psoriasis is an underappreciated phenomenon that catches many dermatologists and most ob.gyns. off guard, he said.

"Fifty to 60% of psoriasis patients have genital involvement. A woman with genital psoriasis in the postpartum period or during delivery really needs help, and I think we in dermatology should be addressing these issues because most of the obstetricians are not sure how to treat these patients," said Dr. Menter, chief of the division of dermatology at Baylor University Medical Center, Dallas, and chair of the American Academy of Dermatology psoriasis guidelines committee.

Psoriasis is equally common in men and women, and two-thirds of affected individuals present before age 40 – for women, the childbearing years. Thorny psoriasis management issues in pregnancy and postpartum are common.

Psoriasis slowly improves during pregnancy in roughly two-thirds of patients, as is true for other immune-mediated diseases. But for that other third, many of the mainstay therapies for tough psoriasis are off limits during pregnancy and/or post partum. UVB is a good, safe option, albeit inconvenient. Retinoids and cyclosporine are out because of teratogenicity.

Cyclosporine probably should be considered the go-to drug for significant disease during pregnancy. Its strengths are its fast onset of action and the safety reassurance provided by vast patient registries started back in the 1980s when the drug was first used in transplant recipients.

"We’re all comfortable using cyclosporine," Dr. Menter said. "Our AAD guidelines state it is appropriate for 1 year of continuous use. The European guidelines say, ‘2 years of continuous use.’ But I think most of us use it as an interventional therapy for 3-6 months. I actually think we should be using it a little more frequently as an interventional therapy."

Cyclosporine must be stopped in month 8 of pregnancy to allow the drug to clear from the patient’s system before delivery, since it is secreted in breast milk.

For the breastfeeding woman experiencing a major disease flare, the options are basically potent topical steroids, which physicians should feel comfortable in prescribing according to the standard dosing schedule used in nonpregnant patients, or – when topical therapy won’t get the job done – the biologic agents, listed by the Food and Drug Administration as category B.

The most forward-thinking approach to take with young women who require systemic therapy for psoriasis is to discuss pregnancy-related issues before pregnancy occurs. In particular, a prospective case-control study from the Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Project concluded that women with psoriasis were significantly more likely to smoke, carry a diagnosis of depression, and be overweight or obese before pregnancy – factors that increase their risk for adverse pregnancy outcomes (Br. J. Dermatol. 2010;163:334-9).

Moreover, other studies have shown that psoriasis patients, men as well as women, have an increased prevalence of the metabolic syndrome, which increases their long-term risk of cardiovascular disease. Women with an adverse cardiovascular risk profile who are considering pregnancy and parenthood may be in a teachable moment where they are more amenable to lifestyle changes that reduce the risks both to their baby and themselves, Dr. Menter said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Of course, half of pregnancies in the United States are unplanned, so the potential for unintended first-trimester fetal exposure to a teratogenic drug is substantial. While methotrexate is rated by the FDA as category X in pregnancy, dermatologists can derive some comfort from a well-executed review of 101 methotrexate-exposed pregnancies in rheumatology patients (Clin. Exp. Rheumatol. 2009;27:678-84). The 23% miscarriage rate wasn’t significantly different from that seen in pregnant psoriasis patients not on systemic agents. The live birth rate was 66%, with a 5% rate of neonatal malformations, all minor.

"The outcomes were actually better than any of us would have anticipated," Dr. Menter commented.

Psoriasis appears to have an inherent adverse impact upon pregnancy, he continued, pointing to an Israeli study of 68 deliveries in 35 women with moderate to severe psoriasis and 237 deliveries in 236 controls without psoriasis matched for age, parity, and gestational age.

"I think this is something we have to very gently discuss with our female patients who are considering pregnancy. We should tell them to be cautious in pregnancy because of this link between psoriasis and a slightly increased risk of spontaneous abortions. And I also discuss it with our ob.gyn. colleagues, who really are not aware of this link," the dermatologist said.

Dr. Menter reported receiving research support and/or consultant or lecture fees from roughly 20 pharmaceutical companies. SDEF and this news organization are owned by the same parent company.

[email protected]

*This story was updated March 1, 2013.

Maternal use of folic acid supplements around the time of conception was associated with a lower risk of autistic disorder, the most severe form of autism spectrum disorders, in the children, according to a Norwegian study reported in the Feb. 13 issue of JAMA.

"This finding does not establish a causal relation between folic acid use and autistic disorder, but provides a rationale for replicating the analyses in other study samples and further investigating genetic factors and other biologic mechanisms that may explain the inverse association," said Dr. Pål Surén of the Norwegian Institute of Public Health, Oslo, and his associates.

thinkstockphotos.com

Folic acid supplements during pregnancy reduce the risk of neural tube defects in the offspring, and there is some evidence that they may also reduce the risk of other neurodevelopmental disorders. A recent analysis of data from the Norwegian Mother and Child Cohort Study found that maternal use of folic acid supplements was associated with a lower risk of severe language delay in their children at age 3 years.

Dr. Surén and his colleagues used data from the same cohort study to examine a possible association between the supplements and risk of autism spectrum disorders. The Norwegian Mother and Child Cohort Study is a national registry of 109,020 children born between 1999 and 2009.

For this analysis, the researchers assessed data concerning 85,176 children in the registry. At final follow-up, the subjects ranged in age from 3.3 years to 10.2 years (mean age, 6.4 years).

A total of 270 of these children (0.32%) were diagnosed as having autism spectrum disorders: 0.13% had autistic disorder, 0.07% had Asperger’s syndrome, and 0.12% had pervasive developmental disorder not otherwise specified.

Approximately 33% of the mothers took folic acid supplements during the interval from 4 weeks before conception to 8 weeks afterward. This period was chosen for the analysis because folic acid’s effects on the developing central nervous system of the fetus are most prominent during this time. "The interval covers or precedes events of critical importance to the fetal brain, such as the closure of the neural tube 28 days after conception and the embryonic period that includes development of the basic brain structures 15-56 days after conception," the investigators noted.

They found an inverse association between the mother’s use of folic acid supplements periconceptually and the risk that the child would develop autistic disorder. Of the children whose mothers took the supplements, 0.10% developed autistic disorder, compared with 0.21% in children whose mothers did not.

The adjusted odds ratio of autistic disorder was 0.61 in children of folic acid users. Further adjusting the data to account for comorbid maternal illness and concomitant medication use did not change this OR, Dr. Surén and his associates reported (JAMA 2013;309:570-7).

Women who took folic acid supplements were more likely to have a college-level education, to have planned the pregnancy, to be nonsmokers, and to have a prepregnancy body mass index less than 25 kg/m², which are all factors that could confound the association with autism. To address this issue, the investigators assessed the use of fish oil supplements in the study sample.

Use of fish oil supplements correlated with the same parental characteristics as did use of folic acid supplements, but it did not correlate with the risk of autistic disorder, they noted.

Similarly, the inverse association for folic acid use in the periconceptual period was not evident in mothers who took the supplements only later in pregnancy.

"Our findings indicate that the inverse association may be largely driven by the children with autistic disorder and severe language delay at 35 months, who were presumably the more severely affected children," the investigators added.

This study was funded in part by the Research Council of Norway. The investigators did not report having any financial conflicts of interest.

Maternal use of folic acid supplements around the time of conception was associated with a lower risk of autistic disorder, the most severe form of autism spectrum disorders, in the children, according to a Norwegian study reported in the Feb. 13 issue of JAMA.

"This finding does not establish a causal relation between folic acid use and autistic disorder, but provides a rationale for replicating the analyses in other study samples and further investigating genetic factors and other biologic mechanisms that may explain the inverse association," said Dr. Pål Surén of the Norwegian Institute of Public Health, Oslo, and his associates.

thinkstockphotos.com

Folic acid supplements during pregnancy reduce the risk of neural tube defects in the offspring, and there is some evidence that they may also reduce the risk of other neurodevelopmental disorders. A recent analysis of data from the Norwegian Mother and Child Cohort Study found that maternal use of folic acid supplements was associated with a lower risk of severe language delay in their children at age 3 years.

Dr. Surén and his colleagues used data from the same cohort study to examine a possible association between the supplements and risk of autism spectrum disorders. The Norwegian Mother and Child Cohort Study is a national registry of 109,020 children born between 1999 and 2009.

For this analysis, the researchers assessed data concerning 85,176 children in the registry. At final follow-up, the subjects ranged in age from 3.3 years to 10.2 years (mean age, 6.4 years).

A total of 270 of these children (0.32%) were diagnosed as having autism spectrum disorders: 0.13% had autistic disorder, 0.07% had Asperger’s syndrome, and 0.12% had pervasive developmental disorder not otherwise specified.

Approximately 33% of the mothers took folic acid supplements during the interval from 4 weeks before conception to 8 weeks afterward. This period was chosen for the analysis because folic acid’s effects on the developing central nervous system of the fetus are most prominent during this time. "The interval covers or precedes events of critical importance to the fetal brain, such as the closure of the neural tube 28 days after conception and the embryonic period that includes development of the basic brain structures 15-56 days after conception," the investigators noted.

They found an inverse association between the mother’s use of folic acid supplements periconceptually and the risk that the child would develop autistic disorder. Of the children whose mothers took the supplements, 0.10% developed autistic disorder, compared with 0.21% in children whose mothers did not.

The adjusted odds ratio of autistic disorder was 0.61 in children of folic acid users. Further adjusting the data to account for comorbid maternal illness and concomitant medication use did not change this OR, Dr. Surén and his associates reported (JAMA 2013;309:570-7).

Women who took folic acid supplements were more likely to have a college-level education, to have planned the pregnancy, to be nonsmokers, and to have a prepregnancy body mass index less than 25 kg/m², which are all factors that could confound the association with autism. To address this issue, the investigators assessed the use of fish oil supplements in the study sample.

Use of fish oil supplements correlated with the same parental characteristics as did use of folic acid supplements, but it did not correlate with the risk of autistic disorder, they noted.

Similarly, the inverse association for folic acid use in the periconceptual period was not evident in mothers who took the supplements only later in pregnancy.

"Our findings indicate that the inverse association may be largely driven by the children with autistic disorder and severe language delay at 35 months, who were presumably the more severely affected children," the investigators added.

This study was funded in part by the Research Council of Norway. The investigators did not report having any financial conflicts of interest.

Maternal use of folic acid supplements around the time of conception was associated with a lower risk of autistic disorder, the most severe form of autism spectrum disorders, in the children, according to a Norwegian study reported in the Feb. 13 issue of JAMA.

"This finding does not establish a causal relation between folic acid use and autistic disorder, but provides a rationale for replicating the analyses in other study samples and further investigating genetic factors and other biologic mechanisms that may explain the inverse association," said Dr. Pål Surén of the Norwegian Institute of Public Health, Oslo, and his associates.

thinkstockphotos.com

Folic acid supplements during pregnancy reduce the risk of neural tube defects in the offspring, and there is some evidence that they may also reduce the risk of other neurodevelopmental disorders. A recent analysis of data from the Norwegian Mother and Child Cohort Study found that maternal use of folic acid supplements was associated with a lower risk of severe language delay in their children at age 3 years.

Dr. Surén and his colleagues used data from the same cohort study to examine a possible association between the supplements and risk of autism spectrum disorders. The Norwegian Mother and Child Cohort Study is a national registry of 109,020 children born between 1999 and 2009.

For this analysis, the researchers assessed data concerning 85,176 children in the registry. At final follow-up, the subjects ranged in age from 3.3 years to 10.2 years (mean age, 6.4 years).

A total of 270 of these children (0.32%) were diagnosed as having autism spectrum disorders: 0.13% had autistic disorder, 0.07% had Asperger’s syndrome, and 0.12% had pervasive developmental disorder not otherwise specified.

Approximately 33% of the mothers took folic acid supplements during the interval from 4 weeks before conception to 8 weeks afterward. This period was chosen for the analysis because folic acid’s effects on the developing central nervous system of the fetus are most prominent during this time. "The interval covers or precedes events of critical importance to the fetal brain, such as the closure of the neural tube 28 days after conception and the embryonic period that includes development of the basic brain structures 15-56 days after conception," the investigators noted.

They found an inverse association between the mother’s use of folic acid supplements periconceptually and the risk that the child would develop autistic disorder. Of the children whose mothers took the supplements, 0.10% developed autistic disorder, compared with 0.21% in children whose mothers did not.

The adjusted odds ratio of autistic disorder was 0.61 in children of folic acid users. Further adjusting the data to account for comorbid maternal illness and concomitant medication use did not change this OR, Dr. Surén and his associates reported (JAMA 2013;309:570-7).

Women who took folic acid supplements were more likely to have a college-level education, to have planned the pregnancy, to be nonsmokers, and to have a prepregnancy body mass index less than 25 kg/m², which are all factors that could confound the association with autism. To address this issue, the investigators assessed the use of fish oil supplements in the study sample.

Use of fish oil supplements correlated with the same parental characteristics as did use of folic acid supplements, but it did not correlate with the risk of autistic disorder, they noted.

Similarly, the inverse association for folic acid use in the periconceptual period was not evident in mothers who took the supplements only later in pregnancy.

"Our findings indicate that the inverse association may be largely driven by the children with autistic disorder and severe language delay at 35 months, who were presumably the more severely affected children," the investigators added.

This study was funded in part by the Research Council of Norway. The investigators did not report having any financial conflicts of interest.

At the SDEF Hawaii Dermatology Seminar, Dr. Alan Menter of Baylor University discussed the particular challenges women with psoriasis face in the peripartum period. Many patients – and many ob.gyns.– are not well informed about postpartum psoriasis flare or what to do if genital psoriasis is present at delivery. The SDEF Hawaii Dermatology Seminar is presented by the Skin Disease Education Foundation/Global Academy for Medical Education and is owned by the same parent company as this news organization.

At the SDEF Hawaii Dermatology Seminar, Dr. Alan Menter of Baylor University discussed the particular challenges women with psoriasis face in the peripartum period. Many patients – and many ob.gyns.– are not well informed about postpartum psoriasis flare or what to do if genital psoriasis is present at delivery. The SDEF Hawaii Dermatology Seminar is presented by the Skin Disease Education Foundation/Global Academy for Medical Education and is owned by the same parent company as this news organization.

At the SDEF Hawaii Dermatology Seminar, Dr. Alan Menter of Baylor University discussed the particular challenges women with psoriasis face in the peripartum period. Many patients – and many ob.gyns.– are not well informed about postpartum psoriasis flare or what to do if genital psoriasis is present at delivery. The SDEF Hawaii Dermatology Seminar is presented by the Skin Disease Education Foundation/Global Academy for Medical Education and is owned by the same parent company as this news organization.

SNOWMASS, COLO–Pregnancy increases the long-term risk of aortic complications in women with Marfan syndrome, according to a recent prospective study causing a stir among adult congenital heart disease specialists.

"This is the first study that says, ‘Even if the aortic root size is okay before pregnancy, the aorta is going to get bigger during pregnancy and it’s not going to go back to baseline. And if your aorta is bigger at the outset, there is a risk for long-term adverse outcomes,’ " Dr. Carole A. Warnes explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology (ACC).

This study on pregnancy’s impact on aortic growth rate and complications in patients with Marfan syndrome sheds much needed light on an area where there has been a paucity of data. The deficiency of data is reflected in discordant recommendations in the current U.S., European, and Canadian guidelines, said Dr. Warnes, professor of medicine at the Mayo Clinic, Rochester, Minn.

The U.S. guidelines put forth jointly by the ACC, American Heart Association, American Association for Thoracic Surgery, and other groups advocate that Marfan syndrome patients avoid pregnancy if their aortic root diameter exceeds 40 mm and recommend prophylactic aortic replacement in those interested in pregnancy (J. Am. Coll. Cardiol. 2010;55:e27-129).

In contrast, the European guidelines (Eur. Heart J. 2010;31:2915-57) consider an aortic root diameter of 45 mm or less to be generally safe, while strongly discouraging pregnancy in Marfan syndrome patients with a measurement above that threshold because of the associated increased dissection risk. The Canadian guidelines take a similar stance, albeit with a safety threshold of 44 mm rather than 45 mm (Can. J. Cardiol. 2010;26:e80-e97).

The Europeans qualify their position by noting that patients with a prepregnancy aortic root diameter of 40-45 mm who have a rapid aortic root growth rate or a family history of dissection ought to be considered high risk for pregnancy. The European and Canadian guidelines characterize dissection as a rare problem in patients with an aortic root diameter of less than 40 mm.

The recent Utah study included 98 women with Marfan syndrome, 69 of whom collectively had 199 pregnancies, with 170 live births, 26 spontaneous abortions, and 2 ectopic pregnancies.

Serial echocardiograms demonstrated that the aortic growth rate was significantly greater during pregnancy than beforehand, and after pregnancy it didn’t return to baseline. Obstetric complications occurred in 10% of pregnancies. Adverse fetal outcomes occurred in 13%.

Reassuringly, there were no catastrophic peripartum complications. No one required cardiac surgery or experienced aortic dissection during pregnancy. However, women with a prior pregnancy had a greater prevalence of both aortic dissection and elective aortic surgery during long-term follow-up, compared with matched childless women with Marfan syndrome. Thus, it’s important during prepregnancy counseling of women with Marfan syndrome to let them know they’ll need to have elective aortic root surgery at a younger age than if they remain childless, Dr. Warnes noted.

A larger initial root diameter and a faster increase in diameter were independent predictors of long-term adverse cardiovascular events in the Utah study.

Besides the recent Utah study, only two other prospective studies of pregnancy’s impact on aortic growth and complications have been done. Both were much smaller. In an editorial accompanying the Utah study, Dutch physicians combined the three studies to get a fuller picture. No type A dissections occurred during 145 pregnancies in 78 nonoperated women with Marfan syndrome. Of 25 women with an aortic root diameter of 40-51 mm during 29 pregnancies, one experienced a type B dissection, two had carotid artery dissections, and one developed accelerated aortic regurgitation, which went from mild to severe during pregnancy.

Five women underwent aortic root replacement (three electively), prior to six pregnancies. Two of them developed a type B dissection during pregnancy. Both women who underwent a valve-sparing elective aortic root replacement prior to pregnancy had pregnancies complicated by a worsening of aortic regurgitation, which went from trivial to moderate. These findings raise a red flag for Dr. Warnes.

"Even if they’ve had a successful root replacement, it doesn’t mean they’re out of the woods in terms of pregnancy. I think we have to question the role of prophylactic root replacement [as recommended in the U.S. guidelines] because these women will still have type B dissections, and trying to look for a type B dissection during pregnancy is a real difficult issue," the cardiologist observed.

The authors of the editorial concluded that Marfan syndrome patients without previous cardiac complications and who have a baseline aortic root diameter not in excess of 45 mm seem to tolerate pregnancy well as long as they receive good clinical care before, during, and after pregnancy. In contrast, pregnancy should be discouraged in patients with a history of aortic dissection because they are at elevated risk for aortic complications (J. Am. Coll. Cardiol. 2012;60:230-1).

Marfan syndrome is a genetic connective tissue disorder with an incidence of roughly 1 in 5,000 and autosomal dominant inheritance, so the fetus of an affected mom has a 50% chance of having the disorder. Dr. Warnes said that because the diagnostic criteria were overhauled in 2010, patients believed to have Marfan syndrome really ought to be referred to a specialized center in order to confirm or refute the diagnosis according to the contemporary Ghent criteria.

Dr. Warnes reported having no relevant financial interests.

[email protected]

SNOWMASS, COLO–Pregnancy increases the long-term risk of aortic complications in women with Marfan syndrome, according to a recent prospective study causing a stir among adult congenital heart disease specialists.

"This is the first study that says, ‘Even if the aortic root size is okay before pregnancy, the aorta is going to get bigger during pregnancy and it’s not going to go back to baseline. And if your aorta is bigger at the outset, there is a risk for long-term adverse outcomes,’ " Dr. Carole A. Warnes explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology (ACC).

This study on pregnancy’s impact on aortic growth rate and complications in patients with Marfan syndrome sheds much needed light on an area where there has been a paucity of data. The deficiency of data is reflected in discordant recommendations in the current U.S., European, and Canadian guidelines, said Dr. Warnes, professor of medicine at the Mayo Clinic, Rochester, Minn.

The U.S. guidelines put forth jointly by the ACC, American Heart Association, American Association for Thoracic Surgery, and other groups advocate that Marfan syndrome patients avoid pregnancy if their aortic root diameter exceeds 40 mm and recommend prophylactic aortic replacement in those interested in pregnancy (J. Am. Coll. Cardiol. 2010;55:e27-129).

In contrast, the European guidelines (Eur. Heart J. 2010;31:2915-57) consider an aortic root diameter of 45 mm or less to be generally safe, while strongly discouraging pregnancy in Marfan syndrome patients with a measurement above that threshold because of the associated increased dissection risk. The Canadian guidelines take a similar stance, albeit with a safety threshold of 44 mm rather than 45 mm (Can. J. Cardiol. 2010;26:e80-e97).

The Europeans qualify their position by noting that patients with a prepregnancy aortic root diameter of 40-45 mm who have a rapid aortic root growth rate or a family history of dissection ought to be considered high risk for pregnancy. The European and Canadian guidelines characterize dissection as a rare problem in patients with an aortic root diameter of less than 40 mm.

The recent Utah study included 98 women with Marfan syndrome, 69 of whom collectively had 199 pregnancies, with 170 live births, 26 spontaneous abortions, and 2 ectopic pregnancies.

Serial echocardiograms demonstrated that the aortic growth rate was significantly greater during pregnancy than beforehand, and after pregnancy it didn’t return to baseline. Obstetric complications occurred in 10% of pregnancies. Adverse fetal outcomes occurred in 13%.

Reassuringly, there were no catastrophic peripartum complications. No one required cardiac surgery or experienced aortic dissection during pregnancy. However, women with a prior pregnancy had a greater prevalence of both aortic dissection and elective aortic surgery during long-term follow-up, compared with matched childless women with Marfan syndrome. Thus, it’s important during prepregnancy counseling of women with Marfan syndrome to let them know they’ll need to have elective aortic root surgery at a younger age than if they remain childless, Dr. Warnes noted.

A larger initial root diameter and a faster increase in diameter were independent predictors of long-term adverse cardiovascular events in the Utah study.

Besides the recent Utah study, only two other prospective studies of pregnancy’s impact on aortic growth and complications have been done. Both were much smaller. In an editorial accompanying the Utah study, Dutch physicians combined the three studies to get a fuller picture. No type A dissections occurred during 145 pregnancies in 78 nonoperated women with Marfan syndrome. Of 25 women with an aortic root diameter of 40-51 mm during 29 pregnancies, one experienced a type B dissection, two had carotid artery dissections, and one developed accelerated aortic regurgitation, which went from mild to severe during pregnancy.

Five women underwent aortic root replacement (three electively), prior to six pregnancies. Two of them developed a type B dissection during pregnancy. Both women who underwent a valve-sparing elective aortic root replacement prior to pregnancy had pregnancies complicated by a worsening of aortic regurgitation, which went from trivial to moderate. These findings raise a red flag for Dr. Warnes.

"Even if they’ve had a successful root replacement, it doesn’t mean they’re out of the woods in terms of pregnancy. I think we have to question the role of prophylactic root replacement [as recommended in the U.S. guidelines] because these women will still have type B dissections, and trying to look for a type B dissection during pregnancy is a real difficult issue," the cardiologist observed.

The authors of the editorial concluded that Marfan syndrome patients without previous cardiac complications and who have a baseline aortic root diameter not in excess of 45 mm seem to tolerate pregnancy well as long as they receive good clinical care before, during, and after pregnancy. In contrast, pregnancy should be discouraged in patients with a history of aortic dissection because they are at elevated risk for aortic complications (J. Am. Coll. Cardiol. 2012;60:230-1).

Marfan syndrome is a genetic connective tissue disorder with an incidence of roughly 1 in 5,000 and autosomal dominant inheritance, so the fetus of an affected mom has a 50% chance of having the disorder. Dr. Warnes said that because the diagnostic criteria were overhauled in 2010, patients believed to have Marfan syndrome really ought to be referred to a specialized center in order to confirm or refute the diagnosis according to the contemporary Ghent criteria.

Dr. Warnes reported having no relevant financial interests.

[email protected]

SNOWMASS, COLO–Pregnancy increases the long-term risk of aortic complications in women with Marfan syndrome, according to a recent prospective study causing a stir among adult congenital heart disease specialists.

"This is the first study that says, ‘Even if the aortic root size is okay before pregnancy, the aorta is going to get bigger during pregnancy and it’s not going to go back to baseline. And if your aorta is bigger at the outset, there is a risk for long-term adverse outcomes,’ " Dr. Carole A. Warnes explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology (ACC).

This study on pregnancy’s impact on aortic growth rate and complications in patients with Marfan syndrome sheds much needed light on an area where there has been a paucity of data. The deficiency of data is reflected in discordant recommendations in the current U.S., European, and Canadian guidelines, said Dr. Warnes, professor of medicine at the Mayo Clinic, Rochester, Minn.

The U.S. guidelines put forth jointly by the ACC, American Heart Association, American Association for Thoracic Surgery, and other groups advocate that Marfan syndrome patients avoid pregnancy if their aortic root diameter exceeds 40 mm and recommend prophylactic aortic replacement in those interested in pregnancy (J. Am. Coll. Cardiol. 2010;55:e27-129).

In contrast, the European guidelines (Eur. Heart J. 2010;31:2915-57) consider an aortic root diameter of 45 mm or less to be generally safe, while strongly discouraging pregnancy in Marfan syndrome patients with a measurement above that threshold because of the associated increased dissection risk. The Canadian guidelines take a similar stance, albeit with a safety threshold of 44 mm rather than 45 mm (Can. J. Cardiol. 2010;26:e80-e97).

The Europeans qualify their position by noting that patients with a prepregnancy aortic root diameter of 40-45 mm who have a rapid aortic root growth rate or a family history of dissection ought to be considered high risk for pregnancy. The European and Canadian guidelines characterize dissection as a rare problem in patients with an aortic root diameter of less than 40 mm.

The recent Utah study included 98 women with Marfan syndrome, 69 of whom collectively had 199 pregnancies, with 170 live births, 26 spontaneous abortions, and 2 ectopic pregnancies.

Serial echocardiograms demonstrated that the aortic growth rate was significantly greater during pregnancy than beforehand, and after pregnancy it didn’t return to baseline. Obstetric complications occurred in 10% of pregnancies. Adverse fetal outcomes occurred in 13%.

Reassuringly, there were no catastrophic peripartum complications. No one required cardiac surgery or experienced aortic dissection during pregnancy. However, women with a prior pregnancy had a greater prevalence of both aortic dissection and elective aortic surgery during long-term follow-up, compared with matched childless women with Marfan syndrome. Thus, it’s important during prepregnancy counseling of women with Marfan syndrome to let them know they’ll need to have elective aortic root surgery at a younger age than if they remain childless, Dr. Warnes noted.

A larger initial root diameter and a faster increase in diameter were independent predictors of long-term adverse cardiovascular events in the Utah study.

Besides the recent Utah study, only two other prospective studies of pregnancy’s impact on aortic growth and complications have been done. Both were much smaller. In an editorial accompanying the Utah study, Dutch physicians combined the three studies to get a fuller picture. No type A dissections occurred during 145 pregnancies in 78 nonoperated women with Marfan syndrome. Of 25 women with an aortic root diameter of 40-51 mm during 29 pregnancies, one experienced a type B dissection, two had carotid artery dissections, and one developed accelerated aortic regurgitation, which went from mild to severe during pregnancy.

Five women underwent aortic root replacement (three electively), prior to six pregnancies. Two of them developed a type B dissection during pregnancy. Both women who underwent a valve-sparing elective aortic root replacement prior to pregnancy had pregnancies complicated by a worsening of aortic regurgitation, which went from trivial to moderate. These findings raise a red flag for Dr. Warnes.

"Even if they’ve had a successful root replacement, it doesn’t mean they’re out of the woods in terms of pregnancy. I think we have to question the role of prophylactic root replacement [as recommended in the U.S. guidelines] because these women will still have type B dissections, and trying to look for a type B dissection during pregnancy is a real difficult issue," the cardiologist observed.

The authors of the editorial concluded that Marfan syndrome patients without previous cardiac complications and who have a baseline aortic root diameter not in excess of 45 mm seem to tolerate pregnancy well as long as they receive good clinical care before, during, and after pregnancy. In contrast, pregnancy should be discouraged in patients with a history of aortic dissection because they are at elevated risk for aortic complications (J. Am. Coll. Cardiol. 2012;60:230-1).

Marfan syndrome is a genetic connective tissue disorder with an incidence of roughly 1 in 5,000 and autosomal dominant inheritance, so the fetus of an affected mom has a 50% chance of having the disorder. Dr. Warnes said that because the diagnostic criteria were overhauled in 2010, patients believed to have Marfan syndrome really ought to be referred to a specialized center in order to confirm or refute the diagnosis according to the contemporary Ghent criteria.

Dr. Warnes reported having no relevant financial interests.

[email protected]

CASE: Shoulder dystocia resulting in persistent injury to C5 and C6

A 30-year-old, G2P1 woman presented in labor at 39 weeks and reported a strong desire to have a natural childbirth. She was taking insulin for gestational diabetes mellitus diagnosed in the second trimester. Her body mass index was 43 kg/m², and her height was 4 ft 11 in. The estimated fetal weight was 9 lb. She had a prior vaginal delivery. During her antepartum care the patient was extensively counseled about the risk of shoulder dystocia and obstetric brachial plexus (OBP) injury.

The patient progressed normally through labor without anesthesia. At birth, the baby delivered occiput posterior and restituted to right occiput transverse. There was a turtle sign, and the obstetrician diagnosed a shoulder dystocia, called for help, and told the mother to stop pushing. An attempt to deliver the fetal head with gentle downward guidance was unsuccessful. The McRoberts maneuver and suprapubic pressure combined with gentle downward guidance on the fetal head did not result in delivery. A mediolateral episiotomy was made and the Rubin and Wood maneuvers were attempted without success. The obstetrician then successfully delivered the posterior arm and the body of the baby was easily delivered.

The shoulder dystocia lasted 2 minutes before successful delivery. The Apgar scores were 3 and 6 at one and five minutes, respectively. The umbilical cord artery pH was 7.18. The birthweight was 9 lb 2 oz. A diagnosis of OBP injury involving C5 and C6 was made. At discharge the OBP injury persisted.

What is OBP injury?

Shoulder dystocia, which affected this mother and fetus, is a problem involving the impaction of the fetal shoulder behind the maternal symphysis pubis. Shoulder dystocia is a “bony problem.” Although shoulder dystocia cannot be predicted reliably, risk factors include:

• fetal macrosomia
• maternal diabetes
• maternal weight gain
• prepregnancy obesity
• multiparity
• operative vaginal delivery.^1-3

The injury can be serious and permanent. The feared consequence of shoulder dystocia is permanent obstetric brachial plexus injury and/or fetal neurologic damage caused by reduced cord blood flow and fetal asphyxia. Occasionally, shoulder dystocia results in fetal death.

Trunks and cords of the brachial plexus
C5 and C6 roots merge to form the upper trunk, C7 root forms the middle trunk, and C8 and T1 roots merge to form the lower trunk.

How can an OBP injury occur?

Most cases are unilateral and arise when one or more of the brachial plexus nerves ( Figure ) are compromised. The forces of labor, fetal position, maternal pushing, and force applied to the fetal head and neck by a clinician all may contribute to an OBP injury.⁴ It is important to note that up to one-third of all OBP injuries occur in births not associated with a recognized shoulder dystocia.⁵

Erb’s palsy. Injuries to the C5 and C6 nerves account for about 50% of cases. The muscle groups impacted by this injury include the deltoid and infraspinatus muscles (mainly C5) and the biceps muscle (mainly C6). This pattern results in an adducted and internally rotated upper arm, an extended forearm, with preservation of hand and wrist movement.

Erb’s palsy plus. Injury to C5, C6, and C7 nerves accounts for about 35% of cases and manifests as adduction and internal rotation of the arm, extension and pronation of the forearm, plus flexion of the wrist and fingers—the so-called waiter’s tip posture.

Klumpke’s palsy. Isolated injury to the C8 nerve and T1 root occurs infrequently and manifests as isolated hand paralysis and Horner’s syndrome.

Approximately one in five OBP injuries persist for years following birth. The incidence of OBP injury ranges from 1.0 to 3.0 cases per 1,000 births.^6-8 In a review of studies with at least 3 years of follow-up and less than 10% loss to follow-up, the authors reported that the three best studies observed a risk of persistent OBP of 10%, 19%, and 27%.⁹

Long-term management of OBP injury

The optimal approach to management of OBP injury is unknown because few high-quality studies are available to guide therapy. Typically, 3 to 9 months of observation and physical therapy are recommended following birth, with the hope that the majority of newborns will recover some or almost all function. Physical therapy is focused on reducing the occurrence of joint contractures and maintaining range of motion in the shoulder, elbow, wrist, and fingers.

Surgical exploration of the plexus is often advised when biceps muscle function is absent at 3 months of age. Some surgeons recommend waiting until 9 months before pursuing surgical exploration.¹⁰ No randomized trials have been performed demonstrating the value of surgical intervention, but case series report that surgical intervention with nerve grafting or nerve transfer is superior to management without neurosurgery.

The consequences of permanent OBP injury

A lifetime of corrective therapy for the child. OBP injury may result in a permanent brachial plexus injury—permanent arm weakness requiring decades of physical therapy and multiple surgeries to try to reduce functional disabilities. Problems that frequently occur in children with OBP injury include:

• shoulder contractures
• limb length differences
• winged scapula
• behavioral and developmental problems.

A patient’s care may be coordinated at a brachial plexus injury specialty center, where coordinated access to pediatric neurologists, neurosurgeons, orthopedic surgeons, and neurophysiologists is available and physical and occupational therapy are provided.

Years of emotional response for the parents. Following a birth complicated by shoulder dystocia, the parents may experience grief and anger. During the decades following the birth, the parents of the child will wonder if the injury could have been avoided. They may be asked by friends and relatives, “Would a cesarean delivery have prevented the injury?” Physical therapists, pediatric neurologists, orthopedic and neurosurgeons may reinforce the idea that the injury was caused when the obstetrician applied excessive lateral force to the head and neck, resulting in an injury to the brachial plexus.

Decades-long exposure to these ideas, unresolved anger, financial stress, and lingering doubts may result in the parents and child pursuing civil litigation against the delivering clinician.

Can we reduce the incidence of OBP injury and our risk of litigation?

There are no interventions proven to reduce the incidence of OBP injury. However, many experts advise that a multifaceted approach to this obstetric emergency may reduce the incidence of severe OBP injury at the same time that we reduce our risk of litigation.

When counseling patients about the risk for OBP injury, use teach-back. Patients tend to misunderstand or forget much of what their clinicians teach them.¹¹ Teach-back is an iterative communication process in which the clinician teaches the patient a concept or technique, then asks the patient to repeat the concept in their own words or demonstrate the technique. The clinician then amplifies the concept or technique and corrects misunderstandings. The patient is then asked to repeat the concept or demonstrate the technique. When using teach-back, the clinician never asks, “Do you understand?” The clinician encourages the patient to teach the concept to the clinician using the patient’s own words.¹²

In the case above, the patient has multiple risk factors for shoulder dystocia, including obesity, short stature, insulin-treated gestational diabetes, and a large fetus. Given the high risk for shoulder dystocia, teach-back might help the patient better understand the situation. After explaining the concepts to the patient, the teach-back questions to the patient might include:

• “Can you tell me what is a shoulder dystocia?”
• “Can you list the health conditions that you have that increase your baby’s risk of shoulder dystocia?”
• “When a shoulder dystocia occurs, what actions will we take at birth to try to fix the shoulder dystocia?”
• “When a baby has experienced a shoulder dystocia, what can happen to the baby’s arm?”

Regularly perform multidisciplinary shoulder dystocia drills. The Joint Commission recommends that clinical drills be performed to help staff prepare for high-risk labor and delivery events, including shoulder dystocia, emergency cesarean delivery, and maternal hemorrhage.¹³

When shoulder dystocia occurs, extensively chart the event and interventions used. The American College of Obstetricians and Gynecologists has developed a patient safety checklist focused on key clinical elements in the antepartum, intrapartum, and postpartum periods and overall timing of the delivery to document when a shoulder dystocia occurs.¹⁴

Stop using the term “traction” in the medical record and obstetric literature. Words are meaningful and open to multiple interpretations. Often, words have unintended consequences. Plaintiff attorneys often highlight the obstetrician’s use of “traction” or “excessive traction” as the cause of an OBP injury. Orthopedic surgeons and pediatricians often state in their records that the OBP injury was a “traction injury,” further supporting the plaintiff attorney’s contention that excessive traction applied by the obstetrician caused the traction injury. Obstetricians do not use traction to deliver a baby. Motorized tractors generate traction, not obstetricians. We use gentle downward guidance to deliver the fetal shoulders and body.

In a high-risk situation, proceed quickly to delivery of the posterior arm. When you recognize a shoulder dystocia in a high-risk situation (maternal diabetes and large fetus), it may be wise to move quickly to delivery of the posterior arm.^15,16 In high-risk situations, delivery of the posterior arm is the maneuver with the greatest likelihood of resolving a severe shoulder dystocia, with the least force applied to the brachial plexus that is trapped under the mother’s symphysis pubis.

Practice, and then practice some more

A difficult-to-resolve shoulder dystocia is one of the most dramatic and frightening obstetric events. We know that we will all experience such cases. If we prepare well and frequently practice shoulder dystocia maneuvers, the dread of being responsible for resolving a shoulder dystocia will diminish. In most cases we will be able to report, “Mother and newborn safely birthed.”

INSTANT POLL: In your experience, what can clinicians do to reduce their exposure to brachial plexus injury litigation? Click here to respond.

CASE: Shoulder dystocia resulting in persistent injury to C5 and C6

A 30-year-old, G2P1 woman presented in labor at 39 weeks and reported a strong desire to have a natural childbirth. She was taking insulin for gestational diabetes mellitus diagnosed in the second trimester. Her body mass index was 43 kg/m², and her height was 4 ft 11 in. The estimated fetal weight was 9 lb. She had a prior vaginal delivery. During her antepartum care the patient was extensively counseled about the risk of shoulder dystocia and obstetric brachial plexus (OBP) injury.

The patient progressed normally through labor without anesthesia. At birth, the baby delivered occiput posterior and restituted to right occiput transverse. There was a turtle sign, and the obstetrician diagnosed a shoulder dystocia, called for help, and told the mother to stop pushing. An attempt to deliver the fetal head with gentle downward guidance was unsuccessful. The McRoberts maneuver and suprapubic pressure combined with gentle downward guidance on the fetal head did not result in delivery. A mediolateral episiotomy was made and the Rubin and Wood maneuvers were attempted without success. The obstetrician then successfully delivered the posterior arm and the body of the baby was easily delivered.

The shoulder dystocia lasted 2 minutes before successful delivery. The Apgar scores were 3 and 6 at one and five minutes, respectively. The umbilical cord artery pH was 7.18. The birthweight was 9 lb 2 oz. A diagnosis of OBP injury involving C5 and C6 was made. At discharge the OBP injury persisted.

What is OBP injury?

Shoulder dystocia, which affected this mother and fetus, is a problem involving the impaction of the fetal shoulder behind the maternal symphysis pubis. Shoulder dystocia is a “bony problem.” Although shoulder dystocia cannot be predicted reliably, risk factors include:

• fetal macrosomia
• maternal diabetes
• maternal weight gain
• prepregnancy obesity
• multiparity
• operative vaginal delivery.^1-3

The injury can be serious and permanent. The feared consequence of shoulder dystocia is permanent obstetric brachial plexus injury and/or fetal neurologic damage caused by reduced cord blood flow and fetal asphyxia. Occasionally, shoulder dystocia results in fetal death.

Trunks and cords of the brachial plexus
C5 and C6 roots merge to form the upper trunk, C7 root forms the middle trunk, and C8 and T1 roots merge to form the lower trunk.

How can an OBP injury occur?

Most cases are unilateral and arise when one or more of the brachial plexus nerves ( Figure ) are compromised. The forces of labor, fetal position, maternal pushing, and force applied to the fetal head and neck by a clinician all may contribute to an OBP injury.⁴ It is important to note that up to one-third of all OBP injuries occur in births not associated with a recognized shoulder dystocia.⁵

Erb’s palsy. Injuries to the C5 and C6 nerves account for about 50% of cases. The muscle groups impacted by this injury include the deltoid and infraspinatus muscles (mainly C5) and the biceps muscle (mainly C6). This pattern results in an adducted and internally rotated upper arm, an extended forearm, with preservation of hand and wrist movement.

Erb’s palsy plus. Injury to C5, C6, and C7 nerves accounts for about 35% of cases and manifests as adduction and internal rotation of the arm, extension and pronation of the forearm, plus flexion of the wrist and fingers—the so-called waiter’s tip posture.

Klumpke’s palsy. Isolated injury to the C8 nerve and T1 root occurs infrequently and manifests as isolated hand paralysis and Horner’s syndrome.

Approximately one in five OBP injuries persist for years following birth. The incidence of OBP injury ranges from 1.0 to 3.0 cases per 1,000 births.^6-8 In a review of studies with at least 3 years of follow-up and less than 10% loss to follow-up, the authors reported that the three best studies observed a risk of persistent OBP of 10%, 19%, and 27%.⁹

Long-term management of OBP injury

The optimal approach to management of OBP injury is unknown because few high-quality studies are available to guide therapy. Typically, 3 to 9 months of observation and physical therapy are recommended following birth, with the hope that the majority of newborns will recover some or almost all function. Physical therapy is focused on reducing the occurrence of joint contractures and maintaining range of motion in the shoulder, elbow, wrist, and fingers.

Surgical exploration of the plexus is often advised when biceps muscle function is absent at 3 months of age. Some surgeons recommend waiting until 9 months before pursuing surgical exploration.¹⁰ No randomized trials have been performed demonstrating the value of surgical intervention, but case series report that surgical intervention with nerve grafting or nerve transfer is superior to management without neurosurgery.

The consequences of permanent OBP injury

A lifetime of corrective therapy for the child. OBP injury may result in a permanent brachial plexus injury—permanent arm weakness requiring decades of physical therapy and multiple surgeries to try to reduce functional disabilities. Problems that frequently occur in children with OBP injury include:

• shoulder contractures
• limb length differences
• winged scapula
• behavioral and developmental problems.

A patient’s care may be coordinated at a brachial plexus injury specialty center, where coordinated access to pediatric neurologists, neurosurgeons, orthopedic surgeons, and neurophysiologists is available and physical and occupational therapy are provided.

Years of emotional response for the parents. Following a birth complicated by shoulder dystocia, the parents may experience grief and anger. During the decades following the birth, the parents of the child will wonder if the injury could have been avoided. They may be asked by friends and relatives, “Would a cesarean delivery have prevented the injury?” Physical therapists, pediatric neurologists, orthopedic and neurosurgeons may reinforce the idea that the injury was caused when the obstetrician applied excessive lateral force to the head and neck, resulting in an injury to the brachial plexus.

Decades-long exposure to these ideas, unresolved anger, financial stress, and lingering doubts may result in the parents and child pursuing civil litigation against the delivering clinician.

Can we reduce the incidence of OBP injury and our risk of litigation?

There are no interventions proven to reduce the incidence of OBP injury. However, many experts advise that a multifaceted approach to this obstetric emergency may reduce the incidence of severe OBP injury at the same time that we reduce our risk of litigation.

When counseling patients about the risk for OBP injury, use teach-back. Patients tend to misunderstand or forget much of what their clinicians teach them.¹¹ Teach-back is an iterative communication process in which the clinician teaches the patient a concept or technique, then asks the patient to repeat the concept in their own words or demonstrate the technique. The clinician then amplifies the concept or technique and corrects misunderstandings. The patient is then asked to repeat the concept or demonstrate the technique. When using teach-back, the clinician never asks, “Do you understand?” The clinician encourages the patient to teach the concept to the clinician using the patient’s own words.¹²

In the case above, the patient has multiple risk factors for shoulder dystocia, including obesity, short stature, insulin-treated gestational diabetes, and a large fetus. Given the high risk for shoulder dystocia, teach-back might help the patient better understand the situation. After explaining the concepts to the patient, the teach-back questions to the patient might include:

• “Can you tell me what is a shoulder dystocia?”
• “Can you list the health conditions that you have that increase your baby’s risk of shoulder dystocia?”
• “When a shoulder dystocia occurs, what actions will we take at birth to try to fix the shoulder dystocia?”
• “When a baby has experienced a shoulder dystocia, what can happen to the baby’s arm?”

Regularly perform multidisciplinary shoulder dystocia drills. The Joint Commission recommends that clinical drills be performed to help staff prepare for high-risk labor and delivery events, including shoulder dystocia, emergency cesarean delivery, and maternal hemorrhage.¹³

When shoulder dystocia occurs, extensively chart the event and interventions used. The American College of Obstetricians and Gynecologists has developed a patient safety checklist focused on key clinical elements in the antepartum, intrapartum, and postpartum periods and overall timing of the delivery to document when a shoulder dystocia occurs.¹⁴

Stop using the term “traction” in the medical record and obstetric literature. Words are meaningful and open to multiple interpretations. Often, words have unintended consequences. Plaintiff attorneys often highlight the obstetrician’s use of “traction” or “excessive traction” as the cause of an OBP injury. Orthopedic surgeons and pediatricians often state in their records that the OBP injury was a “traction injury,” further supporting the plaintiff attorney’s contention that excessive traction applied by the obstetrician caused the traction injury. Obstetricians do not use traction to deliver a baby. Motorized tractors generate traction, not obstetricians. We use gentle downward guidance to deliver the fetal shoulders and body.

In a high-risk situation, proceed quickly to delivery of the posterior arm. When you recognize a shoulder dystocia in a high-risk situation (maternal diabetes and large fetus), it may be wise to move quickly to delivery of the posterior arm.^15,16 In high-risk situations, delivery of the posterior arm is the maneuver with the greatest likelihood of resolving a severe shoulder dystocia, with the least force applied to the brachial plexus that is trapped under the mother’s symphysis pubis.

Practice, and then practice some more

A difficult-to-resolve shoulder dystocia is one of the most dramatic and frightening obstetric events. We know that we will all experience such cases. If we prepare well and frequently practice shoulder dystocia maneuvers, the dread of being responsible for resolving a shoulder dystocia will diminish. In most cases we will be able to report, “Mother and newborn safely birthed.”

INSTANT POLL: In your experience, what can clinicians do to reduce their exposure to brachial plexus injury litigation? Click here to respond.

CASE: Shoulder dystocia resulting in persistent injury to C5 and C6

A 30-year-old, G2P1 woman presented in labor at 39 weeks and reported a strong desire to have a natural childbirth. She was taking insulin for gestational diabetes mellitus diagnosed in the second trimester. Her body mass index was 43 kg/m², and her height was 4 ft 11 in. The estimated fetal weight was 9 lb. She had a prior vaginal delivery. During her antepartum care the patient was extensively counseled about the risk of shoulder dystocia and obstetric brachial plexus (OBP) injury.

The patient progressed normally through labor without anesthesia. At birth, the baby delivered occiput posterior and restituted to right occiput transverse. There was a turtle sign, and the obstetrician diagnosed a shoulder dystocia, called for help, and told the mother to stop pushing. An attempt to deliver the fetal head with gentle downward guidance was unsuccessful. The McRoberts maneuver and suprapubic pressure combined with gentle downward guidance on the fetal head did not result in delivery. A mediolateral episiotomy was made and the Rubin and Wood maneuvers were attempted without success. The obstetrician then successfully delivered the posterior arm and the body of the baby was easily delivered.

The shoulder dystocia lasted 2 minutes before successful delivery. The Apgar scores were 3 and 6 at one and five minutes, respectively. The umbilical cord artery pH was 7.18. The birthweight was 9 lb 2 oz. A diagnosis of OBP injury involving C5 and C6 was made. At discharge the OBP injury persisted.

What is OBP injury?

Shoulder dystocia, which affected this mother and fetus, is a problem involving the impaction of the fetal shoulder behind the maternal symphysis pubis. Shoulder dystocia is a “bony problem.” Although shoulder dystocia cannot be predicted reliably, risk factors include:

• fetal macrosomia
• maternal diabetes
• maternal weight gain
• prepregnancy obesity
• multiparity
• operative vaginal delivery.^1-3

The injury can be serious and permanent. The feared consequence of shoulder dystocia is permanent obstetric brachial plexus injury and/or fetal neurologic damage caused by reduced cord blood flow and fetal asphyxia. Occasionally, shoulder dystocia results in fetal death.

Trunks and cords of the brachial plexus
C5 and C6 roots merge to form the upper trunk, C7 root forms the middle trunk, and C8 and T1 roots merge to form the lower trunk.

How can an OBP injury occur?

Most cases are unilateral and arise when one or more of the brachial plexus nerves ( Figure ) are compromised. The forces of labor, fetal position, maternal pushing, and force applied to the fetal head and neck by a clinician all may contribute to an OBP injury.⁴ It is important to note that up to one-third of all OBP injuries occur in births not associated with a recognized shoulder dystocia.⁵

Erb’s palsy. Injuries to the C5 and C6 nerves account for about 50% of cases. The muscle groups impacted by this injury include the deltoid and infraspinatus muscles (mainly C5) and the biceps muscle (mainly C6). This pattern results in an adducted and internally rotated upper arm, an extended forearm, with preservation of hand and wrist movement.

Erb’s palsy plus. Injury to C5, C6, and C7 nerves accounts for about 35% of cases and manifests as adduction and internal rotation of the arm, extension and pronation of the forearm, plus flexion of the wrist and fingers—the so-called waiter’s tip posture.

Klumpke’s palsy. Isolated injury to the C8 nerve and T1 root occurs infrequently and manifests as isolated hand paralysis and Horner’s syndrome.

Approximately one in five OBP injuries persist for years following birth. The incidence of OBP injury ranges from 1.0 to 3.0 cases per 1,000 births.^6-8 In a review of studies with at least 3 years of follow-up and less than 10% loss to follow-up, the authors reported that the three best studies observed a risk of persistent OBP of 10%, 19%, and 27%.⁹

Long-term management of OBP injury

The optimal approach to management of OBP injury is unknown because few high-quality studies are available to guide therapy. Typically, 3 to 9 months of observation and physical therapy are recommended following birth, with the hope that the majority of newborns will recover some or almost all function. Physical therapy is focused on reducing the occurrence of joint contractures and maintaining range of motion in the shoulder, elbow, wrist, and fingers.

Surgical exploration of the plexus is often advised when biceps muscle function is absent at 3 months of age. Some surgeons recommend waiting until 9 months before pursuing surgical exploration.¹⁰ No randomized trials have been performed demonstrating the value of surgical intervention, but case series report that surgical intervention with nerve grafting or nerve transfer is superior to management without neurosurgery.

The consequences of permanent OBP injury

A lifetime of corrective therapy for the child. OBP injury may result in a permanent brachial plexus injury—permanent arm weakness requiring decades of physical therapy and multiple surgeries to try to reduce functional disabilities. Problems that frequently occur in children with OBP injury include:

• shoulder contractures
• limb length differences
• winged scapula
• behavioral and developmental problems.

A patient’s care may be coordinated at a brachial plexus injury specialty center, where coordinated access to pediatric neurologists, neurosurgeons, orthopedic surgeons, and neurophysiologists is available and physical and occupational therapy are provided.

Years of emotional response for the parents. Following a birth complicated by shoulder dystocia, the parents may experience grief and anger. During the decades following the birth, the parents of the child will wonder if the injury could have been avoided. They may be asked by friends and relatives, “Would a cesarean delivery have prevented the injury?” Physical therapists, pediatric neurologists, orthopedic and neurosurgeons may reinforce the idea that the injury was caused when the obstetrician applied excessive lateral force to the head and neck, resulting in an injury to the brachial plexus.

Decades-long exposure to these ideas, unresolved anger, financial stress, and lingering doubts may result in the parents and child pursuing civil litigation against the delivering clinician.

Can we reduce the incidence of OBP injury and our risk of litigation?

There are no interventions proven to reduce the incidence of OBP injury. However, many experts advise that a multifaceted approach to this obstetric emergency may reduce the incidence of severe OBP injury at the same time that we reduce our risk of litigation.

When counseling patients about the risk for OBP injury, use teach-back. Patients tend to misunderstand or forget much of what their clinicians teach them.¹¹ Teach-back is an iterative communication process in which the clinician teaches the patient a concept or technique, then asks the patient to repeat the concept in their own words or demonstrate the technique. The clinician then amplifies the concept or technique and corrects misunderstandings. The patient is then asked to repeat the concept or demonstrate the technique. When using teach-back, the clinician never asks, “Do you understand?” The clinician encourages the patient to teach the concept to the clinician using the patient’s own words.¹²

In the case above, the patient has multiple risk factors for shoulder dystocia, including obesity, short stature, insulin-treated gestational diabetes, and a large fetus. Given the high risk for shoulder dystocia, teach-back might help the patient better understand the situation. After explaining the concepts to the patient, the teach-back questions to the patient might include:

• “Can you tell me what is a shoulder dystocia?”
• “Can you list the health conditions that you have that increase your baby’s risk of shoulder dystocia?”
• “When a shoulder dystocia occurs, what actions will we take at birth to try to fix the shoulder dystocia?”
• “When a baby has experienced a shoulder dystocia, what can happen to the baby’s arm?”

Regularly perform multidisciplinary shoulder dystocia drills. The Joint Commission recommends that clinical drills be performed to help staff prepare for high-risk labor and delivery events, including shoulder dystocia, emergency cesarean delivery, and maternal hemorrhage.¹³

When shoulder dystocia occurs, extensively chart the event and interventions used. The American College of Obstetricians and Gynecologists has developed a patient safety checklist focused on key clinical elements in the antepartum, intrapartum, and postpartum periods and overall timing of the delivery to document when a shoulder dystocia occurs.¹⁴

Stop using the term “traction” in the medical record and obstetric literature. Words are meaningful and open to multiple interpretations. Often, words have unintended consequences. Plaintiff attorneys often highlight the obstetrician’s use of “traction” or “excessive traction” as the cause of an OBP injury. Orthopedic surgeons and pediatricians often state in their records that the OBP injury was a “traction injury,” further supporting the plaintiff attorney’s contention that excessive traction applied by the obstetrician caused the traction injury. Obstetricians do not use traction to deliver a baby. Motorized tractors generate traction, not obstetricians. We use gentle downward guidance to deliver the fetal shoulders and body.

In a high-risk situation, proceed quickly to delivery of the posterior arm. When you recognize a shoulder dystocia in a high-risk situation (maternal diabetes and large fetus), it may be wise to move quickly to delivery of the posterior arm.^15,16 In high-risk situations, delivery of the posterior arm is the maneuver with the greatest likelihood of resolving a severe shoulder dystocia, with the least force applied to the brachial plexus that is trapped under the mother’s symphysis pubis.

Practice, and then practice some more

A difficult-to-resolve shoulder dystocia is one of the most dramatic and frightening obstetric events. We know that we will all experience such cases. If we prepare well and frequently practice shoulder dystocia maneuvers, the dread of being responsible for resolving a shoulder dystocia will diminish. In most cases we will be able to report, “Mother and newborn safely birthed.”

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