Obstetrics

BETHESDA, MD. – The current two-step method of diagnosing gestational diabetes mellitus in U.S. pregnant women will not change, based on the recommendations of an independent, voluntary panel at a National Institutes of Health Consensus Development Conference.

The panel released their statement March 6, following the 3-day NIH Consensus Development Conference on Diagnosing Gestational Diabetes Mellitus, during which expert and public comments were incorporated into the draft consensus statement.

The conference convened to review the evidence on gestational diabetes mellitus (GDM) diagnosis methods and discuss seven questions regarding the possible adoption of a recommendation for the single-step approach to diagnosing the condition rather than the two-step method currently used most commonly in the United States.

The one-step approach was proposed by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) following a 2008 study suggesting that thousands of women are adversely affected by subclinical hyperglycemia. The independent NIH panel, however, determined that additional research is necessary before recommending the single-step method.

"At present, the panel believes that there is not sufficient evidence to adopt a one-step approach, such as that proposed by the IADPSG," the panel wrote. "The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes."

GDM currently affects approximately 5%-6% of all U.S. pregnancies, including more than 240,000 pregnant women, according to the NIH. This prevalence, however, is based on the use of the current two-step test, and widespread implementation of the single-step test under consideration would likely increase the number of women diagnosed with GDM by two to three times.

A variety of methods exist for screening women for GDM, depending on whether fasting is required, how many grams of glucose the woman consumes for the test, how many appointments the screening requires, and what glucose threshold is used for diagnosis.

The most commonly used method in the United States, recommended by the American College of Obstetricians and Gynecologists, is a two-step method conducted when women are 24-28 weeks pregnant. Women’s blood glucose levels are initially tested 1 hour after consumption of a 50-g glucose drink. If the test indicates a blood glucose level of 130 mg/dL or greater on that test, she undergoes a 3-hour 100-g glucose tolerance test. GDM is diagnosed if a woman’s blood glucose levels reach at least two of the following thresholds: 95 mg/dL after fasting, 180 mg/dL at 1 hour, 155 mg/dL at 2 hours, or 140 mg/dL at 3 hours.

The single-step method involves a fasting plasma glucose and a 75-g 2-hour test between 24 and 28 weeks of pregnancy. A result of at least 92 mg/dL at fasting, 180 mg/dL at 1 hour, or 153 mg/dL at 2 hours would be the threshold for diagnosis of GDM.

The single-step approach is supported by the American Diabetes Association and the World Health Organization (with 110 mg/dL at fasting and 140 mg/dL at 2 hours) and is used in a number of other countries.

However, several doctors have raised concerns that moving to the single-step approach could lead to more interventions for a much larger number of pregnant women who would now be diagnosed, increasing possible harms and costs.

Dr. Peter VanDorsten, the conference panel chairperson and Lawrence L. Hester, Jr. Professor at the Medical University of South Carolina, Charleston, said the research indicates that using the single-step method would increase the number of women diagnosed with GDM to 15%-20% of all pregnancies.

On the plus side, more diagnoses would result in more treatment for these women, which could include nutritional and lifestyle counseling, more clinic visits, and possible insulin therapy. Possible complications associated with GDM include preeclampsia, cesarean delivery, macrosomia, shoulder dystocia, and birth injuries to the mother. Women diagnosed with GDM are also 35%-60% more likely to develop type 2 diabetes later. Babies born to women with GDM are also at a higher risk for hypoglycemia, jaundice, and having difficulty breathing at birth.

On the other hand, more diagnoses would result in higher health care costs and more interventions for women, which could lead to possible harms.

"There is also evidence in some studies that the labeling of these women may have unintended consequences, such as an increase in cesarean delivery and more intensive newborn assessments," the panel wrote in their statement. "In addition, increased patient costs, life disruptions, and psychosocial burdens have been identified. Currently available studies do not provide clear evidence that a one-step approach is cost-effective in comparison with the current two-step approach."

During a teleconference about the panel’s statement, Dr. VanDorsten said it operationally makes sense to get in line with what others are doing in using the 75-g one-time glucose challenge, the same test used in the nonpregnant population – but not yet.

"Until we have evidence that the benefits of extending the possible diagnosis outweigh the harms," he said, the panel did not find it is appropriate to recommend the single-step approach currently.

"We left the door ajar for reconsideration should these data be forthcoming," Dr. VanDorsten added. He noted that funding agencies will often follow with money for research after the NIH has identified research that is needed.

The panel agreed that "a single standard for screening and diagnostic thresholds for GDM should be established by professional organizations" but identified nine major research gaps that must be addressed in determining what this standard should be. These areas include the following:

• Defining the best strategy in developing a diagnostic approach that aligns more closely with international approaches in the most cost-effective manner possible.

• Determining whether women who would be diagnosed with GDM in the single-step – but not two-step – approach would gain benefit from the diagnosis and treatment.

• Understanding the cost-benefit implications of changing the diagnostic standard.

• Understanding the psychological consequences of a GDM diagnosis on women.

• Conducting cohort studies to show the "real-world" impact that GDM treatment has on practices and care utilization.

• Determining what lifestyle interventions might improve outcomes for pregnant women and their children.

• Assessing long-term impacts of changing the GDM diagnostic criteria.

• Understanding the "long-term metabolic, cardiovascular, developmental, and epigenetic impact on offspring whose mothers have been treated for GDM."

• Assessing what interventions might decrease GDM-diagnosed women’s risk of metabolic syndrome, diabetes, and cardiovascular disease.

Dr. VanDorsten did not define a specific timeline regarding when the NIH would revisit this issue, but he noted that as more evidence becomes available from cohort studies and randomized trials reassessing diagnostic screening methods, a recommendation of the single-step method is possible in the future.

The 15 members of the panel include experts from maternal-fetal medicine, obstetrics and gynecology, endocrinology and infertility, pediatrics, nutrition, epidemiology, economics, and statistics. The panel is an independent group whose members’ travel expenses are paid for by the NIH but who do not receive other compensation for serving on the panel.

BETHESDA, MD. – The current two-step method of diagnosing gestational diabetes mellitus in U.S. pregnant women will not change, based on the recommendations of an independent, voluntary panel at a National Institutes of Health Consensus Development Conference.

The panel released their statement March 6, following the 3-day NIH Consensus Development Conference on Diagnosing Gestational Diabetes Mellitus, during which expert and public comments were incorporated into the draft consensus statement.

The conference convened to review the evidence on gestational diabetes mellitus (GDM) diagnosis methods and discuss seven questions regarding the possible adoption of a recommendation for the single-step approach to diagnosing the condition rather than the two-step method currently used most commonly in the United States.

The one-step approach was proposed by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) following a 2008 study suggesting that thousands of women are adversely affected by subclinical hyperglycemia. The independent NIH panel, however, determined that additional research is necessary before recommending the single-step method.

"At present, the panel believes that there is not sufficient evidence to adopt a one-step approach, such as that proposed by the IADPSG," the panel wrote. "The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes."

GDM currently affects approximately 5%-6% of all U.S. pregnancies, including more than 240,000 pregnant women, according to the NIH. This prevalence, however, is based on the use of the current two-step test, and widespread implementation of the single-step test under consideration would likely increase the number of women diagnosed with GDM by two to three times.

A variety of methods exist for screening women for GDM, depending on whether fasting is required, how many grams of glucose the woman consumes for the test, how many appointments the screening requires, and what glucose threshold is used for diagnosis.

The most commonly used method in the United States, recommended by the American College of Obstetricians and Gynecologists, is a two-step method conducted when women are 24-28 weeks pregnant. Women’s blood glucose levels are initially tested 1 hour after consumption of a 50-g glucose drink. If the test indicates a blood glucose level of 130 mg/dL or greater on that test, she undergoes a 3-hour 100-g glucose tolerance test. GDM is diagnosed if a woman’s blood glucose levels reach at least two of the following thresholds: 95 mg/dL after fasting, 180 mg/dL at 1 hour, 155 mg/dL at 2 hours, or 140 mg/dL at 3 hours.

The single-step method involves a fasting plasma glucose and a 75-g 2-hour test between 24 and 28 weeks of pregnancy. A result of at least 92 mg/dL at fasting, 180 mg/dL at 1 hour, or 153 mg/dL at 2 hours would be the threshold for diagnosis of GDM.

The single-step approach is supported by the American Diabetes Association and the World Health Organization (with 110 mg/dL at fasting and 140 mg/dL at 2 hours) and is used in a number of other countries.

However, several doctors have raised concerns that moving to the single-step approach could lead to more interventions for a much larger number of pregnant women who would now be diagnosed, increasing possible harms and costs.

Dr. Peter VanDorsten, the conference panel chairperson and Lawrence L. Hester, Jr. Professor at the Medical University of South Carolina, Charleston, said the research indicates that using the single-step method would increase the number of women diagnosed with GDM to 15%-20% of all pregnancies.

On the plus side, more diagnoses would result in more treatment for these women, which could include nutritional and lifestyle counseling, more clinic visits, and possible insulin therapy. Possible complications associated with GDM include preeclampsia, cesarean delivery, macrosomia, shoulder dystocia, and birth injuries to the mother. Women diagnosed with GDM are also 35%-60% more likely to develop type 2 diabetes later. Babies born to women with GDM are also at a higher risk for hypoglycemia, jaundice, and having difficulty breathing at birth.

On the other hand, more diagnoses would result in higher health care costs and more interventions for women, which could lead to possible harms.

"There is also evidence in some studies that the labeling of these women may have unintended consequences, such as an increase in cesarean delivery and more intensive newborn assessments," the panel wrote in their statement. "In addition, increased patient costs, life disruptions, and psychosocial burdens have been identified. Currently available studies do not provide clear evidence that a one-step approach is cost-effective in comparison with the current two-step approach."

During a teleconference about the panel’s statement, Dr. VanDorsten said it operationally makes sense to get in line with what others are doing in using the 75-g one-time glucose challenge, the same test used in the nonpregnant population – but not yet.

"Until we have evidence that the benefits of extending the possible diagnosis outweigh the harms," he said, the panel did not find it is appropriate to recommend the single-step approach currently.

"We left the door ajar for reconsideration should these data be forthcoming," Dr. VanDorsten added. He noted that funding agencies will often follow with money for research after the NIH has identified research that is needed.

The panel agreed that "a single standard for screening and diagnostic thresholds for GDM should be established by professional organizations" but identified nine major research gaps that must be addressed in determining what this standard should be. These areas include the following:

• Defining the best strategy in developing a diagnostic approach that aligns more closely with international approaches in the most cost-effective manner possible.

• Determining whether women who would be diagnosed with GDM in the single-step – but not two-step – approach would gain benefit from the diagnosis and treatment.

• Understanding the cost-benefit implications of changing the diagnostic standard.

• Understanding the psychological consequences of a GDM diagnosis on women.

• Conducting cohort studies to show the "real-world" impact that GDM treatment has on practices and care utilization.

• Determining what lifestyle interventions might improve outcomes for pregnant women and their children.

• Assessing long-term impacts of changing the GDM diagnostic criteria.

• Understanding the "long-term metabolic, cardiovascular, developmental, and epigenetic impact on offspring whose mothers have been treated for GDM."

• Assessing what interventions might decrease GDM-diagnosed women’s risk of metabolic syndrome, diabetes, and cardiovascular disease.

Dr. VanDorsten did not define a specific timeline regarding when the NIH would revisit this issue, but he noted that as more evidence becomes available from cohort studies and randomized trials reassessing diagnostic screening methods, a recommendation of the single-step method is possible in the future.

The 15 members of the panel include experts from maternal-fetal medicine, obstetrics and gynecology, endocrinology and infertility, pediatrics, nutrition, epidemiology, economics, and statistics. The panel is an independent group whose members’ travel expenses are paid for by the NIH but who do not receive other compensation for serving on the panel.

BETHESDA, MD. – The current two-step method of diagnosing gestational diabetes mellitus in U.S. pregnant women will not change, based on the recommendations of an independent, voluntary panel at a National Institutes of Health Consensus Development Conference.

The panel released their statement March 6, following the 3-day NIH Consensus Development Conference on Diagnosing Gestational Diabetes Mellitus, during which expert and public comments were incorporated into the draft consensus statement.

The conference convened to review the evidence on gestational diabetes mellitus (GDM) diagnosis methods and discuss seven questions regarding the possible adoption of a recommendation for the single-step approach to diagnosing the condition rather than the two-step method currently used most commonly in the United States.

The one-step approach was proposed by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) following a 2008 study suggesting that thousands of women are adversely affected by subclinical hyperglycemia. The independent NIH panel, however, determined that additional research is necessary before recommending the single-step method.

"At present, the panel believes that there is not sufficient evidence to adopt a one-step approach, such as that proposed by the IADPSG," the panel wrote. "The panel is particularly concerned about the adoption of new criteria that would increase the prevalence of GDM, and the corresponding costs and interventions, without clear demonstration of improvements in the most clinically important health and patient-centered outcomes."

GDM currently affects approximately 5%-6% of all U.S. pregnancies, including more than 240,000 pregnant women, according to the NIH. This prevalence, however, is based on the use of the current two-step test, and widespread implementation of the single-step test under consideration would likely increase the number of women diagnosed with GDM by two to three times.

A variety of methods exist for screening women for GDM, depending on whether fasting is required, how many grams of glucose the woman consumes for the test, how many appointments the screening requires, and what glucose threshold is used for diagnosis.

The most commonly used method in the United States, recommended by the American College of Obstetricians and Gynecologists, is a two-step method conducted when women are 24-28 weeks pregnant. Women’s blood glucose levels are initially tested 1 hour after consumption of a 50-g glucose drink. If the test indicates a blood glucose level of 130 mg/dL or greater on that test, she undergoes a 3-hour 100-g glucose tolerance test. GDM is diagnosed if a woman’s blood glucose levels reach at least two of the following thresholds: 95 mg/dL after fasting, 180 mg/dL at 1 hour, 155 mg/dL at 2 hours, or 140 mg/dL at 3 hours.

The single-step method involves a fasting plasma glucose and a 75-g 2-hour test between 24 and 28 weeks of pregnancy. A result of at least 92 mg/dL at fasting, 180 mg/dL at 1 hour, or 153 mg/dL at 2 hours would be the threshold for diagnosis of GDM.

The single-step approach is supported by the American Diabetes Association and the World Health Organization (with 110 mg/dL at fasting and 140 mg/dL at 2 hours) and is used in a number of other countries.

However, several doctors have raised concerns that moving to the single-step approach could lead to more interventions for a much larger number of pregnant women who would now be diagnosed, increasing possible harms and costs.

Dr. Peter VanDorsten, the conference panel chairperson and Lawrence L. Hester, Jr. Professor at the Medical University of South Carolina, Charleston, said the research indicates that using the single-step method would increase the number of women diagnosed with GDM to 15%-20% of all pregnancies.

On the plus side, more diagnoses would result in more treatment for these women, which could include nutritional and lifestyle counseling, more clinic visits, and possible insulin therapy. Possible complications associated with GDM include preeclampsia, cesarean delivery, macrosomia, shoulder dystocia, and birth injuries to the mother. Women diagnosed with GDM are also 35%-60% more likely to develop type 2 diabetes later. Babies born to women with GDM are also at a higher risk for hypoglycemia, jaundice, and having difficulty breathing at birth.

On the other hand, more diagnoses would result in higher health care costs and more interventions for women, which could lead to possible harms.

"There is also evidence in some studies that the labeling of these women may have unintended consequences, such as an increase in cesarean delivery and more intensive newborn assessments," the panel wrote in their statement. "In addition, increased patient costs, life disruptions, and psychosocial burdens have been identified. Currently available studies do not provide clear evidence that a one-step approach is cost-effective in comparison with the current two-step approach."

During a teleconference about the panel’s statement, Dr. VanDorsten said it operationally makes sense to get in line with what others are doing in using the 75-g one-time glucose challenge, the same test used in the nonpregnant population – but not yet.

"Until we have evidence that the benefits of extending the possible diagnosis outweigh the harms," he said, the panel did not find it is appropriate to recommend the single-step approach currently.

"We left the door ajar for reconsideration should these data be forthcoming," Dr. VanDorsten added. He noted that funding agencies will often follow with money for research after the NIH has identified research that is needed.

The panel agreed that "a single standard for screening and diagnostic thresholds for GDM should be established by professional organizations" but identified nine major research gaps that must be addressed in determining what this standard should be. These areas include the following:

• Defining the best strategy in developing a diagnostic approach that aligns more closely with international approaches in the most cost-effective manner possible.

• Determining whether women who would be diagnosed with GDM in the single-step – but not two-step – approach would gain benefit from the diagnosis and treatment.

• Understanding the cost-benefit implications of changing the diagnostic standard.

• Understanding the psychological consequences of a GDM diagnosis on women.

• Conducting cohort studies to show the "real-world" impact that GDM treatment has on practices and care utilization.

• Determining what lifestyle interventions might improve outcomes for pregnant women and their children.

• Assessing long-term impacts of changing the GDM diagnostic criteria.

• Understanding the "long-term metabolic, cardiovascular, developmental, and epigenetic impact on offspring whose mothers have been treated for GDM."

• Assessing what interventions might decrease GDM-diagnosed women’s risk of metabolic syndrome, diabetes, and cardiovascular disease.

Dr. VanDorsten did not define a specific timeline regarding when the NIH would revisit this issue, but he noted that as more evidence becomes available from cohort studies and randomized trials reassessing diagnostic screening methods, a recommendation of the single-step method is possible in the future.

The 15 members of the panel include experts from maternal-fetal medicine, obstetrics and gynecology, endocrinology and infertility, pediatrics, nutrition, epidemiology, economics, and statistics. The panel is an independent group whose members’ travel expenses are paid for by the NIH but who do not receive other compensation for serving on the panel.

Restricting physical activity does not reduce the odds of preterm birth in asymptomatic nulliparous women with a singleton pregnancy who have a short cervix, and doing so may even be harmful, a study has shown.

More than a third of the 646 women with a short cervix who were studied were placed on some kind of activity restriction, despite the general lack of evidence and guideline endorsement for the practice in this context, Dr. William Grobman reported at the annual meeting of the Society for Maternal-Fetal Medicine.

Compared with their counterparts who were not placed on any kind of activity restriction, women who rested had a more than doubling of the odds of giving birth before 37 weeks after other factors, including cervical length, were considered.

"To me, the key important point is that there is no evidence of benefit, [and there are] multiple potential paths of harm," said Dr. Grobman, who is a maternal-fetal medicine specialist at Northwestern Memorial Hospital in Chicago.

"Even if there is not harm for preterm birth, there probably is harm in other regards – in terms of deconditioning, in terms of bone loss," he said. Placing such women on activity restriction, sometimes in the hospital, also has major implications for resource use and lost productivity.

The findings are consistent with earlier research, he added. "There’s no good evidence from any study that [activity restriction] makes a difference. ... Personally, [at my institution], we never did put women on activity restriction," given the lack of compelling evidence of benefit. That’s just been the cultural practice in obstetrics, he said.

The new data should temper current screening trends, according to Dr. Grobman. "There has been increasing emphasis on the value of screening asymptomatic women and how that might be beneficial," he explained. "But oftentimes, what is not accounted for in that are the unintended consequences that you bring." The study is not arguing against screening, "but it suggests that if we screen, we have to be very cognizant of that."

In the larger context, about three-fourths of such women with a short cervix will not be delivered preterm, and those who do often give birth many weeks after the condition is first detected, according to Dr. Grobman.

In addition, especially when women are receiving prenatal care, there is usually sufficient opportunity to detect early labor and intervene. "I can remember in 20 years, one woman coming in at 24 weeks in preterm labor and us not having the opportunity to give her steroids or whatever," he commented.

The women studied were participants in the SCAN trial of progesterone for preventing preterm birth in nulliparous women with a short cervix. Those with prolapsing membranes were excluded.

All had a cervix measuring less than 30 mm on second-trimester transvaginal ultrasound, with an interquartile range of about 19-28 mm, Dr. Grobman reported on behalf of investigators with the maternal-fetal medicine unit (MFMU) network of the National Institute of Child Health and Human Development.

Study results, presented in a poster session, showed that 39% of the women were put on some type of activity restriction, meaning pelvic rest (prohibition of sexual activity), reduction of work activity, and/or reduction of nonwork activity. The majority were put on all three types and usually at home, on an outpatient basis.

After adjustment for potential confounders, relative to their peers who were not put on activity restriction, women who were had significantly higher odds of being delivered before 37 weeks (odds ratio, 2.4) and before 34 weeks (OR, 2.8).

The numbers were generally too small to look at associations for individual types of activity restriction, as most women were prescribed all three types, according to Dr. Grobman.

"I think the message is when people get plunked on bed rest, they get shut down," he commented. But analyses among the subset placed solely on work restrictions yielded the same results.

In closing, Dr. Grobman cautioned that the results apply only to the population studied. "I’m not talking about bed rest for anyone, ever, for anything. These are asymptomatic women in a study [who were] found to have a short cervix," he said.

Dr. Grobman disclosed no relevant financial conflicts.

Restricting physical activity does not reduce the odds of preterm birth in asymptomatic nulliparous women with a singleton pregnancy who have a short cervix, and doing so may even be harmful, a study has shown.

More than a third of the 646 women with a short cervix who were studied were placed on some kind of activity restriction, despite the general lack of evidence and guideline endorsement for the practice in this context, Dr. William Grobman reported at the annual meeting of the Society for Maternal-Fetal Medicine.

Compared with their counterparts who were not placed on any kind of activity restriction, women who rested had a more than doubling of the odds of giving birth before 37 weeks after other factors, including cervical length, were considered.

"To me, the key important point is that there is no evidence of benefit, [and there are] multiple potential paths of harm," said Dr. Grobman, who is a maternal-fetal medicine specialist at Northwestern Memorial Hospital in Chicago.

"Even if there is not harm for preterm birth, there probably is harm in other regards – in terms of deconditioning, in terms of bone loss," he said. Placing such women on activity restriction, sometimes in the hospital, also has major implications for resource use and lost productivity.

The findings are consistent with earlier research, he added. "There’s no good evidence from any study that [activity restriction] makes a difference. ... Personally, [at my institution], we never did put women on activity restriction," given the lack of compelling evidence of benefit. That’s just been the cultural practice in obstetrics, he said.

The new data should temper current screening trends, according to Dr. Grobman. "There has been increasing emphasis on the value of screening asymptomatic women and how that might be beneficial," he explained. "But oftentimes, what is not accounted for in that are the unintended consequences that you bring." The study is not arguing against screening, "but it suggests that if we screen, we have to be very cognizant of that."

In the larger context, about three-fourths of such women with a short cervix will not be delivered preterm, and those who do often give birth many weeks after the condition is first detected, according to Dr. Grobman.

In addition, especially when women are receiving prenatal care, there is usually sufficient opportunity to detect early labor and intervene. "I can remember in 20 years, one woman coming in at 24 weeks in preterm labor and us not having the opportunity to give her steroids or whatever," he commented.

The women studied were participants in the SCAN trial of progesterone for preventing preterm birth in nulliparous women with a short cervix. Those with prolapsing membranes were excluded.

All had a cervix measuring less than 30 mm on second-trimester transvaginal ultrasound, with an interquartile range of about 19-28 mm, Dr. Grobman reported on behalf of investigators with the maternal-fetal medicine unit (MFMU) network of the National Institute of Child Health and Human Development.

Study results, presented in a poster session, showed that 39% of the women were put on some type of activity restriction, meaning pelvic rest (prohibition of sexual activity), reduction of work activity, and/or reduction of nonwork activity. The majority were put on all three types and usually at home, on an outpatient basis.

After adjustment for potential confounders, relative to their peers who were not put on activity restriction, women who were had significantly higher odds of being delivered before 37 weeks (odds ratio, 2.4) and before 34 weeks (OR, 2.8).

The numbers were generally too small to look at associations for individual types of activity restriction, as most women were prescribed all three types, according to Dr. Grobman.

"I think the message is when people get plunked on bed rest, they get shut down," he commented. But analyses among the subset placed solely on work restrictions yielded the same results.

In closing, Dr. Grobman cautioned that the results apply only to the population studied. "I’m not talking about bed rest for anyone, ever, for anything. These are asymptomatic women in a study [who were] found to have a short cervix," he said.

Dr. Grobman disclosed no relevant financial conflicts.

Restricting physical activity does not reduce the odds of preterm birth in asymptomatic nulliparous women with a singleton pregnancy who have a short cervix, and doing so may even be harmful, a study has shown.

More than a third of the 646 women with a short cervix who were studied were placed on some kind of activity restriction, despite the general lack of evidence and guideline endorsement for the practice in this context, Dr. William Grobman reported at the annual meeting of the Society for Maternal-Fetal Medicine.

Compared with their counterparts who were not placed on any kind of activity restriction, women who rested had a more than doubling of the odds of giving birth before 37 weeks after other factors, including cervical length, were considered.

"To me, the key important point is that there is no evidence of benefit, [and there are] multiple potential paths of harm," said Dr. Grobman, who is a maternal-fetal medicine specialist at Northwestern Memorial Hospital in Chicago.

"Even if there is not harm for preterm birth, there probably is harm in other regards – in terms of deconditioning, in terms of bone loss," he said. Placing such women on activity restriction, sometimes in the hospital, also has major implications for resource use and lost productivity.

The findings are consistent with earlier research, he added. "There’s no good evidence from any study that [activity restriction] makes a difference. ... Personally, [at my institution], we never did put women on activity restriction," given the lack of compelling evidence of benefit. That’s just been the cultural practice in obstetrics, he said.

The new data should temper current screening trends, according to Dr. Grobman. "There has been increasing emphasis on the value of screening asymptomatic women and how that might be beneficial," he explained. "But oftentimes, what is not accounted for in that are the unintended consequences that you bring." The study is not arguing against screening, "but it suggests that if we screen, we have to be very cognizant of that."

In the larger context, about three-fourths of such women with a short cervix will not be delivered preterm, and those who do often give birth many weeks after the condition is first detected, according to Dr. Grobman.

In addition, especially when women are receiving prenatal care, there is usually sufficient opportunity to detect early labor and intervene. "I can remember in 20 years, one woman coming in at 24 weeks in preterm labor and us not having the opportunity to give her steroids or whatever," he commented.

The women studied were participants in the SCAN trial of progesterone for preventing preterm birth in nulliparous women with a short cervix. Those with prolapsing membranes were excluded.

All had a cervix measuring less than 30 mm on second-trimester transvaginal ultrasound, with an interquartile range of about 19-28 mm, Dr. Grobman reported on behalf of investigators with the maternal-fetal medicine unit (MFMU) network of the National Institute of Child Health and Human Development.

Study results, presented in a poster session, showed that 39% of the women were put on some type of activity restriction, meaning pelvic rest (prohibition of sexual activity), reduction of work activity, and/or reduction of nonwork activity. The majority were put on all three types and usually at home, on an outpatient basis.

After adjustment for potential confounders, relative to their peers who were not put on activity restriction, women who were had significantly higher odds of being delivered before 37 weeks (odds ratio, 2.4) and before 34 weeks (OR, 2.8).

The numbers were generally too small to look at associations for individual types of activity restriction, as most women were prescribed all three types, according to Dr. Grobman.

"I think the message is when people get plunked on bed rest, they get shut down," he commented. But analyses among the subset placed solely on work restrictions yielded the same results.

In closing, Dr. Grobman cautioned that the results apply only to the population studied. "I’m not talking about bed rest for anyone, ever, for anything. These are asymptomatic women in a study [who were] found to have a short cervix," he said.

Dr. Grobman disclosed no relevant financial conflicts.

SAN FRANCISCO – Intra-amniotic debris is a strong independent risk factor for early preterm birth in asymptomatic nulliparous women who have a short cervix, finds a study presented at the Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine.

In the secondary analysis of 657 women participating in a randomized prevention trial, those who had intra-amniotic debris (sometimes called sludge) on ultrasound were about twice as likely to deliver before 35 weeks’ gestation and before 34 weeks, and three times as likely to deliver before 32 weeks.

The women with intra-amniotic debris also had higher odds of giving birth to an infant with perinatal problems, such as a low Apgar score or need for neonatal intensive care admission. But this association vanished after adjustment for gestational age.

"Intra-amniotic debris increases the risk of early preterm birth independently of the cervical length," lead investigator Dr. George R. Saade, professor of obstetrics and gynecology at the University of Texas Medical Branch, Galveston, commented. "Presence of debris is associated with worse perinatal outcome through its effect on preterm birth."

One attendee said, "I’m curious as to whether you have data on infectious complications among women with debris compared to those without, such as chorioamnionitis."

Those analyses are still ongoing, and the mechanism behind the association of debris with preterm birth remains unclear, according to Dr. Saade, who was presenting the study’s results on behalf of investigators with the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

"The rate of severe growth restriction, which we should consider as indicated preterm birth, was actually lower in the group with debris. So it must be something else with the debris that’s causing these preterm births," he added.

The women studied were participants in the SCAN trial of progesterone to prevent preterm birth in nulliparous women with a short cervix. All were between 16 and 22 weeks of a singleton gestation and had a cervical length of less than 30 mm on transvaginal ultrasound but no other risk factors for preterm birth.

During the ultrasound to measure cervical length, the sonographer also assessed the presence of cervical funneling and intra-amniotic debris.

All sonographers were trained according to published methods (N. Engl. J. Med. 1996;334:567-72) and certified by central image review before the study, Dr. Saade said, noting that other studies have been limited by a lack of standardized training.

Main trials results, previously reported, showed no significant benefit of progesterone in reducing preterm birth (Am. J. Obstet. Gynecol. 2012;207:390.e1-8).

In the secondary analysis, ultrasound revealed that 24% of the women had cervical funneling, 12% had intra-amniotic debris, and 7% had both.

Relative to other women, women who had funneling and/or debris were older and more likely to be of minority race/ethnicity, and had a higher prepregnancy body mass index. They also were more likely to have had a prior pregnancy loss before 20 weeks’ gestation, an older gestational age at trial screening, and a shorter cervical length.

Cervical funneling and intra-amniotic debris were each significantly associated with a higher rate of preterm birth at multiple gestational cutoffs in an unadjusted analysis and in an adjusted analysis that took into account progesterone treatment.

After further adjustment for cervical length, cervical funneling no longer predicted preterm birth at any cutoff. But intra-amniotic debris still predicted preterm birth before 35 weeks (odds ratio, 1.90), before 34 weeks (2.04), and before 32 weeks (3.10).

In absolute terms, 27% of women having intra-amniotic debris on ultrasound delivered before 32 weeks’ gestation, compared with just 7% of their counterparts without debris, according to Dr. Saade.

Intra-amniotic debris also was associated with a composite of eight adverse perinatal outcomes in the infant in an analysis adjusted for progesterone treatment. But the association was no longer significant after additional adjustment for cervical length and gestational age.

Dr. Saade disclosed no relevant financial conflicts of interest.

[email protected]

SAN FRANCISCO – Intra-amniotic debris is a strong independent risk factor for early preterm birth in asymptomatic nulliparous women who have a short cervix, finds a study presented at the Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine.

In the secondary analysis of 657 women participating in a randomized prevention trial, those who had intra-amniotic debris (sometimes called sludge) on ultrasound were about twice as likely to deliver before 35 weeks’ gestation and before 34 weeks, and three times as likely to deliver before 32 weeks.

The women with intra-amniotic debris also had higher odds of giving birth to an infant with perinatal problems, such as a low Apgar score or need for neonatal intensive care admission. But this association vanished after adjustment for gestational age.

"Intra-amniotic debris increases the risk of early preterm birth independently of the cervical length," lead investigator Dr. George R. Saade, professor of obstetrics and gynecology at the University of Texas Medical Branch, Galveston, commented. "Presence of debris is associated with worse perinatal outcome through its effect on preterm birth."

One attendee said, "I’m curious as to whether you have data on infectious complications among women with debris compared to those without, such as chorioamnionitis."

Those analyses are still ongoing, and the mechanism behind the association of debris with preterm birth remains unclear, according to Dr. Saade, who was presenting the study’s results on behalf of investigators with the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

"The rate of severe growth restriction, which we should consider as indicated preterm birth, was actually lower in the group with debris. So it must be something else with the debris that’s causing these preterm births," he added.

The women studied were participants in the SCAN trial of progesterone to prevent preterm birth in nulliparous women with a short cervix. All were between 16 and 22 weeks of a singleton gestation and had a cervical length of less than 30 mm on transvaginal ultrasound but no other risk factors for preterm birth.

During the ultrasound to measure cervical length, the sonographer also assessed the presence of cervical funneling and intra-amniotic debris.

All sonographers were trained according to published methods (N. Engl. J. Med. 1996;334:567-72) and certified by central image review before the study, Dr. Saade said, noting that other studies have been limited by a lack of standardized training.

Main trials results, previously reported, showed no significant benefit of progesterone in reducing preterm birth (Am. J. Obstet. Gynecol. 2012;207:390.e1-8).

In the secondary analysis, ultrasound revealed that 24% of the women had cervical funneling, 12% had intra-amniotic debris, and 7% had both.

Relative to other women, women who had funneling and/or debris were older and more likely to be of minority race/ethnicity, and had a higher prepregnancy body mass index. They also were more likely to have had a prior pregnancy loss before 20 weeks’ gestation, an older gestational age at trial screening, and a shorter cervical length.

Cervical funneling and intra-amniotic debris were each significantly associated with a higher rate of preterm birth at multiple gestational cutoffs in an unadjusted analysis and in an adjusted analysis that took into account progesterone treatment.

After further adjustment for cervical length, cervical funneling no longer predicted preterm birth at any cutoff. But intra-amniotic debris still predicted preterm birth before 35 weeks (odds ratio, 1.90), before 34 weeks (2.04), and before 32 weeks (3.10).

In absolute terms, 27% of women having intra-amniotic debris on ultrasound delivered before 32 weeks’ gestation, compared with just 7% of their counterparts without debris, according to Dr. Saade.

Intra-amniotic debris also was associated with a composite of eight adverse perinatal outcomes in the infant in an analysis adjusted for progesterone treatment. But the association was no longer significant after additional adjustment for cervical length and gestational age.

Dr. Saade disclosed no relevant financial conflicts of interest.

[email protected]

SAN FRANCISCO – Intra-amniotic debris is a strong independent risk factor for early preterm birth in asymptomatic nulliparous women who have a short cervix, finds a study presented at the Pregnancy Meeting, the annual meeting of the Society for Maternal-Fetal Medicine.

In the secondary analysis of 657 women participating in a randomized prevention trial, those who had intra-amniotic debris (sometimes called sludge) on ultrasound were about twice as likely to deliver before 35 weeks’ gestation and before 34 weeks, and three times as likely to deliver before 32 weeks.

The women with intra-amniotic debris also had higher odds of giving birth to an infant with perinatal problems, such as a low Apgar score or need for neonatal intensive care admission. But this association vanished after adjustment for gestational age.

"Intra-amniotic debris increases the risk of early preterm birth independently of the cervical length," lead investigator Dr. George R. Saade, professor of obstetrics and gynecology at the University of Texas Medical Branch, Galveston, commented. "Presence of debris is associated with worse perinatal outcome through its effect on preterm birth."

One attendee said, "I’m curious as to whether you have data on infectious complications among women with debris compared to those without, such as chorioamnionitis."

Those analyses are still ongoing, and the mechanism behind the association of debris with preterm birth remains unclear, according to Dr. Saade, who was presenting the study’s results on behalf of investigators with the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

"The rate of severe growth restriction, which we should consider as indicated preterm birth, was actually lower in the group with debris. So it must be something else with the debris that’s causing these preterm births," he added.

The women studied were participants in the SCAN trial of progesterone to prevent preterm birth in nulliparous women with a short cervix. All were between 16 and 22 weeks of a singleton gestation and had a cervical length of less than 30 mm on transvaginal ultrasound but no other risk factors for preterm birth.

During the ultrasound to measure cervical length, the sonographer also assessed the presence of cervical funneling and intra-amniotic debris.

All sonographers were trained according to published methods (N. Engl. J. Med. 1996;334:567-72) and certified by central image review before the study, Dr. Saade said, noting that other studies have been limited by a lack of standardized training.

Main trials results, previously reported, showed no significant benefit of progesterone in reducing preterm birth (Am. J. Obstet. Gynecol. 2012;207:390.e1-8).

In the secondary analysis, ultrasound revealed that 24% of the women had cervical funneling, 12% had intra-amniotic debris, and 7% had both.

Relative to other women, women who had funneling and/or debris were older and more likely to be of minority race/ethnicity, and had a higher prepregnancy body mass index. They also were more likely to have had a prior pregnancy loss before 20 weeks’ gestation, an older gestational age at trial screening, and a shorter cervical length.

Cervical funneling and intra-amniotic debris were each significantly associated with a higher rate of preterm birth at multiple gestational cutoffs in an unadjusted analysis and in an adjusted analysis that took into account progesterone treatment.

After further adjustment for cervical length, cervical funneling no longer predicted preterm birth at any cutoff. But intra-amniotic debris still predicted preterm birth before 35 weeks (odds ratio, 1.90), before 34 weeks (2.04), and before 32 weeks (3.10).

In absolute terms, 27% of women having intra-amniotic debris on ultrasound delivered before 32 weeks’ gestation, compared with just 7% of their counterparts without debris, according to Dr. Saade.

Intra-amniotic debris also was associated with a composite of eight adverse perinatal outcomes in the infant in an analysis adjusted for progesterone treatment. But the association was no longer significant after additional adjustment for cervical length and gestational age.

Dr. Saade disclosed no relevant financial conflicts of interest.

[email protected]

The risks of pregnancy loss and of preterm birth were higher in women who had vasculitis before they conceived than in women who were diagnosed as having vasculitis after conception in a retrospective cohort study.

Women who conceived before receiving a diagnosis of vasculitis had a rate of pregnancy loss similar to the general population, whereas women who conceived after they had received a diagnosis of vasculitis had a significantly higher rate of pregnancy loss, reported Dr. Megan E. B. Clowse of the division of rheumatology and immunology at Duke University, Durham, N.C., and her associates in the Vasculitis Clinical Research Consortium.

The investigators examined pregnancy outcomes among women with vasculitis, as well as the outcomes of pregnancies fathered by men with the disease, because so little is known about the subject. Such pregnancies were rare until recent improvements in treatments helped patients survive longer and lead fuller lives.

"Our goal was to identify pregnancies that occurred within a large cohort of women and men with vasculitis and assess whether such pregnancies were at greater risk for adverse outcomes and whether vasculitis activity increased during pregnancy," the researchers wrote.

They invited patients listed in a registry of rare diseases to complete an anonymous questionnaire regarding their reproductive health. A total of 329 women (who had 496 pregnancies) and 107 men (who fathered 156 pregnancies) were included in the analysis (Arthritis Care Res. 2013 Feb. 11 [doi:10.1002/acr.21983]).

Among the women, 140 had granulomatosis with polyangiitis, 22 had microscopic polyangiitis, 59 had Churg-Strauss syndrome, 18 had polyarteritis nodosa, 43 had Behcet’s disease, and 46 had Takayasu’s arteritis. The mean age at diagnosis was 39.7 years (range, 10-78 years). The mean age at the time of the study was 47 years.

The rate of pregnancy loss was significantly higher among the women who had vasculitis when they conceived (33.8%) than it was among women who conceived before they were diagnosed as having vasculitis (22.4%), giving a relative risk of 1.77 (CI 1.02-3.09; P = .04). This 22.4% rate of pregnancy loss is comparable with that reported in the general population (15%-20%), while the rate found in women who already had vasculitis was significantly higher than that in the general population, Dr. Clowse and her associates said.

Similarly, the rate of preterm birth was significantly higher in pregnancies that occurred after a diagnosis of vasculitis (23.3%) than in pregnancies that occurred before a diagnosis of vasculitis (11.4%), giving a relative risk of 2.35 (CI 1.07-5.16; P =.03).

However, the researchers said, it is important to note that the maternal age at conception was approximately 5 years older for women who became pregnant after they had vasculitis, which could have influenced the increased morbidity in this group.

Most (59%) of the women who had vasculitis when they conceived reported no change in their disease activity during pregnancy, and another 23% reported an improvement in vasculitis activity during pregnancy. Only 18% of women who had vasculitis when they conceived reported increased symptoms during pregnancy. Increased disease activity did not have a statistically significant effect on pregnancy loss or preterm delivery.

Exposure to cyclophosphamide or prednisone did not appear to affect pregnancy outcomes. However, the numbers of pregnancies among women taking these medications was small.

Among the men, 61 had granulomatosis with polyangitis, 8 had microscopic polyangiitis, 24 had Churg-Strauss syndrome, 9 had polyarteritis nodosa, 4 had Behcet’s disease, and 1 had Takayasu’s arteritis. The average age at diagnosis was 54.6 years (range, 23-86 years)

Six men fathered 18 pregnancies after they had been diagnosed as having vasculitis, and 48 men fathered 138 pregnancies before they were diagnosed as having vasculitis. The rate of pregnancy loss was 41.2% for fathers with vasculitis and 23.0% for fathers who did not yet have a diagnosis of vasculitis, a difference that did not reach statistical significance.

One man treated with cyclophosphamide fathered two pregnancies within a few years that resulted in live births without complications. However, two other men who had received cyclophosphamide at least 10 years before fathering a pregnancy reported a total of seven pregnancy losses (including one with anencephaly) and four live births.

This study was limited in that it relied on retrospective self-report for diagnosis and was not powered to ascertain the role of confounding factors such as maternal age at the time of conception, prior pregnancy complications, and tobacco use. It also may have been biased because patients who had pregnancy difficulties may have been more likely than those who did not to complete a long questionnaire on that topic.

In addition, the number of men in the cohort was low, and a high proportion of them reported multiple pregnancy losses. It remains unclear whether this reflects a true increase in pregnancy loss rate for fathers with vasculitis or "simply reflects the greater interest that these particular men might have in responding to such a survey," Dr. Clowse and her colleagues said.

This study was supported by the Vasculitis Foundation and the Vasculitis Clinical Research Consortium, which receives support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Center for Research Resources, and the Office of Rare Diseases Research. No financial conflicts of interest were reported.

[email protected]

The risks of pregnancy loss and of preterm birth were higher in women who had vasculitis before they conceived than in women who were diagnosed as having vasculitis after conception in a retrospective cohort study.

Women who conceived before receiving a diagnosis of vasculitis had a rate of pregnancy loss similar to the general population, whereas women who conceived after they had received a diagnosis of vasculitis had a significantly higher rate of pregnancy loss, reported Dr. Megan E. B. Clowse of the division of rheumatology and immunology at Duke University, Durham, N.C., and her associates in the Vasculitis Clinical Research Consortium.

The investigators examined pregnancy outcomes among women with vasculitis, as well as the outcomes of pregnancies fathered by men with the disease, because so little is known about the subject. Such pregnancies were rare until recent improvements in treatments helped patients survive longer and lead fuller lives.

"Our goal was to identify pregnancies that occurred within a large cohort of women and men with vasculitis and assess whether such pregnancies were at greater risk for adverse outcomes and whether vasculitis activity increased during pregnancy," the researchers wrote.

They invited patients listed in a registry of rare diseases to complete an anonymous questionnaire regarding their reproductive health. A total of 329 women (who had 496 pregnancies) and 107 men (who fathered 156 pregnancies) were included in the analysis (Arthritis Care Res. 2013 Feb. 11 [doi:10.1002/acr.21983]).

Among the women, 140 had granulomatosis with polyangiitis, 22 had microscopic polyangiitis, 59 had Churg-Strauss syndrome, 18 had polyarteritis nodosa, 43 had Behcet’s disease, and 46 had Takayasu’s arteritis. The mean age at diagnosis was 39.7 years (range, 10-78 years). The mean age at the time of the study was 47 years.

The rate of pregnancy loss was significantly higher among the women who had vasculitis when they conceived (33.8%) than it was among women who conceived before they were diagnosed as having vasculitis (22.4%), giving a relative risk of 1.77 (CI 1.02-3.09; P = .04). This 22.4% rate of pregnancy loss is comparable with that reported in the general population (15%-20%), while the rate found in women who already had vasculitis was significantly higher than that in the general population, Dr. Clowse and her associates said.

Similarly, the rate of preterm birth was significantly higher in pregnancies that occurred after a diagnosis of vasculitis (23.3%) than in pregnancies that occurred before a diagnosis of vasculitis (11.4%), giving a relative risk of 2.35 (CI 1.07-5.16; P =.03).

However, the researchers said, it is important to note that the maternal age at conception was approximately 5 years older for women who became pregnant after they had vasculitis, which could have influenced the increased morbidity in this group.

Most (59%) of the women who had vasculitis when they conceived reported no change in their disease activity during pregnancy, and another 23% reported an improvement in vasculitis activity during pregnancy. Only 18% of women who had vasculitis when they conceived reported increased symptoms during pregnancy. Increased disease activity did not have a statistically significant effect on pregnancy loss or preterm delivery.

Exposure to cyclophosphamide or prednisone did not appear to affect pregnancy outcomes. However, the numbers of pregnancies among women taking these medications was small.

Among the men, 61 had granulomatosis with polyangitis, 8 had microscopic polyangiitis, 24 had Churg-Strauss syndrome, 9 had polyarteritis nodosa, 4 had Behcet’s disease, and 1 had Takayasu’s arteritis. The average age at diagnosis was 54.6 years (range, 23-86 years)

Six men fathered 18 pregnancies after they had been diagnosed as having vasculitis, and 48 men fathered 138 pregnancies before they were diagnosed as having vasculitis. The rate of pregnancy loss was 41.2% for fathers with vasculitis and 23.0% for fathers who did not yet have a diagnosis of vasculitis, a difference that did not reach statistical significance.

One man treated with cyclophosphamide fathered two pregnancies within a few years that resulted in live births without complications. However, two other men who had received cyclophosphamide at least 10 years before fathering a pregnancy reported a total of seven pregnancy losses (including one with anencephaly) and four live births.

This study was limited in that it relied on retrospective self-report for diagnosis and was not powered to ascertain the role of confounding factors such as maternal age at the time of conception, prior pregnancy complications, and tobacco use. It also may have been biased because patients who had pregnancy difficulties may have been more likely than those who did not to complete a long questionnaire on that topic.

In addition, the number of men in the cohort was low, and a high proportion of them reported multiple pregnancy losses. It remains unclear whether this reflects a true increase in pregnancy loss rate for fathers with vasculitis or "simply reflects the greater interest that these particular men might have in responding to such a survey," Dr. Clowse and her colleagues said.

This study was supported by the Vasculitis Foundation and the Vasculitis Clinical Research Consortium, which receives support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Center for Research Resources, and the Office of Rare Diseases Research. No financial conflicts of interest were reported.

[email protected]

The risks of pregnancy loss and of preterm birth were higher in women who had vasculitis before they conceived than in women who were diagnosed as having vasculitis after conception in a retrospective cohort study.

Women who conceived before receiving a diagnosis of vasculitis had a rate of pregnancy loss similar to the general population, whereas women who conceived after they had received a diagnosis of vasculitis had a significantly higher rate of pregnancy loss, reported Dr. Megan E. B. Clowse of the division of rheumatology and immunology at Duke University, Durham, N.C., and her associates in the Vasculitis Clinical Research Consortium.

The investigators examined pregnancy outcomes among women with vasculitis, as well as the outcomes of pregnancies fathered by men with the disease, because so little is known about the subject. Such pregnancies were rare until recent improvements in treatments helped patients survive longer and lead fuller lives.

"Our goal was to identify pregnancies that occurred within a large cohort of women and men with vasculitis and assess whether such pregnancies were at greater risk for adverse outcomes and whether vasculitis activity increased during pregnancy," the researchers wrote.

They invited patients listed in a registry of rare diseases to complete an anonymous questionnaire regarding their reproductive health. A total of 329 women (who had 496 pregnancies) and 107 men (who fathered 156 pregnancies) were included in the analysis (Arthritis Care Res. 2013 Feb. 11 [doi:10.1002/acr.21983]).

Among the women, 140 had granulomatosis with polyangiitis, 22 had microscopic polyangiitis, 59 had Churg-Strauss syndrome, 18 had polyarteritis nodosa, 43 had Behcet’s disease, and 46 had Takayasu’s arteritis. The mean age at diagnosis was 39.7 years (range, 10-78 years). The mean age at the time of the study was 47 years.

The rate of pregnancy loss was significantly higher among the women who had vasculitis when they conceived (33.8%) than it was among women who conceived before they were diagnosed as having vasculitis (22.4%), giving a relative risk of 1.77 (CI 1.02-3.09; P = .04). This 22.4% rate of pregnancy loss is comparable with that reported in the general population (15%-20%), while the rate found in women who already had vasculitis was significantly higher than that in the general population, Dr. Clowse and her associates said.

Similarly, the rate of preterm birth was significantly higher in pregnancies that occurred after a diagnosis of vasculitis (23.3%) than in pregnancies that occurred before a diagnosis of vasculitis (11.4%), giving a relative risk of 2.35 (CI 1.07-5.16; P =.03).

However, the researchers said, it is important to note that the maternal age at conception was approximately 5 years older for women who became pregnant after they had vasculitis, which could have influenced the increased morbidity in this group.

Most (59%) of the women who had vasculitis when they conceived reported no change in their disease activity during pregnancy, and another 23% reported an improvement in vasculitis activity during pregnancy. Only 18% of women who had vasculitis when they conceived reported increased symptoms during pregnancy. Increased disease activity did not have a statistically significant effect on pregnancy loss or preterm delivery.

Exposure to cyclophosphamide or prednisone did not appear to affect pregnancy outcomes. However, the numbers of pregnancies among women taking these medications was small.

Among the men, 61 had granulomatosis with polyangitis, 8 had microscopic polyangiitis, 24 had Churg-Strauss syndrome, 9 had polyarteritis nodosa, 4 had Behcet’s disease, and 1 had Takayasu’s arteritis. The average age at diagnosis was 54.6 years (range, 23-86 years)

Six men fathered 18 pregnancies after they had been diagnosed as having vasculitis, and 48 men fathered 138 pregnancies before they were diagnosed as having vasculitis. The rate of pregnancy loss was 41.2% for fathers with vasculitis and 23.0% for fathers who did not yet have a diagnosis of vasculitis, a difference that did not reach statistical significance.

One man treated with cyclophosphamide fathered two pregnancies within a few years that resulted in live births without complications. However, two other men who had received cyclophosphamide at least 10 years before fathering a pregnancy reported a total of seven pregnancy losses (including one with anencephaly) and four live births.

This study was limited in that it relied on retrospective self-report for diagnosis and was not powered to ascertain the role of confounding factors such as maternal age at the time of conception, prior pregnancy complications, and tobacco use. It also may have been biased because patients who had pregnancy difficulties may have been more likely than those who did not to complete a long questionnaire on that topic.

In addition, the number of men in the cohort was low, and a high proportion of them reported multiple pregnancy losses. It remains unclear whether this reflects a true increase in pregnancy loss rate for fathers with vasculitis or "simply reflects the greater interest that these particular men might have in responding to such a survey," Dr. Clowse and her colleagues said.

This study was supported by the Vasculitis Foundation and the Vasculitis Clinical Research Consortium, which receives support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Center for Research Resources, and the Office of Rare Diseases Research. No financial conflicts of interest were reported.

[email protected]

Two small studies now add to the very sparse clinical experience with the use of anti-TNF-alpha agents in women who have inflammatory bowel disease and become pregnant, according to separate groups of researchers writing in the March issue of Clinical Gastroenterology and Hepatology.

Both studies confirm that two TNF antagonists do cross the placenta to the fetus at high levels and persist in the infant for months after birth. Discontinuing the drugs during the second trimester lessens but does not eliminate this exposure.

"At this time, we do not know what a safe or harmful level of drug in the newborn is, and what the full consequences of neonatal anti-TNF-alpha exposure to newborn development will be. The risks and benefits of therapy should be individualized, and pediatricians should be cautioned to monitor for potential infections and other abnormalities," said Dr. Uma Mahadevan of the University of California, San Francisco, and her associates (Clin. Gastroenterol. Hepatol. 2012 [doi:10.1016/j.cgh.2012.11.011]).

In their study, Dr. Mahadevan and her colleagues identified 31 pregnant women in their practice or in the Crohn’s Colitis Foundation of America’s Pregnancy IBD and Neonatal Outcomes registry who had Crohn’s disease and were taking infliximab (11 women), adalimumab (10 women), or certolizumab (10 women).

The first two of these anti-TNF-alpha agents are both of the IgG1 subclass and thus should, in theory, cross the placenta at high rates during the third trimester. Certolizumab, a pegylated fragment of an anti-TNF-alpha monoclonal antibody, in theory should not be transported across the placenta. To test these theories, the researchers determined the concentrations of each medication in samples of cord blood, infant serum, and the mother’s plasma taken on the day of birth. None of the infants had birth defects or required neonatal ICU care.

In the infliximab group, the median interval between the last dose of the agent and delivery was 35 days (range, 2-91 days). In every case, cord blood and infant serum samples showed much higher levels of the TNF-alpha antagonist than did maternal plasma samples, at a median ratio of 160:100. The drug persisted in the infants’ circulation for 2-7 months postpartum.

In the adalimumab group, the median interval between the last dose of the agent and delivery was 5.5 weeks. Again, in every case, cord blood and infant serum samples showed much higher levels of the TNF-alpha antagonist than did maternal plasma samples, at a median ratio of 179:100. The drug persisted in the infants’ circulation for at least 11 weeks.

In contrast, no certolizumab was detected in any of the infant samples.

"Based on the results of this study and available safety data, infliximab, adalimumab, and certolizumab can be used through conception and the first and second trimester of pregnancy on schedule. However, the significant placental transfer and subsequent slow postpartum clearance of infliximab and adalimumab raise concerns about their use during the third trimester," Dr. Mahadevan and her associates said.

Such concerns must be balanced against the risk of a flare of IBD, "which has far more consequences to neonatal development," impairing nutritional status of mother and fetus; raising the risk of preterm delivery; and possibly requiring harmful diagnostic testing, medication, and even surgery on the pregnant patient.

Physicians may consider switching patients to certolizumab during pregnancy because of its lack of transfer to the fetus, but "if a pregnant patient is doing well on infliximab or adalimumab, there is no indication, and even a potential risk, of switching ... as the primary goal remains to maintain a quiescent disease state that is critical for a successful pregnancy," they noted.

In the other study, Dr. Zuzana Zelinkova of Erasmus Medical Center, Rotterdam, the Netherlands, and her associates assessed 28 pregnant women who had Crohn’s disease or ulcerative colitis for which they were taking TNF-alpha antagonists.

Of the 17 taking infliximab, 12 had IBD in remission and discontinued the drug at a mean of 23 weeks’ gestation. Three others had perianal fistulas but discontinued early in the second trimester, while two had perianal fistulas and active luminal disease and didn’t discontinue the drug until weeks 30 and 34. None developed IBD relapses.

All 11 study subjects who were taking adalimumab had quiescent disease in the second trimester and discontinued the drug at a mean gestation of 22 weeks (range, 21-27 weeks). Two of them (18%) developed relapses of IBD.

There were three spontaneous miscarriages during the first trimester, and one child was born with polydactyly.

Levels of TNF-alpha antagonists in cord blood samples were significantly lower in the group who discontinued the drugs early, compared with the group who continued taking them until 10 or fewer weeks before delivery. "We recommend considering the discontinuation of anti-TNF-alpha treatment in patients who have quiescent disease at the beginning of the second trimester," to decrease but not completely eliminate the child’s exposure to these agents, Dr. Zelinkova and her associates said.

Dr. Mahadevan’s study was supported by Abbott (marketer of adalimumab), UCB (marketer of certolizumab), Prometheus Labs, and the Crohn’s Colitis Foundation of America. Dr. Mahadevan and her associates reported ties to Janssen (marketer of infliximab), UCB, and Abbott. Dr. Zelinkova and her associates reported ties to Abbott; Merck, Sharp & Dohme; and Shire.

Two small studies now add to the very sparse clinical experience with the use of anti-TNF-alpha agents in women who have inflammatory bowel disease and become pregnant, according to separate groups of researchers writing in the March issue of Clinical Gastroenterology and Hepatology.

Both studies confirm that two TNF antagonists do cross the placenta to the fetus at high levels and persist in the infant for months after birth. Discontinuing the drugs during the second trimester lessens but does not eliminate this exposure.

"At this time, we do not know what a safe or harmful level of drug in the newborn is, and what the full consequences of neonatal anti-TNF-alpha exposure to newborn development will be. The risks and benefits of therapy should be individualized, and pediatricians should be cautioned to monitor for potential infections and other abnormalities," said Dr. Uma Mahadevan of the University of California, San Francisco, and her associates (Clin. Gastroenterol. Hepatol. 2012 [doi:10.1016/j.cgh.2012.11.011]).

In their study, Dr. Mahadevan and her colleagues identified 31 pregnant women in their practice or in the Crohn’s Colitis Foundation of America’s Pregnancy IBD and Neonatal Outcomes registry who had Crohn’s disease and were taking infliximab (11 women), adalimumab (10 women), or certolizumab (10 women).

The first two of these anti-TNF-alpha agents are both of the IgG1 subclass and thus should, in theory, cross the placenta at high rates during the third trimester. Certolizumab, a pegylated fragment of an anti-TNF-alpha monoclonal antibody, in theory should not be transported across the placenta. To test these theories, the researchers determined the concentrations of each medication in samples of cord blood, infant serum, and the mother’s plasma taken on the day of birth. None of the infants had birth defects or required neonatal ICU care.

In the infliximab group, the median interval between the last dose of the agent and delivery was 35 days (range, 2-91 days). In every case, cord blood and infant serum samples showed much higher levels of the TNF-alpha antagonist than did maternal plasma samples, at a median ratio of 160:100. The drug persisted in the infants’ circulation for 2-7 months postpartum.

In the adalimumab group, the median interval between the last dose of the agent and delivery was 5.5 weeks. Again, in every case, cord blood and infant serum samples showed much higher levels of the TNF-alpha antagonist than did maternal plasma samples, at a median ratio of 179:100. The drug persisted in the infants’ circulation for at least 11 weeks.

In contrast, no certolizumab was detected in any of the infant samples.

"Based on the results of this study and available safety data, infliximab, adalimumab, and certolizumab can be used through conception and the first and second trimester of pregnancy on schedule. However, the significant placental transfer and subsequent slow postpartum clearance of infliximab and adalimumab raise concerns about their use during the third trimester," Dr. Mahadevan and her associates said.

Such concerns must be balanced against the risk of a flare of IBD, "which has far more consequences to neonatal development," impairing nutritional status of mother and fetus; raising the risk of preterm delivery; and possibly requiring harmful diagnostic testing, medication, and even surgery on the pregnant patient.

Physicians may consider switching patients to certolizumab during pregnancy because of its lack of transfer to the fetus, but "if a pregnant patient is doing well on infliximab or adalimumab, there is no indication, and even a potential risk, of switching ... as the primary goal remains to maintain a quiescent disease state that is critical for a successful pregnancy," they noted.

In the other study, Dr. Zuzana Zelinkova of Erasmus Medical Center, Rotterdam, the Netherlands, and her associates assessed 28 pregnant women who had Crohn’s disease or ulcerative colitis for which they were taking TNF-alpha antagonists.

Of the 17 taking infliximab, 12 had IBD in remission and discontinued the drug at a mean of 23 weeks’ gestation. Three others had perianal fistulas but discontinued early in the second trimester, while two had perianal fistulas and active luminal disease and didn’t discontinue the drug until weeks 30 and 34. None developed IBD relapses.

All 11 study subjects who were taking adalimumab had quiescent disease in the second trimester and discontinued the drug at a mean gestation of 22 weeks (range, 21-27 weeks). Two of them (18%) developed relapses of IBD.

There were three spontaneous miscarriages during the first trimester, and one child was born with polydactyly.

Levels of TNF-alpha antagonists in cord blood samples were significantly lower in the group who discontinued the drugs early, compared with the group who continued taking them until 10 or fewer weeks before delivery. "We recommend considering the discontinuation of anti-TNF-alpha treatment in patients who have quiescent disease at the beginning of the second trimester," to decrease but not completely eliminate the child’s exposure to these agents, Dr. Zelinkova and her associates said.

Dr. Mahadevan’s study was supported by Abbott (marketer of adalimumab), UCB (marketer of certolizumab), Prometheus Labs, and the Crohn’s Colitis Foundation of America. Dr. Mahadevan and her associates reported ties to Janssen (marketer of infliximab), UCB, and Abbott. Dr. Zelinkova and her associates reported ties to Abbott; Merck, Sharp & Dohme; and Shire.

Two small studies now add to the very sparse clinical experience with the use of anti-TNF-alpha agents in women who have inflammatory bowel disease and become pregnant, according to separate groups of researchers writing in the March issue of Clinical Gastroenterology and Hepatology.

Both studies confirm that two TNF antagonists do cross the placenta to the fetus at high levels and persist in the infant for months after birth. Discontinuing the drugs during the second trimester lessens but does not eliminate this exposure.

"At this time, we do not know what a safe or harmful level of drug in the newborn is, and what the full consequences of neonatal anti-TNF-alpha exposure to newborn development will be. The risks and benefits of therapy should be individualized, and pediatricians should be cautioned to monitor for potential infections and other abnormalities," said Dr. Uma Mahadevan of the University of California, San Francisco, and her associates (Clin. Gastroenterol. Hepatol. 2012 [doi:10.1016/j.cgh.2012.11.011]).

In their study, Dr. Mahadevan and her colleagues identified 31 pregnant women in their practice or in the Crohn’s Colitis Foundation of America’s Pregnancy IBD and Neonatal Outcomes registry who had Crohn’s disease and were taking infliximab (11 women), adalimumab (10 women), or certolizumab (10 women).

The first two of these anti-TNF-alpha agents are both of the IgG1 subclass and thus should, in theory, cross the placenta at high rates during the third trimester. Certolizumab, a pegylated fragment of an anti-TNF-alpha monoclonal antibody, in theory should not be transported across the placenta. To test these theories, the researchers determined the concentrations of each medication in samples of cord blood, infant serum, and the mother’s plasma taken on the day of birth. None of the infants had birth defects or required neonatal ICU care.

In the infliximab group, the median interval between the last dose of the agent and delivery was 35 days (range, 2-91 days). In every case, cord blood and infant serum samples showed much higher levels of the TNF-alpha antagonist than did maternal plasma samples, at a median ratio of 160:100. The drug persisted in the infants’ circulation for 2-7 months postpartum.

In the adalimumab group, the median interval between the last dose of the agent and delivery was 5.5 weeks. Again, in every case, cord blood and infant serum samples showed much higher levels of the TNF-alpha antagonist than did maternal plasma samples, at a median ratio of 179:100. The drug persisted in the infants’ circulation for at least 11 weeks.

In contrast, no certolizumab was detected in any of the infant samples.

"Based on the results of this study and available safety data, infliximab, adalimumab, and certolizumab can be used through conception and the first and second trimester of pregnancy on schedule. However, the significant placental transfer and subsequent slow postpartum clearance of infliximab and adalimumab raise concerns about their use during the third trimester," Dr. Mahadevan and her associates said.

Such concerns must be balanced against the risk of a flare of IBD, "which has far more consequences to neonatal development," impairing nutritional status of mother and fetus; raising the risk of preterm delivery; and possibly requiring harmful diagnostic testing, medication, and even surgery on the pregnant patient.

Physicians may consider switching patients to certolizumab during pregnancy because of its lack of transfer to the fetus, but "if a pregnant patient is doing well on infliximab or adalimumab, there is no indication, and even a potential risk, of switching ... as the primary goal remains to maintain a quiescent disease state that is critical for a successful pregnancy," they noted.

In the other study, Dr. Zuzana Zelinkova of Erasmus Medical Center, Rotterdam, the Netherlands, and her associates assessed 28 pregnant women who had Crohn’s disease or ulcerative colitis for which they were taking TNF-alpha antagonists.

Of the 17 taking infliximab, 12 had IBD in remission and discontinued the drug at a mean of 23 weeks’ gestation. Three others had perianal fistulas but discontinued early in the second trimester, while two had perianal fistulas and active luminal disease and didn’t discontinue the drug until weeks 30 and 34. None developed IBD relapses.

All 11 study subjects who were taking adalimumab had quiescent disease in the second trimester and discontinued the drug at a mean gestation of 22 weeks (range, 21-27 weeks). Two of them (18%) developed relapses of IBD.

There were three spontaneous miscarriages during the first trimester, and one child was born with polydactyly.

Levels of TNF-alpha antagonists in cord blood samples were significantly lower in the group who discontinued the drugs early, compared with the group who continued taking them until 10 or fewer weeks before delivery. "We recommend considering the discontinuation of anti-TNF-alpha treatment in patients who have quiescent disease at the beginning of the second trimester," to decrease but not completely eliminate the child’s exposure to these agents, Dr. Zelinkova and her associates said.

Dr. Mahadevan’s study was supported by Abbott (marketer of adalimumab), UCB (marketer of certolizumab), Prometheus Labs, and the Crohn’s Colitis Foundation of America. Dr. Mahadevan and her associates reported ties to Janssen (marketer of infliximab), UCB, and Abbott. Dr. Zelinkova and her associates reported ties to Abbott; Merck, Sharp & Dohme; and Shire.

Maternal use of folic acid supplements around the time of conception is associated with a reduced risk of having children with autistic disorder, according to a study published in the Journal of the American Medical Association.

To determine whether prenatal folic acid use reduces the risk of neurodevelopmental disorders in addition to neural tube defects, Pål Surén, MD, MPH, from the Norwegian Institute of Public Health in Oslo, and colleagues examined the association between folic acid supplement use 4 weeks before to 8 weeks after the start of pregnancy and risk of autism spectrum disorders in 85,176 children born between 2002 and 2008.

As of March 31, 2012, the researchers found that 270 children (0.32%) had been diagnosed with an autism spectrum disorder (114 with autistic disorder, 56 with Asperger syndrome, and 100 with pervasive developmental disorder–not otherwise specified [PDD-NOS]). The risk of being diagnosed with an autistic disorder was significantly lower for children whose mothers had taken folic acid (0.10% versus 0.21%; adjusted odds ratio, 0.61). In contrast, there was no association between folic acid use and Asperger syndrome or PDD-NOS.

“Our main finding was that maternal use of folic acid supplements around the time of conception was associated with a lower risk of autistic disorder,” Surén and colleagues conclude. “This finding does not establish a causal relation between folic acid use and autistic disorder but provides a rationale for replicating the analyses in other study samples and further investigating genetic factors and other biological mechanisms that may explain the inverse association.”

To access the abstract of “Association Between Maternal Use of Folic Acid Supplements and Risk of Autism Spectrum Disorders in Children,” click here.

Maternal use of folic acid supplements around the time of conception is associated with a reduced risk of having children with autistic disorder, according to a study published in the Journal of the American Medical Association.

To determine whether prenatal folic acid use reduces the risk of neurodevelopmental disorders in addition to neural tube defects, Pål Surén, MD, MPH, from the Norwegian Institute of Public Health in Oslo, and colleagues examined the association between folic acid supplement use 4 weeks before to 8 weeks after the start of pregnancy and risk of autism spectrum disorders in 85,176 children born between 2002 and 2008.

As of March 31, 2012, the researchers found that 270 children (0.32%) had been diagnosed with an autism spectrum disorder (114 with autistic disorder, 56 with Asperger syndrome, and 100 with pervasive developmental disorder–not otherwise specified [PDD-NOS]). The risk of being diagnosed with an autistic disorder was significantly lower for children whose mothers had taken folic acid (0.10% versus 0.21%; adjusted odds ratio, 0.61). In contrast, there was no association between folic acid use and Asperger syndrome or PDD-NOS.

“Our main finding was that maternal use of folic acid supplements around the time of conception was associated with a lower risk of autistic disorder,” Surén and colleagues conclude. “This finding does not establish a causal relation between folic acid use and autistic disorder but provides a rationale for replicating the analyses in other study samples and further investigating genetic factors and other biological mechanisms that may explain the inverse association.”

To access the abstract of “Association Between Maternal Use of Folic Acid Supplements and Risk of Autism Spectrum Disorders in Children,” click here.

Maternal use of folic acid supplements around the time of conception is associated with a reduced risk of having children with autistic disorder, according to a study published in the Journal of the American Medical Association.

To determine whether prenatal folic acid use reduces the risk of neurodevelopmental disorders in addition to neural tube defects, Pål Surén, MD, MPH, from the Norwegian Institute of Public Health in Oslo, and colleagues examined the association between folic acid supplement use 4 weeks before to 8 weeks after the start of pregnancy and risk of autism spectrum disorders in 85,176 children born between 2002 and 2008.

As of March 31, 2012, the researchers found that 270 children (0.32%) had been diagnosed with an autism spectrum disorder (114 with autistic disorder, 56 with Asperger syndrome, and 100 with pervasive developmental disorder–not otherwise specified [PDD-NOS]). The risk of being diagnosed with an autistic disorder was significantly lower for children whose mothers had taken folic acid (0.10% versus 0.21%; adjusted odds ratio, 0.61). In contrast, there was no association between folic acid use and Asperger syndrome or PDD-NOS.

“Our main finding was that maternal use of folic acid supplements around the time of conception was associated with a lower risk of autistic disorder,” Surén and colleagues conclude. “This finding does not establish a causal relation between folic acid use and autistic disorder but provides a rationale for replicating the analyses in other study samples and further investigating genetic factors and other biological mechanisms that may explain the inverse association.”

To access the abstract of “Association Between Maternal Use of Folic Acid Supplements and Risk of Autism Spectrum Disorders in Children,” click here.

Shoulder dystocia is an obstetric complication that occurs in up to 1.4% of deliveries.¹ Although the vast majority can be managed successfully, the complication is associated with risk of fetal injury. The most serious injury is brachial plexus palsy, which occurs in 4% to 40% of shoulder dystocia cases, although less than 10% of these injuries are permanent. Other injuries include fractures of the clavicle and humerus; in rare instances the complication may be associated with fetal asphyxia and death. Early recognition of the complication followed by an orderly approach to management will reduce the risk of fetal injury.

First, recognize shoulder dystocia and take control

Recognition of shoulder dystocia immediately followed by avoidance of further impaction, particularly of the anterior shoulder against the symphysis pubis, will likely increase the chances of successful resolution.

These factors should lead you to anticipate shoulder dystocia during delivery:

• suspected macrosomia
• diabetic parturient
• prolonged second stage.

However, a high percentage of cases occur in women without risk factors. Because persistent or forceful traction, used in an attempt to deliver the anterior shoulder, may be one of the causes of brachial plexus injury, early recognition of shoulder dystocia, followed by a halt of further traction, reduces the risk of that injury.

In my experience, if some movement of the anterior shoulder does not occur after 2 to 3 seconds of gentle downward guidance, you need to consider the possibility of shoulder dystocia. It is also important to take control of the situation: Instruct the patient to stop pushing and family members to stop urging the patient to push.

Avoid panic. Initiate a care-team management algorithm.

Having a management algorithm that can be quickly recalled and initiated allows the care team to proceed in an orderly fashion and remain calm and avoid panic, particularly if the dystocia is severe. In obstetric emergencies, panic is your enemy, leading to inefficient activity, team confusion, and an increased likelihood that an error in judgment (too much traction, fundal pressure) may occur. I advise my residents that whenever there are risk factors for shoulder dystocia, or it is suspected for any reason, to do a mental run-through of the management steps.

Rehearse the algorithm. It will make a difference in the delivery room.

To most effectively use a management algorithm, rehearsal using team training drills or simulation is necessary. Studies support simulation and team training even for individuals who have completed training in obstetrics or midwifery. Crofts and colleagues videotaped 450 simulations of shoulder dystocia involving 95 certified nurse midwives and 45 physicians.² The authors noted that 1) shoulder dystocia could not be resolved in 57% of cases, and 2) there was frequent confusion regarding how to perform the internal maneuvers, with poor communication among team members. This same group of researchers later demonstrated that skills in managing shoulder dystocia improved significantly after simulation training. In fact, a high proportion of “trainees” maintained their skill level when tested a year later.³

Finally, when evaluating the impact of training on actual clinical outcomes in their hospital, Crofts and colleagues noted that the rate of obstetric brachial plexus injury fell from 7.4% in a 4-year period prior to training, to 2.3% in a 4-year period after training.⁴

Practice within your own L&D unit

The use of in situ simulation (ie, simulation within the labor and delivery unit) has two major advantages:

• It is more realistic than practicing within a lab. Systems issues, such as lack of a uniform procedure for getting help or a lack of chairs in the labor room to assist with performance of suprapubic pressure, can be identified.
• The full team, including ward clerks and other support personnel, can be part of the simulation more readily.

The box on this page provides a possible process to use in managing shoulder dystocia. If there has not been an opportunity for this training, practitioners, at the very least, should be cognizant of the steps they are going to take in managing such cases.

What should you do after primary maneuvers fail?

Try to deliver the posterior arm. Although the order of maneuvers in the proposed algorithm may vary, a recent study using a database of more than 130,000 deliveries suggests that use of posterior arm delivery after failure of primary maneuvers, such as McRoberts or suprapubic pressure, may more likely result in resolution.⁵

Start from the beginning, and try again. If the first set of maneuvers does not resolve the problem, running through them again usually leads to success. Although the risk of fetal hypoxia increases the longer it takes to resolve the dystocia, it may actually facilitate delivery because fetal tone may also decrease.

Zavanelli maneuver. In general, use of the Zavanelli maneuver with replacement of the fetal head accompanied by cesarean section is a last resort; there is a lack of data to support its use earlier in the process or more frequently. This maneuver requires reversing the cardinal movements related to head descent in order to successfully complete replacement.

Shoulder dystocia in obese patients proves more difficult

In my own experience with obese patients, suprapubic pressure is often ineffective due to the presence of a large fat pad or pannus. Use of an anterior Rubin’s maneuver to rotate the shoulders about 30° to the oblique often facilitates delivery.

Liberal use of episiotomy to facilitate posterior arm delivery or rotational maneuvers is often necessary with obese patients.

Documentation is key

Documentation of the dystocia event in the patient’s permanent record should not occur until after the care team has discussed the case. This will ensure that the maneuvers utilized and the related timing of events are recorded accurately. This is critically important should a lawsuit occur, since discrepancies or errors in charting will hamper defense of the case. A checklist, such as the one provided by the American College of Obstetricians and Gynecologists, lists key points that should be recorded and outlines important steps related to the event.⁶

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

Shoulder dystocia is an obstetric complication that occurs in up to 1.4% of deliveries.¹ Although the vast majority can be managed successfully, the complication is associated with risk of fetal injury. The most serious injury is brachial plexus palsy, which occurs in 4% to 40% of shoulder dystocia cases, although less than 10% of these injuries are permanent. Other injuries include fractures of the clavicle and humerus; in rare instances the complication may be associated with fetal asphyxia and death. Early recognition of the complication followed by an orderly approach to management will reduce the risk of fetal injury.

First, recognize shoulder dystocia and take control

Recognition of shoulder dystocia immediately followed by avoidance of further impaction, particularly of the anterior shoulder against the symphysis pubis, will likely increase the chances of successful resolution.

These factors should lead you to anticipate shoulder dystocia during delivery:

• suspected macrosomia
• diabetic parturient
• prolonged second stage.

However, a high percentage of cases occur in women without risk factors. Because persistent or forceful traction, used in an attempt to deliver the anterior shoulder, may be one of the causes of brachial plexus injury, early recognition of shoulder dystocia, followed by a halt of further traction, reduces the risk of that injury.

In my experience, if some movement of the anterior shoulder does not occur after 2 to 3 seconds of gentle downward guidance, you need to consider the possibility of shoulder dystocia. It is also important to take control of the situation: Instruct the patient to stop pushing and family members to stop urging the patient to push.

Avoid panic. Initiate a care-team management algorithm.

Having a management algorithm that can be quickly recalled and initiated allows the care team to proceed in an orderly fashion and remain calm and avoid panic, particularly if the dystocia is severe. In obstetric emergencies, panic is your enemy, leading to inefficient activity, team confusion, and an increased likelihood that an error in judgment (too much traction, fundal pressure) may occur. I advise my residents that whenever there are risk factors for shoulder dystocia, or it is suspected for any reason, to do a mental run-through of the management steps.

Rehearse the algorithm. It will make a difference in the delivery room.

To most effectively use a management algorithm, rehearsal using team training drills or simulation is necessary. Studies support simulation and team training even for individuals who have completed training in obstetrics or midwifery. Crofts and colleagues videotaped 450 simulations of shoulder dystocia involving 95 certified nurse midwives and 45 physicians.² The authors noted that 1) shoulder dystocia could not be resolved in 57% of cases, and 2) there was frequent confusion regarding how to perform the internal maneuvers, with poor communication among team members. This same group of researchers later demonstrated that skills in managing shoulder dystocia improved significantly after simulation training. In fact, a high proportion of “trainees” maintained their skill level when tested a year later.³

Finally, when evaluating the impact of training on actual clinical outcomes in their hospital, Crofts and colleagues noted that the rate of obstetric brachial plexus injury fell from 7.4% in a 4-year period prior to training, to 2.3% in a 4-year period after training.⁴

Practice within your own L&D unit

The use of in situ simulation (ie, simulation within the labor and delivery unit) has two major advantages:

• It is more realistic than practicing within a lab. Systems issues, such as lack of a uniform procedure for getting help or a lack of chairs in the labor room to assist with performance of suprapubic pressure, can be identified.
• The full team, including ward clerks and other support personnel, can be part of the simulation more readily.

The box on this page provides a possible process to use in managing shoulder dystocia. If there has not been an opportunity for this training, practitioners, at the very least, should be cognizant of the steps they are going to take in managing such cases.

What should you do after primary maneuvers fail?

Try to deliver the posterior arm. Although the order of maneuvers in the proposed algorithm may vary, a recent study using a database of more than 130,000 deliveries suggests that use of posterior arm delivery after failure of primary maneuvers, such as McRoberts or suprapubic pressure, may more likely result in resolution.⁵

Start from the beginning, and try again. If the first set of maneuvers does not resolve the problem, running through them again usually leads to success. Although the risk of fetal hypoxia increases the longer it takes to resolve the dystocia, it may actually facilitate delivery because fetal tone may also decrease.

Zavanelli maneuver. In general, use of the Zavanelli maneuver with replacement of the fetal head accompanied by cesarean section is a last resort; there is a lack of data to support its use earlier in the process or more frequently. This maneuver requires reversing the cardinal movements related to head descent in order to successfully complete replacement.

Shoulder dystocia in obese patients proves more difficult

In my own experience with obese patients, suprapubic pressure is often ineffective due to the presence of a large fat pad or pannus. Use of an anterior Rubin’s maneuver to rotate the shoulders about 30° to the oblique often facilitates delivery.

Liberal use of episiotomy to facilitate posterior arm delivery or rotational maneuvers is often necessary with obese patients.

Documentation is key

Documentation of the dystocia event in the patient’s permanent record should not occur until after the care team has discussed the case. This will ensure that the maneuvers utilized and the related timing of events are recorded accurately. This is critically important should a lawsuit occur, since discrepancies or errors in charting will hamper defense of the case. A checklist, such as the one provided by the American College of Obstetricians and Gynecologists, lists key points that should be recorded and outlines important steps related to the event.⁶

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

Shoulder dystocia is an obstetric complication that occurs in up to 1.4% of deliveries.¹ Although the vast majority can be managed successfully, the complication is associated with risk of fetal injury. The most serious injury is brachial plexus palsy, which occurs in 4% to 40% of shoulder dystocia cases, although less than 10% of these injuries are permanent. Other injuries include fractures of the clavicle and humerus; in rare instances the complication may be associated with fetal asphyxia and death. Early recognition of the complication followed by an orderly approach to management will reduce the risk of fetal injury.

First, recognize shoulder dystocia and take control

Recognition of shoulder dystocia immediately followed by avoidance of further impaction, particularly of the anterior shoulder against the symphysis pubis, will likely increase the chances of successful resolution.

These factors should lead you to anticipate shoulder dystocia during delivery:

• suspected macrosomia
• diabetic parturient
• prolonged second stage.

However, a high percentage of cases occur in women without risk factors. Because persistent or forceful traction, used in an attempt to deliver the anterior shoulder, may be one of the causes of brachial plexus injury, early recognition of shoulder dystocia, followed by a halt of further traction, reduces the risk of that injury.

In my experience, if some movement of the anterior shoulder does not occur after 2 to 3 seconds of gentle downward guidance, you need to consider the possibility of shoulder dystocia. It is also important to take control of the situation: Instruct the patient to stop pushing and family members to stop urging the patient to push.

Avoid panic. Initiate a care-team management algorithm.

Having a management algorithm that can be quickly recalled and initiated allows the care team to proceed in an orderly fashion and remain calm and avoid panic, particularly if the dystocia is severe. In obstetric emergencies, panic is your enemy, leading to inefficient activity, team confusion, and an increased likelihood that an error in judgment (too much traction, fundal pressure) may occur. I advise my residents that whenever there are risk factors for shoulder dystocia, or it is suspected for any reason, to do a mental run-through of the management steps.

Rehearse the algorithm. It will make a difference in the delivery room.

To most effectively use a management algorithm, rehearsal using team training drills or simulation is necessary. Studies support simulation and team training even for individuals who have completed training in obstetrics or midwifery. Crofts and colleagues videotaped 450 simulations of shoulder dystocia involving 95 certified nurse midwives and 45 physicians.² The authors noted that 1) shoulder dystocia could not be resolved in 57% of cases, and 2) there was frequent confusion regarding how to perform the internal maneuvers, with poor communication among team members. This same group of researchers later demonstrated that skills in managing shoulder dystocia improved significantly after simulation training. In fact, a high proportion of “trainees” maintained their skill level when tested a year later.³

Finally, when evaluating the impact of training on actual clinical outcomes in their hospital, Crofts and colleagues noted that the rate of obstetric brachial plexus injury fell from 7.4% in a 4-year period prior to training, to 2.3% in a 4-year period after training.⁴

Practice within your own L&D unit

The use of in situ simulation (ie, simulation within the labor and delivery unit) has two major advantages:

• It is more realistic than practicing within a lab. Systems issues, such as lack of a uniform procedure for getting help or a lack of chairs in the labor room to assist with performance of suprapubic pressure, can be identified.
• The full team, including ward clerks and other support personnel, can be part of the simulation more readily.

The box on this page provides a possible process to use in managing shoulder dystocia. If there has not been an opportunity for this training, practitioners, at the very least, should be cognizant of the steps they are going to take in managing such cases.

What should you do after primary maneuvers fail?

Try to deliver the posterior arm. Although the order of maneuvers in the proposed algorithm may vary, a recent study using a database of more than 130,000 deliveries suggests that use of posterior arm delivery after failure of primary maneuvers, such as McRoberts or suprapubic pressure, may more likely result in resolution.⁵

Start from the beginning, and try again. If the first set of maneuvers does not resolve the problem, running through them again usually leads to success. Although the risk of fetal hypoxia increases the longer it takes to resolve the dystocia, it may actually facilitate delivery because fetal tone may also decrease.

Zavanelli maneuver. In general, use of the Zavanelli maneuver with replacement of the fetal head accompanied by cesarean section is a last resort; there is a lack of data to support its use earlier in the process or more frequently. This maneuver requires reversing the cardinal movements related to head descent in order to successfully complete replacement.

Shoulder dystocia in obese patients proves more difficult

In my own experience with obese patients, suprapubic pressure is often ineffective due to the presence of a large fat pad or pannus. Use of an anterior Rubin’s maneuver to rotate the shoulders about 30° to the oblique often facilitates delivery.

Liberal use of episiotomy to facilitate posterior arm delivery or rotational maneuvers is often necessary with obese patients.

Documentation is key

Documentation of the dystocia event in the patient’s permanent record should not occur until after the care team has discussed the case. This will ensure that the maneuvers utilized and the related timing of events are recorded accurately. This is critically important should a lawsuit occur, since discrepancies or errors in charting will hamper defense of the case. A checklist, such as the one provided by the American College of Obstetricians and Gynecologists, lists key points that should be recorded and outlines important steps related to the event.⁶

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

It is not uncommon to see a patient in her first trimester who is experiencing abdominal pain or vaginal bleeding or both. At my institution, we use the beta human chorionic gonadotropin (ß-hCG) value in conjunction with transvaginal ultrasonography to determine whether the pregnancy is a viable intrauterine pregnancy, a missed spontaneous abortion, or an ectopic gestation. However, even a combination of modalities can be inconclusive, necessitating repeated ß-hCG measurements and several ultrasound images. For the patient, it can provoke considerable anxiety to be told to wait and see if the pregnancy will continue.

Testing will not distinguish ectopic from intrauterine gestations

In their meta-analysis, Verhaegen and colleagues focused on a single measurement of progesterone to predict the pregnancy outcome in women who experienced pain or bleeding, or both. In early pregnancy, progesterone is produced first by the corpus luteum, then by the placenta. It stands to reason that nonviable pregnancies would have a lower level.

Although measurement of the progesterone level will not help distinguish an ectopic gestation from an intrauterine pregnancy, it does help identify nonviable pregnancy. This study found that a progesterone level below 6 ng/mL excluded a viable pregnancy in 99.2% of cases. Measuring progesterone could be very helpful when the ß-hCG level is low and ultrasound imaging is inconclusive. Currently, we tell patients under these circumstances that we need more time to sort it all out—we need to establish a trend for the ß-hCG and repeat ultrasonography. However, if we added assessment of the progesterone level and it were less than 6 ng/mL, we would be able to determine with near certainty that the pregnancy is nonviable. As a result, we could provide patients with some certainty earlier than we would otherwise be able to, even if it were not the news they had hoped to hear.

When the serum progesterone level is higher than 6 ng/mL, it doesn’t guarantee a viable pregnancy. Rather, it leaves us about where we were without it—somewhat unsure as to how things will turn out.

Testing may save money in the long run

Another advantage of adding the assessment of progesterone level may be lowered costs. If the progesterone level is less than 6 ng/mL and we can determine with almost 100% assurance when a pregnancy is nonviable, we stand to save the costs associated with additional visits, imaging, and ß-hCG testing. The authors did not address this issue, but perhaps another study will look at it more closely.

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

It is not uncommon to see a patient in her first trimester who is experiencing abdominal pain or vaginal bleeding or both. At my institution, we use the beta human chorionic gonadotropin (ß-hCG) value in conjunction with transvaginal ultrasonography to determine whether the pregnancy is a viable intrauterine pregnancy, a missed spontaneous abortion, or an ectopic gestation. However, even a combination of modalities can be inconclusive, necessitating repeated ß-hCG measurements and several ultrasound images. For the patient, it can provoke considerable anxiety to be told to wait and see if the pregnancy will continue.

Testing will not distinguish ectopic from intrauterine gestations

In their meta-analysis, Verhaegen and colleagues focused on a single measurement of progesterone to predict the pregnancy outcome in women who experienced pain or bleeding, or both. In early pregnancy, progesterone is produced first by the corpus luteum, then by the placenta. It stands to reason that nonviable pregnancies would have a lower level.

Although measurement of the progesterone level will not help distinguish an ectopic gestation from an intrauterine pregnancy, it does help identify nonviable pregnancy. This study found that a progesterone level below 6 ng/mL excluded a viable pregnancy in 99.2% of cases. Measuring progesterone could be very helpful when the ß-hCG level is low and ultrasound imaging is inconclusive. Currently, we tell patients under these circumstances that we need more time to sort it all out—we need to establish a trend for the ß-hCG and repeat ultrasonography. However, if we added assessment of the progesterone level and it were less than 6 ng/mL, we would be able to determine with near certainty that the pregnancy is nonviable. As a result, we could provide patients with some certainty earlier than we would otherwise be able to, even if it were not the news they had hoped to hear.

When the serum progesterone level is higher than 6 ng/mL, it doesn’t guarantee a viable pregnancy. Rather, it leaves us about where we were without it—somewhat unsure as to how things will turn out.

Testing may save money in the long run

Another advantage of adding the assessment of progesterone level may be lowered costs. If the progesterone level is less than 6 ng/mL and we can determine with almost 100% assurance when a pregnancy is nonviable, we stand to save the costs associated with additional visits, imaging, and ß-hCG testing. The authors did not address this issue, but perhaps another study will look at it more closely.

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

It is not uncommon to see a patient in her first trimester who is experiencing abdominal pain or vaginal bleeding or both. At my institution, we use the beta human chorionic gonadotropin (ß-hCG) value in conjunction with transvaginal ultrasonography to determine whether the pregnancy is a viable intrauterine pregnancy, a missed spontaneous abortion, or an ectopic gestation. However, even a combination of modalities can be inconclusive, necessitating repeated ß-hCG measurements and several ultrasound images. For the patient, it can provoke considerable anxiety to be told to wait and see if the pregnancy will continue.

Testing will not distinguish ectopic from intrauterine gestations

In their meta-analysis, Verhaegen and colleagues focused on a single measurement of progesterone to predict the pregnancy outcome in women who experienced pain or bleeding, or both. In early pregnancy, progesterone is produced first by the corpus luteum, then by the placenta. It stands to reason that nonviable pregnancies would have a lower level.

Although measurement of the progesterone level will not help distinguish an ectopic gestation from an intrauterine pregnancy, it does help identify nonviable pregnancy. This study found that a progesterone level below 6 ng/mL excluded a viable pregnancy in 99.2% of cases. Measuring progesterone could be very helpful when the ß-hCG level is low and ultrasound imaging is inconclusive. Currently, we tell patients under these circumstances that we need more time to sort it all out—we need to establish a trend for the ß-hCG and repeat ultrasonography. However, if we added assessment of the progesterone level and it were less than 6 ng/mL, we would be able to determine with near certainty that the pregnancy is nonviable. As a result, we could provide patients with some certainty earlier than we would otherwise be able to, even if it were not the news they had hoped to hear.

When the serum progesterone level is higher than 6 ng/mL, it doesn’t guarantee a viable pregnancy. Rather, it leaves us about where we were without it—somewhat unsure as to how things will turn out.

Testing may save money in the long run

Another advantage of adding the assessment of progesterone level may be lowered costs. If the progesterone level is less than 6 ng/mL and we can determine with almost 100% assurance when a pregnancy is nonviable, we stand to save the costs associated with additional visits, imaging, and ß-hCG testing. The authors did not address this issue, but perhaps another study will look at it more closely.

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Cesarean delivery is both a major surgical procedure and a momentous and miraculous event in the life of a family. Historically, the medical rituals and processes common to major surgical procedures have dominated the cesarean birth process. In most obstetric units, babies born by cesarean delivery are brought to a newborn resuscitation unit, examined, cleaned, banded, administered medications, weighed, and swaddled before being introduced to the mother. In cesarean deliveries early skin to skin (STS) contact and early initiation of breastfeeding are not common.¹ In contrast, for vaginal delivery, many obstetric units have developed mother-, baby- and family-centered birth processes that emphasize immediate STS contact and the early initiation of breastfeeding.^2,3

Research indicates that the traditional surgical rituals and processes of cesarean delivery prevent mothers from connecting to important physical and emotional aspects of the birth process.⁴ Practices that prevent early maternal-infant bonding and slow the initiation of breastfeeding may result in lower breastfeeding rates at 6 months of life and impact maternal behaviors.^5,6

A new approach to cesarean delivery is the mother- and baby-centered cesarean delivery, also known as the “natural cesarean” delivery. In this approach, there is a reduced emphasis on traditional surgical rituals and an increased emphasis on facilitating the early interaction of the mother and family with their baby.^7,8 The mother- and baby-centered cesarean celebrates the momentous birth event and encourages early mother–infant bonding.

Related Article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Clinical processes that support a mother- and baby-centered approach to cesarean
The mother- and baby-centered cesarean, with its focus on early STS contact and breastfeeding, is not recommended to be used routinely:

• with preterm births
• in emergency cesarean deliveries
• in cases where the baby is at risk for a low Apgar score.

The mother- and baby-centered cesarean is an optimal approach:

• when cesarean delivery is scheduled (such as in an uncomplicated repeat cesarean)
• for a primary cesarean delivery following failure to progress in labor with a reassuring fetal heart-rate tracing.

Prepare with calming music and a video preview. Encourage the mother and family to select music to be played in the delivery room that they will find soothing.^9,10 If the cesarean is a scheduled procedure, have the mother and her support partners view a video clip of a mother- and baby-centered cesarean delivery. A 12-minute video, “The Natural Caesarean: A Woman-Centred Technique” by the Jentle Childbirth Foundation is particularly well done.

Adjust anesthesia preparations to support STS contact and early breastfeeding. To accomplish this, free the mother’s dominant arm and chest for contact with the newborn by placing the oximeter, intravenous catheter, and the blood pressure cuff on the nondominant arm. Place the echocardiogram leads on the back or far laterally to facilitate early chest contact between mother and baby.

Recent evidence does not support maternal supplemental oxygen for routine uncomplicated cesarean delivery. Consider allowing the mother to breath room air without the bothersome mask.^11,12

Use a gentle surgical technique that reduces the use of cutting, such as the Misgav Ladach cesarean technique.^13,14

Offer the mother and her support partners the option to view the birth of their baby as active participants. If the mother desires to see the birth of her newborn, use clear drapes to permit the patient to view the birth of the head of the newborn (FIGURE), or drop the drapes prior to the birth of the head of the newborn.¹⁵ Raising the head of the table can facilitate the mother’s view of the birth of her baby.

Clear drapes facilitate the mother’s view of the birth during cesarean delivery. For mothers who have enlisted the support of a doula, consider welcoming the doula along with one other support person into the operating room for the birth.

Related Article: Cost-conscious choices for minimally invasive gynecologic surgery Joseph S. Sanfilippo, MD, MBA, and Meredith L. Snook, MD (November 2013)

Slow the delivery process. Gently deliver the head and leave the baby’s body in the uterus for a few moments. Some authorities believe that the contraction of the uterus around the body of the fetus, along with the initiation of breathing and crying will help clear the fetal respiratory system of fluid. Delay cord clamping to permit autotransfusion and improve neonatal iron stores.¹⁶

Plan for immediate STS contact. Immediately transfer the baby to the mother’s chest. Dropping the surgical drapes prior to delivery will help with this transfer. If the mother’s chest is not available or accessible for any reason, consider early STS contact with the father.^17,18 Banding and vitamin K administration can be performed with the baby on the mother’s chest.

Encourage intraoperative breastfeeding. Early contact between the infant’s lips and the mother’s nipple is associated with increased initiation and duration of breastfeeding. Breastfeeding should be started as soon as a possible after birth, preferably within the first hour of life.^19,20 Weighing, measuring, and routine care for the infant can be delayed until after the first feeding is completed.

Keep the mother and baby together. Rather than separating the mother and newborn for the trip to the recovery area, have the mother cradle the newborn on her chest during the transport process.

Challenges
Transient tachypnea of the newborn. Scheduled cesarean delivery is associated with an increased risk of transient tachypnea of the newborn (TTN).²¹ In a review of more than 29,000 deliveries, the incidence of TTN was 3.1% with scheduled cesarean delivery and 1.1% with vaginal delivery.

The plan to promote early STS contact and keep the newborn with the mother may need to be altered if the newborn needs more intensive support at the resuscitation table for symptoms of TTN; symptoms are often apparent at birth, or TTN is diagnosed within 2 hours after delivery. Symptoms include:

• respiratory rate faster than 60 breaths/min (most prominent feature)
• cyanosis
• increased work to breathe (including nasal flaring, intercostal and subcostal retractions, and expiratory grunting).

The syndrome typically resolves within 12 to 72 hours after diagnosis.

Thermal regulation. Although preterm infants are at greater risk than term infants for hypothermia, some term infants will become hypothermic.²² Careful attention to ensuring that the baby is not left exposed to the cold operating room temperatures is helpful to reduce the risk of hypothermia. Early STS contact at cesarean delivery has been reported to improve maintenance of neonatal thermoregulation.²³

Monitor the safety of the baby on the mother’s chest. If the cesarean surgery triggers an episode of nausea and vomiting, the baby may need to be removed from the mother’s chest until the episode is resolved. An additional nurse may be required in the operating room to safely monitor the baby on the mother’s chest as the surgery is completed.

Additional clinicians at the head of the surgical table. Moving the initial care of the infant to the mother’s chest increases the number of clinicians who need access to the head of the surgical table; this may create a “traffic jam.” The anesthesiologist and nurse will need to cooperate to share this space, and also to include any support persons. Moreover, the operating obstetrician and assistant will need to understand that the area above the surgical field may be a bit “busier” than they are used to.

Obviously, there may be limitations in the event of any surgical or anesthetic instability. However, as long as the procedure remains uncomplicated, as most cesareans are, than early infant care at the head of the operating table, or even directly on the mother’s chest, is a very achievable goal. Educational efforts directed at all stakeholders (anesthesiologist, obstetrician, pediatric and nursing staff) will facilitate the introduction of this model of care.

It is possible.
Is it possible to transform a major surgical procedure—a cesarean delivery—into a mother-, baby- and family-centered experience? For many cesarean delivery procedures the answer is a resounding, “Yes.” Re-engineering the clinical processes that surround the traditional cesarean delivery requires the commitment and cooperation of many disciplines. Obstetricians, anesthesiologists, and maternity nurses are the leaders who must work together to facilitate this important practice change.

Cesarean delivery is both a major surgical procedure and a momentous and miraculous event in the life of a family. Historically, the medical rituals and processes common to major surgical procedures have dominated the cesarean birth process. In most obstetric units, babies born by cesarean delivery are brought to a newborn resuscitation unit, examined, cleaned, banded, administered medications, weighed, and swaddled before being introduced to the mother. In cesarean deliveries early skin to skin (STS) contact and early initiation of breastfeeding are not common.¹ In contrast, for vaginal delivery, many obstetric units have developed mother-, baby- and family-centered birth processes that emphasize immediate STS contact and the early initiation of breastfeeding.^2,3

Research indicates that the traditional surgical rituals and processes of cesarean delivery prevent mothers from connecting to important physical and emotional aspects of the birth process.⁴ Practices that prevent early maternal-infant bonding and slow the initiation of breastfeeding may result in lower breastfeeding rates at 6 months of life and impact maternal behaviors.^5,6

A new approach to cesarean delivery is the mother- and baby-centered cesarean delivery, also known as the “natural cesarean” delivery. In this approach, there is a reduced emphasis on traditional surgical rituals and an increased emphasis on facilitating the early interaction of the mother and family with their baby.^7,8 The mother- and baby-centered cesarean celebrates the momentous birth event and encourages early mother–infant bonding.

Related Article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Clinical processes that support a mother- and baby-centered approach to cesarean
The mother- and baby-centered cesarean, with its focus on early STS contact and breastfeeding, is not recommended to be used routinely:

• with preterm births
• in emergency cesarean deliveries
• in cases where the baby is at risk for a low Apgar score.

The mother- and baby-centered cesarean is an optimal approach:

• when cesarean delivery is scheduled (such as in an uncomplicated repeat cesarean)
• for a primary cesarean delivery following failure to progress in labor with a reassuring fetal heart-rate tracing.

Prepare with calming music and a video preview. Encourage the mother and family to select music to be played in the delivery room that they will find soothing.^9,10 If the cesarean is a scheduled procedure, have the mother and her support partners view a video clip of a mother- and baby-centered cesarean delivery. A 12-minute video, “The Natural Caesarean: A Woman-Centred Technique” by the Jentle Childbirth Foundation is particularly well done.

Adjust anesthesia preparations to support STS contact and early breastfeeding. To accomplish this, free the mother’s dominant arm and chest for contact with the newborn by placing the oximeter, intravenous catheter, and the blood pressure cuff on the nondominant arm. Place the echocardiogram leads on the back or far laterally to facilitate early chest contact between mother and baby.

Recent evidence does not support maternal supplemental oxygen for routine uncomplicated cesarean delivery. Consider allowing the mother to breath room air without the bothersome mask.^11,12

Use a gentle surgical technique that reduces the use of cutting, such as the Misgav Ladach cesarean technique.^13,14

Offer the mother and her support partners the option to view the birth of their baby as active participants. If the mother desires to see the birth of her newborn, use clear drapes to permit the patient to view the birth of the head of the newborn (FIGURE), or drop the drapes prior to the birth of the head of the newborn.¹⁵ Raising the head of the table can facilitate the mother’s view of the birth of her baby.

Clear drapes facilitate the mother’s view of the birth during cesarean delivery. For mothers who have enlisted the support of a doula, consider welcoming the doula along with one other support person into the operating room for the birth.

Related Article: Cost-conscious choices for minimally invasive gynecologic surgery Joseph S. Sanfilippo, MD, MBA, and Meredith L. Snook, MD (November 2013)

Slow the delivery process. Gently deliver the head and leave the baby’s body in the uterus for a few moments. Some authorities believe that the contraction of the uterus around the body of the fetus, along with the initiation of breathing and crying will help clear the fetal respiratory system of fluid. Delay cord clamping to permit autotransfusion and improve neonatal iron stores.¹⁶

Plan for immediate STS contact. Immediately transfer the baby to the mother’s chest. Dropping the surgical drapes prior to delivery will help with this transfer. If the mother’s chest is not available or accessible for any reason, consider early STS contact with the father.^17,18 Banding and vitamin K administration can be performed with the baby on the mother’s chest.

Encourage intraoperative breastfeeding. Early contact between the infant’s lips and the mother’s nipple is associated with increased initiation and duration of breastfeeding. Breastfeeding should be started as soon as a possible after birth, preferably within the first hour of life.^19,20 Weighing, measuring, and routine care for the infant can be delayed until after the first feeding is completed.

Keep the mother and baby together. Rather than separating the mother and newborn for the trip to the recovery area, have the mother cradle the newborn on her chest during the transport process.

Challenges
Transient tachypnea of the newborn. Scheduled cesarean delivery is associated with an increased risk of transient tachypnea of the newborn (TTN).²¹ In a review of more than 29,000 deliveries, the incidence of TTN was 3.1% with scheduled cesarean delivery and 1.1% with vaginal delivery.

The plan to promote early STS contact and keep the newborn with the mother may need to be altered if the newborn needs more intensive support at the resuscitation table for symptoms of TTN; symptoms are often apparent at birth, or TTN is diagnosed within 2 hours after delivery. Symptoms include:

• respiratory rate faster than 60 breaths/min (most prominent feature)
• cyanosis
• increased work to breathe (including nasal flaring, intercostal and subcostal retractions, and expiratory grunting).

The syndrome typically resolves within 12 to 72 hours after diagnosis.

Thermal regulation. Although preterm infants are at greater risk than term infants for hypothermia, some term infants will become hypothermic.²² Careful attention to ensuring that the baby is not left exposed to the cold operating room temperatures is helpful to reduce the risk of hypothermia. Early STS contact at cesarean delivery has been reported to improve maintenance of neonatal thermoregulation.²³

Monitor the safety of the baby on the mother’s chest. If the cesarean surgery triggers an episode of nausea and vomiting, the baby may need to be removed from the mother’s chest until the episode is resolved. An additional nurse may be required in the operating room to safely monitor the baby on the mother’s chest as the surgery is completed.

Additional clinicians at the head of the surgical table. Moving the initial care of the infant to the mother’s chest increases the number of clinicians who need access to the head of the surgical table; this may create a “traffic jam.” The anesthesiologist and nurse will need to cooperate to share this space, and also to include any support persons. Moreover, the operating obstetrician and assistant will need to understand that the area above the surgical field may be a bit “busier” than they are used to.

Obviously, there may be limitations in the event of any surgical or anesthetic instability. However, as long as the procedure remains uncomplicated, as most cesareans are, than early infant care at the head of the operating table, or even directly on the mother’s chest, is a very achievable goal. Educational efforts directed at all stakeholders (anesthesiologist, obstetrician, pediatric and nursing staff) will facilitate the introduction of this model of care.

It is possible.
Is it possible to transform a major surgical procedure—a cesarean delivery—into a mother-, baby- and family-centered experience? For many cesarean delivery procedures the answer is a resounding, “Yes.” Re-engineering the clinical processes that surround the traditional cesarean delivery requires the commitment and cooperation of many disciplines. Obstetricians, anesthesiologists, and maternity nurses are the leaders who must work together to facilitate this important practice change.

Cesarean delivery is both a major surgical procedure and a momentous and miraculous event in the life of a family. Historically, the medical rituals and processes common to major surgical procedures have dominated the cesarean birth process. In most obstetric units, babies born by cesarean delivery are brought to a newborn resuscitation unit, examined, cleaned, banded, administered medications, weighed, and swaddled before being introduced to the mother. In cesarean deliveries early skin to skin (STS) contact and early initiation of breastfeeding are not common.¹ In contrast, for vaginal delivery, many obstetric units have developed mother-, baby- and family-centered birth processes that emphasize immediate STS contact and the early initiation of breastfeeding.^2,3

Research indicates that the traditional surgical rituals and processes of cesarean delivery prevent mothers from connecting to important physical and emotional aspects of the birth process.⁴ Practices that prevent early maternal-infant bonding and slow the initiation of breastfeeding may result in lower breastfeeding rates at 6 months of life and impact maternal behaviors.^5,6

A new approach to cesarean delivery is the mother- and baby-centered cesarean delivery, also known as the “natural cesarean” delivery. In this approach, there is a reduced emphasis on traditional surgical rituals and an increased emphasis on facilitating the early interaction of the mother and family with their baby.^7,8 The mother- and baby-centered cesarean celebrates the momentous birth event and encourages early mother–infant bonding.

Related Article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Clinical processes that support a mother- and baby-centered approach to cesarean
The mother- and baby-centered cesarean, with its focus on early STS contact and breastfeeding, is not recommended to be used routinely:

• with preterm births
• in emergency cesarean deliveries
• in cases where the baby is at risk for a low Apgar score.

The mother- and baby-centered cesarean is an optimal approach:

• when cesarean delivery is scheduled (such as in an uncomplicated repeat cesarean)
• for a primary cesarean delivery following failure to progress in labor with a reassuring fetal heart-rate tracing.

Prepare with calming music and a video preview. Encourage the mother and family to select music to be played in the delivery room that they will find soothing.^9,10 If the cesarean is a scheduled procedure, have the mother and her support partners view a video clip of a mother- and baby-centered cesarean delivery. A 12-minute video, “The Natural Caesarean: A Woman-Centred Technique” by the Jentle Childbirth Foundation is particularly well done.

Adjust anesthesia preparations to support STS contact and early breastfeeding. To accomplish this, free the mother’s dominant arm and chest for contact with the newborn by placing the oximeter, intravenous catheter, and the blood pressure cuff on the nondominant arm. Place the echocardiogram leads on the back or far laterally to facilitate early chest contact between mother and baby.

Recent evidence does not support maternal supplemental oxygen for routine uncomplicated cesarean delivery. Consider allowing the mother to breath room air without the bothersome mask.^11,12

Use a gentle surgical technique that reduces the use of cutting, such as the Misgav Ladach cesarean technique.^13,14

Offer the mother and her support partners the option to view the birth of their baby as active participants. If the mother desires to see the birth of her newborn, use clear drapes to permit the patient to view the birth of the head of the newborn (FIGURE), or drop the drapes prior to the birth of the head of the newborn.¹⁵ Raising the head of the table can facilitate the mother’s view of the birth of her baby.

Clear drapes facilitate the mother’s view of the birth during cesarean delivery. For mothers who have enlisted the support of a doula, consider welcoming the doula along with one other support person into the operating room for the birth.

Related Article: Cost-conscious choices for minimally invasive gynecologic surgery Joseph S. Sanfilippo, MD, MBA, and Meredith L. Snook, MD (November 2013)

Slow the delivery process. Gently deliver the head and leave the baby’s body in the uterus for a few moments. Some authorities believe that the contraction of the uterus around the body of the fetus, along with the initiation of breathing and crying will help clear the fetal respiratory system of fluid. Delay cord clamping to permit autotransfusion and improve neonatal iron stores.¹⁶

Plan for immediate STS contact. Immediately transfer the baby to the mother’s chest. Dropping the surgical drapes prior to delivery will help with this transfer. If the mother’s chest is not available or accessible for any reason, consider early STS contact with the father.^17,18 Banding and vitamin K administration can be performed with the baby on the mother’s chest.

Encourage intraoperative breastfeeding. Early contact between the infant’s lips and the mother’s nipple is associated with increased initiation and duration of breastfeeding. Breastfeeding should be started as soon as a possible after birth, preferably within the first hour of life.^19,20 Weighing, measuring, and routine care for the infant can be delayed until after the first feeding is completed.

Keep the mother and baby together. Rather than separating the mother and newborn for the trip to the recovery area, have the mother cradle the newborn on her chest during the transport process.

Challenges
Transient tachypnea of the newborn. Scheduled cesarean delivery is associated with an increased risk of transient tachypnea of the newborn (TTN).²¹ In a review of more than 29,000 deliveries, the incidence of TTN was 3.1% with scheduled cesarean delivery and 1.1% with vaginal delivery.

The plan to promote early STS contact and keep the newborn with the mother may need to be altered if the newborn needs more intensive support at the resuscitation table for symptoms of TTN; symptoms are often apparent at birth, or TTN is diagnosed within 2 hours after delivery. Symptoms include:

• respiratory rate faster than 60 breaths/min (most prominent feature)
• cyanosis
• increased work to breathe (including nasal flaring, intercostal and subcostal retractions, and expiratory grunting).

The syndrome typically resolves within 12 to 72 hours after diagnosis.

Thermal regulation. Although preterm infants are at greater risk than term infants for hypothermia, some term infants will become hypothermic.²² Careful attention to ensuring that the baby is not left exposed to the cold operating room temperatures is helpful to reduce the risk of hypothermia. Early STS contact at cesarean delivery has been reported to improve maintenance of neonatal thermoregulation.²³

Monitor the safety of the baby on the mother’s chest. If the cesarean surgery triggers an episode of nausea and vomiting, the baby may need to be removed from the mother’s chest until the episode is resolved. An additional nurse may be required in the operating room to safely monitor the baby on the mother’s chest as the surgery is completed.

Additional clinicians at the head of the surgical table. Moving the initial care of the infant to the mother’s chest increases the number of clinicians who need access to the head of the surgical table; this may create a “traffic jam.” The anesthesiologist and nurse will need to cooperate to share this space, and also to include any support persons. Moreover, the operating obstetrician and assistant will need to understand that the area above the surgical field may be a bit “busier” than they are used to.

Obviously, there may be limitations in the event of any surgical or anesthetic instability. However, as long as the procedure remains uncomplicated, as most cesareans are, than early infant care at the head of the operating table, or even directly on the mother’s chest, is a very achievable goal. Educational efforts directed at all stakeholders (anesthesiologist, obstetrician, pediatric and nursing staff) will facilitate the introduction of this model of care.

It is possible.
Is it possible to transform a major surgical procedure—a cesarean delivery—into a mother-, baby- and family-centered experience? For many cesarean delivery procedures the answer is a resounding, “Yes.” Re-engineering the clinical processes that surround the traditional cesarean delivery requires the commitment and cooperation of many disciplines. Obstetricians, anesthesiologists, and maternity nurses are the leaders who must work together to facilitate this important practice change.