Obstetrics

NEW ORLEANS – Weight gain between pregnancies decreases the likelihood of a successful vaginal birth after cesarean section, according to findings from a large population-based retrospective cohort study.

The more weight a woman gains between pregnancies, the lower her chances are of a successful vaginal birth after cesarean section (VBAC); conversely, overweight and obese women who lose weight between pregnancies may improve their chances of a successful VBAC, Dr. Lisa S. Callegari reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The overall VBAC success rate among 8,861 women included in the study was 66%, but differences were seen with VBAC success based on prepregnancy body mass index category: The success rate was 70% for normal-weight women, 62% for overweight women, and 56% for obese women, said Dr. Callegari of the University of Washington, Seattle.

After adjustment for a number of factors, including demographics, smoking status, interpregnancy interval, birth year of second pregnancy (to account for temporal changes in VBAC practices), and prenatal care adequacy, weight loss among normal-weight women was not found to be associated with VBAC success, but weight gain of between one and two BMI units (about 6-12 pounds) among normal-weight women was associated with a 7% decrease in the VBAC success rate, compared with weight maintenance.

High weight gain, defined as an increase of more than two BMI units (about 12 pounds) between pregnancies, was associated with a 13% decrease in the VBAC success rate, compared with weight maintenance.

For overweight and obese women, moderate and high weight gain did not affect VBAC success, but weight loss in overweight women was associated with a 12% increase in VBAC success, and weight loss equivalent to 1 or more BMI units in obese women was associated with a 24% increase in VBAC success, Dr. Callegari said.

The findings are based on an analysis of longitudinal birth certificate data linked with hospitalization records between 1992 and 2009. Women who were included underwent primary cesarean delivery for their first birth, and attempted a trial of labor for their second birth.

Although limited by the use of birth certificate data, and also by a large number of cases with missing BMI information, the findings are bolstered by the use of population-based data, an observed dose-response effect, and the biologic plausibility for the findings, Dr. Callegari said.

The findings are important because increasing the rates of VBAC has been proposed as a strategy for decreasing cesarean section rates. However, VBAC rates have been declining in recent years, falling from 23% in 1996 to less than 10% currently. The causes are multifactorial, but these findings suggest that the modifiable risk factors of overweight and obesity are among them, Dr. Callegari said.

"In terms of clinical implications, normal-weight women should return to within one BMI unit of their prepregnancy weight, and overweight and obese women should lose greater than or equal to one BMI unit between pregnancies in order to optimize their chances of VBAC success," she concluded.

Dr. Callegari reported having no disclosures.

NEW ORLEANS – Weight gain between pregnancies decreases the likelihood of a successful vaginal birth after cesarean section, according to findings from a large population-based retrospective cohort study.

The more weight a woman gains between pregnancies, the lower her chances are of a successful vaginal birth after cesarean section (VBAC); conversely, overweight and obese women who lose weight between pregnancies may improve their chances of a successful VBAC, Dr. Lisa S. Callegari reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The overall VBAC success rate among 8,861 women included in the study was 66%, but differences were seen with VBAC success based on prepregnancy body mass index category: The success rate was 70% for normal-weight women, 62% for overweight women, and 56% for obese women, said Dr. Callegari of the University of Washington, Seattle.

After adjustment for a number of factors, including demographics, smoking status, interpregnancy interval, birth year of second pregnancy (to account for temporal changes in VBAC practices), and prenatal care adequacy, weight loss among normal-weight women was not found to be associated with VBAC success, but weight gain of between one and two BMI units (about 6-12 pounds) among normal-weight women was associated with a 7% decrease in the VBAC success rate, compared with weight maintenance.

High weight gain, defined as an increase of more than two BMI units (about 12 pounds) between pregnancies, was associated with a 13% decrease in the VBAC success rate, compared with weight maintenance.

For overweight and obese women, moderate and high weight gain did not affect VBAC success, but weight loss in overweight women was associated with a 12% increase in VBAC success, and weight loss equivalent to 1 or more BMI units in obese women was associated with a 24% increase in VBAC success, Dr. Callegari said.

The findings are based on an analysis of longitudinal birth certificate data linked with hospitalization records between 1992 and 2009. Women who were included underwent primary cesarean delivery for their first birth, and attempted a trial of labor for their second birth.

Although limited by the use of birth certificate data, and also by a large number of cases with missing BMI information, the findings are bolstered by the use of population-based data, an observed dose-response effect, and the biologic plausibility for the findings, Dr. Callegari said.

The findings are important because increasing the rates of VBAC has been proposed as a strategy for decreasing cesarean section rates. However, VBAC rates have been declining in recent years, falling from 23% in 1996 to less than 10% currently. The causes are multifactorial, but these findings suggest that the modifiable risk factors of overweight and obesity are among them, Dr. Callegari said.

"In terms of clinical implications, normal-weight women should return to within one BMI unit of their prepregnancy weight, and overweight and obese women should lose greater than or equal to one BMI unit between pregnancies in order to optimize their chances of VBAC success," she concluded.

Dr. Callegari reported having no disclosures.

NEW ORLEANS – Weight gain between pregnancies decreases the likelihood of a successful vaginal birth after cesarean section, according to findings from a large population-based retrospective cohort study.

The more weight a woman gains between pregnancies, the lower her chances are of a successful vaginal birth after cesarean section (VBAC); conversely, overweight and obese women who lose weight between pregnancies may improve their chances of a successful VBAC, Dr. Lisa S. Callegari reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The overall VBAC success rate among 8,861 women included in the study was 66%, but differences were seen with VBAC success based on prepregnancy body mass index category: The success rate was 70% for normal-weight women, 62% for overweight women, and 56% for obese women, said Dr. Callegari of the University of Washington, Seattle.

After adjustment for a number of factors, including demographics, smoking status, interpregnancy interval, birth year of second pregnancy (to account for temporal changes in VBAC practices), and prenatal care adequacy, weight loss among normal-weight women was not found to be associated with VBAC success, but weight gain of between one and two BMI units (about 6-12 pounds) among normal-weight women was associated with a 7% decrease in the VBAC success rate, compared with weight maintenance.

High weight gain, defined as an increase of more than two BMI units (about 12 pounds) between pregnancies, was associated with a 13% decrease in the VBAC success rate, compared with weight maintenance.

For overweight and obese women, moderate and high weight gain did not affect VBAC success, but weight loss in overweight women was associated with a 12% increase in VBAC success, and weight loss equivalent to 1 or more BMI units in obese women was associated with a 24% increase in VBAC success, Dr. Callegari said.

The findings are based on an analysis of longitudinal birth certificate data linked with hospitalization records between 1992 and 2009. Women who were included underwent primary cesarean delivery for their first birth, and attempted a trial of labor for their second birth.

Although limited by the use of birth certificate data, and also by a large number of cases with missing BMI information, the findings are bolstered by the use of population-based data, an observed dose-response effect, and the biologic plausibility for the findings, Dr. Callegari said.

The findings are important because increasing the rates of VBAC has been proposed as a strategy for decreasing cesarean section rates. However, VBAC rates have been declining in recent years, falling from 23% in 1996 to less than 10% currently. The causes are multifactorial, but these findings suggest that the modifiable risk factors of overweight and obesity are among them, Dr. Callegari said.

"In terms of clinical implications, normal-weight women should return to within one BMI unit of their prepregnancy weight, and overweight and obese women should lose greater than or equal to one BMI unit between pregnancies in order to optimize their chances of VBAC success," she concluded.

Dr. Callegari reported having no disclosures.

Americans should lower sodium consumption to optimize their health – but not below levels of 2,300 mg per day, according to a new report from the Institute of Medicine.

People aged 51 years and older, African-Americans, and those with hypertension, diabetes, or chronic kidney disease can follow the same advice, according to authors of the report, released during a webinar May 14.

© Georges Lievre / Fotolia.com

That recommendation is a departure from the current Dietary Guidelines for Americans from the U.S. Department of Health and Human Services, which recommends that these higher-risk groups limit sodium intake to 1,500 mg daily. The HHS guidelines recommend that most other people aged 14-50 years limit sodium intake to 2,300 mg per day.

On average, Americans consume 3,400 mg or more of sodium a day (equivalent to 1.5 teaspoons of salt), despite efforts over the past few decades to reduce sodium consumption, according to the IOM report, which was sponsored by the Centers for Disease Control and Prevention.

"We found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes," said Dr. Brian L. Strom, George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania, Philadelphia, who chaired the committee that released the report.

The committee did not suggest an optimal target range for sodium consumption.

Dr. Strom and his colleagues reviewed medical studies from 2003 to 2012 that evaluated the direct impact of sodium intake on outcomes such as heart disease and death. Although the studies varied widely in the quality of their methodology and data collection, the report’s authors came to the following conclusions:

• There was a positive relationship between higher levels of sodium and risk of heart disease, consistent with previous research looking at sodium’s effects on blood pressure.

• There were insufficient data to determine if lowering sodium intake below 2,300 mg/day conferred any increase or decrease in the risk of heart disease, stroke, or death.

• Sodium intake of 1,840 mg/day or less may increase the risk of adverse health effects such as cardiovascular events or death among people with mid- to late-stage heart failure receiving aggressive treatment.

• Health outcomes studies provide little evidence about the effects of low sodium intake among those with diabetes, kidney disease, and heart disease, suggesting that people affected by these conditions could follow recommendations for the general public.

But the recommendations prompted calls for caution by some health experts.

The IOM report included "weak studies with numerous problems" and did not include evidence on the effects of sodium reduction on blood pressure, "a key determinant of health and the largest determinant of preventable mortality worldwide," Dr. Lawrence Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University, Baltimore, said in an interview.

Dr. Appel said he still supports the recommendations of the Dietary Guidelines, which he helped create. "Middle- and older-aged adults, African Americans, and patients with hypertension, diabetes, and chronic kidney disease are those at greatest risk for blood pressure–related heart disease and stroke," he said, and they stand to benefit from keeping sodium levels to 1,500 mg/day or less.

Americans should lower sodium consumption to optimize their health – but not below levels of 2,300 mg per day, according to a new report from the Institute of Medicine.

People aged 51 years and older, African-Americans, and those with hypertension, diabetes, or chronic kidney disease can follow the same advice, according to authors of the report, released during a webinar May 14.

© Georges Lievre / Fotolia.com

That recommendation is a departure from the current Dietary Guidelines for Americans from the U.S. Department of Health and Human Services, which recommends that these higher-risk groups limit sodium intake to 1,500 mg daily. The HHS guidelines recommend that most other people aged 14-50 years limit sodium intake to 2,300 mg per day.

On average, Americans consume 3,400 mg or more of sodium a day (equivalent to 1.5 teaspoons of salt), despite efforts over the past few decades to reduce sodium consumption, according to the IOM report, which was sponsored by the Centers for Disease Control and Prevention.

"We found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes," said Dr. Brian L. Strom, George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania, Philadelphia, who chaired the committee that released the report.

The committee did not suggest an optimal target range for sodium consumption.

Dr. Strom and his colleagues reviewed medical studies from 2003 to 2012 that evaluated the direct impact of sodium intake on outcomes such as heart disease and death. Although the studies varied widely in the quality of their methodology and data collection, the report’s authors came to the following conclusions:

• There was a positive relationship between higher levels of sodium and risk of heart disease, consistent with previous research looking at sodium’s effects on blood pressure.

• There were insufficient data to determine if lowering sodium intake below 2,300 mg/day conferred any increase or decrease in the risk of heart disease, stroke, or death.

• Sodium intake of 1,840 mg/day or less may increase the risk of adverse health effects such as cardiovascular events or death among people with mid- to late-stage heart failure receiving aggressive treatment.

• Health outcomes studies provide little evidence about the effects of low sodium intake among those with diabetes, kidney disease, and heart disease, suggesting that people affected by these conditions could follow recommendations for the general public.

But the recommendations prompted calls for caution by some health experts.

The IOM report included "weak studies with numerous problems" and did not include evidence on the effects of sodium reduction on blood pressure, "a key determinant of health and the largest determinant of preventable mortality worldwide," Dr. Lawrence Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University, Baltimore, said in an interview.

Dr. Appel said he still supports the recommendations of the Dietary Guidelines, which he helped create. "Middle- and older-aged adults, African Americans, and patients with hypertension, diabetes, and chronic kidney disease are those at greatest risk for blood pressure–related heart disease and stroke," he said, and they stand to benefit from keeping sodium levels to 1,500 mg/day or less.

Americans should lower sodium consumption to optimize their health – but not below levels of 2,300 mg per day, according to a new report from the Institute of Medicine.

People aged 51 years and older, African-Americans, and those with hypertension, diabetes, or chronic kidney disease can follow the same advice, according to authors of the report, released during a webinar May 14.

© Georges Lievre / Fotolia.com

That recommendation is a departure from the current Dietary Guidelines for Americans from the U.S. Department of Health and Human Services, which recommends that these higher-risk groups limit sodium intake to 1,500 mg daily. The HHS guidelines recommend that most other people aged 14-50 years limit sodium intake to 2,300 mg per day.

On average, Americans consume 3,400 mg or more of sodium a day (equivalent to 1.5 teaspoons of salt), despite efforts over the past few decades to reduce sodium consumption, according to the IOM report, which was sponsored by the Centers for Disease Control and Prevention.

"We found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes," said Dr. Brian L. Strom, George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania, Philadelphia, who chaired the committee that released the report.

The committee did not suggest an optimal target range for sodium consumption.

Dr. Strom and his colleagues reviewed medical studies from 2003 to 2012 that evaluated the direct impact of sodium intake on outcomes such as heart disease and death. Although the studies varied widely in the quality of their methodology and data collection, the report’s authors came to the following conclusions:

• There was a positive relationship between higher levels of sodium and risk of heart disease, consistent with previous research looking at sodium’s effects on blood pressure.

• There were insufficient data to determine if lowering sodium intake below 2,300 mg/day conferred any increase or decrease in the risk of heart disease, stroke, or death.

• Sodium intake of 1,840 mg/day or less may increase the risk of adverse health effects such as cardiovascular events or death among people with mid- to late-stage heart failure receiving aggressive treatment.

• Health outcomes studies provide little evidence about the effects of low sodium intake among those with diabetes, kidney disease, and heart disease, suggesting that people affected by these conditions could follow recommendations for the general public.

But the recommendations prompted calls for caution by some health experts.

The IOM report included "weak studies with numerous problems" and did not include evidence on the effects of sodium reduction on blood pressure, "a key determinant of health and the largest determinant of preventable mortality worldwide," Dr. Lawrence Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University, Baltimore, said in an interview.

Dr. Appel said he still supports the recommendations of the Dietary Guidelines, which he helped create. "Middle- and older-aged adults, African Americans, and patients with hypertension, diabetes, and chronic kidney disease are those at greatest risk for blood pressure–related heart disease and stroke," he said, and they stand to benefit from keeping sodium levels to 1,500 mg/day or less.

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

[email protected]

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

[email protected]

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

[email protected]

Valproate sodium and related drugs should never be used to prevent migraines in pregnant women, according to a Food and Drug Administration warning. The safety advisory cites the final results of a study indicating that prenatal exposure to these drugs "can cause decreased IQ scores" in children whose mothers took them during pregnancy.

The pregnancy category for valproate for the migraine indication will be changed from a "D" – designated for drugs where the potential benefit for a pregnant woman might be acceptable despite its potential risks – to a category "X," designating that the risk of the drug in a pregnant woman "clearly outweighs any possible benefit of the drug," according to the advisory, issued May 6 by the FDA.

Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and generic versions of these products. They also are used to treat epilepsy and manic episodes associated with bipolar disorder, and for these indications, they will remain in category "D" and "should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable." Women who can become pregnant should not use valproate unless it is essential to managing their medical condition, the FDA states.

"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in a May 6 statement issued by the FDA to announce the advisory.

The data cited by the FDA are the final results of the Neurodevelopmental Effects of Antiepileptic Drugs study, published in March 2013, which found that at age 6, children whose mothers had taken valproate products while pregnant had lower IQs, compared with those whose mothers took other antiepileptic drugs. In the study, the mean IQ among the children exposed to valproate in utero was 97, compared with a mean of 105 among those exposed to carbamazepine, 108 among those exposed to lamotrigine, and 108 among those exposed to phenytoin (Lancet Neurol. 2013;12:244-52).

In June 2011, the FDA issued an alert when interim results of this study found that at age 3 years, children exposed to valproate had lower scores on cognitive tests, information that was added to the labels at that time.

The FDA notes that the results of the study are similar to other epidemiologic studies that have associated in utero exposure to valproate to lower IQ scores, when compared with children exposed to another AED or no AED in utero.

Since women in the study were taking antiepileptic drugs throughout pregnancy, it is unclear whether the effects on IQ are related to the timing or duration of prenatal valproate exposure, so "exposure to valproate at any time during pregnancy should be considered to have the potential to result in decreased IQ in children," the advisory says.

The prescribing information for valproate medications already include a boxed warning about the fetal risks, especially neural tube defects and other major malformations, associated with prenatal exposure.

Adverse events associated with valproate products should be reported to the FDA’s MedWatch program or at 800-332-1088. In addition, the agency is asking physicians to encourage their pregnant patients on valproate to enroll in the North American Antiepileptic Drug Registry online or at 888-233-2334.

[email protected]

Valproate sodium and related drugs should never be used to prevent migraines in pregnant women, according to a Food and Drug Administration warning. The safety advisory cites the final results of a study indicating that prenatal exposure to these drugs "can cause decreased IQ scores" in children whose mothers took them during pregnancy.

The pregnancy category for valproate for the migraine indication will be changed from a "D" – designated for drugs where the potential benefit for a pregnant woman might be acceptable despite its potential risks – to a category "X," designating that the risk of the drug in a pregnant woman "clearly outweighs any possible benefit of the drug," according to the advisory, issued May 6 by the FDA.

Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and generic versions of these products. They also are used to treat epilepsy and manic episodes associated with bipolar disorder, and for these indications, they will remain in category "D" and "should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable." Women who can become pregnant should not use valproate unless it is essential to managing their medical condition, the FDA states.

"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in a May 6 statement issued by the FDA to announce the advisory.

The data cited by the FDA are the final results of the Neurodevelopmental Effects of Antiepileptic Drugs study, published in March 2013, which found that at age 6, children whose mothers had taken valproate products while pregnant had lower IQs, compared with those whose mothers took other antiepileptic drugs. In the study, the mean IQ among the children exposed to valproate in utero was 97, compared with a mean of 105 among those exposed to carbamazepine, 108 among those exposed to lamotrigine, and 108 among those exposed to phenytoin (Lancet Neurol. 2013;12:244-52).

In June 2011, the FDA issued an alert when interim results of this study found that at age 3 years, children exposed to valproate had lower scores on cognitive tests, information that was added to the labels at that time.

The FDA notes that the results of the study are similar to other epidemiologic studies that have associated in utero exposure to valproate to lower IQ scores, when compared with children exposed to another AED or no AED in utero.

Since women in the study were taking antiepileptic drugs throughout pregnancy, it is unclear whether the effects on IQ are related to the timing or duration of prenatal valproate exposure, so "exposure to valproate at any time during pregnancy should be considered to have the potential to result in decreased IQ in children," the advisory says.

The prescribing information for valproate medications already include a boxed warning about the fetal risks, especially neural tube defects and other major malformations, associated with prenatal exposure.

Adverse events associated with valproate products should be reported to the FDA’s MedWatch program or at 800-332-1088. In addition, the agency is asking physicians to encourage their pregnant patients on valproate to enroll in the North American Antiepileptic Drug Registry online or at 888-233-2334.

[email protected]

Valproate sodium and related drugs should never be used to prevent migraines in pregnant women, according to a Food and Drug Administration warning. The safety advisory cites the final results of a study indicating that prenatal exposure to these drugs "can cause decreased IQ scores" in children whose mothers took them during pregnancy.

The pregnancy category for valproate for the migraine indication will be changed from a "D" – designated for drugs where the potential benefit for a pregnant woman might be acceptable despite its potential risks – to a category "X," designating that the risk of the drug in a pregnant woman "clearly outweighs any possible benefit of the drug," according to the advisory, issued May 6 by the FDA.

Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and generic versions of these products. They also are used to treat epilepsy and manic episodes associated with bipolar disorder, and for these indications, they will remain in category "D" and "should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable." Women who can become pregnant should not use valproate unless it is essential to managing their medical condition, the FDA states.

"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in a May 6 statement issued by the FDA to announce the advisory.

The data cited by the FDA are the final results of the Neurodevelopmental Effects of Antiepileptic Drugs study, published in March 2013, which found that at age 6, children whose mothers had taken valproate products while pregnant had lower IQs, compared with those whose mothers took other antiepileptic drugs. In the study, the mean IQ among the children exposed to valproate in utero was 97, compared with a mean of 105 among those exposed to carbamazepine, 108 among those exposed to lamotrigine, and 108 among those exposed to phenytoin (Lancet Neurol. 2013;12:244-52).

In June 2011, the FDA issued an alert when interim results of this study found that at age 3 years, children exposed to valproate had lower scores on cognitive tests, information that was added to the labels at that time.

The FDA notes that the results of the study are similar to other epidemiologic studies that have associated in utero exposure to valproate to lower IQ scores, when compared with children exposed to another AED or no AED in utero.

Since women in the study were taking antiepileptic drugs throughout pregnancy, it is unclear whether the effects on IQ are related to the timing or duration of prenatal valproate exposure, so "exposure to valproate at any time during pregnancy should be considered to have the potential to result in decreased IQ in children," the advisory says.

The prescribing information for valproate medications already include a boxed warning about the fetal risks, especially neural tube defects and other major malformations, associated with prenatal exposure.

Adverse events associated with valproate products should be reported to the FDA’s MedWatch program or at 800-332-1088. In addition, the agency is asking physicians to encourage their pregnant patients on valproate to enroll in the North American Antiepileptic Drug Registry online or at 888-233-2334.

[email protected]

NEW YORK – Positive signs from the nearly completed first stage of a prospective prevention trial for cardiac neonatal lupus are giving investigators hope that hydroxychloroquine can reduce the risk of fetal heart block if given during pregnancy to women with systemic lupus erythematosus who have previously had a child with the condition.

The first stage of the PATCH (Preventive Approach to Congenital Heart Block With Hydroxychloroquine) study has enrolled all of its intended 19 pregnant women with systemic lupus erythematosus (SLE) and anti-SSA/Ro and anti-SSB/La antibodies who had a previous child with cardiac neonatal lupus (CNL). So far, cardiac abnormalities have been found in only 1 of 17 completed pregnancies in women who began taking 400-mg hydroxychloroquine (HCQ) before 10 weeks’ gestation. The study will go on to a second stage if fewer than three cases of second- or third-degree heart block occur. Enrollment of an additional 35 women is planned for the second stage, Dr. Jill P. Buyon said at the New York University Seminar in Advanced Rheumatology. She is director of the New York University Lupus Center, a professor in the division of rheumatology at New York University, and the principal investigator of the open-label PATCH study.

HCQ treatment will be considered efficacious if fewer than 6 mothers of the 54 total have a child with advanced congenital heart block. With this design, the study has 90% power to conclude that HCQ is preventive if the true recurrence rate with the treatment is 5%. In addition, the probability of rejecting the treatment for further study is 95% if the true recurrence rate is 18%, according to Dr. Buyon and her colleagues.

Women in the trial are given weekly serial fetal echocardiograms and blood tests for potential biomarkers of efficacy and compliance. The results of the study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy, according to the investigators.

"We need prophylactic treatment for autoimmune-associated congenital heart block because of the significant morbidity and mortality. The fibrosis is immutable, and there is no sustained reversal of complete heart block," Dr. Buyon said at the meeting sponsored by NYU. In previous work, Dr. Buyon reported a 17.5% mortality rate of neonates with cardiac neonatal lupus (CNL), 30% in utero (Circulation 2011;124:1927-35).

Congenital atrioventricular block and cardiomyopathy are the two major manifestations of CNL. The risk of CNL is approximately 2% in women with SLE who have given birth to an unaffected child, but the recurrence rate is 17.4% in those who have previously given birth to a baby with CNL. Mechanistically, HCQ’s inhibitory effect on toll-like receptors is thought to interfere with the pathophysiologic cascade underlying CNL.

Research leading up to the PATCH study indicated that HCQ might reduce the risk of CNL by 65% when pregnant mothers with SLE took HCQ throughout their pregnancy, Dr. Buyon said.

She and her colleagues analyzed a historical cohort gathered from three international databases (the Research Registry for Neonatal Lupus, the PRIDE study, and the PROMISSE study). In total, 257 pregnancies of anti-SSA/Ro–positive mothers with SLE who had previously given birth to a child with CNL were identified. Forty of the women were exposed throughout their pregnancies (starting before 10 weeks of gestation) to HCQ and 217 were not exposed to HCQ during pregnancy (Circulation 2012;126:76-82).

Significantly more fetuses in the unexposed group developed CNL (46 [21%] of 217) than in the exposed group (3 [8%] of 40 fetuses) (P = .05). The overall case fatality rate of the CNL fetuses in the unexposed group was 22%, compared with no deaths in the exposed group. No reduction in CNL recurrence was found for prednisone, dexamethasone, or fluorinated steroids.

Dr. Buyon reported having no relevant financial disclosures.

[email protected]

NEW YORK – Positive signs from the nearly completed first stage of a prospective prevention trial for cardiac neonatal lupus are giving investigators hope that hydroxychloroquine can reduce the risk of fetal heart block if given during pregnancy to women with systemic lupus erythematosus who have previously had a child with the condition.

The first stage of the PATCH (Preventive Approach to Congenital Heart Block With Hydroxychloroquine) study has enrolled all of its intended 19 pregnant women with systemic lupus erythematosus (SLE) and anti-SSA/Ro and anti-SSB/La antibodies who had a previous child with cardiac neonatal lupus (CNL). So far, cardiac abnormalities have been found in only 1 of 17 completed pregnancies in women who began taking 400-mg hydroxychloroquine (HCQ) before 10 weeks’ gestation. The study will go on to a second stage if fewer than three cases of second- or third-degree heart block occur. Enrollment of an additional 35 women is planned for the second stage, Dr. Jill P. Buyon said at the New York University Seminar in Advanced Rheumatology. She is director of the New York University Lupus Center, a professor in the division of rheumatology at New York University, and the principal investigator of the open-label PATCH study.

HCQ treatment will be considered efficacious if fewer than 6 mothers of the 54 total have a child with advanced congenital heart block. With this design, the study has 90% power to conclude that HCQ is preventive if the true recurrence rate with the treatment is 5%. In addition, the probability of rejecting the treatment for further study is 95% if the true recurrence rate is 18%, according to Dr. Buyon and her colleagues.

Women in the trial are given weekly serial fetal echocardiograms and blood tests for potential biomarkers of efficacy and compliance. The results of the study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy, according to the investigators.

"We need prophylactic treatment for autoimmune-associated congenital heart block because of the significant morbidity and mortality. The fibrosis is immutable, and there is no sustained reversal of complete heart block," Dr. Buyon said at the meeting sponsored by NYU. In previous work, Dr. Buyon reported a 17.5% mortality rate of neonates with cardiac neonatal lupus (CNL), 30% in utero (Circulation 2011;124:1927-35).

Congenital atrioventricular block and cardiomyopathy are the two major manifestations of CNL. The risk of CNL is approximately 2% in women with SLE who have given birth to an unaffected child, but the recurrence rate is 17.4% in those who have previously given birth to a baby with CNL. Mechanistically, HCQ’s inhibitory effect on toll-like receptors is thought to interfere with the pathophysiologic cascade underlying CNL.

Research leading up to the PATCH study indicated that HCQ might reduce the risk of CNL by 65% when pregnant mothers with SLE took HCQ throughout their pregnancy, Dr. Buyon said.

She and her colleagues analyzed a historical cohort gathered from three international databases (the Research Registry for Neonatal Lupus, the PRIDE study, and the PROMISSE study). In total, 257 pregnancies of anti-SSA/Ro–positive mothers with SLE who had previously given birth to a child with CNL were identified. Forty of the women were exposed throughout their pregnancies (starting before 10 weeks of gestation) to HCQ and 217 were not exposed to HCQ during pregnancy (Circulation 2012;126:76-82).

Significantly more fetuses in the unexposed group developed CNL (46 [21%] of 217) than in the exposed group (3 [8%] of 40 fetuses) (P = .05). The overall case fatality rate of the CNL fetuses in the unexposed group was 22%, compared with no deaths in the exposed group. No reduction in CNL recurrence was found for prednisone, dexamethasone, or fluorinated steroids.

Dr. Buyon reported having no relevant financial disclosures.

[email protected]

NEW YORK – Positive signs from the nearly completed first stage of a prospective prevention trial for cardiac neonatal lupus are giving investigators hope that hydroxychloroquine can reduce the risk of fetal heart block if given during pregnancy to women with systemic lupus erythematosus who have previously had a child with the condition.

The first stage of the PATCH (Preventive Approach to Congenital Heart Block With Hydroxychloroquine) study has enrolled all of its intended 19 pregnant women with systemic lupus erythematosus (SLE) and anti-SSA/Ro and anti-SSB/La antibodies who had a previous child with cardiac neonatal lupus (CNL). So far, cardiac abnormalities have been found in only 1 of 17 completed pregnancies in women who began taking 400-mg hydroxychloroquine (HCQ) before 10 weeks’ gestation. The study will go on to a second stage if fewer than three cases of second- or third-degree heart block occur. Enrollment of an additional 35 women is planned for the second stage, Dr. Jill P. Buyon said at the New York University Seminar in Advanced Rheumatology. She is director of the New York University Lupus Center, a professor in the division of rheumatology at New York University, and the principal investigator of the open-label PATCH study.

HCQ treatment will be considered efficacious if fewer than 6 mothers of the 54 total have a child with advanced congenital heart block. With this design, the study has 90% power to conclude that HCQ is preventive if the true recurrence rate with the treatment is 5%. In addition, the probability of rejecting the treatment for further study is 95% if the true recurrence rate is 18%, according to Dr. Buyon and her colleagues.

Women in the trial are given weekly serial fetal echocardiograms and blood tests for potential biomarkers of efficacy and compliance. The results of the study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy, according to the investigators.

"We need prophylactic treatment for autoimmune-associated congenital heart block because of the significant morbidity and mortality. The fibrosis is immutable, and there is no sustained reversal of complete heart block," Dr. Buyon said at the meeting sponsored by NYU. In previous work, Dr. Buyon reported a 17.5% mortality rate of neonates with cardiac neonatal lupus (CNL), 30% in utero (Circulation 2011;124:1927-35).

Congenital atrioventricular block and cardiomyopathy are the two major manifestations of CNL. The risk of CNL is approximately 2% in women with SLE who have given birth to an unaffected child, but the recurrence rate is 17.4% in those who have previously given birth to a baby with CNL. Mechanistically, HCQ’s inhibitory effect on toll-like receptors is thought to interfere with the pathophysiologic cascade underlying CNL.

Research leading up to the PATCH study indicated that HCQ might reduce the risk of CNL by 65% when pregnant mothers with SLE took HCQ throughout their pregnancy, Dr. Buyon said.

She and her colleagues analyzed a historical cohort gathered from three international databases (the Research Registry for Neonatal Lupus, the PRIDE study, and the PROMISSE study). In total, 257 pregnancies of anti-SSA/Ro–positive mothers with SLE who had previously given birth to a child with CNL were identified. Forty of the women were exposed throughout their pregnancies (starting before 10 weeks of gestation) to HCQ and 217 were not exposed to HCQ during pregnancy (Circulation 2012;126:76-82).

Significantly more fetuses in the unexposed group developed CNL (46 [21%] of 217) than in the exposed group (3 [8%] of 40 fetuses) (P = .05). The overall case fatality rate of the CNL fetuses in the unexposed group was 22%, compared with no deaths in the exposed group. No reduction in CNL recurrence was found for prednisone, dexamethasone, or fluorinated steroids.

Dr. Buyon reported having no relevant financial disclosures.

[email protected]

For healthy full-term infants, development at age 12 months is associated with gestational age, with scores increasing for each additional week of gestation, according to a study published online in Pediatrics.

Olga Rose, MD, from Massachusetts General Hospital in Boston, and colleagues investigated the correlation between gestational age and mental and psychomotor development scores in a cohort of 1,562 healthy full-term infants born between 37 and 41 weeks. The Bayley Scales of Infant Development were used to assess development at 12 months.

The researchers found that, after controlling for birth weight percentile, gender, socioeconomic status, and home environment, the Mental Development Index increased by 0.8 points, and the Psychomotor Development Index increased by 1.4 points for every additional week of gestation.

“There is increasing evidence that birth at 39 to 41 weeks provides developmental advantages compared with birth at 37 to 38 weeks,” the authors write. “Because cesarean deliveries and early-term inductions have increased to 40% of all births, consideration of ongoing brain development during the full-term period is an important medical and policy issue.”

To access the abstract of the article published in Pediatrics, click here.

For healthy full-term infants, development at age 12 months is associated with gestational age, with scores increasing for each additional week of gestation, according to a study published online in Pediatrics.

Olga Rose, MD, from Massachusetts General Hospital in Boston, and colleagues investigated the correlation between gestational age and mental and psychomotor development scores in a cohort of 1,562 healthy full-term infants born between 37 and 41 weeks. The Bayley Scales of Infant Development were used to assess development at 12 months.

The researchers found that, after controlling for birth weight percentile, gender, socioeconomic status, and home environment, the Mental Development Index increased by 0.8 points, and the Psychomotor Development Index increased by 1.4 points for every additional week of gestation.

“There is increasing evidence that birth at 39 to 41 weeks provides developmental advantages compared with birth at 37 to 38 weeks,” the authors write. “Because cesarean deliveries and early-term inductions have increased to 40% of all births, consideration of ongoing brain development during the full-term period is an important medical and policy issue.”

To access the abstract of the article published in Pediatrics, click here.

For healthy full-term infants, development at age 12 months is associated with gestational age, with scores increasing for each additional week of gestation, according to a study published online in Pediatrics.

Olga Rose, MD, from Massachusetts General Hospital in Boston, and colleagues investigated the correlation between gestational age and mental and psychomotor development scores in a cohort of 1,562 healthy full-term infants born between 37 and 41 weeks. The Bayley Scales of Infant Development were used to assess development at 12 months.

The researchers found that, after controlling for birth weight percentile, gender, socioeconomic status, and home environment, the Mental Development Index increased by 0.8 points, and the Psychomotor Development Index increased by 1.4 points for every additional week of gestation.

“There is increasing evidence that birth at 39 to 41 weeks provides developmental advantages compared with birth at 37 to 38 weeks,” the authors write. “Because cesarean deliveries and early-term inductions have increased to 40% of all births, consideration of ongoing brain development during the full-term period is an important medical and policy issue.”

To access the abstract of the article published in Pediatrics, click here.

In this trial, women who had a singleton pregnancy at 35 weeks’ gestation or later were randomly allocated to the Foley bulb plus vaginal misoprostol (n = 56) or to vaginal misoprostol alone (n = 61) for cervical ripening and labor induction. All women had a vertex presentation, intact membranes, and an unfavorable cervix.

Women assigned to the combination group received vaginal misoprostol 25 μg every 4 hours and a Foley bulb inserted into the internal cervical os and filled with 60 mL of normal saline. Women assigned to vaginal misoprostol alone were given 25 μg every 4 hours. Intravenous oxytocin was given in each group when indicated, according to the discretion of the managing physician, at a rate of 2 mU/min, increasing by 2 mU every 20 min until regular uterine contractions occurred.

The primary outcome of the trial was the time from induction to delivery. Secondary outcomes were mode of delivery, tachysystole, and postpartum hemorrhage.

The median Bishop score was 3 in each group (range, 3–6).

Strengths and limitations of the trial

The strength of this study is its randomized design.

Among the limitations are its small sample size, which was inadequate to evaluate serious maternal and neonatal morbidities, and its lack of blinding, which may introduce bias among the managing physicians.

The primary outcome of induction-to-delivery time is not clinically important, particularly when multiparous women and those with a Bishop score above 5 are included, as they were in this study. Moreover, only women with a gestational age of at least 35 weeks were included, so the results do not apply to those with lower gestational ages.

Goal of induction is to achieve vaginal delivery within 24 hours

In the United States, at least one in every four pregnant women undergo induction of labor for any of a variety of obstetric, medical, and social indications.¹ In nulliparous women who have an unfavorable cervix, induction of labor is associated with increased rates of prolonged labor, cesarean delivery, chorioamnionitis, and postpartum hemorrhage. The goal of induction of labor should be to achieve vaginal delivery within 24 hours and reduce the rate of cesarean delivery without increasing adverse maternal and neonatal outcomes.

Several methods are used for induction of labor with or without cervical ripening. They include the administration of oxytocin, oral or vaginal misoprostol in various doses, different preparations of prostaglandins, use of a Foley balloon filled with 30 to 100 mL of saline, or a combination of these methods. To date, none of these approaches has been shown to reduce the rate of cesarean delivery.

A similarly designed study produced very different findings. Data from multiple studies are mixed in regard to the induction-to-delivery time, rate of delivery within 24 and 48 hours, and side effects.^1-6 These studies vary in inclusion criteria, method of induction or cervical ripening, dose of induction agent, Bishop score at randomization, primary outcomes, and sample size. A study from Brazil with a design similar to that of the study by Carbone and colleagues found a shorter mean time from induction to vaginal delivery in the vaginal misoprostol group, compared with the group allocated to the Foley bulb plus oxytocin. There were also more vaginal deliveries in the misoprostol group at 12 hours and 18 hours.⁶

We want to hear from you! Tell us what you think.

In this trial, women who had a singleton pregnancy at 35 weeks’ gestation or later were randomly allocated to the Foley bulb plus vaginal misoprostol (n = 56) or to vaginal misoprostol alone (n = 61) for cervical ripening and labor induction. All women had a vertex presentation, intact membranes, and an unfavorable cervix.

Women assigned to the combination group received vaginal misoprostol 25 μg every 4 hours and a Foley bulb inserted into the internal cervical os and filled with 60 mL of normal saline. Women assigned to vaginal misoprostol alone were given 25 μg every 4 hours. Intravenous oxytocin was given in each group when indicated, according to the discretion of the managing physician, at a rate of 2 mU/min, increasing by 2 mU every 20 min until regular uterine contractions occurred.

The primary outcome of the trial was the time from induction to delivery. Secondary outcomes were mode of delivery, tachysystole, and postpartum hemorrhage.

The median Bishop score was 3 in each group (range, 3–6).

Strengths and limitations of the trial

The strength of this study is its randomized design.

Among the limitations are its small sample size, which was inadequate to evaluate serious maternal and neonatal morbidities, and its lack of blinding, which may introduce bias among the managing physicians.

The primary outcome of induction-to-delivery time is not clinically important, particularly when multiparous women and those with a Bishop score above 5 are included, as they were in this study. Moreover, only women with a gestational age of at least 35 weeks were included, so the results do not apply to those with lower gestational ages.

Goal of induction is to achieve vaginal delivery within 24 hours

In the United States, at least one in every four pregnant women undergo induction of labor for any of a variety of obstetric, medical, and social indications.¹ In nulliparous women who have an unfavorable cervix, induction of labor is associated with increased rates of prolonged labor, cesarean delivery, chorioamnionitis, and postpartum hemorrhage. The goal of induction of labor should be to achieve vaginal delivery within 24 hours and reduce the rate of cesarean delivery without increasing adverse maternal and neonatal outcomes.

Several methods are used for induction of labor with or without cervical ripening. They include the administration of oxytocin, oral or vaginal misoprostol in various doses, different preparations of prostaglandins, use of a Foley balloon filled with 30 to 100 mL of saline, or a combination of these methods. To date, none of these approaches has been shown to reduce the rate of cesarean delivery.

A similarly designed study produced very different findings. Data from multiple studies are mixed in regard to the induction-to-delivery time, rate of delivery within 24 and 48 hours, and side effects.^1-6 These studies vary in inclusion criteria, method of induction or cervical ripening, dose of induction agent, Bishop score at randomization, primary outcomes, and sample size. A study from Brazil with a design similar to that of the study by Carbone and colleagues found a shorter mean time from induction to vaginal delivery in the vaginal misoprostol group, compared with the group allocated to the Foley bulb plus oxytocin. There were also more vaginal deliveries in the misoprostol group at 12 hours and 18 hours.⁶

We want to hear from you! Tell us what you think.

In this trial, women who had a singleton pregnancy at 35 weeks’ gestation or later were randomly allocated to the Foley bulb plus vaginal misoprostol (n = 56) or to vaginal misoprostol alone (n = 61) for cervical ripening and labor induction. All women had a vertex presentation, intact membranes, and an unfavorable cervix.

Women assigned to the combination group received vaginal misoprostol 25 μg every 4 hours and a Foley bulb inserted into the internal cervical os and filled with 60 mL of normal saline. Women assigned to vaginal misoprostol alone were given 25 μg every 4 hours. Intravenous oxytocin was given in each group when indicated, according to the discretion of the managing physician, at a rate of 2 mU/min, increasing by 2 mU every 20 min until regular uterine contractions occurred.

The primary outcome of the trial was the time from induction to delivery. Secondary outcomes were mode of delivery, tachysystole, and postpartum hemorrhage.

The median Bishop score was 3 in each group (range, 3–6).

Strengths and limitations of the trial

The strength of this study is its randomized design.

Among the limitations are its small sample size, which was inadequate to evaluate serious maternal and neonatal morbidities, and its lack of blinding, which may introduce bias among the managing physicians.

The primary outcome of induction-to-delivery time is not clinically important, particularly when multiparous women and those with a Bishop score above 5 are included, as they were in this study. Moreover, only women with a gestational age of at least 35 weeks were included, so the results do not apply to those with lower gestational ages.

Goal of induction is to achieve vaginal delivery within 24 hours

In the United States, at least one in every four pregnant women undergo induction of labor for any of a variety of obstetric, medical, and social indications.¹ In nulliparous women who have an unfavorable cervix, induction of labor is associated with increased rates of prolonged labor, cesarean delivery, chorioamnionitis, and postpartum hemorrhage. The goal of induction of labor should be to achieve vaginal delivery within 24 hours and reduce the rate of cesarean delivery without increasing adverse maternal and neonatal outcomes.

Several methods are used for induction of labor with or without cervical ripening. They include the administration of oxytocin, oral or vaginal misoprostol in various doses, different preparations of prostaglandins, use of a Foley balloon filled with 30 to 100 mL of saline, or a combination of these methods. To date, none of these approaches has been shown to reduce the rate of cesarean delivery.

A similarly designed study produced very different findings. Data from multiple studies are mixed in regard to the induction-to-delivery time, rate of delivery within 24 and 48 hours, and side effects.^1-6 These studies vary in inclusion criteria, method of induction or cervical ripening, dose of induction agent, Bishop score at randomization, primary outcomes, and sample size. A study from Brazil with a design similar to that of the study by Carbone and colleagues found a shorter mean time from induction to vaginal delivery in the vaginal misoprostol group, compared with the group allocated to the Foley bulb plus oxytocin. There were also more vaginal deliveries in the misoprostol group at 12 hours and 18 hours.⁶

We want to hear from you! Tell us what you think.

CASE: Unexpectedly high fetal weight, shoulder dystocia

A nurse midwife is managing the labor of a 41-year-old, G3P2 woman who had two prior spontaneous vaginal deliveries. Results of her glucose-loading test were normal. The midwife estimates the fetal weight as 7 lb 8 oz, but the birth weight proves to be 10 lb 6 oz. After delivery of the head, a turtle sign is obvious, and a shoulder dystocia is declared.

An emergency call for help is made to the front desk. The mother is asked to stop pushing. The obstetric nurse and midwife perform a McRoberts maneuver and apply suprapubic pressure without success. The woman is placed in the Gaskin’s all-fours position, but delivery cannot be accomplished.

Roused from your call room, you quickly proceed to help the team. At 3 minutes into the shoulder dystocia, you enter the room. As the emergency responder, what sequence of maneuvers will you use to resolve the shoulder dystocia?

In response to a shoulder dystocia emergency, most of us have practiced a sequence of actions:

1. recognize shoulder dystocia early and communicate with staff
2. instruct the mother to stop pushing and move the mother’s buttocks to the edge of the birthing bed
3. ensure there is not a tight nuchal cord
4. commit to avoid using excessive force on the fetal head and neck
5. call for emergency help from other expert clinicians
6. perform the McRoberts maneuver combined with suprapubic pressure
7. consider performing an episiotomy
8. use a rotational maneuver such as the Woods screw or Rubin maneuver
9. deliver the posterior arm
10. consider rarely used “salvage maneuvers,” such as the Zavanelli maneuver with cesarean delivery.¹

When you are called to a shoulder dystocia as the emergency responder, the sequence of maneuvers is likely dependent on the actions already attempted by the primary clinician and the length of time from identification of the shoulder dystocia to the responder’s arrival at the patient’s bedside.

Based on my experience, if the primary clinician already has attempted the McRoberts maneuver, suprapubic pressure, and other advanced maneuvers without success, it is best for you to immediately move to the advanced maneuvers with which you are most comfortable. These advanced maneuvers typically include:

• consider an episiotomy and then a rotational maneuver (Woods screw or Rubin maneuver)
• attempt to deliver the posterior arm.

Woods screw and Rubin rotational maneuvers

Woods screw: Removing a well-placed screw requires a rotational maneuver. The Woods screw maneuver is based on the idea that a large baby is like a screw that must maneuver through pelvic threads. You cannot easily directly pull a well-set screw from its threads.

In Woods’ original description of the maneuver, the fetal spine was toward the mother’s right. Woods described a rotational maneuver that is performed by placing the left hand on the mother’s abdomen to provide judicious downward thrust on the fetal buttocks while simultaneously using the fingers of the right hand, placed on the ANTERIOR aspect of the shoulder, to create a clockwise rotational force on the fetus. Using the right hand, the fetal shoulder is moved through >180°, past the 12 o’clock position. At the same time, the fundal pressure and the fingers of the right hand are used to guide the fetus down the birth canal. This maneuver moves the anterior shoulder to the posterior position.

If delivery cannot be completed, a second step in the procedure is to then place the fingers of the right hand on the ANTERIOR aspect of the posterior shoulder (previously the anterior shoulder) and rotate the fetus in a counter-clockwise arc to the 12 o’clock position while gently guiding the fetus down the birth canal.²

Rubin rotational maneuver. Rubin observed that if you adduct the shoulders, the diameter of the shoulders are reduced, thereby easing the passage of the fetus through the birth canal. Adduction is the movement of a body part toward the MIDLINE sagittal plane.

Rubin recommended applying pressure to the POSTERIOR surface of the posterior (6 o’clock) fetal shoulder to help push the shoulder toward the midline of the chest (adduction). If the fetal spine is toward the mother’s left side, you place your right hand on the POSTERIOR surface of the shoulder at the 6 o’clock position, rotating the shoulder in a clockwise arc to the 12 o’clock position while simultaneously guiding the fetus down the birth canal.

Rubin also recommended the use of judicious fundal pressure after the anterior shoulder is disimpacted, if necessary, to facilitate delivery.³ Although both Woods and Rubin recommended the use of judiciously applied fundal pressure, most modern textbooks of obstetrics do not endorse the use of fundal pressure.

Delivery of the posterior arm: My preferred first maneuver

When I arrive as an emergency responder to a shoulder dystocia delivery, my preferred maneuver is to deliver the posterior arm. Many experts recommend prioritizing this maneuver when attempting to resolve a difficult shoulder dystocia.^4-7

Delivery of the posterior arm is performed by inserting the hand and forearm into the sacral hollow. The left hand and forearm are used if the fetal spine is toward the mother’s left, and vice-versa. The posterior humerus is identified and followed to the elbow. The fetal forearm is flexed and swept across the fetal chest. The wrist or hand is then grasped and the arm is extended along the fetal trunk and face, which delivers the posterior arm from the vagina. This results in a reduction in the presenting diameter and the anterior shoulder usually can be delivered with minimal force.

If the delivery of the posterior arm does not resolve the shoulder dystocia, gently support the fetal head and posterior arm, and rotate the fetus 180° using pressure on the posterior surface of the shoulder.

When a fetus is macrosomic, the posterior arm can be fully extended in utero, with the hand below the level of the fetal groin. In such situations, it can be difficult to execute the delivery of the posterior arm.⁸ A back-up technique is to manipulate the posterior axilla to accomplish delivery.

Manipulation of the posterior axilla

When the posterior arm cannot be reached, these maneuvers may be helpful

One of the earliest written descriptions of resolving a severe shoulder dystocia by manipulating the posterior axilla was provided by Percival Willughby (born 1596, died 1685). He wrote:

• “After the head is born, if the child through the greatness of the shoulders, should stick at the neck, let the midwife put her fingers under the child’s armpit and give it a nudge, thrusting it to the other side with her finger, drawing the child or she may quickly bring forth the shoulders, without offering to put it forth by her hands clasped about the neck, which might endanger the breaking of the neck.”⁹

Manipulation of the posterior axilla can either involve a rotational maneuver (using the axilla to rotate the fetus through 180°) or it can be used to pull the posterior shoulder into the hollow of the sacrum and down the birth canal.

Schramm advocated using the posterior axilla to rotate the fetus. She recommended placing 1 or 2 fingers of the right hand in the posterior axilla and then rotating the posterior shoulder into the 12 o’clock position while simultaneously using the left hand to provide gentle guidance on the fetal neck.¹⁰

Menticoglou advocated using manipulation of the posterior axilla to draw the fetal shoulder into the sacral hollow and down the birth canal, thereby releasing the anterior shoulder. In the Menticoglou maneuver the middle fingers of the right and left hand of the obstetrician are hooked into the fetal axilla, one finger from the fetus’ front and the other from the fetus’ back. The fingers overlap each other within the fetal posterior axilla. Downward traction is then exerted on the fetal axilla and the posterior shoulder is pulled outward along the curve of the sacrum (FIGURE).¹¹

Sandmire recommended combining fundal pressure with axillary traction and rotation to facilitate delivery.¹²

The posterior axillary maneuvers are seldom described in modern textbooks of obstetrics and represent a lost art. I have found that they can be useful when the posterior arm cannot be reached. The fetal posterior axilla is almost always closer to the vaginal introitus than the fetal hand or arm, and if the posterior arm cannot be reached, it is a valuable maneuver to have in your armamentarium.

My recommendation

Shoulder dystocia emergencies are an important cause of neonatal injury, including brachial plexus injury, fractures of the humerus, and hypoxic-ischemic encephalopathy. Obstetricians and midwives relentlessly train to resolve shoulder dystocia births with alacrity and minimal fetal trauma. When you are called as an emergency responder in a shoulder dystocia birth, I recommend that you prioritize a rotational maneuver or delivery of the posterior arm, and add manipulation of the posterior axilla to your armamentarium.

CASE: Unexpectedly high fetal weight, shoulder dystocia

A nurse midwife is managing the labor of a 41-year-old, G3P2 woman who had two prior spontaneous vaginal deliveries. Results of her glucose-loading test were normal. The midwife estimates the fetal weight as 7 lb 8 oz, but the birth weight proves to be 10 lb 6 oz. After delivery of the head, a turtle sign is obvious, and a shoulder dystocia is declared.

An emergency call for help is made to the front desk. The mother is asked to stop pushing. The obstetric nurse and midwife perform a McRoberts maneuver and apply suprapubic pressure without success. The woman is placed in the Gaskin’s all-fours position, but delivery cannot be accomplished.

Roused from your call room, you quickly proceed to help the team. At 3 minutes into the shoulder dystocia, you enter the room. As the emergency responder, what sequence of maneuvers will you use to resolve the shoulder dystocia?

In response to a shoulder dystocia emergency, most of us have practiced a sequence of actions:

1. recognize shoulder dystocia early and communicate with staff
2. instruct the mother to stop pushing and move the mother’s buttocks to the edge of the birthing bed
3. ensure there is not a tight nuchal cord
4. commit to avoid using excessive force on the fetal head and neck
5. call for emergency help from other expert clinicians
6. perform the McRoberts maneuver combined with suprapubic pressure
7. consider performing an episiotomy
8. use a rotational maneuver such as the Woods screw or Rubin maneuver
9. deliver the posterior arm
10. consider rarely used “salvage maneuvers,” such as the Zavanelli maneuver with cesarean delivery.¹

When you are called to a shoulder dystocia as the emergency responder, the sequence of maneuvers is likely dependent on the actions already attempted by the primary clinician and the length of time from identification of the shoulder dystocia to the responder’s arrival at the patient’s bedside.

Based on my experience, if the primary clinician already has attempted the McRoberts maneuver, suprapubic pressure, and other advanced maneuvers without success, it is best for you to immediately move to the advanced maneuvers with which you are most comfortable. These advanced maneuvers typically include:

• consider an episiotomy and then a rotational maneuver (Woods screw or Rubin maneuver)
• attempt to deliver the posterior arm.

Woods screw and Rubin rotational maneuvers

Woods screw: Removing a well-placed screw requires a rotational maneuver. The Woods screw maneuver is based on the idea that a large baby is like a screw that must maneuver through pelvic threads. You cannot easily directly pull a well-set screw from its threads.

In Woods’ original description of the maneuver, the fetal spine was toward the mother’s right. Woods described a rotational maneuver that is performed by placing the left hand on the mother’s abdomen to provide judicious downward thrust on the fetal buttocks while simultaneously using the fingers of the right hand, placed on the ANTERIOR aspect of the shoulder, to create a clockwise rotational force on the fetus. Using the right hand, the fetal shoulder is moved through >180°, past the 12 o’clock position. At the same time, the fundal pressure and the fingers of the right hand are used to guide the fetus down the birth canal. This maneuver moves the anterior shoulder to the posterior position.

If delivery cannot be completed, a second step in the procedure is to then place the fingers of the right hand on the ANTERIOR aspect of the posterior shoulder (previously the anterior shoulder) and rotate the fetus in a counter-clockwise arc to the 12 o’clock position while gently guiding the fetus down the birth canal.²

Rubin rotational maneuver. Rubin observed that if you adduct the shoulders, the diameter of the shoulders are reduced, thereby easing the passage of the fetus through the birth canal. Adduction is the movement of a body part toward the MIDLINE sagittal plane.

Rubin recommended applying pressure to the POSTERIOR surface of the posterior (6 o’clock) fetal shoulder to help push the shoulder toward the midline of the chest (adduction). If the fetal spine is toward the mother’s left side, you place your right hand on the POSTERIOR surface of the shoulder at the 6 o’clock position, rotating the shoulder in a clockwise arc to the 12 o’clock position while simultaneously guiding the fetus down the birth canal.

Rubin also recommended the use of judicious fundal pressure after the anterior shoulder is disimpacted, if necessary, to facilitate delivery.³ Although both Woods and Rubin recommended the use of judiciously applied fundal pressure, most modern textbooks of obstetrics do not endorse the use of fundal pressure.

Delivery of the posterior arm: My preferred first maneuver

When I arrive as an emergency responder to a shoulder dystocia delivery, my preferred maneuver is to deliver the posterior arm. Many experts recommend prioritizing this maneuver when attempting to resolve a difficult shoulder dystocia.^4-7

Delivery of the posterior arm is performed by inserting the hand and forearm into the sacral hollow. The left hand and forearm are used if the fetal spine is toward the mother’s left, and vice-versa. The posterior humerus is identified and followed to the elbow. The fetal forearm is flexed and swept across the fetal chest. The wrist or hand is then grasped and the arm is extended along the fetal trunk and face, which delivers the posterior arm from the vagina. This results in a reduction in the presenting diameter and the anterior shoulder usually can be delivered with minimal force.

If the delivery of the posterior arm does not resolve the shoulder dystocia, gently support the fetal head and posterior arm, and rotate the fetus 180° using pressure on the posterior surface of the shoulder.

When a fetus is macrosomic, the posterior arm can be fully extended in utero, with the hand below the level of the fetal groin. In such situations, it can be difficult to execute the delivery of the posterior arm.⁸ A back-up technique is to manipulate the posterior axilla to accomplish delivery.

Manipulation of the posterior axilla

When the posterior arm cannot be reached, these maneuvers may be helpful

One of the earliest written descriptions of resolving a severe shoulder dystocia by manipulating the posterior axilla was provided by Percival Willughby (born 1596, died 1685). He wrote:

• “After the head is born, if the child through the greatness of the shoulders, should stick at the neck, let the midwife put her fingers under the child’s armpit and give it a nudge, thrusting it to the other side with her finger, drawing the child or she may quickly bring forth the shoulders, without offering to put it forth by her hands clasped about the neck, which might endanger the breaking of the neck.”⁹

Manipulation of the posterior axilla can either involve a rotational maneuver (using the axilla to rotate the fetus through 180°) or it can be used to pull the posterior shoulder into the hollow of the sacrum and down the birth canal.

Schramm advocated using the posterior axilla to rotate the fetus. She recommended placing 1 or 2 fingers of the right hand in the posterior axilla and then rotating the posterior shoulder into the 12 o’clock position while simultaneously using the left hand to provide gentle guidance on the fetal neck.¹⁰

Menticoglou advocated using manipulation of the posterior axilla to draw the fetal shoulder into the sacral hollow and down the birth canal, thereby releasing the anterior shoulder. In the Menticoglou maneuver the middle fingers of the right and left hand of the obstetrician are hooked into the fetal axilla, one finger from the fetus’ front and the other from the fetus’ back. The fingers overlap each other within the fetal posterior axilla. Downward traction is then exerted on the fetal axilla and the posterior shoulder is pulled outward along the curve of the sacrum (FIGURE).¹¹

Sandmire recommended combining fundal pressure with axillary traction and rotation to facilitate delivery.¹²

The posterior axillary maneuvers are seldom described in modern textbooks of obstetrics and represent a lost art. I have found that they can be useful when the posterior arm cannot be reached. The fetal posterior axilla is almost always closer to the vaginal introitus than the fetal hand or arm, and if the posterior arm cannot be reached, it is a valuable maneuver to have in your armamentarium.

My recommendation

Shoulder dystocia emergencies are an important cause of neonatal injury, including brachial plexus injury, fractures of the humerus, and hypoxic-ischemic encephalopathy. Obstetricians and midwives relentlessly train to resolve shoulder dystocia births with alacrity and minimal fetal trauma. When you are called as an emergency responder in a shoulder dystocia birth, I recommend that you prioritize a rotational maneuver or delivery of the posterior arm, and add manipulation of the posterior axilla to your armamentarium.

CASE: Unexpectedly high fetal weight, shoulder dystocia

A nurse midwife is managing the labor of a 41-year-old, G3P2 woman who had two prior spontaneous vaginal deliveries. Results of her glucose-loading test were normal. The midwife estimates the fetal weight as 7 lb 8 oz, but the birth weight proves to be 10 lb 6 oz. After delivery of the head, a turtle sign is obvious, and a shoulder dystocia is declared.

An emergency call for help is made to the front desk. The mother is asked to stop pushing. The obstetric nurse and midwife perform a McRoberts maneuver and apply suprapubic pressure without success. The woman is placed in the Gaskin’s all-fours position, but delivery cannot be accomplished.

Roused from your call room, you quickly proceed to help the team. At 3 minutes into the shoulder dystocia, you enter the room. As the emergency responder, what sequence of maneuvers will you use to resolve the shoulder dystocia?

In response to a shoulder dystocia emergency, most of us have practiced a sequence of actions:

1. recognize shoulder dystocia early and communicate with staff
2. instruct the mother to stop pushing and move the mother’s buttocks to the edge of the birthing bed
3. ensure there is not a tight nuchal cord
4. commit to avoid using excessive force on the fetal head and neck
5. call for emergency help from other expert clinicians
6. perform the McRoberts maneuver combined with suprapubic pressure
7. consider performing an episiotomy
8. use a rotational maneuver such as the Woods screw or Rubin maneuver
9. deliver the posterior arm
10. consider rarely used “salvage maneuvers,” such as the Zavanelli maneuver with cesarean delivery.¹

When you are called to a shoulder dystocia as the emergency responder, the sequence of maneuvers is likely dependent on the actions already attempted by the primary clinician and the length of time from identification of the shoulder dystocia to the responder’s arrival at the patient’s bedside.

Based on my experience, if the primary clinician already has attempted the McRoberts maneuver, suprapubic pressure, and other advanced maneuvers without success, it is best for you to immediately move to the advanced maneuvers with which you are most comfortable. These advanced maneuvers typically include:

• consider an episiotomy and then a rotational maneuver (Woods screw or Rubin maneuver)
• attempt to deliver the posterior arm.

Woods screw and Rubin rotational maneuvers

Woods screw: Removing a well-placed screw requires a rotational maneuver. The Woods screw maneuver is based on the idea that a large baby is like a screw that must maneuver through pelvic threads. You cannot easily directly pull a well-set screw from its threads.

In Woods’ original description of the maneuver, the fetal spine was toward the mother’s right. Woods described a rotational maneuver that is performed by placing the left hand on the mother’s abdomen to provide judicious downward thrust on the fetal buttocks while simultaneously using the fingers of the right hand, placed on the ANTERIOR aspect of the shoulder, to create a clockwise rotational force on the fetus. Using the right hand, the fetal shoulder is moved through >180°, past the 12 o’clock position. At the same time, the fundal pressure and the fingers of the right hand are used to guide the fetus down the birth canal. This maneuver moves the anterior shoulder to the posterior position.

If delivery cannot be completed, a second step in the procedure is to then place the fingers of the right hand on the ANTERIOR aspect of the posterior shoulder (previously the anterior shoulder) and rotate the fetus in a counter-clockwise arc to the 12 o’clock position while gently guiding the fetus down the birth canal.²

Rubin rotational maneuver. Rubin observed that if you adduct the shoulders, the diameter of the shoulders are reduced, thereby easing the passage of the fetus through the birth canal. Adduction is the movement of a body part toward the MIDLINE sagittal plane.

Rubin recommended applying pressure to the POSTERIOR surface of the posterior (6 o’clock) fetal shoulder to help push the shoulder toward the midline of the chest (adduction). If the fetal spine is toward the mother’s left side, you place your right hand on the POSTERIOR surface of the shoulder at the 6 o’clock position, rotating the shoulder in a clockwise arc to the 12 o’clock position while simultaneously guiding the fetus down the birth canal.

Rubin also recommended the use of judicious fundal pressure after the anterior shoulder is disimpacted, if necessary, to facilitate delivery.³ Although both Woods and Rubin recommended the use of judiciously applied fundal pressure, most modern textbooks of obstetrics do not endorse the use of fundal pressure.

Delivery of the posterior arm: My preferred first maneuver

When I arrive as an emergency responder to a shoulder dystocia delivery, my preferred maneuver is to deliver the posterior arm. Many experts recommend prioritizing this maneuver when attempting to resolve a difficult shoulder dystocia.^4-7

Delivery of the posterior arm is performed by inserting the hand and forearm into the sacral hollow. The left hand and forearm are used if the fetal spine is toward the mother’s left, and vice-versa. The posterior humerus is identified and followed to the elbow. The fetal forearm is flexed and swept across the fetal chest. The wrist or hand is then grasped and the arm is extended along the fetal trunk and face, which delivers the posterior arm from the vagina. This results in a reduction in the presenting diameter and the anterior shoulder usually can be delivered with minimal force.

If the delivery of the posterior arm does not resolve the shoulder dystocia, gently support the fetal head and posterior arm, and rotate the fetus 180° using pressure on the posterior surface of the shoulder.

When a fetus is macrosomic, the posterior arm can be fully extended in utero, with the hand below the level of the fetal groin. In such situations, it can be difficult to execute the delivery of the posterior arm.⁸ A back-up technique is to manipulate the posterior axilla to accomplish delivery.

Manipulation of the posterior axilla

When the posterior arm cannot be reached, these maneuvers may be helpful

One of the earliest written descriptions of resolving a severe shoulder dystocia by manipulating the posterior axilla was provided by Percival Willughby (born 1596, died 1685). He wrote:

• “After the head is born, if the child through the greatness of the shoulders, should stick at the neck, let the midwife put her fingers under the child’s armpit and give it a nudge, thrusting it to the other side with her finger, drawing the child or she may quickly bring forth the shoulders, without offering to put it forth by her hands clasped about the neck, which might endanger the breaking of the neck.”⁹

Manipulation of the posterior axilla can either involve a rotational maneuver (using the axilla to rotate the fetus through 180°) or it can be used to pull the posterior shoulder into the hollow of the sacrum and down the birth canal.

Schramm advocated using the posterior axilla to rotate the fetus. She recommended placing 1 or 2 fingers of the right hand in the posterior axilla and then rotating the posterior shoulder into the 12 o’clock position while simultaneously using the left hand to provide gentle guidance on the fetal neck.¹⁰

Menticoglou advocated using manipulation of the posterior axilla to draw the fetal shoulder into the sacral hollow and down the birth canal, thereby releasing the anterior shoulder. In the Menticoglou maneuver the middle fingers of the right and left hand of the obstetrician are hooked into the fetal axilla, one finger from the fetus’ front and the other from the fetus’ back. The fingers overlap each other within the fetal posterior axilla. Downward traction is then exerted on the fetal axilla and the posterior shoulder is pulled outward along the curve of the sacrum (FIGURE).¹¹

Sandmire recommended combining fundal pressure with axillary traction and rotation to facilitate delivery.¹²

The posterior axillary maneuvers are seldom described in modern textbooks of obstetrics and represent a lost art. I have found that they can be useful when the posterior arm cannot be reached. The fetal posterior axilla is almost always closer to the vaginal introitus than the fetal hand or arm, and if the posterior arm cannot be reached, it is a valuable maneuver to have in your armamentarium.

My recommendation

Shoulder dystocia emergencies are an important cause of neonatal injury, including brachial plexus injury, fractures of the humerus, and hypoxic-ischemic encephalopathy. Obstetricians and midwives relentlessly train to resolve shoulder dystocia births with alacrity and minimal fetal trauma. When you are called as an emergency responder in a shoulder dystocia birth, I recommend that you prioritize a rotational maneuver or delivery of the posterior arm, and add manipulation of the posterior axilla to your armamentarium.

“MOTHER-, BABY-, AND FAMILY-CENTERED CESAREAN DELIVERY:
IT IS POSSIBLE”
WILLIAM CAMANN, MD, AND ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2013)

Fathers can participate in skin-to-skin cesarean, too

I read about skin-to-skin cesarean delivery with great interest. I’d like to make a suggestion using a term coined by a physician whose wife required a cesarean: skin to win. The physician shared his wife’s disappointment when their obstetrician decided it would be wise to forego vaginal delivery in favor of cesarean. Because skin-to-skin was not offered at the hospital, the husband volunteered his skin. Since that occasion, I offer father-to-neonate “skin to win” as a general practice.

I have found this service to be incredibly rewarding for the father, and the mother is protected from feeling overwhelmed, worrying about dropping the baby, battling nausea and vomiting, and so on.

I must admit I never conceived of this possibility before. Now I tell all of my families about the smart fellow who coined the term.

T. M. Gordon, MD
Toledo, Ohio

Patient-centered cesarean is fraught with risks

I read with interest the article on so-called family-centered cesarean delivery. While no one would argue the point that the cesarean delivery procedure ultimately culminates in a happy outcome in a majority of cases, I have some very deep concerns.

The first involves the concept of early bonding, in which the newborn infant is placed on the mother’s chest immediately after delivery while the maternal abdomen is still open. In my opinion, this practice is fraught with risks, most important among them the substantial risk of contamination of the operative field. Lest we forget, although cesarean delivery is generally a happy occasion, it is still a laparotomy during which there is a risk of hemorrhage and the possible need for an abrupt shift in the care plan. While the operation is ongoing, the entire focus of the surgeon and the anesthesiologist or certified registered nurse anesthetist should be the mother, with the infant left to the care of the neonatal staff for assessment and transition.

I disagree with Dr. Camann and Dr. Barbieri that early bonding is easily achievable. I would assert that it is difficult, if not impossible, to accomplish with the newborn juxtaposed to the field and with additional people crowding the anesthesiologist’s working area. There is also the risk of contamination I mentioned earlier, which, once it occurs, poses a significant risk of unwarranted morbidity or even death.

The notion of breastfeeding on the operating table, in the middle of a major open surgical procedure, is even more ludicrous and dangerous. I know very few anesthesiologists in today’s litigious environment who would ever entertain this type of cesarean as an option in the surgical suite. The closing of the procedure generally can be completed in a matter of a few minutes by a competent surgeon, after which there is ample time for bonding and for family time in a much safer venue.

That said, there are some aspects of the article that could be adopted without jeopardizing the safety of the surgery itself. At the end of the day, however, the notion of “feel-good, touchy-feely” can be carried to an extreme. This article is one example. As surgeons, we have a sacred duty to protect our patients from unnecessary risk. It is my opinion that parts of the practice described in this editorial would violate that duty if employed as described.

Timothy E. Hughes, MD
Mobile, Alabama

Dr. Barbieri responds

Dr. Gordon’s patient has coined an elegant tagline to describe one of the goals of family-centered cesarean practices: “skin to win.” I thank Dr. Gordon for sharing it.

Dr. Hughes raises the important concerns that family-centered cesarean practices may result in contamination of the surgical field, crowding at the head of the table, and divert the surgeon’s attention from the important task of safely completing the operation. I agree that early skin-to-skin contact and breastfeeding in the operating room may require an additional nurse to ensure the safety of the baby and mother.

In my practice, two clinical variables raise my concern about postoperative infection: a long labor with ruptured membranes and an obese mother. More data are needed, but I doubt that family-centered delivery practices will increase the risk of postoperative infection.

We want to hear from you! Tell us what you think.

“MOTHER-, BABY-, AND FAMILY-CENTERED CESAREAN DELIVERY:
IT IS POSSIBLE”
WILLIAM CAMANN, MD, AND ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2013)

Fathers can participate in skin-to-skin cesarean, too

I read about skin-to-skin cesarean delivery with great interest. I’d like to make a suggestion using a term coined by a physician whose wife required a cesarean: skin to win. The physician shared his wife’s disappointment when their obstetrician decided it would be wise to forego vaginal delivery in favor of cesarean. Because skin-to-skin was not offered at the hospital, the husband volunteered his skin. Since that occasion, I offer father-to-neonate “skin to win” as a general practice.

I have found this service to be incredibly rewarding for the father, and the mother is protected from feeling overwhelmed, worrying about dropping the baby, battling nausea and vomiting, and so on.

I must admit I never conceived of this possibility before. Now I tell all of my families about the smart fellow who coined the term.

T. M. Gordon, MD
Toledo, Ohio

Patient-centered cesarean is fraught with risks

I read with interest the article on so-called family-centered cesarean delivery. While no one would argue the point that the cesarean delivery procedure ultimately culminates in a happy outcome in a majority of cases, I have some very deep concerns.

The first involves the concept of early bonding, in which the newborn infant is placed on the mother’s chest immediately after delivery while the maternal abdomen is still open. In my opinion, this practice is fraught with risks, most important among them the substantial risk of contamination of the operative field. Lest we forget, although cesarean delivery is generally a happy occasion, it is still a laparotomy during which there is a risk of hemorrhage and the possible need for an abrupt shift in the care plan. While the operation is ongoing, the entire focus of the surgeon and the anesthesiologist or certified registered nurse anesthetist should be the mother, with the infant left to the care of the neonatal staff for assessment and transition.

I disagree with Dr. Camann and Dr. Barbieri that early bonding is easily achievable. I would assert that it is difficult, if not impossible, to accomplish with the newborn juxtaposed to the field and with additional people crowding the anesthesiologist’s working area. There is also the risk of contamination I mentioned earlier, which, once it occurs, poses a significant risk of unwarranted morbidity or even death.

The notion of breastfeeding on the operating table, in the middle of a major open surgical procedure, is even more ludicrous and dangerous. I know very few anesthesiologists in today’s litigious environment who would ever entertain this type of cesarean as an option in the surgical suite. The closing of the procedure generally can be completed in a matter of a few minutes by a competent surgeon, after which there is ample time for bonding and for family time in a much safer venue.

That said, there are some aspects of the article that could be adopted without jeopardizing the safety of the surgery itself. At the end of the day, however, the notion of “feel-good, touchy-feely” can be carried to an extreme. This article is one example. As surgeons, we have a sacred duty to protect our patients from unnecessary risk. It is my opinion that parts of the practice described in this editorial would violate that duty if employed as described.

Timothy E. Hughes, MD
Mobile, Alabama

Dr. Barbieri responds

Dr. Gordon’s patient has coined an elegant tagline to describe one of the goals of family-centered cesarean practices: “skin to win.” I thank Dr. Gordon for sharing it.

Dr. Hughes raises the important concerns that family-centered cesarean practices may result in contamination of the surgical field, crowding at the head of the table, and divert the surgeon’s attention from the important task of safely completing the operation. I agree that early skin-to-skin contact and breastfeeding in the operating room may require an additional nurse to ensure the safety of the baby and mother.

In my practice, two clinical variables raise my concern about postoperative infection: a long labor with ruptured membranes and an obese mother. More data are needed, but I doubt that family-centered delivery practices will increase the risk of postoperative infection.

We want to hear from you! Tell us what you think.

“MOTHER-, BABY-, AND FAMILY-CENTERED CESAREAN DELIVERY:
IT IS POSSIBLE”
WILLIAM CAMANN, MD, AND ROBERT L. BARBIERI, MD (EDITORIAL; MARCH 2013)

Fathers can participate in skin-to-skin cesarean, too

I read about skin-to-skin cesarean delivery with great interest. I’d like to make a suggestion using a term coined by a physician whose wife required a cesarean: skin to win. The physician shared his wife’s disappointment when their obstetrician decided it would be wise to forego vaginal delivery in favor of cesarean. Because skin-to-skin was not offered at the hospital, the husband volunteered his skin. Since that occasion, I offer father-to-neonate “skin to win” as a general practice.

I have found this service to be incredibly rewarding for the father, and the mother is protected from feeling overwhelmed, worrying about dropping the baby, battling nausea and vomiting, and so on.

I must admit I never conceived of this possibility before. Now I tell all of my families about the smart fellow who coined the term.

T. M. Gordon, MD
Toledo, Ohio

Patient-centered cesarean is fraught with risks

I read with interest the article on so-called family-centered cesarean delivery. While no one would argue the point that the cesarean delivery procedure ultimately culminates in a happy outcome in a majority of cases, I have some very deep concerns.

The first involves the concept of early bonding, in which the newborn infant is placed on the mother’s chest immediately after delivery while the maternal abdomen is still open. In my opinion, this practice is fraught with risks, most important among them the substantial risk of contamination of the operative field. Lest we forget, although cesarean delivery is generally a happy occasion, it is still a laparotomy during which there is a risk of hemorrhage and the possible need for an abrupt shift in the care plan. While the operation is ongoing, the entire focus of the surgeon and the anesthesiologist or certified registered nurse anesthetist should be the mother, with the infant left to the care of the neonatal staff for assessment and transition.

I disagree with Dr. Camann and Dr. Barbieri that early bonding is easily achievable. I would assert that it is difficult, if not impossible, to accomplish with the newborn juxtaposed to the field and with additional people crowding the anesthesiologist’s working area. There is also the risk of contamination I mentioned earlier, which, once it occurs, poses a significant risk of unwarranted morbidity or even death.

The notion of breastfeeding on the operating table, in the middle of a major open surgical procedure, is even more ludicrous and dangerous. I know very few anesthesiologists in today’s litigious environment who would ever entertain this type of cesarean as an option in the surgical suite. The closing of the procedure generally can be completed in a matter of a few minutes by a competent surgeon, after which there is ample time for bonding and for family time in a much safer venue.

That said, there are some aspects of the article that could be adopted without jeopardizing the safety of the surgery itself. At the end of the day, however, the notion of “feel-good, touchy-feely” can be carried to an extreme. This article is one example. As surgeons, we have a sacred duty to protect our patients from unnecessary risk. It is my opinion that parts of the practice described in this editorial would violate that duty if employed as described.

Timothy E. Hughes, MD
Mobile, Alabama

Dr. Barbieri responds

Dr. Gordon’s patient has coined an elegant tagline to describe one of the goals of family-centered cesarean practices: “skin to win.” I thank Dr. Gordon for sharing it.

Dr. Hughes raises the important concerns that family-centered cesarean practices may result in contamination of the surgical field, crowding at the head of the table, and divert the surgeon’s attention from the important task of safely completing the operation. I agree that early skin-to-skin contact and breastfeeding in the operating room may require an additional nurse to ensure the safety of the baby and mother.

In my practice, two clinical variables raise my concern about postoperative infection: a long labor with ruptured membranes and an obese mother. More data are needed, but I doubt that family-centered delivery practices will increase the risk of postoperative infection.

We want to hear from you! Tell us what you think.