Obstetrics

VANCOUVER, B.C. – Despite agreeing to use birth control and receiving frequent counseling about pregnancy avoidance, a sizable share of teens with type 2 diabetes mellitus become pregnant, and these pregnancies often have poor outcomes, researchers reported at the World Diabetes Congress.

The analysis was based on 452 female participants in the national Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, the largest trial in youth with this form of diabetes to date and one designed to have good representation of various racial/ethnic groups.

Overall, 10% of the girls became pregnant during a period of up to 6.5 years. The majority were not using contraception and did not recall the counseling. More than one-fourth of the pregnancies ended in fetal loss or stillbirth. And one-fifth of live-born infants had major congenital anomalies.

“We need to better understand the reasons for pregnancy in youth with type 2 diabetes and why, despite counseling, they become pregnant,” commented first author Dr. Kristen J. Nadeau of the division of pediatric endocrinology, department of pediatrics, University of Colorado, Aurora.

“Best practices for metabolically unhealthy pregnancy prevention in type 2 diabetic teens also requires further study,” she added. “Long-acting contraception, we think, currently is the best method and likely the way to go in these girls who are not retaining the education and [adhering to] the behaviors that we are hoping for.”

“This study is critically important and horribly depressing,” commented session comoderator Dr. Robert E. Ratner, professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association, Alexandria, Va.

“It points out the difficulties of being a teenager and the even greater difficulties of being a teenager with a chronic disease,” he said in an interview, adding that there are no easy solutions.

“The combination of a teen pregnancy in someone with type 2 diabetes creates the perfect storm,” Dr. Nadeau noted. “Diabetes control is worse in adolescence than in any other time in the lifespan, and with increasing rates of type 2 diabetes in youth, increases in a teen pregnancy that are complicated by diabetes are anticipated,” she added.

At baseline, participants in TODAY were 10-17 years old, were overweight or obese, and had a diabetes duration of less than 2 years and a hemoglobin A_1c level of less than 8%. They were randomized to three treatment arms (metformin alone, metformin plus rosiglitazone, or metformin plus an intensive lifestyle program).

Consent for the trial required the use of a birth control method, including abstinence; in addition, every 2-3 months, the girls received diabetes education and counseling to defer pregnancy until their HbA_1c level fell below 6%. They also had regular pregnancy testing, and those with a positive result were taken off their trial medication and referred to a maternal-fetal medicine specialist.

The results reported at the meeting and simultaneously published in Diabetes Care (doi: 10.2337/dc15-1206) showed that 46 (10.2%) of the girls had 63 pregnancies. On average, they were 18 years old at the time of a first pregnancy.

Despite the counseling, only about 5% of those teens who became pregnant reported that they had been using contraception. Moreover, just 13% recalled the counseling.

The median body mass index closest to conception was 35.2 kg/m², and the median HbA_1c level was 7%. “Because of the fact that we were so heavily monitoring these girls, we had their HbA_1c under better control than is typical. In our typical clinic, the mean is more like 8.5%-9%,” Dr. Nadeau noted.

Relative to peers who did not become pregnant, those who did were significantly older, were less likely to be living with both parents or their mother, and had a lower household income.

Seven of the 63 pregnancies were electively terminated. Of the 53 remaining pregnancies with data, 12 ended in pregnancy loss and 2 ended in a stillbirth.

Among the 39 live-born infants, 6 were preterm and 8 had major congenital anomalies. And among the 37 with known birth weight, 10 were either small or large for gestational age.

Girls randomized to metformin plus rosiglitazone had a higher rate of term normal births than peers in the other arms (P = .027). “Of note, none of the participants reported taking the rosiglitazone after the pregnancy was discovered, as was per the study protocol,” Dr. Nadeau commented. In contrast, neither maternal body mass index nor – surprisingly – HbA_1c level was significantly associated with pregnancy outcome.

The rate of preterm birth observed in the teens studied was similar to what has been seen in adult women with diabetes, she noted. But the rate of major congenital anomalies was about four times higher.

“This potentially might be due to lower overall socioeconomic status of the girls in the TODAY study. Other reasons for the anomalies are uncertain, but might include metabolic control, smoking, or extreme obesity,” she said.

Dr. Nadeau disclosed that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Despite agreeing to use birth control and receiving frequent counseling about pregnancy avoidance, a sizable share of teens with type 2 diabetes mellitus become pregnant, and these pregnancies often have poor outcomes, researchers reported at the World Diabetes Congress.

The analysis was based on 452 female participants in the national Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, the largest trial in youth with this form of diabetes to date and one designed to have good representation of various racial/ethnic groups.

Overall, 10% of the girls became pregnant during a period of up to 6.5 years. The majority were not using contraception and did not recall the counseling. More than one-fourth of the pregnancies ended in fetal loss or stillbirth. And one-fifth of live-born infants had major congenital anomalies.

“We need to better understand the reasons for pregnancy in youth with type 2 diabetes and why, despite counseling, they become pregnant,” commented first author Dr. Kristen J. Nadeau of the division of pediatric endocrinology, department of pediatrics, University of Colorado, Aurora.

“Best practices for metabolically unhealthy pregnancy prevention in type 2 diabetic teens also requires further study,” she added. “Long-acting contraception, we think, currently is the best method and likely the way to go in these girls who are not retaining the education and [adhering to] the behaviors that we are hoping for.”

“This study is critically important and horribly depressing,” commented session comoderator Dr. Robert E. Ratner, professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association, Alexandria, Va.

“It points out the difficulties of being a teenager and the even greater difficulties of being a teenager with a chronic disease,” he said in an interview, adding that there are no easy solutions.

“The combination of a teen pregnancy in someone with type 2 diabetes creates the perfect storm,” Dr. Nadeau noted. “Diabetes control is worse in adolescence than in any other time in the lifespan, and with increasing rates of type 2 diabetes in youth, increases in a teen pregnancy that are complicated by diabetes are anticipated,” she added.

At baseline, participants in TODAY were 10-17 years old, were overweight or obese, and had a diabetes duration of less than 2 years and a hemoglobin A_1c level of less than 8%. They were randomized to three treatment arms (metformin alone, metformin plus rosiglitazone, or metformin plus an intensive lifestyle program).

Consent for the trial required the use of a birth control method, including abstinence; in addition, every 2-3 months, the girls received diabetes education and counseling to defer pregnancy until their HbA_1c level fell below 6%. They also had regular pregnancy testing, and those with a positive result were taken off their trial medication and referred to a maternal-fetal medicine specialist.

The results reported at the meeting and simultaneously published in Diabetes Care (doi: 10.2337/dc15-1206) showed that 46 (10.2%) of the girls had 63 pregnancies. On average, they were 18 years old at the time of a first pregnancy.

Despite the counseling, only about 5% of those teens who became pregnant reported that they had been using contraception. Moreover, just 13% recalled the counseling.

The median body mass index closest to conception was 35.2 kg/m², and the median HbA_1c level was 7%. “Because of the fact that we were so heavily monitoring these girls, we had their HbA_1c under better control than is typical. In our typical clinic, the mean is more like 8.5%-9%,” Dr. Nadeau noted.

Relative to peers who did not become pregnant, those who did were significantly older, were less likely to be living with both parents or their mother, and had a lower household income.

Seven of the 63 pregnancies were electively terminated. Of the 53 remaining pregnancies with data, 12 ended in pregnancy loss and 2 ended in a stillbirth.

Among the 39 live-born infants, 6 were preterm and 8 had major congenital anomalies. And among the 37 with known birth weight, 10 were either small or large for gestational age.

Girls randomized to metformin plus rosiglitazone had a higher rate of term normal births than peers in the other arms (P = .027). “Of note, none of the participants reported taking the rosiglitazone after the pregnancy was discovered, as was per the study protocol,” Dr. Nadeau commented. In contrast, neither maternal body mass index nor – surprisingly – HbA_1c level was significantly associated with pregnancy outcome.

The rate of preterm birth observed in the teens studied was similar to what has been seen in adult women with diabetes, she noted. But the rate of major congenital anomalies was about four times higher.

“This potentially might be due to lower overall socioeconomic status of the girls in the TODAY study. Other reasons for the anomalies are uncertain, but might include metabolic control, smoking, or extreme obesity,” she said.

Dr. Nadeau disclosed that she had no relevant conflicts of interest.

VANCOUVER, B.C. – Despite agreeing to use birth control and receiving frequent counseling about pregnancy avoidance, a sizable share of teens with type 2 diabetes mellitus become pregnant, and these pregnancies often have poor outcomes, researchers reported at the World Diabetes Congress.

The analysis was based on 452 female participants in the national Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, the largest trial in youth with this form of diabetes to date and one designed to have good representation of various racial/ethnic groups.

Overall, 10% of the girls became pregnant during a period of up to 6.5 years. The majority were not using contraception and did not recall the counseling. More than one-fourth of the pregnancies ended in fetal loss or stillbirth. And one-fifth of live-born infants had major congenital anomalies.

“We need to better understand the reasons for pregnancy in youth with type 2 diabetes and why, despite counseling, they become pregnant,” commented first author Dr. Kristen J. Nadeau of the division of pediatric endocrinology, department of pediatrics, University of Colorado, Aurora.

“Best practices for metabolically unhealthy pregnancy prevention in type 2 diabetic teens also requires further study,” she added. “Long-acting contraception, we think, currently is the best method and likely the way to go in these girls who are not retaining the education and [adhering to] the behaviors that we are hoping for.”

“This study is critically important and horribly depressing,” commented session comoderator Dr. Robert E. Ratner, professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association, Alexandria, Va.

“It points out the difficulties of being a teenager and the even greater difficulties of being a teenager with a chronic disease,” he said in an interview, adding that there are no easy solutions.

“The combination of a teen pregnancy in someone with type 2 diabetes creates the perfect storm,” Dr. Nadeau noted. “Diabetes control is worse in adolescence than in any other time in the lifespan, and with increasing rates of type 2 diabetes in youth, increases in a teen pregnancy that are complicated by diabetes are anticipated,” she added.

At baseline, participants in TODAY were 10-17 years old, were overweight or obese, and had a diabetes duration of less than 2 years and a hemoglobin A_1c level of less than 8%. They were randomized to three treatment arms (metformin alone, metformin plus rosiglitazone, or metformin plus an intensive lifestyle program).

Consent for the trial required the use of a birth control method, including abstinence; in addition, every 2-3 months, the girls received diabetes education and counseling to defer pregnancy until their HbA_1c level fell below 6%. They also had regular pregnancy testing, and those with a positive result were taken off their trial medication and referred to a maternal-fetal medicine specialist.

The results reported at the meeting and simultaneously published in Diabetes Care (doi: 10.2337/dc15-1206) showed that 46 (10.2%) of the girls had 63 pregnancies. On average, they were 18 years old at the time of a first pregnancy.

Despite the counseling, only about 5% of those teens who became pregnant reported that they had been using contraception. Moreover, just 13% recalled the counseling.

The median body mass index closest to conception was 35.2 kg/m², and the median HbA_1c level was 7%. “Because of the fact that we were so heavily monitoring these girls, we had their HbA_1c under better control than is typical. In our typical clinic, the mean is more like 8.5%-9%,” Dr. Nadeau noted.

Relative to peers who did not become pregnant, those who did were significantly older, were less likely to be living with both parents or their mother, and had a lower household income.

Seven of the 63 pregnancies were electively terminated. Of the 53 remaining pregnancies with data, 12 ended in pregnancy loss and 2 ended in a stillbirth.

Among the 39 live-born infants, 6 were preterm and 8 had major congenital anomalies. And among the 37 with known birth weight, 10 were either small or large for gestational age.

Girls randomized to metformin plus rosiglitazone had a higher rate of term normal births than peers in the other arms (P = .027). “Of note, none of the participants reported taking the rosiglitazone after the pregnancy was discovered, as was per the study protocol,” Dr. Nadeau commented. In contrast, neither maternal body mass index nor – surprisingly – HbA_1c level was significantly associated with pregnancy outcome.

The rate of preterm birth observed in the teens studied was similar to what has been seen in adult women with diabetes, she noted. But the rate of major congenital anomalies was about four times higher.

“This potentially might be due to lower overall socioeconomic status of the girls in the TODAY study. Other reasons for the anomalies are uncertain, but might include metabolic control, smoking, or extreme obesity,” she said.

Dr. Nadeau disclosed that she had no relevant conflicts of interest.

Steroids and hydroxychloroquine remain the most widely prescribed treatment options for pregnant women with rheumatologic diseases, according to a study looking at prescribing patterns in a cohort of women diagnosed with systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Lead investigator Dr. Rishi J. Desai of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and his colleagues found that the use of biologic agents during pregnancy, though still low, rose for 2,645 women from all regions of the United States covered by private insurance or Medicaid between 2001 and 2012. The investigators evaluated prescription filling records for steroids, nonbiologic disease-modifying agents, and biologics. The women in the study all had live births. Dr. Desai and his colleagues looked at scripts for individual agents filled in the 3-month period prior to each woman’s pregnancy and during her pregnancy (Arthritis Rheumatol. 2015 Nov 25. doi: 10.1002/art.39521).

©monkeybusinessimages/thinkstock.com

Nearly two-thirds of women with psoriatic arthritis or ankylosing spondylitis stopped filling immunomodulatory prescriptions during their pregnancies, while only 26% of lupus and 34.5% of rheumatoid arthritis patients did so. In the cohort as a whole, steroids and hydroxychloroquine were the most frequently used agents in pregnancy (48.4% and 27.1%, respectively). Steroid use during pregnancy dropped over time, from 54.4 per 100 deliveries to 42.4 between 2001 and 2012, while rates for biologics increased from 5.1 per 100 to 16.6 (P less than .001 for both trends).

“More comparative research on the safety of steroids as well as disease-modifying agents used during pregnancy will be critical for providing the necessary evidence to guide treatment decisions in future,” Dr. Desai and his colleagues wrote in their analysis.

The findings also suggest, the investigators wrote, “that with availability of some reassuring data indicating absence of a major fetal adverse event after biologic use in pregnancy, physicians have become more comfortable with continuing treatment with these agents.”

Use of agents potentially harmful to a developing fetus, including methotrexate, mycophenolate mofetil, and leflunomide, was very low in the study. However, the investigators noted, because their study enrolled only women with successful pregnancies, it could have underestimated the use of some of these agents, as women using them may have chosen to terminate their pregnancies.

The study received no outside funding. Two coauthors reported financial relationships with AstraZeneca, and one of them also reported funding from Pfizer and Eli Lilly.

Steroids and hydroxychloroquine remain the most widely prescribed treatment options for pregnant women with rheumatologic diseases, according to a study looking at prescribing patterns in a cohort of women diagnosed with systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Lead investigator Dr. Rishi J. Desai of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and his colleagues found that the use of biologic agents during pregnancy, though still low, rose for 2,645 women from all regions of the United States covered by private insurance or Medicaid between 2001 and 2012. The investigators evaluated prescription filling records for steroids, nonbiologic disease-modifying agents, and biologics. The women in the study all had live births. Dr. Desai and his colleagues looked at scripts for individual agents filled in the 3-month period prior to each woman’s pregnancy and during her pregnancy (Arthritis Rheumatol. 2015 Nov 25. doi: 10.1002/art.39521).

©monkeybusinessimages/thinkstock.com

Nearly two-thirds of women with psoriatic arthritis or ankylosing spondylitis stopped filling immunomodulatory prescriptions during their pregnancies, while only 26% of lupus and 34.5% of rheumatoid arthritis patients did so. In the cohort as a whole, steroids and hydroxychloroquine were the most frequently used agents in pregnancy (48.4% and 27.1%, respectively). Steroid use during pregnancy dropped over time, from 54.4 per 100 deliveries to 42.4 between 2001 and 2012, while rates for biologics increased from 5.1 per 100 to 16.6 (P less than .001 for both trends).

“More comparative research on the safety of steroids as well as disease-modifying agents used during pregnancy will be critical for providing the necessary evidence to guide treatment decisions in future,” Dr. Desai and his colleagues wrote in their analysis.

The findings also suggest, the investigators wrote, “that with availability of some reassuring data indicating absence of a major fetal adverse event after biologic use in pregnancy, physicians have become more comfortable with continuing treatment with these agents.”

Use of agents potentially harmful to a developing fetus, including methotrexate, mycophenolate mofetil, and leflunomide, was very low in the study. However, the investigators noted, because their study enrolled only women with successful pregnancies, it could have underestimated the use of some of these agents, as women using them may have chosen to terminate their pregnancies.

The study received no outside funding. Two coauthors reported financial relationships with AstraZeneca, and one of them also reported funding from Pfizer and Eli Lilly.

Steroids and hydroxychloroquine remain the most widely prescribed treatment options for pregnant women with rheumatologic diseases, according to a study looking at prescribing patterns in a cohort of women diagnosed with systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Lead investigator Dr. Rishi J. Desai of Brigham and Women’s Hospital and Harvard Medical School, both in Boston, and his colleagues found that the use of biologic agents during pregnancy, though still low, rose for 2,645 women from all regions of the United States covered by private insurance or Medicaid between 2001 and 2012. The investigators evaluated prescription filling records for steroids, nonbiologic disease-modifying agents, and biologics. The women in the study all had live births. Dr. Desai and his colleagues looked at scripts for individual agents filled in the 3-month period prior to each woman’s pregnancy and during her pregnancy (Arthritis Rheumatol. 2015 Nov 25. doi: 10.1002/art.39521).

©monkeybusinessimages/thinkstock.com

Nearly two-thirds of women with psoriatic arthritis or ankylosing spondylitis stopped filling immunomodulatory prescriptions during their pregnancies, while only 26% of lupus and 34.5% of rheumatoid arthritis patients did so. In the cohort as a whole, steroids and hydroxychloroquine were the most frequently used agents in pregnancy (48.4% and 27.1%, respectively). Steroid use during pregnancy dropped over time, from 54.4 per 100 deliveries to 42.4 between 2001 and 2012, while rates for biologics increased from 5.1 per 100 to 16.6 (P less than .001 for both trends).

“More comparative research on the safety of steroids as well as disease-modifying agents used during pregnancy will be critical for providing the necessary evidence to guide treatment decisions in future,” Dr. Desai and his colleagues wrote in their analysis.

The findings also suggest, the investigators wrote, “that with availability of some reassuring data indicating absence of a major fetal adverse event after biologic use in pregnancy, physicians have become more comfortable with continuing treatment with these agents.”

Use of agents potentially harmful to a developing fetus, including methotrexate, mycophenolate mofetil, and leflunomide, was very low in the study. However, the investigators noted, because their study enrolled only women with successful pregnancies, it could have underestimated the use of some of these agents, as women using them may have chosen to terminate their pregnancies.

The study received no outside funding. Two coauthors reported financial relationships with AstraZeneca, and one of them also reported funding from Pfizer and Eli Lilly.

The risk of stillbirth increases linearly with interpregnancy weight gain, according to a Swedish population-based cohort study.

The researchers found that between-pregnancy weight gain greater than four body mass index units – about 11 kg or 24 lbs – was associated with more than a 50% increase in stillbirth risk in a second pregnancy, even after controlling for confounders such as maternal education and smoking.

©JGI/Thinkstock.com

The Swedish study of 456,711 women who had their first and second singleton births between 1992 and 2012 showed an increased risk of infant mortality for women who had a healthy weight in their first pregnancy and then gained weight. For those that gained between two and four body mass index (BMI) units, the relative risk was 27%, compared with stable weight women. There was a 60% increased risk of infant mortality among women who gained more than four BMI units, according to the findings published online in the Lancet on Dec. 2.

Each BMI unit corresponds to about 2.8 kg (6 lbs) in an average height woman (167 cm, or 5 feet 5 inches).

Already overweight women did not show an increased risk of infant mortality with weight gain, but did show significantly reduced infant mortality with weight loss greater than two BMI units between pregnancies (relative risk 0.49; 95% confidence interval, 0.27-0.88). But that same weight loss in healthy-weight women increased the risk of infant mortality (Lancet. 2015 Dec 2. doi: 10.1016/S0140-6736(15)00990-3).

“Obesity and weight gain are associated with inflammatory upregulation, and inflammation has been proposed as one mechanism for the associations between maternal overweight and obesity and several adverse pregnancy outcomes,” wrote Dr. Sven Cnattingius, from the Karolinska Institute, Stockholm, and Dr. Eduardo Villamor from the University of Michigan, Ann Arbor.

The study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Karolinska Institute. The researchers reported having no financial disclosures. 

The risk of stillbirth increases linearly with interpregnancy weight gain, according to a Swedish population-based cohort study.

The researchers found that between-pregnancy weight gain greater than four body mass index units – about 11 kg or 24 lbs – was associated with more than a 50% increase in stillbirth risk in a second pregnancy, even after controlling for confounders such as maternal education and smoking.

©JGI/Thinkstock.com

The Swedish study of 456,711 women who had their first and second singleton births between 1992 and 2012 showed an increased risk of infant mortality for women who had a healthy weight in their first pregnancy and then gained weight. For those that gained between two and four body mass index (BMI) units, the relative risk was 27%, compared with stable weight women. There was a 60% increased risk of infant mortality among women who gained more than four BMI units, according to the findings published online in the Lancet on Dec. 2.

Each BMI unit corresponds to about 2.8 kg (6 lbs) in an average height woman (167 cm, or 5 feet 5 inches).

Already overweight women did not show an increased risk of infant mortality with weight gain, but did show significantly reduced infant mortality with weight loss greater than two BMI units between pregnancies (relative risk 0.49; 95% confidence interval, 0.27-0.88). But that same weight loss in healthy-weight women increased the risk of infant mortality (Lancet. 2015 Dec 2. doi: 10.1016/S0140-6736(15)00990-3).

“Obesity and weight gain are associated with inflammatory upregulation, and inflammation has been proposed as one mechanism for the associations between maternal overweight and obesity and several adverse pregnancy outcomes,” wrote Dr. Sven Cnattingius, from the Karolinska Institute, Stockholm, and Dr. Eduardo Villamor from the University of Michigan, Ann Arbor.

The study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Karolinska Institute. The researchers reported having no financial disclosures. 

The risk of stillbirth increases linearly with interpregnancy weight gain, according to a Swedish population-based cohort study.

The researchers found that between-pregnancy weight gain greater than four body mass index units – about 11 kg or 24 lbs – was associated with more than a 50% increase in stillbirth risk in a second pregnancy, even after controlling for confounders such as maternal education and smoking.

©JGI/Thinkstock.com

The Swedish study of 456,711 women who had their first and second singleton births between 1992 and 2012 showed an increased risk of infant mortality for women who had a healthy weight in their first pregnancy and then gained weight. For those that gained between two and four body mass index (BMI) units, the relative risk was 27%, compared with stable weight women. There was a 60% increased risk of infant mortality among women who gained more than four BMI units, according to the findings published online in the Lancet on Dec. 2.

Each BMI unit corresponds to about 2.8 kg (6 lbs) in an average height woman (167 cm, or 5 feet 5 inches).

Already overweight women did not show an increased risk of infant mortality with weight gain, but did show significantly reduced infant mortality with weight loss greater than two BMI units between pregnancies (relative risk 0.49; 95% confidence interval, 0.27-0.88). But that same weight loss in healthy-weight women increased the risk of infant mortality (Lancet. 2015 Dec 2. doi: 10.1016/S0140-6736(15)00990-3).

“Obesity and weight gain are associated with inflammatory upregulation, and inflammation has been proposed as one mechanism for the associations between maternal overweight and obesity and several adverse pregnancy outcomes,” wrote Dr. Sven Cnattingius, from the Karolinska Institute, Stockholm, and Dr. Eduardo Villamor from the University of Michigan, Ann Arbor.

The study was supported by the Swedish Research Council for Health, Working Life and Welfare, and the Karolinska Institute. The researchers reported having no financial disclosures. 

Administering flu vaccines to pregnant women during their second and third trimesters results in high seroprotection against all influenza strains for most women and for more than half of their newly born babies, reported Dr. M.P. Kostinov and colleagues at the I.I. Mechnikov Scientific Research Institute of Vaccines and Sera, at Ul’yanovsk State University, Moscow. The study was published in the Journal of Vaccines & Vaccination.

Researchers gave influenza vaccines (the Grippol Plus vaccine) to 27 women in their second trimesters and 21 women in their third trimesters of pregnancy during 2010-2012. Each 0.5-mL dose of the preservative-free vaccine contained antigens of the following strains: A/California/7/2009/H1N1/v-like (5 mcg), A/H₃N₂/(Victoria)-like (5 mcg), and B/Brisbane-like (5 mcg) flu.

kdshutterman/Thinkstock.com

Within 1 month after vaccination, the seroprotection rate against all influenza strains was above the recommended threshold level of 1:40 in more than 70% of pregnant women. A gradual decrease in the seroprotection rates against all three influenza strains was reported in the postpartum period.

In infants, protective levels of antibodies were detected within 2-3 days of delivery and ranged from 52% to 62% regardless of the trimester when the vaccination was given. Within 3 months, this seroprotection decreased, and within 6 months it disappeared. The mothers’ protective levels against vaccine strains were 46%-65% after delivery.

Read the article in the Journal of Vaccines & Vaccination (Pakhomov et al. J Vaccines Vaccin. 2015,6:5).

Administering flu vaccines to pregnant women during their second and third trimesters results in high seroprotection against all influenza strains for most women and for more than half of their newly born babies, reported Dr. M.P. Kostinov and colleagues at the I.I. Mechnikov Scientific Research Institute of Vaccines and Sera, at Ul’yanovsk State University, Moscow. The study was published in the Journal of Vaccines & Vaccination.

Researchers gave influenza vaccines (the Grippol Plus vaccine) to 27 women in their second trimesters and 21 women in their third trimesters of pregnancy during 2010-2012. Each 0.5-mL dose of the preservative-free vaccine contained antigens of the following strains: A/California/7/2009/H1N1/v-like (5 mcg), A/H₃N₂/(Victoria)-like (5 mcg), and B/Brisbane-like (5 mcg) flu.

kdshutterman/Thinkstock.com

Within 1 month after vaccination, the seroprotection rate against all influenza strains was above the recommended threshold level of 1:40 in more than 70% of pregnant women. A gradual decrease in the seroprotection rates against all three influenza strains was reported in the postpartum period.

In infants, protective levels of antibodies were detected within 2-3 days of delivery and ranged from 52% to 62% regardless of the trimester when the vaccination was given. Within 3 months, this seroprotection decreased, and within 6 months it disappeared. The mothers’ protective levels against vaccine strains were 46%-65% after delivery.

Read the article in the Journal of Vaccines & Vaccination (Pakhomov et al. J Vaccines Vaccin. 2015,6:5).

Administering flu vaccines to pregnant women during their second and third trimesters results in high seroprotection against all influenza strains for most women and for more than half of their newly born babies, reported Dr. M.P. Kostinov and colleagues at the I.I. Mechnikov Scientific Research Institute of Vaccines and Sera, at Ul’yanovsk State University, Moscow. The study was published in the Journal of Vaccines & Vaccination.

Researchers gave influenza vaccines (the Grippol Plus vaccine) to 27 women in their second trimesters and 21 women in their third trimesters of pregnancy during 2010-2012. Each 0.5-mL dose of the preservative-free vaccine contained antigens of the following strains: A/California/7/2009/H1N1/v-like (5 mcg), A/H₃N₂/(Victoria)-like (5 mcg), and B/Brisbane-like (5 mcg) flu.

kdshutterman/Thinkstock.com

Within 1 month after vaccination, the seroprotection rate against all influenza strains was above the recommended threshold level of 1:40 in more than 70% of pregnant women. A gradual decrease in the seroprotection rates against all three influenza strains was reported in the postpartum period.

In infants, protective levels of antibodies were detected within 2-3 days of delivery and ranged from 52% to 62% regardless of the trimester when the vaccination was given. Within 3 months, this seroprotection decreased, and within 6 months it disappeared. The mothers’ protective levels against vaccine strains were 46%-65% after delivery.

Read the article in the Journal of Vaccines & Vaccination (Pakhomov et al. J Vaccines Vaccin. 2015,6:5).

Countries with a cesarean delivery rate as high as 19% have lower maternal and neonatal mortality, compared with countries that have higher c-section rates, according to a report published online Dec. 1 in JAMA.

The findings suggest that the current World Health Organization (WHO) recommendation that national rates of cesarean delivery shouldn’t exceed 10%-15% of live births may be setting the target rate too low, according to Dr. George Molina of Ariadne Labs at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, and his associates.

“The WHO recommendation that population level cesarean delivery rates should not exceed 10%-15% was a consensus opinion based on the observation that some countries with the lowest perinatal mortality rates had cesarean delivery rates that were less than 10/100 live births,” the researchers wrote. “Prior studies suggesting that lower cesarean delivery rate thresholds were optimal for maternal and neonatal mortality were incomplete because they examined data from limited sets of countries and often examined outcomes in wealthier countries.”

Martin Valigursky/Thinkstock.com

The researchers estimated that globally, the number of cesarean deliveries was 22.9 million in 2012 for a global cesarean delivery rate of 19.4/100 live births.

Cesarean delivery rates of up to 19.1/100 live births were inversely correlated with the maternal mortality ratio at the country level, and cesarean delivery rates of up to 19.4/100 live births were inversely correlated with the neonatal mortality ratio.

Dr. Molina and his colleagues analyzed the most recent information concerning modes of delivery, per capita health expenditures, life expectancy, and numerous other related factors using several multinational health databases. The goal was to estimate national rates of cesarean delivery and relate those figures to maternal and neonatal mortality for as many countries as possible, focusing on the most recent single year (2012) for which adequate data were available.

A sensitivity analysis of the 76 countries with the highest-quality cesarean delivery rate information showed that cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio. Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (JAMA. 2015 Dec 1;314[21]:2263-70. doi: 10.1001/jama.2015.15553).

The researchers noted that they focused solely on mortality and did not assess other health outcomes. This means that they could not address the many possible benefits of cesarean delivery, such as reduced morbidity from complicated vaginal delivery or from prolonged obstructed labor.

In a separate report, a different research group found that children born by planned cesarean delivery, as compared with vaginal delivery, had a slightly increased risk of asthma requiring hospital admission, of needing a prescription for a salbutamol inhaler at age 5 years, and of all-cause mortality by age 21 years.

Dr. Mairead Blackof the University of Aberdeen (England) and her associates examined the relationship between planned cesarean delivery and chronic illness and death among the offspring. They assessed outcomes in 321,287 singleton live births to first-time mothers that occurred in Scotland in 1993-2007; the children were followed until January 2015, for a mean follow-up of 14.8 years.

In this cohort, 12,355 children (3.8%) were born by planned cesarean delivery, 56,015 (17.5%) by unscheduled cesarean, and 252,917 (78.7%) by vaginal delivery.

Children born by planned C-sections were slightly, but significantly more likely than were those born vaginally to develop asthma requiring hospital admission (3.73% vs. 3.41%; hazard ratio, 1.22).

Compared with children delivered vaginally, those delivered by planned cesarean section also were slightly, but significantly more likely to require a prescription for a salbutamol inhaler at age 5 years (10.34% vs. 9.62%; HR, 1.13) and to die before the age of 21 years(0.40% vs. 0.32%; HR, 1.41).

However, there were no significant differences between the two study groups in risk of developing inflammatory bowel disease (0.11% vs. 0.13%) or cancer (0.23% vs 0.21%), they noted (JAMA. 2015 Dec 1;314[21]:2271-9. doi: 10.1001/jama.2015.16176).

These findings “suggest that avoidance of vaginal birth may be an important early-life factor in the growing global burden of asthma, although absolute increase in risk to individuals is low,” Dr. Black and her associates wrote.

The researchers in both studies reported having no relevant financial disclosures. Dr. Black’s study was supported in part by the Wellcome Trust. 

Countries with a cesarean delivery rate as high as 19% have lower maternal and neonatal mortality, compared with countries that have higher c-section rates, according to a report published online Dec. 1 in JAMA.

The findings suggest that the current World Health Organization (WHO) recommendation that national rates of cesarean delivery shouldn’t exceed 10%-15% of live births may be setting the target rate too low, according to Dr. George Molina of Ariadne Labs at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, and his associates.

“The WHO recommendation that population level cesarean delivery rates should not exceed 10%-15% was a consensus opinion based on the observation that some countries with the lowest perinatal mortality rates had cesarean delivery rates that were less than 10/100 live births,” the researchers wrote. “Prior studies suggesting that lower cesarean delivery rate thresholds were optimal for maternal and neonatal mortality were incomplete because they examined data from limited sets of countries and often examined outcomes in wealthier countries.”

Martin Valigursky/Thinkstock.com

The researchers estimated that globally, the number of cesarean deliveries was 22.9 million in 2012 for a global cesarean delivery rate of 19.4/100 live births.

Cesarean delivery rates of up to 19.1/100 live births were inversely correlated with the maternal mortality ratio at the country level, and cesarean delivery rates of up to 19.4/100 live births were inversely correlated with the neonatal mortality ratio.

Dr. Molina and his colleagues analyzed the most recent information concerning modes of delivery, per capita health expenditures, life expectancy, and numerous other related factors using several multinational health databases. The goal was to estimate national rates of cesarean delivery and relate those figures to maternal and neonatal mortality for as many countries as possible, focusing on the most recent single year (2012) for which adequate data were available.

A sensitivity analysis of the 76 countries with the highest-quality cesarean delivery rate information showed that cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio. Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (JAMA. 2015 Dec 1;314[21]:2263-70. doi: 10.1001/jama.2015.15553).

The researchers noted that they focused solely on mortality and did not assess other health outcomes. This means that they could not address the many possible benefits of cesarean delivery, such as reduced morbidity from complicated vaginal delivery or from prolonged obstructed labor.

In a separate report, a different research group found that children born by planned cesarean delivery, as compared with vaginal delivery, had a slightly increased risk of asthma requiring hospital admission, of needing a prescription for a salbutamol inhaler at age 5 years, and of all-cause mortality by age 21 years.

Dr. Mairead Blackof the University of Aberdeen (England) and her associates examined the relationship between planned cesarean delivery and chronic illness and death among the offspring. They assessed outcomes in 321,287 singleton live births to first-time mothers that occurred in Scotland in 1993-2007; the children were followed until January 2015, for a mean follow-up of 14.8 years.

In this cohort, 12,355 children (3.8%) were born by planned cesarean delivery, 56,015 (17.5%) by unscheduled cesarean, and 252,917 (78.7%) by vaginal delivery.

Children born by planned C-sections were slightly, but significantly more likely than were those born vaginally to develop asthma requiring hospital admission (3.73% vs. 3.41%; hazard ratio, 1.22).

Compared with children delivered vaginally, those delivered by planned cesarean section also were slightly, but significantly more likely to require a prescription for a salbutamol inhaler at age 5 years (10.34% vs. 9.62%; HR, 1.13) and to die before the age of 21 years(0.40% vs. 0.32%; HR, 1.41).

However, there were no significant differences between the two study groups in risk of developing inflammatory bowel disease (0.11% vs. 0.13%) or cancer (0.23% vs 0.21%), they noted (JAMA. 2015 Dec 1;314[21]:2271-9. doi: 10.1001/jama.2015.16176).

These findings “suggest that avoidance of vaginal birth may be an important early-life factor in the growing global burden of asthma, although absolute increase in risk to individuals is low,” Dr. Black and her associates wrote.

The researchers in both studies reported having no relevant financial disclosures. Dr. Black’s study was supported in part by the Wellcome Trust. 

Countries with a cesarean delivery rate as high as 19% have lower maternal and neonatal mortality, compared with countries that have higher c-section rates, according to a report published online Dec. 1 in JAMA.

The findings suggest that the current World Health Organization (WHO) recommendation that national rates of cesarean delivery shouldn’t exceed 10%-15% of live births may be setting the target rate too low, according to Dr. George Molina of Ariadne Labs at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, and his associates.

“The WHO recommendation that population level cesarean delivery rates should not exceed 10%-15% was a consensus opinion based on the observation that some countries with the lowest perinatal mortality rates had cesarean delivery rates that were less than 10/100 live births,” the researchers wrote. “Prior studies suggesting that lower cesarean delivery rate thresholds were optimal for maternal and neonatal mortality were incomplete because they examined data from limited sets of countries and often examined outcomes in wealthier countries.”

Martin Valigursky/Thinkstock.com

The researchers estimated that globally, the number of cesarean deliveries was 22.9 million in 2012 for a global cesarean delivery rate of 19.4/100 live births.

Cesarean delivery rates of up to 19.1/100 live births were inversely correlated with the maternal mortality ratio at the country level, and cesarean delivery rates of up to 19.4/100 live births were inversely correlated with the neonatal mortality ratio.

Dr. Molina and his colleagues analyzed the most recent information concerning modes of delivery, per capita health expenditures, life expectancy, and numerous other related factors using several multinational health databases. The goal was to estimate national rates of cesarean delivery and relate those figures to maternal and neonatal mortality for as many countries as possible, focusing on the most recent single year (2012) for which adequate data were available.

A sensitivity analysis of the 76 countries with the highest-quality cesarean delivery rate information showed that cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio. Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (JAMA. 2015 Dec 1;314[21]:2263-70. doi: 10.1001/jama.2015.15553).

The researchers noted that they focused solely on mortality and did not assess other health outcomes. This means that they could not address the many possible benefits of cesarean delivery, such as reduced morbidity from complicated vaginal delivery or from prolonged obstructed labor.

In a separate report, a different research group found that children born by planned cesarean delivery, as compared with vaginal delivery, had a slightly increased risk of asthma requiring hospital admission, of needing a prescription for a salbutamol inhaler at age 5 years, and of all-cause mortality by age 21 years.

Dr. Mairead Blackof the University of Aberdeen (England) and her associates examined the relationship between planned cesarean delivery and chronic illness and death among the offspring. They assessed outcomes in 321,287 singleton live births to first-time mothers that occurred in Scotland in 1993-2007; the children were followed until January 2015, for a mean follow-up of 14.8 years.

In this cohort, 12,355 children (3.8%) were born by planned cesarean delivery, 56,015 (17.5%) by unscheduled cesarean, and 252,917 (78.7%) by vaginal delivery.

Children born by planned C-sections were slightly, but significantly more likely than were those born vaginally to develop asthma requiring hospital admission (3.73% vs. 3.41%; hazard ratio, 1.22).

Compared with children delivered vaginally, those delivered by planned cesarean section also were slightly, but significantly more likely to require a prescription for a salbutamol inhaler at age 5 years (10.34% vs. 9.62%; HR, 1.13) and to die before the age of 21 years(0.40% vs. 0.32%; HR, 1.41).

However, there were no significant differences between the two study groups in risk of developing inflammatory bowel disease (0.11% vs. 0.13%) or cancer (0.23% vs 0.21%), they noted (JAMA. 2015 Dec 1;314[21]:2271-9. doi: 10.1001/jama.2015.16176).

These findings “suggest that avoidance of vaginal birth may be an important early-life factor in the growing global burden of asthma, although absolute increase in risk to individuals is low,” Dr. Black and her associates wrote.

The researchers in both studies reported having no relevant financial disclosures. Dr. Black’s study was supported in part by the Wellcome Trust. 

“SHOULD THE 30-MINUTE RULE FOR EMERGENT CESAREAN DELIVERY BE APPLIED UNIVERSALLY?”

“Where is it safe to practice obstetrics?” is a broader question Drs. Chauhan and Mendez-Figueroa presented a thoughtful series of case studies. Unfortunately, the cases were intended for the considerate ObGyn—the one who can appreciate that every case has a differing set of variables—and did not account for the context and legal environment in which we practice. In the theater that is our malpractice reality, these cases would carry little weight with a jury that is empathizing with a child with cerebral palsy, often years after the event.

“Where is it safe to practice obstetrics?” is a broader, and perhaps more interesting, question. And a more relevant case would involve a smaller hospital, perhaps in a rural area, that does not have in-house anesthesia available for 30-minute starts.

Daniel R. Szekely, MD, PhD
Tacoma, Washington

We are hoisted on a petard of our own makingThere is absolutely no justification for ObGyns being held to this so-called “standard of care.” The evidence is scant or lacking that delivery in a 30-minute timeframe has any significant bearing on the neonatal outcome. Despite this, the lay public and medical-legal community see this as an absolute rule to be followed. If there is a less-than-perfect outcome, we are hoisted on this petard of our own making.

We as a group (that is, the American College of Obstetricians and  
Gynecologists) need to work to right this unfortunate wrong!

William H. Deschner, MD
Seattle, Washington

Practicing is downright scary
The “30-minute rule” is no help to ObGyns in the field. At a community hospital, where surgical teams are called in from home (we cannot afford to do otherwise), it is often impossible to meet this standard. University-level care even cannot meet the measure at times. We never should have been painted into this corner. Now, any attempts to loosen the rule will be seen as trying to practice defensive medicine.

People who do not do what we do for a living have no concept of the anxiety and sleep loss we incur while seeking the best outcomes for our patients. I long for the soon-to-come day when I retire. Due to the litigious environment, I am saddened that I cannot heartily recommend the field to young doctors.

James Nunn, MD
Chicago, Illinois

“UPDATE ON VAGINAL HYSTERECTOMY”
BARBARA S. LEVY, MD (SEPTEMBER 2015)

Why has TAH remained the dominant hysterectomy route for generations?I read with great interest Dr. Levy’s recent comments on the benefits of new technology to improve the vaginal hysterectomy (VH) rate. Thank you and Dr. Levy for all the work you have done to advance the care of our patients. I have some other fundamental concerns about the future of hysterectomy.

Why has total abdominal hysterectomy (TAH) remained the dominant route of hysterectomy for generations? Why have past efforts to minimize TAH met with limited results?

Dr. Levy maintains in her article that, “the biggest barrier to widespread use [of VH] may simply be the lack of industry support.” What industry has supported TAH in a manner not also applicable to VH?

What do the techniques in Dr. Levy’s article and the efforts by ACOG and other authorities¹ offer that will materially increase the adoption of VH?  What evidence is there that the use of such devices as VITOM system will overcome the low rate of VH? How much training is required before a surgeon can realize patient-centered benefit from using the VITOM or other new devices during VH?

The lack of evidence-based training and implementation of robotic surgery has resulted in well-deserved criticism of robotics, centered, in part, around complications. Will the complication rate rise as those who do not perform VH transition to its adoption using VITOM and other devices?

I hope that the generations-long failure of all efforts to raise the VH rate is overcome with evidence-based educational protocols.

Antonio R. Pizarro, MD
Shreveport, Louisiana

Reference
1. Bosworth T. ACOG taking steps to increase vaginal hysterectomy rates. Ob.Gyn. News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=392609&cHash=d78b8bea4aa3483c10dc5d843207d211. Posted April 6, 2015. Accessed October 2, 2015.

The problem: lack of trainingSadly, lack of training is the problem in this best approach to removing the benign uterus. These tools are helpful and should be in the surgeon’s armamentarium. We need experienced vaginal surgeons to teach this procedure. In some ways, just as much skill and dexterity are needed as with laparoscopic or robotic methods.

William H. Deschner, MD
Seattle, Washington

Dr. Levy respondsI appreciate the insightful comments of Drs. Pizarro and Deschner. Clearly,  as the volume of hysterectomies has decreased and the number of techniques we must teach our residents has expanded, we are challenged to provide robust training in all hysterectomy routes. TAH, as the status quo, has not required the development of new equipment and technology, whereas assisting gynecologic surgeons to convert open procedures to minimally invasive approaches has been advanced and driven by our industry partners.

I totally agree with the concern that we cannot rely on historic data to determine the safest and most cost-effective route for hysterectomy. I encourage all of us to track and publically report our outcomes and monitor the complication rates of gynecologic surgical procedures. Our ongoing commitment to delivering the best care for our patients requires nothing less.

“REDUCING MATERNAL MORTALITY IN THE UNITED STATES—LET’S GET ORGANIZED!”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2015)

Structured business methods will improve outcomesDr. Barbieri’s call for getting organized and breaking down health care silos while establishing multidisciplinary teams is of great importance. Most providers have not witnessed a maternal mortality in their careers and many are not aware of the near misses. Incorporating foundations of established business methods has been advocated to reduce waste, improve collaboration, decrease variance, and improve patient safety.

If we view the adverse outcomes through this lens, then the increase in maternal mortality and morbidity are lagging indicators in the structured analysis methods (such as Six Sigma and Lean Six Sigma). These methods lead us to focus and measure the leading indicators of input and process (prenatal care and pregnancy management). Our reliance on lagging indicators often comes too late to make any change effective.

Around 1973, several important processes were introduced into obstetric practice: fetal heart-rate monitoring; ultrasonography; and a reduction of the use of forceps with an increase in the use of vacuum extraction. Safety rates improved, but we witnessed the 8% cesarean delivery rate in 1973 rise to 32% in 2013.^1,2 The maternal mortality rate reported in 2013 is now the same as it was in 1973. A corresponding increase in the cesarean delivery rate over this time frame could be inferred.

By focusing on analysis and management of variables in pregnancy and implementing standardization of care based on good evidence from all disciplines involved in patient safety, we can improve maternal mortality. Simulations and debriefings are critical instruments to enhance management of all aspects of prenatal management, particularly emergent care.

As leaders in improving maternal quality, ObGyns must implement structured business methods (input and process analysis) to improve outcomes. A culture also can be positively altered if the mission and vision are clearly elucidated. Transparent, dynamic, granular, accurate, and reliable data will facilitate “buy-in” of the caregivers and provide more successful solutions. Decreased variance is critical. Expect resistance due to provider autonomy. The alteration in culture of the multidisciplinary team takes time, but a reduction in cesarean delivery rates should be number one on the list to reduce maternal mortality. The unintended consequences of all interventions and monitoring methods also should be pursued.

Robert A. Knuppel, MD, MPH, MBA
Naples, Florida
Judith Withers, RN, MN, MBA
San Diego, California

References
1. Blanchette E. The rising cesarean delivery rate in America. Obstet Gynecol. 2011;118(3):687–690.
2. Knuppel RA. Personal review of Centers for Disease Control and Prevention, National Vital Statistics Reports, 1973–2015.

Dr. Barbieri respondsI wholeheartedly agree with Dr. Knuppel and Ms. Withers: increasing the use of high reliability clinical processes is critically important in our quest to reduce maternal mortality. In addition to decreasing the cesarean delivery rate, I would prioritize ensuring the use of highly effective contraceptives by women with serious medical comorbidities that increase their risk of maternal mortality.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“SHOULD THE 30-MINUTE RULE FOR EMERGENT CESAREAN DELIVERY BE APPLIED UNIVERSALLY?”

“Where is it safe to practice obstetrics?” is a broader question Drs. Chauhan and Mendez-Figueroa presented a thoughtful series of case studies. Unfortunately, the cases were intended for the considerate ObGyn—the one who can appreciate that every case has a differing set of variables—and did not account for the context and legal environment in which we practice. In the theater that is our malpractice reality, these cases would carry little weight with a jury that is empathizing with a child with cerebral palsy, often years after the event.

“Where is it safe to practice obstetrics?” is a broader, and perhaps more interesting, question. And a more relevant case would involve a smaller hospital, perhaps in a rural area, that does not have in-house anesthesia available for 30-minute starts.

Daniel R. Szekely, MD, PhD
Tacoma, Washington

We are hoisted on a petard of our own makingThere is absolutely no justification for ObGyns being held to this so-called “standard of care.” The evidence is scant or lacking that delivery in a 30-minute timeframe has any significant bearing on the neonatal outcome. Despite this, the lay public and medical-legal community see this as an absolute rule to be followed. If there is a less-than-perfect outcome, we are hoisted on this petard of our own making.

We as a group (that is, the American College of Obstetricians and  
Gynecologists) need to work to right this unfortunate wrong!

William H. Deschner, MD
Seattle, Washington

Practicing is downright scary
The “30-minute rule” is no help to ObGyns in the field. At a community hospital, where surgical teams are called in from home (we cannot afford to do otherwise), it is often impossible to meet this standard. University-level care even cannot meet the measure at times. We never should have been painted into this corner. Now, any attempts to loosen the rule will be seen as trying to practice defensive medicine.

People who do not do what we do for a living have no concept of the anxiety and sleep loss we incur while seeking the best outcomes for our patients. I long for the soon-to-come day when I retire. Due to the litigious environment, I am saddened that I cannot heartily recommend the field to young doctors.

James Nunn, MD
Chicago, Illinois

“UPDATE ON VAGINAL HYSTERECTOMY”
BARBARA S. LEVY, MD (SEPTEMBER 2015)

Why has TAH remained the dominant hysterectomy route for generations?I read with great interest Dr. Levy’s recent comments on the benefits of new technology to improve the vaginal hysterectomy (VH) rate. Thank you and Dr. Levy for all the work you have done to advance the care of our patients. I have some other fundamental concerns about the future of hysterectomy.

Why has total abdominal hysterectomy (TAH) remained the dominant route of hysterectomy for generations? Why have past efforts to minimize TAH met with limited results?

Dr. Levy maintains in her article that, “the biggest barrier to widespread use [of VH] may simply be the lack of industry support.” What industry has supported TAH in a manner not also applicable to VH?

What do the techniques in Dr. Levy’s article and the efforts by ACOG and other authorities¹ offer that will materially increase the adoption of VH?  What evidence is there that the use of such devices as VITOM system will overcome the low rate of VH? How much training is required before a surgeon can realize patient-centered benefit from using the VITOM or other new devices during VH?

The lack of evidence-based training and implementation of robotic surgery has resulted in well-deserved criticism of robotics, centered, in part, around complications. Will the complication rate rise as those who do not perform VH transition to its adoption using VITOM and other devices?

I hope that the generations-long failure of all efforts to raise the VH rate is overcome with evidence-based educational protocols.

Antonio R. Pizarro, MD
Shreveport, Louisiana

Reference
1. Bosworth T. ACOG taking steps to increase vaginal hysterectomy rates. Ob.Gyn. News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=392609&cHash=d78b8bea4aa3483c10dc5d843207d211. Posted April 6, 2015. Accessed October 2, 2015.

The problem: lack of trainingSadly, lack of training is the problem in this best approach to removing the benign uterus. These tools are helpful and should be in the surgeon’s armamentarium. We need experienced vaginal surgeons to teach this procedure. In some ways, just as much skill and dexterity are needed as with laparoscopic or robotic methods.

William H. Deschner, MD
Seattle, Washington

Dr. Levy respondsI appreciate the insightful comments of Drs. Pizarro and Deschner. Clearly,  as the volume of hysterectomies has decreased and the number of techniques we must teach our residents has expanded, we are challenged to provide robust training in all hysterectomy routes. TAH, as the status quo, has not required the development of new equipment and technology, whereas assisting gynecologic surgeons to convert open procedures to minimally invasive approaches has been advanced and driven by our industry partners.

I totally agree with the concern that we cannot rely on historic data to determine the safest and most cost-effective route for hysterectomy. I encourage all of us to track and publically report our outcomes and monitor the complication rates of gynecologic surgical procedures. Our ongoing commitment to delivering the best care for our patients requires nothing less.

“REDUCING MATERNAL MORTALITY IN THE UNITED STATES—LET’S GET ORGANIZED!”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2015)

Structured business methods will improve outcomesDr. Barbieri’s call for getting organized and breaking down health care silos while establishing multidisciplinary teams is of great importance. Most providers have not witnessed a maternal mortality in their careers and many are not aware of the near misses. Incorporating foundations of established business methods has been advocated to reduce waste, improve collaboration, decrease variance, and improve patient safety.

If we view the adverse outcomes through this lens, then the increase in maternal mortality and morbidity are lagging indicators in the structured analysis methods (such as Six Sigma and Lean Six Sigma). These methods lead us to focus and measure the leading indicators of input and process (prenatal care and pregnancy management). Our reliance on lagging indicators often comes too late to make any change effective.

Around 1973, several important processes were introduced into obstetric practice: fetal heart-rate monitoring; ultrasonography; and a reduction of the use of forceps with an increase in the use of vacuum extraction. Safety rates improved, but we witnessed the 8% cesarean delivery rate in 1973 rise to 32% in 2013.^1,2 The maternal mortality rate reported in 2013 is now the same as it was in 1973. A corresponding increase in the cesarean delivery rate over this time frame could be inferred.

By focusing on analysis and management of variables in pregnancy and implementing standardization of care based on good evidence from all disciplines involved in patient safety, we can improve maternal mortality. Simulations and debriefings are critical instruments to enhance management of all aspects of prenatal management, particularly emergent care.

As leaders in improving maternal quality, ObGyns must implement structured business methods (input and process analysis) to improve outcomes. A culture also can be positively altered if the mission and vision are clearly elucidated. Transparent, dynamic, granular, accurate, and reliable data will facilitate “buy-in” of the caregivers and provide more successful solutions. Decreased variance is critical. Expect resistance due to provider autonomy. The alteration in culture of the multidisciplinary team takes time, but a reduction in cesarean delivery rates should be number one on the list to reduce maternal mortality. The unintended consequences of all interventions and monitoring methods also should be pursued.

Robert A. Knuppel, MD, MPH, MBA
Naples, Florida
Judith Withers, RN, MN, MBA
San Diego, California

References
1. Blanchette E. The rising cesarean delivery rate in America. Obstet Gynecol. 2011;118(3):687–690.
2. Knuppel RA. Personal review of Centers for Disease Control and Prevention, National Vital Statistics Reports, 1973–2015.

Dr. Barbieri respondsI wholeheartedly agree with Dr. Knuppel and Ms. Withers: increasing the use of high reliability clinical processes is critically important in our quest to reduce maternal mortality. In addition to decreasing the cesarean delivery rate, I would prioritize ensuring the use of highly effective contraceptives by women with serious medical comorbidities that increase their risk of maternal mortality.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

“SHOULD THE 30-MINUTE RULE FOR EMERGENT CESAREAN DELIVERY BE APPLIED UNIVERSALLY?”

“Where is it safe to practice obstetrics?” is a broader question Drs. Chauhan and Mendez-Figueroa presented a thoughtful series of case studies. Unfortunately, the cases were intended for the considerate ObGyn—the one who can appreciate that every case has a differing set of variables—and did not account for the context and legal environment in which we practice. In the theater that is our malpractice reality, these cases would carry little weight with a jury that is empathizing with a child with cerebral palsy, often years after the event.

“Where is it safe to practice obstetrics?” is a broader, and perhaps more interesting, question. And a more relevant case would involve a smaller hospital, perhaps in a rural area, that does not have in-house anesthesia available for 30-minute starts.

Daniel R. Szekely, MD, PhD
Tacoma, Washington

We are hoisted on a petard of our own makingThere is absolutely no justification for ObGyns being held to this so-called “standard of care.” The evidence is scant or lacking that delivery in a 30-minute timeframe has any significant bearing on the neonatal outcome. Despite this, the lay public and medical-legal community see this as an absolute rule to be followed. If there is a less-than-perfect outcome, we are hoisted on this petard of our own making.

We as a group (that is, the American College of Obstetricians and  
Gynecologists) need to work to right this unfortunate wrong!

William H. Deschner, MD
Seattle, Washington

Practicing is downright scary
The “30-minute rule” is no help to ObGyns in the field. At a community hospital, where surgical teams are called in from home (we cannot afford to do otherwise), it is often impossible to meet this standard. University-level care even cannot meet the measure at times. We never should have been painted into this corner. Now, any attempts to loosen the rule will be seen as trying to practice defensive medicine.

People who do not do what we do for a living have no concept of the anxiety and sleep loss we incur while seeking the best outcomes for our patients. I long for the soon-to-come day when I retire. Due to the litigious environment, I am saddened that I cannot heartily recommend the field to young doctors.

James Nunn, MD
Chicago, Illinois

“UPDATE ON VAGINAL HYSTERECTOMY”
BARBARA S. LEVY, MD (SEPTEMBER 2015)

Why has TAH remained the dominant hysterectomy route for generations?I read with great interest Dr. Levy’s recent comments on the benefits of new technology to improve the vaginal hysterectomy (VH) rate. Thank you and Dr. Levy for all the work you have done to advance the care of our patients. I have some other fundamental concerns about the future of hysterectomy.

Why has total abdominal hysterectomy (TAH) remained the dominant route of hysterectomy for generations? Why have past efforts to minimize TAH met with limited results?

Dr. Levy maintains in her article that, “the biggest barrier to widespread use [of VH] may simply be the lack of industry support.” What industry has supported TAH in a manner not also applicable to VH?

What do the techniques in Dr. Levy’s article and the efforts by ACOG and other authorities¹ offer that will materially increase the adoption of VH?  What evidence is there that the use of such devices as VITOM system will overcome the low rate of VH? How much training is required before a surgeon can realize patient-centered benefit from using the VITOM or other new devices during VH?

The lack of evidence-based training and implementation of robotic surgery has resulted in well-deserved criticism of robotics, centered, in part, around complications. Will the complication rate rise as those who do not perform VH transition to its adoption using VITOM and other devices?

I hope that the generations-long failure of all efforts to raise the VH rate is overcome with evidence-based educational protocols.

Antonio R. Pizarro, MD
Shreveport, Louisiana

Reference
1. Bosworth T. ACOG taking steps to increase vaginal hysterectomy rates. Ob.Gyn. News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=392609&cHash=d78b8bea4aa3483c10dc5d843207d211. Posted April 6, 2015. Accessed October 2, 2015.

The problem: lack of trainingSadly, lack of training is the problem in this best approach to removing the benign uterus. These tools are helpful and should be in the surgeon’s armamentarium. We need experienced vaginal surgeons to teach this procedure. In some ways, just as much skill and dexterity are needed as with laparoscopic or robotic methods.

William H. Deschner, MD
Seattle, Washington

Dr. Levy respondsI appreciate the insightful comments of Drs. Pizarro and Deschner. Clearly,  as the volume of hysterectomies has decreased and the number of techniques we must teach our residents has expanded, we are challenged to provide robust training in all hysterectomy routes. TAH, as the status quo, has not required the development of new equipment and technology, whereas assisting gynecologic surgeons to convert open procedures to minimally invasive approaches has been advanced and driven by our industry partners.

I totally agree with the concern that we cannot rely on historic data to determine the safest and most cost-effective route for hysterectomy. I encourage all of us to track and publically report our outcomes and monitor the complication rates of gynecologic surgical procedures. Our ongoing commitment to delivering the best care for our patients requires nothing less.

“REDUCING MATERNAL MORTALITY IN THE UNITED STATES—LET’S GET ORGANIZED!”
ROBERT L. BARBIERI, MD (EDITORIAL; SEPTEMBER 2015)

Structured business methods will improve outcomesDr. Barbieri’s call for getting organized and breaking down health care silos while establishing multidisciplinary teams is of great importance. Most providers have not witnessed a maternal mortality in their careers and many are not aware of the near misses. Incorporating foundations of established business methods has been advocated to reduce waste, improve collaboration, decrease variance, and improve patient safety.

If we view the adverse outcomes through this lens, then the increase in maternal mortality and morbidity are lagging indicators in the structured analysis methods (such as Six Sigma and Lean Six Sigma). These methods lead us to focus and measure the leading indicators of input and process (prenatal care and pregnancy management). Our reliance on lagging indicators often comes too late to make any change effective.

Around 1973, several important processes were introduced into obstetric practice: fetal heart-rate monitoring; ultrasonography; and a reduction of the use of forceps with an increase in the use of vacuum extraction. Safety rates improved, but we witnessed the 8% cesarean delivery rate in 1973 rise to 32% in 2013.^1,2 The maternal mortality rate reported in 2013 is now the same as it was in 1973. A corresponding increase in the cesarean delivery rate over this time frame could be inferred.

By focusing on analysis and management of variables in pregnancy and implementing standardization of care based on good evidence from all disciplines involved in patient safety, we can improve maternal mortality. Simulations and debriefings are critical instruments to enhance management of all aspects of prenatal management, particularly emergent care.

As leaders in improving maternal quality, ObGyns must implement structured business methods (input and process analysis) to improve outcomes. A culture also can be positively altered if the mission and vision are clearly elucidated. Transparent, dynamic, granular, accurate, and reliable data will facilitate “buy-in” of the caregivers and provide more successful solutions. Decreased variance is critical. Expect resistance due to provider autonomy. The alteration in culture of the multidisciplinary team takes time, but a reduction in cesarean delivery rates should be number one on the list to reduce maternal mortality. The unintended consequences of all interventions and monitoring methods also should be pursued.

Robert A. Knuppel, MD, MPH, MBA
Naples, Florida
Judith Withers, RN, MN, MBA
San Diego, California

References
1. Blanchette E. The rising cesarean delivery rate in America. Obstet Gynecol. 2011;118(3):687–690.
2. Knuppel RA. Personal review of Centers for Disease Control and Prevention, National Vital Statistics Reports, 1973–2015.

Dr. Barbieri respondsI wholeheartedly agree with Dr. Knuppel and Ms. Withers: increasing the use of high reliability clinical processes is critically important in our quest to reduce maternal mortality. In addition to decreasing the cesarean delivery rate, I would prioritize ensuring the use of highly effective contraceptives by women with serious medical comorbidities that increase their risk of maternal mortality.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

SAN FRANCISCO – It might be best to keep women with rheumatoid arthritis on their tumor necrosis factor blockers during pregnancy, according to German investigators.

They found that women are likely to flare without them and need more prednisolone, which is associated with preterm birth and other problems, while an increasing body of evidence suggests that tumor necrosis factor inhibitors (TNFis) are relatively safe during pregnancy.

“We should” rethink discontinuing TNFis during pregnancy, as recommended in some quarters. “We do not want women to flare during pregnancy,” said investigator Dr. Rebecca Fischer-Betz of the department of rheumatology at Heinrich Heine University in Düsseldorf.

She and her colleagues compared birth outcomes in 18 rheumatoid arthritis (RA) patients who discontinued TNFi treatment shortly after they got pregnant against those of 24 women with RA who were never exposed to a TNFi because, in general, they had less severe disease.

Twelve of the women (75%) in the TNFi group flared, versus four women (17%) in the control group. Although patients in both groups started with a mean 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) below 3.0, women in the TNFi group had a rise in activity to a mean of about 3.5 in the second trimester, while disease activity in control patients remained stable.

Compared with controls, women who stopped TNFis were also far more likely to flare (odds ratio, 10.0; 95% confidence interval, 2.3-42.8; P = .002), even after adjusting for age, DAS28-CRP at conception, rheumatoid factor and cyclic citrullinated peptide status, and other potential confounders. They also relied more heavily on prednisolone, taking, for example, a mean dose of 13 mg in the second trimester versus 8 mg in the control group. Perhaps not surprisingly, the mean duration of pregnancy was 37 weeks in the TNFi group, with six women (33%) delivering at or before 37 weeks; women in the control group delivered, on average, at 39 weeks, with four (17%) delivering at or before week 37.

The investigators found that the risk of preterm birth increased with every cumulative milligram of prednisolone (OR, 1.08; 95% CI, 1.02-1.15; P less than .01).

“Women with RA who discontinue TNFis at conception face a high risk for flares during pregnancy, independently of known risk factors like seropositivity. Flares are usually treated with prednisolone. We found a dose-dependent, significant increased risk for preterm birth associated with prednisolone. In this era of treat-to-target management of RA, our paradigm for RA pregnancy management may need adjusting. By controlling RA activity with medications considered relatively safe in pregnancy, we may be able to improve both the pregnancy experience and pregnancy outcomes,” the investigators concluded.

The women were 33 years old on average, and all had live births; four early miscarriages were excluded from analysis. All the pregnancies were planned, with methotrexate discontinued at least 3 months before conception. There was no statistical difference in the rate of seropositivity between the groups, “which is interesting because we know seropositivity is a risk factor for staying active during pregnancy,” Dr. Fischer-Betz said.

Two boys born to women who took TNFis had minor malformations, one with nasal bone aplasia, retrognathia, and hydronephrosis, and the other with hypospadias. Both of their mothers had taken etanercept (Enbrel) in the first trimester. There was one malformation in the control group, a girl born with hydronephrosis.

There was no outside funding for the work, and the investigators have no disclosures.

[email protected]

SAN FRANCISCO – It might be best to keep women with rheumatoid arthritis on their tumor necrosis factor blockers during pregnancy, according to German investigators.

They found that women are likely to flare without them and need more prednisolone, which is associated with preterm birth and other problems, while an increasing body of evidence suggests that tumor necrosis factor inhibitors (TNFis) are relatively safe during pregnancy.

“We should” rethink discontinuing TNFis during pregnancy, as recommended in some quarters. “We do not want women to flare during pregnancy,” said investigator Dr. Rebecca Fischer-Betz of the department of rheumatology at Heinrich Heine University in Düsseldorf.

She and her colleagues compared birth outcomes in 18 rheumatoid arthritis (RA) patients who discontinued TNFi treatment shortly after they got pregnant against those of 24 women with RA who were never exposed to a TNFi because, in general, they had less severe disease.

Twelve of the women (75%) in the TNFi group flared, versus four women (17%) in the control group. Although patients in both groups started with a mean 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) below 3.0, women in the TNFi group had a rise in activity to a mean of about 3.5 in the second trimester, while disease activity in control patients remained stable.

Compared with controls, women who stopped TNFis were also far more likely to flare (odds ratio, 10.0; 95% confidence interval, 2.3-42.8; P = .002), even after adjusting for age, DAS28-CRP at conception, rheumatoid factor and cyclic citrullinated peptide status, and other potential confounders. They also relied more heavily on prednisolone, taking, for example, a mean dose of 13 mg in the second trimester versus 8 mg in the control group. Perhaps not surprisingly, the mean duration of pregnancy was 37 weeks in the TNFi group, with six women (33%) delivering at or before 37 weeks; women in the control group delivered, on average, at 39 weeks, with four (17%) delivering at or before week 37.

The investigators found that the risk of preterm birth increased with every cumulative milligram of prednisolone (OR, 1.08; 95% CI, 1.02-1.15; P less than .01).

“Women with RA who discontinue TNFis at conception face a high risk for flares during pregnancy, independently of known risk factors like seropositivity. Flares are usually treated with prednisolone. We found a dose-dependent, significant increased risk for preterm birth associated with prednisolone. In this era of treat-to-target management of RA, our paradigm for RA pregnancy management may need adjusting. By controlling RA activity with medications considered relatively safe in pregnancy, we may be able to improve both the pregnancy experience and pregnancy outcomes,” the investigators concluded.

The women were 33 years old on average, and all had live births; four early miscarriages were excluded from analysis. All the pregnancies were planned, with methotrexate discontinued at least 3 months before conception. There was no statistical difference in the rate of seropositivity between the groups, “which is interesting because we know seropositivity is a risk factor for staying active during pregnancy,” Dr. Fischer-Betz said.

Two boys born to women who took TNFis had minor malformations, one with nasal bone aplasia, retrognathia, and hydronephrosis, and the other with hypospadias. Both of their mothers had taken etanercept (Enbrel) in the first trimester. There was one malformation in the control group, a girl born with hydronephrosis.

There was no outside funding for the work, and the investigators have no disclosures.

[email protected]

SAN FRANCISCO – It might be best to keep women with rheumatoid arthritis on their tumor necrosis factor blockers during pregnancy, according to German investigators.

They found that women are likely to flare without them and need more prednisolone, which is associated with preterm birth and other problems, while an increasing body of evidence suggests that tumor necrosis factor inhibitors (TNFis) are relatively safe during pregnancy.

“We should” rethink discontinuing TNFis during pregnancy, as recommended in some quarters. “We do not want women to flare during pregnancy,” said investigator Dr. Rebecca Fischer-Betz of the department of rheumatology at Heinrich Heine University in Düsseldorf.

She and her colleagues compared birth outcomes in 18 rheumatoid arthritis (RA) patients who discontinued TNFi treatment shortly after they got pregnant against those of 24 women with RA who were never exposed to a TNFi because, in general, they had less severe disease.

Twelve of the women (75%) in the TNFi group flared, versus four women (17%) in the control group. Although patients in both groups started with a mean 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) below 3.0, women in the TNFi group had a rise in activity to a mean of about 3.5 in the second trimester, while disease activity in control patients remained stable.

Compared with controls, women who stopped TNFis were also far more likely to flare (odds ratio, 10.0; 95% confidence interval, 2.3-42.8; P = .002), even after adjusting for age, DAS28-CRP at conception, rheumatoid factor and cyclic citrullinated peptide status, and other potential confounders. They also relied more heavily on prednisolone, taking, for example, a mean dose of 13 mg in the second trimester versus 8 mg in the control group. Perhaps not surprisingly, the mean duration of pregnancy was 37 weeks in the TNFi group, with six women (33%) delivering at or before 37 weeks; women in the control group delivered, on average, at 39 weeks, with four (17%) delivering at or before week 37.

The investigators found that the risk of preterm birth increased with every cumulative milligram of prednisolone (OR, 1.08; 95% CI, 1.02-1.15; P less than .01).

“Women with RA who discontinue TNFis at conception face a high risk for flares during pregnancy, independently of known risk factors like seropositivity. Flares are usually treated with prednisolone. We found a dose-dependent, significant increased risk for preterm birth associated with prednisolone. In this era of treat-to-target management of RA, our paradigm for RA pregnancy management may need adjusting. By controlling RA activity with medications considered relatively safe in pregnancy, we may be able to improve both the pregnancy experience and pregnancy outcomes,” the investigators concluded.

The women were 33 years old on average, and all had live births; four early miscarriages were excluded from analysis. All the pregnancies were planned, with methotrexate discontinued at least 3 months before conception. There was no statistical difference in the rate of seropositivity between the groups, “which is interesting because we know seropositivity is a risk factor for staying active during pregnancy,” Dr. Fischer-Betz said.

Two boys born to women who took TNFis had minor malformations, one with nasal bone aplasia, retrognathia, and hydronephrosis, and the other with hypospadias. Both of their mothers had taken etanercept (Enbrel) in the first trimester. There was one malformation in the control group, a girl born with hydronephrosis.

There was no outside funding for the work, and the investigators have no disclosures.

[email protected]