Obstetrics

NEW ORLEANS – Few adolescent girls who visited an emergency department were screened for pregnancy, even if they presented with lower abdominal pain or underwent a radiologic exam, according to analysis of national data.

Several factors could contribute to the lapse, according to lead author Dr. Monika Goyal.

"We, as providers, consider pregnancy to be more an adult issue and often fail to consider it when evaluating teenagers," said Dr. Goyal of the departments of pediatrics and emergency medicine at George Washington University, Washington.

Dr. Cora Collette Breuner, discussant and a member of the AAP Committee on Adolescence, noted that it can be difficult to see an adolescent confidentially in the ED setting. "We’re afraid of offending the patients and their families," she said.

Indeed, interventions that standardize sexual history taking for every adolescent, and pregnancy screening when patients may be exposed to teratogenic tests is among the solutions to increase the screening rates, said Dr. Goyal, who is also an attending ED physician at Children’s National Medical Center in Washington.

In her retrospective analysis, Dr. Goyal and her colleagues used the National Hospital Ambulatory Medical Care Survey from 2000 to 2009, identifying 22,866 records of female patients aged 14-21 years who were evaluated in EDs.

Of the 77 million female adolescents who visited ED during the 9-year-period, about 19% (14.5 million) received a pregnancy test.

Of those who presented with lower abdominal pain, 42% were tested. Meanwhile, 22% of those who underwent radiologic imaging were tested for pregnancy, so did 28% of the patients were exposed to potentially teratogenic radiation, such as chest radiographs or CT scans. Black patients, as well as those with non-private health insurance, who were admitted, and those with a chief complaint of lower abdominal pain or genitourinary symptoms were significantly more likely to be screened for pregnancy.

"This is a well-done study, and the findings are a bit surprising," commented Dr. Breuner, who is also a professor of adolescent medicine at the University of Washington, Seattle. "I really thought the numbers [for pregnancy screening] would be higher for abdominal pain."

Dr. Goyal advised pediatricians to conduct a confidential sexual history with every adolescent patient.

"Furthermore, we should have standardized protocols for pregnancy testing for complaints that may be associated with pregnancy related symptoms or anytime a patient may be exposed to therapies or diagnostics that may be harmful if pregnant."

Dr. Goyal and Dr. Breuner had no disclosures.

NEW ORLEANS – Few adolescent girls who visited an emergency department were screened for pregnancy, even if they presented with lower abdominal pain or underwent a radiologic exam, according to analysis of national data.

Several factors could contribute to the lapse, according to lead author Dr. Monika Goyal.

"We, as providers, consider pregnancy to be more an adult issue and often fail to consider it when evaluating teenagers," said Dr. Goyal of the departments of pediatrics and emergency medicine at George Washington University, Washington.

Dr. Cora Collette Breuner, discussant and a member of the AAP Committee on Adolescence, noted that it can be difficult to see an adolescent confidentially in the ED setting. "We’re afraid of offending the patients and their families," she said.

Indeed, interventions that standardize sexual history taking for every adolescent, and pregnancy screening when patients may be exposed to teratogenic tests is among the solutions to increase the screening rates, said Dr. Goyal, who is also an attending ED physician at Children’s National Medical Center in Washington.

In her retrospective analysis, Dr. Goyal and her colleagues used the National Hospital Ambulatory Medical Care Survey from 2000 to 2009, identifying 22,866 records of female patients aged 14-21 years who were evaluated in EDs.

Of the 77 million female adolescents who visited ED during the 9-year-period, about 19% (14.5 million) received a pregnancy test.

Of those who presented with lower abdominal pain, 42% were tested. Meanwhile, 22% of those who underwent radiologic imaging were tested for pregnancy, so did 28% of the patients were exposed to potentially teratogenic radiation, such as chest radiographs or CT scans. Black patients, as well as those with non-private health insurance, who were admitted, and those with a chief complaint of lower abdominal pain or genitourinary symptoms were significantly more likely to be screened for pregnancy.

"This is a well-done study, and the findings are a bit surprising," commented Dr. Breuner, who is also a professor of adolescent medicine at the University of Washington, Seattle. "I really thought the numbers [for pregnancy screening] would be higher for abdominal pain."

Dr. Goyal advised pediatricians to conduct a confidential sexual history with every adolescent patient.

"Furthermore, we should have standardized protocols for pregnancy testing for complaints that may be associated with pregnancy related symptoms or anytime a patient may be exposed to therapies or diagnostics that may be harmful if pregnant."

Dr. Goyal and Dr. Breuner had no disclosures.

NEW ORLEANS – Few adolescent girls who visited an emergency department were screened for pregnancy, even if they presented with lower abdominal pain or underwent a radiologic exam, according to analysis of national data.

Several factors could contribute to the lapse, according to lead author Dr. Monika Goyal.

"We, as providers, consider pregnancy to be more an adult issue and often fail to consider it when evaluating teenagers," said Dr. Goyal of the departments of pediatrics and emergency medicine at George Washington University, Washington.

Dr. Cora Collette Breuner, discussant and a member of the AAP Committee on Adolescence, noted that it can be difficult to see an adolescent confidentially in the ED setting. "We’re afraid of offending the patients and their families," she said.

Indeed, interventions that standardize sexual history taking for every adolescent, and pregnancy screening when patients may be exposed to teratogenic tests is among the solutions to increase the screening rates, said Dr. Goyal, who is also an attending ED physician at Children’s National Medical Center in Washington.

In her retrospective analysis, Dr. Goyal and her colleagues used the National Hospital Ambulatory Medical Care Survey from 2000 to 2009, identifying 22,866 records of female patients aged 14-21 years who were evaluated in EDs.

Of the 77 million female adolescents who visited ED during the 9-year-period, about 19% (14.5 million) received a pregnancy test.

Of those who presented with lower abdominal pain, 42% were tested. Meanwhile, 22% of those who underwent radiologic imaging were tested for pregnancy, so did 28% of the patients were exposed to potentially teratogenic radiation, such as chest radiographs or CT scans. Black patients, as well as those with non-private health insurance, who were admitted, and those with a chief complaint of lower abdominal pain or genitourinary symptoms were significantly more likely to be screened for pregnancy.

"This is a well-done study, and the findings are a bit surprising," commented Dr. Breuner, who is also a professor of adolescent medicine at the University of Washington, Seattle. "I really thought the numbers [for pregnancy screening] would be higher for abdominal pain."

Dr. Goyal advised pediatricians to conduct a confidential sexual history with every adolescent patient.

"Furthermore, we should have standardized protocols for pregnancy testing for complaints that may be associated with pregnancy related symptoms or anytime a patient may be exposed to therapies or diagnostics that may be harmful if pregnant."

Dr. Goyal and Dr. Breuner had no disclosures.

Managing psoriasis during pregnancy includes consideration for quality of life and medication safety issues, according to Dr. Alan Menter.

"Treatment of pregnant women with psoriasis should take into consideration the benefit of the therapy to her and the safety of her fetus. The full spectrum of safe and effective therapies during pregnancy needs to be reviewed," Dr. Menter said at the Women’s & Pediatric Dermatology Seminar, sponsored by the Skin Disease Education Foundation (SDEF).

"Most people present with psoriasis before age 40 years. The disease affects women and men equally, so many women with psoriasis are of reproductive age and are considering pregnancy," said Dr. Menter, chairman of the dermatology division at Baylor University Medical Center, Dallas.

"Maintaining quality of life is particularly important for females with psoriasis who are considering becoming pregnant, as well as during pregnancy and while breastfeeding."

Treatment Options

Patients with mild psoriasis can be treated safely with topical agents during pregnancy, most commonly with steroid and vitamin D preparations. For women with psoriasis unresponsive to topicals, a course of phototherapy with narrow-band UVB is safe and effective before conception, during pregnancy, and during the lactation period, Dr. Menter said.

Methotrexate, which should be stopped 3 months before conceiving, and the retinoid acitretin (Soriatane), which is contraindicated in females of childbearing potential, are pregnancy category X drugs and are not options during pregnancy.

As for cyclosporine, more than 20 years of pregnancy registry data on organ transplant recipients treated with the drug – who are on higher doses than used in psoriasis – indicate that cyclosporine is a "viable drug to be used during pregnancy if absolutely necessary," he said.

For moderate to severe psoriasis, "cyclosporine works very well at relatively low dosages, but has to be discontinued before the baby is born because it is excreted in breast milk," he added. A potential adverse effect of cyclosporine is that it may aggravate hypertension of pregnancy, and, in a small percentage of patients, it produces a pregnancy that is 3-4 weeks shorter than normal.

The biologic treatments etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), and ustekinumab (Stelara), which are all category B drugs, could interfere with normal embryonic development and affect fetal and newborn immunity. However, there are numerous pregnancy registries for both psoriasis and other inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, which show that biologics have had no long-term implications for the normal development of the infant immune system.

Psoriasis improves spontaneously in about 60% of women during pregnancy, although they are at an increased risk for postpartum flares. After delivery, "psoriasis can flare up very quickly and can spread from head to toe within days or weeks ... [and is] sometimes a lot worse than what they had previously," he said.

Patients should be advised to alert their physicians at the first sign of a flare after delivery. Phototherapy and topical treatments are options, but cyclosporine should not be used in breastfeeding patients. There is almost no excretion of the four injectable biologics into breast milk, which can thus be considered safe in lactating women.

Case Studies

Among the cases he presented at the conference was a 26-year-old female with a 5-year history of severe psoriasis who started treatment with cyclosporine. At 12 months, she was 90% clear and the dose was tapered. She became pregnant at 16 weeks. Cyclosporine was discontinued at 27 weeks gestation, and she remained relatively clear for the rest of her pregnancy and delivered a healthy baby at term.

Courtesy Dr. Alan Menter

She had a severe postpartum flare, with only a moderate response obtained with the reintroduction of cyclosporine after she stopped breastfeeding. She was then started on a 12-week course of the biologic agent alefacept and UVB treatment, which produced a moderate response. During the second month of alefacept treatment, she became pregnant again. The moderate response achieved with the alefacept was maintained throughout the pregnancy, even after the 12-week course of alefacept was stopped. She delivered a normal, healthy baby.

The same patient was started on infliximab for a significant flare of psoriasis a month after her second delivery. She was 95% clear after three induction infusions and was maintained on infliximab for 5 years. She became pregnant again during treatment with infliximab and had a healthy baby, with a normal delivery. She remains 90% clear to date on infliximab at a dose of 7.5 mg/kg every 8 weeks.

Another patient Dr. Menter described became pregnant while on methotrexate, and had a healthy baby despite the risk of miscarriage and fetal abnormalities with methotrexate. She stopped methotrexate treatment at week 13 of pregnancy, but developed a significant flare and started treatment with cyclosporine, which was tapered and discontinued at 8 months of pregnancy when the patient’s ustekinumab therapy was initiated. Three weeks later, she delivered a healthy baby who is "thriving" at age 3 years; her psoriasis remains 75% clear on a dose of 45 mg of ustekinumab every 12 weeks, Dr. Menter said.

Clinicians should be aware that women with psoriasis are at a slightly increased risk for spontaneous abortion and premature rupture of the membranes, he said, referring to the results of a case-control study that found an increased risk for these pregnancy complications, as well as macrosomia and induced abortions in women with psoriasis (J. Eur. Acad. Dermatol. Venereol. 2011:25;1041-7).

Dr. Menter has received research support from, been a consultant to, or served as a lecturer for Abbott, Amgen, and other companies.

SDEF and this news organization are owned by Frontline Medical Communications.

Managing psoriasis during pregnancy includes consideration for quality of life and medication safety issues, according to Dr. Alan Menter.

"Treatment of pregnant women with psoriasis should take into consideration the benefit of the therapy to her and the safety of her fetus. The full spectrum of safe and effective therapies during pregnancy needs to be reviewed," Dr. Menter said at the Women’s & Pediatric Dermatology Seminar, sponsored by the Skin Disease Education Foundation (SDEF).

"Most people present with psoriasis before age 40 years. The disease affects women and men equally, so many women with psoriasis are of reproductive age and are considering pregnancy," said Dr. Menter, chairman of the dermatology division at Baylor University Medical Center, Dallas.

"Maintaining quality of life is particularly important for females with psoriasis who are considering becoming pregnant, as well as during pregnancy and while breastfeeding."

Treatment Options

Patients with mild psoriasis can be treated safely with topical agents during pregnancy, most commonly with steroid and vitamin D preparations. For women with psoriasis unresponsive to topicals, a course of phototherapy with narrow-band UVB is safe and effective before conception, during pregnancy, and during the lactation period, Dr. Menter said.

Methotrexate, which should be stopped 3 months before conceiving, and the retinoid acitretin (Soriatane), which is contraindicated in females of childbearing potential, are pregnancy category X drugs and are not options during pregnancy.

As for cyclosporine, more than 20 years of pregnancy registry data on organ transplant recipients treated with the drug – who are on higher doses than used in psoriasis – indicate that cyclosporine is a "viable drug to be used during pregnancy if absolutely necessary," he said.

For moderate to severe psoriasis, "cyclosporine works very well at relatively low dosages, but has to be discontinued before the baby is born because it is excreted in breast milk," he added. A potential adverse effect of cyclosporine is that it may aggravate hypertension of pregnancy, and, in a small percentage of patients, it produces a pregnancy that is 3-4 weeks shorter than normal.

The biologic treatments etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), and ustekinumab (Stelara), which are all category B drugs, could interfere with normal embryonic development and affect fetal and newborn immunity. However, there are numerous pregnancy registries for both psoriasis and other inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, which show that biologics have had no long-term implications for the normal development of the infant immune system.

Psoriasis improves spontaneously in about 60% of women during pregnancy, although they are at an increased risk for postpartum flares. After delivery, "psoriasis can flare up very quickly and can spread from head to toe within days or weeks ... [and is] sometimes a lot worse than what they had previously," he said.

Patients should be advised to alert their physicians at the first sign of a flare after delivery. Phototherapy and topical treatments are options, but cyclosporine should not be used in breastfeeding patients. There is almost no excretion of the four injectable biologics into breast milk, which can thus be considered safe in lactating women.

Case Studies

Among the cases he presented at the conference was a 26-year-old female with a 5-year history of severe psoriasis who started treatment with cyclosporine. At 12 months, she was 90% clear and the dose was tapered. She became pregnant at 16 weeks. Cyclosporine was discontinued at 27 weeks gestation, and she remained relatively clear for the rest of her pregnancy and delivered a healthy baby at term.

Courtesy Dr. Alan Menter

She had a severe postpartum flare, with only a moderate response obtained with the reintroduction of cyclosporine after she stopped breastfeeding. She was then started on a 12-week course of the biologic agent alefacept and UVB treatment, which produced a moderate response. During the second month of alefacept treatment, she became pregnant again. The moderate response achieved with the alefacept was maintained throughout the pregnancy, even after the 12-week course of alefacept was stopped. She delivered a normal, healthy baby.

The same patient was started on infliximab for a significant flare of psoriasis a month after her second delivery. She was 95% clear after three induction infusions and was maintained on infliximab for 5 years. She became pregnant again during treatment with infliximab and had a healthy baby, with a normal delivery. She remains 90% clear to date on infliximab at a dose of 7.5 mg/kg every 8 weeks.

Another patient Dr. Menter described became pregnant while on methotrexate, and had a healthy baby despite the risk of miscarriage and fetal abnormalities with methotrexate. She stopped methotrexate treatment at week 13 of pregnancy, but developed a significant flare and started treatment with cyclosporine, which was tapered and discontinued at 8 months of pregnancy when the patient’s ustekinumab therapy was initiated. Three weeks later, she delivered a healthy baby who is "thriving" at age 3 years; her psoriasis remains 75% clear on a dose of 45 mg of ustekinumab every 12 weeks, Dr. Menter said.

Clinicians should be aware that women with psoriasis are at a slightly increased risk for spontaneous abortion and premature rupture of the membranes, he said, referring to the results of a case-control study that found an increased risk for these pregnancy complications, as well as macrosomia and induced abortions in women with psoriasis (J. Eur. Acad. Dermatol. Venereol. 2011:25;1041-7).

Dr. Menter has received research support from, been a consultant to, or served as a lecturer for Abbott, Amgen, and other companies.

SDEF and this news organization are owned by Frontline Medical Communications.

Managing psoriasis during pregnancy includes consideration for quality of life and medication safety issues, according to Dr. Alan Menter.

"Treatment of pregnant women with psoriasis should take into consideration the benefit of the therapy to her and the safety of her fetus. The full spectrum of safe and effective therapies during pregnancy needs to be reviewed," Dr. Menter said at the Women’s & Pediatric Dermatology Seminar, sponsored by the Skin Disease Education Foundation (SDEF).

"Most people present with psoriasis before age 40 years. The disease affects women and men equally, so many women with psoriasis are of reproductive age and are considering pregnancy," said Dr. Menter, chairman of the dermatology division at Baylor University Medical Center, Dallas.

"Maintaining quality of life is particularly important for females with psoriasis who are considering becoming pregnant, as well as during pregnancy and while breastfeeding."

Treatment Options

Patients with mild psoriasis can be treated safely with topical agents during pregnancy, most commonly with steroid and vitamin D preparations. For women with psoriasis unresponsive to topicals, a course of phototherapy with narrow-band UVB is safe and effective before conception, during pregnancy, and during the lactation period, Dr. Menter said.

Methotrexate, which should be stopped 3 months before conceiving, and the retinoid acitretin (Soriatane), which is contraindicated in females of childbearing potential, are pregnancy category X drugs and are not options during pregnancy.

As for cyclosporine, more than 20 years of pregnancy registry data on organ transplant recipients treated with the drug – who are on higher doses than used in psoriasis – indicate that cyclosporine is a "viable drug to be used during pregnancy if absolutely necessary," he said.

For moderate to severe psoriasis, "cyclosporine works very well at relatively low dosages, but has to be discontinued before the baby is born because it is excreted in breast milk," he added. A potential adverse effect of cyclosporine is that it may aggravate hypertension of pregnancy, and, in a small percentage of patients, it produces a pregnancy that is 3-4 weeks shorter than normal.

The biologic treatments etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), and ustekinumab (Stelara), which are all category B drugs, could interfere with normal embryonic development and affect fetal and newborn immunity. However, there are numerous pregnancy registries for both psoriasis and other inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, which show that biologics have had no long-term implications for the normal development of the infant immune system.

Psoriasis improves spontaneously in about 60% of women during pregnancy, although they are at an increased risk for postpartum flares. After delivery, "psoriasis can flare up very quickly and can spread from head to toe within days or weeks ... [and is] sometimes a lot worse than what they had previously," he said.

Patients should be advised to alert their physicians at the first sign of a flare after delivery. Phototherapy and topical treatments are options, but cyclosporine should not be used in breastfeeding patients. There is almost no excretion of the four injectable biologics into breast milk, which can thus be considered safe in lactating women.

Case Studies

Among the cases he presented at the conference was a 26-year-old female with a 5-year history of severe psoriasis who started treatment with cyclosporine. At 12 months, she was 90% clear and the dose was tapered. She became pregnant at 16 weeks. Cyclosporine was discontinued at 27 weeks gestation, and she remained relatively clear for the rest of her pregnancy and delivered a healthy baby at term.

Courtesy Dr. Alan Menter

She had a severe postpartum flare, with only a moderate response obtained with the reintroduction of cyclosporine after she stopped breastfeeding. She was then started on a 12-week course of the biologic agent alefacept and UVB treatment, which produced a moderate response. During the second month of alefacept treatment, she became pregnant again. The moderate response achieved with the alefacept was maintained throughout the pregnancy, even after the 12-week course of alefacept was stopped. She delivered a normal, healthy baby.

The same patient was started on infliximab for a significant flare of psoriasis a month after her second delivery. She was 95% clear after three induction infusions and was maintained on infliximab for 5 years. She became pregnant again during treatment with infliximab and had a healthy baby, with a normal delivery. She remains 90% clear to date on infliximab at a dose of 7.5 mg/kg every 8 weeks.

Another patient Dr. Menter described became pregnant while on methotrexate, and had a healthy baby despite the risk of miscarriage and fetal abnormalities with methotrexate. She stopped methotrexate treatment at week 13 of pregnancy, but developed a significant flare and started treatment with cyclosporine, which was tapered and discontinued at 8 months of pregnancy when the patient’s ustekinumab therapy was initiated. Three weeks later, she delivered a healthy baby who is "thriving" at age 3 years; her psoriasis remains 75% clear on a dose of 45 mg of ustekinumab every 12 weeks, Dr. Menter said.

Clinicians should be aware that women with psoriasis are at a slightly increased risk for spontaneous abortion and premature rupture of the membranes, he said, referring to the results of a case-control study that found an increased risk for these pregnancy complications, as well as macrosomia and induced abortions in women with psoriasis (J. Eur. Acad. Dermatol. Venereol. 2011:25;1041-7).

Dr. Menter has received research support from, been a consultant to, or served as a lecturer for Abbott, Amgen, and other companies.

SDEF and this news organization are owned by Frontline Medical Communications.

BERLIN – Vitamin D deficiency during the first trimester of pregnancy linked with a significantly increased risk for the development of gestational diabetes by the second trimester in a study of 655 pregnant women.

The study results also indicated that increased insulin resistance explained the significant association between vitamin D deficiency and an increased incidence of gestational diabetes, Marilyn Lacroix said at the annual meeting of the European Association for the Study of Diabetes.

Mitchel L. Zoler/IMNG Medical Media

The analysis showed that for every standard-deviation decrease in blood levels of 25-hydroxyvitamin D identified during the first trimester, women had a statistically significant 40% increased rate of having gestational diabetes during their second trimester, after adjustment for age, season of blood sampling, use of vitamin D supplements, and degree of adiposity, reported Ms. Lacroix, an endocrinology researcher at Sherbrooke (Que.) University. In the population studied, a standard-deviation reduction in blood levels of vitamin D corresponded to a drop of 19 nmol/L.

The study included 655 pregnant women aged 18 or older at 6-13 weeks’ gestation with a singleton pregnancy and no history of diabetes or gestational diabetes, miscarriage, or alcohol or drug abuse. The researchers measured each woman’s blood level of 25-hydroxyvitamin D at gestational week 6-13, and then assessed each woman for diabetes at week 24-28. During the study, 54 of the women (8%) developed gestational diabetes.

The prevalence of first-trimester vitamin D deficiency – a blood level of less than 50 nmol/L – was 26% among the 601 women who were normoglycemic during the second trimester, and 37% among women who developed gestational diabetes by the second trimester.

The analysis also showed a significantly reduced average Matsuda index (Diabetes Care 1999;22:1462-70), as well as a significantly reduced insulin secretion sensitivity index (Diabetic Medicine 2009;26:1198-1203) among patients who went on to have gestational diabetes. These reductions suggest that insulin resistance forms the link between low vitamin D levels and incident gestational diabetes, Ms. Lacroix said.

Ms. Lacroix reported that she and her associates also had no relevant financial disclosures.

BERLIN – Vitamin D deficiency during the first trimester of pregnancy linked with a significantly increased risk for the development of gestational diabetes by the second trimester in a study of 655 pregnant women.

The study results also indicated that increased insulin resistance explained the significant association between vitamin D deficiency and an increased incidence of gestational diabetes, Marilyn Lacroix said at the annual meeting of the European Association for the Study of Diabetes.

Mitchel L. Zoler/IMNG Medical Media

The analysis showed that for every standard-deviation decrease in blood levels of 25-hydroxyvitamin D identified during the first trimester, women had a statistically significant 40% increased rate of having gestational diabetes during their second trimester, after adjustment for age, season of blood sampling, use of vitamin D supplements, and degree of adiposity, reported Ms. Lacroix, an endocrinology researcher at Sherbrooke (Que.) University. In the population studied, a standard-deviation reduction in blood levels of vitamin D corresponded to a drop of 19 nmol/L.

The study included 655 pregnant women aged 18 or older at 6-13 weeks’ gestation with a singleton pregnancy and no history of diabetes or gestational diabetes, miscarriage, or alcohol or drug abuse. The researchers measured each woman’s blood level of 25-hydroxyvitamin D at gestational week 6-13, and then assessed each woman for diabetes at week 24-28. During the study, 54 of the women (8%) developed gestational diabetes.

The prevalence of first-trimester vitamin D deficiency – a blood level of less than 50 nmol/L – was 26% among the 601 women who were normoglycemic during the second trimester, and 37% among women who developed gestational diabetes by the second trimester.

The analysis also showed a significantly reduced average Matsuda index (Diabetes Care 1999;22:1462-70), as well as a significantly reduced insulin secretion sensitivity index (Diabetic Medicine 2009;26:1198-1203) among patients who went on to have gestational diabetes. These reductions suggest that insulin resistance forms the link between low vitamin D levels and incident gestational diabetes, Ms. Lacroix said.

Ms. Lacroix reported that she and her associates also had no relevant financial disclosures.

BERLIN – Vitamin D deficiency during the first trimester of pregnancy linked with a significantly increased risk for the development of gestational diabetes by the second trimester in a study of 655 pregnant women.

The study results also indicated that increased insulin resistance explained the significant association between vitamin D deficiency and an increased incidence of gestational diabetes, Marilyn Lacroix said at the annual meeting of the European Association for the Study of Diabetes.

Mitchel L. Zoler/IMNG Medical Media

The analysis showed that for every standard-deviation decrease in blood levels of 25-hydroxyvitamin D identified during the first trimester, women had a statistically significant 40% increased rate of having gestational diabetes during their second trimester, after adjustment for age, season of blood sampling, use of vitamin D supplements, and degree of adiposity, reported Ms. Lacroix, an endocrinology researcher at Sherbrooke (Que.) University. In the population studied, a standard-deviation reduction in blood levels of vitamin D corresponded to a drop of 19 nmol/L.

The study included 655 pregnant women aged 18 or older at 6-13 weeks’ gestation with a singleton pregnancy and no history of diabetes or gestational diabetes, miscarriage, or alcohol or drug abuse. The researchers measured each woman’s blood level of 25-hydroxyvitamin D at gestational week 6-13, and then assessed each woman for diabetes at week 24-28. During the study, 54 of the women (8%) developed gestational diabetes.

The prevalence of first-trimester vitamin D deficiency – a blood level of less than 50 nmol/L – was 26% among the 601 women who were normoglycemic during the second trimester, and 37% among women who developed gestational diabetes by the second trimester.

The analysis also showed a significantly reduced average Matsuda index (Diabetes Care 1999;22:1462-70), as well as a significantly reduced insulin secretion sensitivity index (Diabetic Medicine 2009;26:1198-1203) among patients who went on to have gestational diabetes. These reductions suggest that insulin resistance forms the link between low vitamin D levels and incident gestational diabetes, Ms. Lacroix said.

Ms. Lacroix reported that she and her associates also had no relevant financial disclosures.

Publication of results from the landmark Management of Myelomeningocele Study last year established fetal surgery as a viable option, and possibly the best option for ameliorating the complications of spina bifida.

But the Management of Myelomeningocele Study (MOMS) also appears to have had farther-reaching effects. In the 18 months since the trial results appeared (N. Engl. J. Med. 2011;364:993-1004), myelomeningocele (MMC) repair in fetuses repositioned from investigational surgery performed at just three U.S. centers to arguably standard of care that could potentially be done at whichever centers gear up to offer it. Beyond that, the possibility of effective and reasonably safe fetal MMC repair that the MOMS results documented is also proving to be a catalyst in the transformation of the still-young field of fetal surgery from an investigational, niche specialty to a more mainstream intervention.

Courtesy Children's Hospital of Philadelphia

"For many of the other [fetal surgery] interventions, there are so few cases that having more than a few centers doing them did not make sense. To have a fetal center you need a dedicated, multidisciplinary team available 24/7/365 that does a certain number of cases per year to keep up its team’s skills. For fetal surgery to be successful, it will need to be regionalized so that there is access for all patients, but also focused at centers of excellence so there is enough volume to keep skills sharp," said Dr. Mark P. Johnson, obstetrical director of the Center for Fetal Diagnosis and Treatment at the Children’s Hospital of Philadelphia (CHOP).

The MOMS result "has already had a profound effect on the treatment of MMC, on reimbursement standards for fetal intervention, and has defined how fetal surgery centers should be organized and staffed across the United States," wrote Dr. Shinjiro Hirose, a fetal surgeon at the University of California, San Francisco (UCSF), and his associates in an article on maternal-fetal surgery that appeared in June (Clin. Perinatology 2012;39:269-78).

Growing fetal-intervention options also put unprecedented responsibility on the physicians who provide primary obstetrical care to identify pregnancies early that may have an anomaly that’s amenable to surgical intervention and make an appropriate referral so that the disorder can be confirmed and intervention offered if it is possible.

Growing Numbers of MMC Repairs and Other Fetal Surgeries

Although the exact number of fetal MMC repairs done in the United States during the 18 months since publication of the MOMS results is hard to pin down, experts estimate roughly 80 surgeries occurred during April 2011-March 2012. They project as many as 100 or more being done in 2012, with about eight U.S. centers now offering the surgery, including the three centers that participated in MOMS and another five or so that have begun performing the procedure since the results were announced.

The other "high volume" fetal surgery now done is fetoscopic laser ablation of communicating vessels on the placental chorionic plate in monochorionic twin pregnancies that develop Twin-Twin transfusion syndrome (TTTS), which first became established as standard of care in 2004 (N. Engl. J. Med. 2004;351:136-44). It is now widely accepted as the preferred option in these cases, done on upward of 500 U.S. pregnancies a year. When the annualized rate of 600+ MMC repairs and laser ablations for TTTS couples with various low-volume fetal surgeries done for selected, rare anomalies, U.S. fetal surgery is on track this year to treat some 700-1,000 cases, and this number will likely rise substantially in the near future. The current, annual U.S. incidence of spina bifida in fetuses is about 2,500 (with about 1,500 infants born with MMC each year), suggesting that as fetal MMC repair becomes more widely accepted and performed, the number of U.S. surgeries for this indication could eventually run into several hundred a year.

Planning for Fetal MMC Repairs After MOMS

Driven primarily by concerns about how the MOMS results would translate into routine practice, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the agency that sponsored MOMS, organized an expert panel with representatives from 11 U.S. professional and patient groups to come up with recommendations on which centers should perform fetal MMC repairs and the clinical issues that the teams at each center should address. Participants came from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Institute of Ultrasound in Medicine, the Society for Maternal-Fetal Medicine, the Spina Bifida Association, and six other groups.

Formal publication of these recommendations had not occurred yet but was expected before the end of 2012. The article by Dr. Hirose and his coauthors provided a preview of some of the panel’s key recommendations, including a minimum annual volume of at least five MMC repairs as well as at least 30 fetuses with MMC evaluated for surgery; strict adherence to the MOMS protocol until improvements are proven better; comprehensive counseling that includes a reflective period for families of at least 24 hours; and participation in a national registry.

That article was removed from Clinics in Perinatology in early October at the request of the publication’s consulting editor.

According to a note on the publica­tion’s website, "It was learned after pub­lication that the guidelines for fetal repair of myelomeningocele that were pre­sented as being published by the NIH were neither supplied by the NIH nor published by them. To prevent this in­formation from being erroneously cit­ed, the article has been removed."

At press time, the article was still ac­cessible via the National Library of Med­icine’s PubMed.gov.*

Having a U.S. agency sponsor a major trial and then organize an expert panel to deliberate on how to best implement its results is unusual, but fetal MMC repair is unusual surgery, said Dr. Julie S. Moldenhauer, a maternal-fetal medicine physician and a representative to the NICHD panel appointed by the North American Fetal Therapy Network. "It is very high-risk surgery that is elective, it is an open procedure, not fetoscopic, and it depends on a very multidisciplinary team," she said in an interview. These are a combination of features that makes it unique, said Dr. Moldenhauer, who is an attending physician at the Center for Fetal Diagnosis and Treatment and the medical director of the special delivery unit, both at CHOP.

One other element of MOMS also adds to its special character: The trial lasted nearly 8 years and randomized just 183 patients, and during that time fetal MMC repair for U.S. patients was limited to three centers – CHOP, UCSF, and Vanderbilt University in Nashville, Tenn. Then, when the researchers reported their positive results last year, NICHD officials and others in this field faced the dilemma of how to make the surgery available elsewhere while ensuring that the results would be as good as in MOMS. "What the NICHD fears is that if MMC repair is offered uncontrolled, the outcomes won’t be what they were in MOMS," said Dr. Johnson.

Making Fetal MMC Repair Better

MMC repair is not easy and still has limitations, most notably the risk for extreme prematurity. "The risk of prematurity is the big obstacle to making it more mainstream," said Dr. Noel B. Tulipan, professor and director of pediatric neurosurgery at Vanderbilt University Medical Center.

Most fetuses treated in MOMS were delivered at 34 weeks’ gestation or later, and "these days, we almost don’t consider 34 weeks premature, because most of these babies do extremely well," Dr. Tulipan said in an interview. "But in MOMS, there was a 13% rate of extreme prematurity" with the infants delivered at less than 30 weeks.

This limitation is improving. The challenge, he said, is the incision and closure of the uterus. Dr. Tulipan and his colleagues have recently given increased attention to suturing the amniotic membranes to prevent them from separating from the uterine wall "With this change, our results have gotten substantially better. We’re getting to a rate that could make it mainstream. If the [extreme] prematurity rate was less than 5%, it would be hard to argue against this surgery."

Fetal MMC repair "will continue to grow, but not by an order of magnitude until there is a new technique that could be offered earlier in gestation and in a minimally-invasive way," said Dr. N. Scott Adzick, surgeon in chief and director of the Center for Fetal Diagnosis and Treatment at CHOP. Currently, MMC repairs are done at 20 weeks’-25 weeks’ 6 days gestation. His group at CHOP, as well as others, is also trying to perfect less-invasive approaches. "We are working on a tissue-engineering approach to seal the MMC defect before birth, and thus prevent exposure of the spinal cord to damaging amniotic fluid, and also prevent leakage of the cerebrospinal fluid from the spina bifida. CSF leakage is the underlying cause of hindbrain herniation and hydrocephalus seen with spina bifida. The goal is for this tissue-engineered component to be introduced through a single fetoscopic port or through an amniocentesis needle under sonographic guidance," Dr. Adzick said.

The risk of prematurity, as well as potential complications for the mother, means that centers offering fetal MMC repair provide extensive counseling for potential parents. "We are proud of the fact that over half of our families decide not to have prenatal surgery after the counseling," said Dr. Hanmin Lee, professor and chief of pediatric surgery at UCSF, and one of the leaders of that center’s MMC fetal repair program.

At CHOP, during the first year after the MOMS publication 238 pregnancies underwent evaluation, with 137 making it to a more extensive stage of assessment. Of these, 40 mothers (29%) underwent fetal MMC repair, Dr. Adzick said.

At Cincinnati Children’s Hospital, which began offering fetal MMC repairs following publication of the MOMS results, the winnowing was about as sharp as at CHOP. Since the program began, the Cincinnati team evaluated 53 pregnancies and performed 10 repairs, said Dr. Foong-Yen Lim, surgical director of the Fetal Care Center there. A handful of these patients who were first seen at Cincinnati decided to travel to Vanderbilt or CHOP instead for the surgery and thereby take advantage of the greater experience those centers offered.

That sentiment underscores a challenge faced by the programs that are trying to establish themselves as new options for fetal MMC repair, as the procedure rolls out post-MOMS.

"There is nothing wrong with patients going to a higher-volume center; they know that their outcome will be close to what is available today, compared with new centers that have not done as many of these procedures," Dr. Lim said in an interview. "Patients should hear the options and pick what’s best for them, not just whether to choose the procedure, but also to decide where to go. The reason why MOMS had such difficulty recruiting patients was that they had to uproot themselves to go to a MMC repair center, and a lot of patients decided not to go.

"Regionalization is the future. Spina bifida is one of the most common birth defects, so there is a large number of cases that could benefit" from fetal repair. But what does it mean to be a fetal surgery center, and what does it require," said CHOP’s Dr. Johnson. "These are the ideas that the fetal surgery community is struggling with and trying to address. The big question is which will be the centers of excellence. The first step toward answering this will be to see whether the new centers can replicate the MOMS results, he added.

Spreading the Word About Fetal Surgery

Another key element in growing fetal MMC repair, and fetal surgeries of all types, is boosting awareness of repair options among primary care obstetrical providers and making referrals more timely.

"The market is controlled by the number of physicians who are aware of surgical interventions," said Dr. Mark I. Evans, a clinical professor of obstetrics, gynecology, and reproductive services at Mount Sinai Medical Center in New York. "The number of anomalies that are potentially amenable to treatment is a small percent of all pregnancies, but with more than 4 million U.S. births per year, it adds up to a fairly substantial number."

Fetal interventions "are accepted therapies; in the fetal community, I don’t think anyone thinks they are still investigational. But the number of cases is small, and a lot of the people who are diagnosing these may not be aware of how successful a lot of the procedures are," said Dr. Johnson.

"Obstetricians and maternal-fetal medicine physicians need to be more aware of what we can do. Our biggest challenge is to disseminate the information. The treatments are safe and effective, and families should at least have the option of going to centers to get more information and make informed decisions."

In addition, "screening ultrasound at between 18 to 20 weeks would be a great thing," he added.

"In the United States, ultrasound screening is becoming more the standard of care, but a lot of screening is not done until 22 or 23 weeks, often too late for patients to be referred to fetal treatment centers for evaluations before 24 weeks so that the option of termination is often no longer available to them. Also, with some anomalies irreversible damage has already occurred by 24 weeks so that fetal therapy would not help. In cases of lower urinary tract obstructions, well over half the cases we see are too late to offer therapy. It is recognized that screening at 19-20 weeks won’t pick up all anomalies, but it would pick up a lot of major anomalies," Dr. Johnson said.

A Fetal Surgery Checklist

Aside from myelomeningocele repair, placental laser ablation in cases of severe twin-twin transfusion syndrome is the fetal surgery with the best evidence base and, for now, it’s also the most frequently performed fetal surgery, although experts say it’s also underused.

"The success story of fetal surgery is laser ablation for TTTS," said Dr. Francois I. Luks, director of the Fetal Treatment Program at Hasbro Children’s Hospital in Providence, R.I. "Left untreated, severe TTTS leads to greater than 80% dual mortality. With laser surgery, survival of at least one twin is in excess of 80%."

First established as a good alternative to standard amnioreduction therapy in a 2004 randomized trial (N. Engl. J. Med. 2004;351:136-44), placental laser ablation has since become standard-of-care for TTTS.

"More and more groups are taking [laser ablation for TTTS] on because they believe they should provide it to patients," and it currently is available at about 30 U.S. centers, said Dr. Lim. "The maternal risk [from placental laser ablation] is acceptable and the outcomes are quite good. But some cases [of TTTS] are still being misdiagnosed," he said.

"Awareness is more widespread, but not at the rate it should be. We still have patients who are not referred until something bad happens," Dr. Lim said in an interview.

In Cincinnati alone, the program does more than 100 placental laser ablations each year, he added.

About 80 per year are performed at CHOP, and roughly 300-400 per year total at the 24 U.S. and Canadian centers that form the North American Fetal Therapy Network (NAFTNet), said Dr. Luks. (CHOP and Cincinnati Children’s are members of NAFTNet.) At least two other U.S. centers not in NAFTNet do more than 100 laser ablations each annually, and several other hospitals outside of NAFTNet do smaller numbers yearly, which means that while the current annual U.S. volume of these cases is uncertain it easily exceeds 500, Dr. Luks said.

All the other fetal surgeries each occur in fewer than about 50 U.S. cases a year, are available at fewer U.S. centers and, in some cases, have a checkered history of success and failure although today several are considered effective, relatively safe, and standard therapy.

The third most-common fetal surgery, based on NAFTNet records, are various types of selective umbilical cord occlusions in twin pregnancies, for reasons such as intrauterine growth retardation, placental insufficiency, and other situations in which problems with one twin puts a healthy twin at risk, said Dr. Johnson.

Dr. Johnson, Dr. Hirose, Dr. Adzick, Dr. Moldenhauer, Dr. Lee, Dr. Tulipan, Dr. Lim, and Dr. Evans all said that they had no relevant financial disclosures.

* This story was updated on 10/3/1012.

Publication of results from the landmark Management of Myelomeningocele Study last year established fetal surgery as a viable option, and possibly the best option for ameliorating the complications of spina bifida.

But the Management of Myelomeningocele Study (MOMS) also appears to have had farther-reaching effects. In the 18 months since the trial results appeared (N. Engl. J. Med. 2011;364:993-1004), myelomeningocele (MMC) repair in fetuses repositioned from investigational surgery performed at just three U.S. centers to arguably standard of care that could potentially be done at whichever centers gear up to offer it. Beyond that, the possibility of effective and reasonably safe fetal MMC repair that the MOMS results documented is also proving to be a catalyst in the transformation of the still-young field of fetal surgery from an investigational, niche specialty to a more mainstream intervention.

Courtesy Children's Hospital of Philadelphia

"For many of the other [fetal surgery] interventions, there are so few cases that having more than a few centers doing them did not make sense. To have a fetal center you need a dedicated, multidisciplinary team available 24/7/365 that does a certain number of cases per year to keep up its team’s skills. For fetal surgery to be successful, it will need to be regionalized so that there is access for all patients, but also focused at centers of excellence so there is enough volume to keep skills sharp," said Dr. Mark P. Johnson, obstetrical director of the Center for Fetal Diagnosis and Treatment at the Children’s Hospital of Philadelphia (CHOP).

The MOMS result "has already had a profound effect on the treatment of MMC, on reimbursement standards for fetal intervention, and has defined how fetal surgery centers should be organized and staffed across the United States," wrote Dr. Shinjiro Hirose, a fetal surgeon at the University of California, San Francisco (UCSF), and his associates in an article on maternal-fetal surgery that appeared in June (Clin. Perinatology 2012;39:269-78).

Growing fetal-intervention options also put unprecedented responsibility on the physicians who provide primary obstetrical care to identify pregnancies early that may have an anomaly that’s amenable to surgical intervention and make an appropriate referral so that the disorder can be confirmed and intervention offered if it is possible.

Growing Numbers of MMC Repairs and Other Fetal Surgeries

Although the exact number of fetal MMC repairs done in the United States during the 18 months since publication of the MOMS results is hard to pin down, experts estimate roughly 80 surgeries occurred during April 2011-March 2012. They project as many as 100 or more being done in 2012, with about eight U.S. centers now offering the surgery, including the three centers that participated in MOMS and another five or so that have begun performing the procedure since the results were announced.

The other "high volume" fetal surgery now done is fetoscopic laser ablation of communicating vessels on the placental chorionic plate in monochorionic twin pregnancies that develop Twin-Twin transfusion syndrome (TTTS), which first became established as standard of care in 2004 (N. Engl. J. Med. 2004;351:136-44). It is now widely accepted as the preferred option in these cases, done on upward of 500 U.S. pregnancies a year. When the annualized rate of 600+ MMC repairs and laser ablations for TTTS couples with various low-volume fetal surgeries done for selected, rare anomalies, U.S. fetal surgery is on track this year to treat some 700-1,000 cases, and this number will likely rise substantially in the near future. The current, annual U.S. incidence of spina bifida in fetuses is about 2,500 (with about 1,500 infants born with MMC each year), suggesting that as fetal MMC repair becomes more widely accepted and performed, the number of U.S. surgeries for this indication could eventually run into several hundred a year.

Planning for Fetal MMC Repairs After MOMS

Driven primarily by concerns about how the MOMS results would translate into routine practice, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the agency that sponsored MOMS, organized an expert panel with representatives from 11 U.S. professional and patient groups to come up with recommendations on which centers should perform fetal MMC repairs and the clinical issues that the teams at each center should address. Participants came from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Institute of Ultrasound in Medicine, the Society for Maternal-Fetal Medicine, the Spina Bifida Association, and six other groups.

Formal publication of these recommendations had not occurred yet but was expected before the end of 2012. The article by Dr. Hirose and his coauthors provided a preview of some of the panel’s key recommendations, including a minimum annual volume of at least five MMC repairs as well as at least 30 fetuses with MMC evaluated for surgery; strict adherence to the MOMS protocol until improvements are proven better; comprehensive counseling that includes a reflective period for families of at least 24 hours; and participation in a national registry.

That article was removed from Clinics in Perinatology in early October at the request of the publication’s consulting editor.

According to a note on the publica­tion’s website, "It was learned after pub­lication that the guidelines for fetal repair of myelomeningocele that were pre­sented as being published by the NIH were neither supplied by the NIH nor published by them. To prevent this in­formation from being erroneously cit­ed, the article has been removed."

At press time, the article was still ac­cessible via the National Library of Med­icine’s PubMed.gov.*

Having a U.S. agency sponsor a major trial and then organize an expert panel to deliberate on how to best implement its results is unusual, but fetal MMC repair is unusual surgery, said Dr. Julie S. Moldenhauer, a maternal-fetal medicine physician and a representative to the NICHD panel appointed by the North American Fetal Therapy Network. "It is very high-risk surgery that is elective, it is an open procedure, not fetoscopic, and it depends on a very multidisciplinary team," she said in an interview. These are a combination of features that makes it unique, said Dr. Moldenhauer, who is an attending physician at the Center for Fetal Diagnosis and Treatment and the medical director of the special delivery unit, both at CHOP.

One other element of MOMS also adds to its special character: The trial lasted nearly 8 years and randomized just 183 patients, and during that time fetal MMC repair for U.S. patients was limited to three centers – CHOP, UCSF, and Vanderbilt University in Nashville, Tenn. Then, when the researchers reported their positive results last year, NICHD officials and others in this field faced the dilemma of how to make the surgery available elsewhere while ensuring that the results would be as good as in MOMS. "What the NICHD fears is that if MMC repair is offered uncontrolled, the outcomes won’t be what they were in MOMS," said Dr. Johnson.

Making Fetal MMC Repair Better

MMC repair is not easy and still has limitations, most notably the risk for extreme prematurity. "The risk of prematurity is the big obstacle to making it more mainstream," said Dr. Noel B. Tulipan, professor and director of pediatric neurosurgery at Vanderbilt University Medical Center.

Most fetuses treated in MOMS were delivered at 34 weeks’ gestation or later, and "these days, we almost don’t consider 34 weeks premature, because most of these babies do extremely well," Dr. Tulipan said in an interview. "But in MOMS, there was a 13% rate of extreme prematurity" with the infants delivered at less than 30 weeks.

This limitation is improving. The challenge, he said, is the incision and closure of the uterus. Dr. Tulipan and his colleagues have recently given increased attention to suturing the amniotic membranes to prevent them from separating from the uterine wall "With this change, our results have gotten substantially better. We’re getting to a rate that could make it mainstream. If the [extreme] prematurity rate was less than 5%, it would be hard to argue against this surgery."

Fetal MMC repair "will continue to grow, but not by an order of magnitude until there is a new technique that could be offered earlier in gestation and in a minimally-invasive way," said Dr. N. Scott Adzick, surgeon in chief and director of the Center for Fetal Diagnosis and Treatment at CHOP. Currently, MMC repairs are done at 20 weeks’-25 weeks’ 6 days gestation. His group at CHOP, as well as others, is also trying to perfect less-invasive approaches. "We are working on a tissue-engineering approach to seal the MMC defect before birth, and thus prevent exposure of the spinal cord to damaging amniotic fluid, and also prevent leakage of the cerebrospinal fluid from the spina bifida. CSF leakage is the underlying cause of hindbrain herniation and hydrocephalus seen with spina bifida. The goal is for this tissue-engineered component to be introduced through a single fetoscopic port or through an amniocentesis needle under sonographic guidance," Dr. Adzick said.

The risk of prematurity, as well as potential complications for the mother, means that centers offering fetal MMC repair provide extensive counseling for potential parents. "We are proud of the fact that over half of our families decide not to have prenatal surgery after the counseling," said Dr. Hanmin Lee, professor and chief of pediatric surgery at UCSF, and one of the leaders of that center’s MMC fetal repair program.

At CHOP, during the first year after the MOMS publication 238 pregnancies underwent evaluation, with 137 making it to a more extensive stage of assessment. Of these, 40 mothers (29%) underwent fetal MMC repair, Dr. Adzick said.

At Cincinnati Children’s Hospital, which began offering fetal MMC repairs following publication of the MOMS results, the winnowing was about as sharp as at CHOP. Since the program began, the Cincinnati team evaluated 53 pregnancies and performed 10 repairs, said Dr. Foong-Yen Lim, surgical director of the Fetal Care Center there. A handful of these patients who were first seen at Cincinnati decided to travel to Vanderbilt or CHOP instead for the surgery and thereby take advantage of the greater experience those centers offered.

That sentiment underscores a challenge faced by the programs that are trying to establish themselves as new options for fetal MMC repair, as the procedure rolls out post-MOMS.

"There is nothing wrong with patients going to a higher-volume center; they know that their outcome will be close to what is available today, compared with new centers that have not done as many of these procedures," Dr. Lim said in an interview. "Patients should hear the options and pick what’s best for them, not just whether to choose the procedure, but also to decide where to go. The reason why MOMS had such difficulty recruiting patients was that they had to uproot themselves to go to a MMC repair center, and a lot of patients decided not to go.

"Regionalization is the future. Spina bifida is one of the most common birth defects, so there is a large number of cases that could benefit" from fetal repair. But what does it mean to be a fetal surgery center, and what does it require," said CHOP’s Dr. Johnson. "These are the ideas that the fetal surgery community is struggling with and trying to address. The big question is which will be the centers of excellence. The first step toward answering this will be to see whether the new centers can replicate the MOMS results, he added.

Spreading the Word About Fetal Surgery

Another key element in growing fetal MMC repair, and fetal surgeries of all types, is boosting awareness of repair options among primary care obstetrical providers and making referrals more timely.

"The market is controlled by the number of physicians who are aware of surgical interventions," said Dr. Mark I. Evans, a clinical professor of obstetrics, gynecology, and reproductive services at Mount Sinai Medical Center in New York. "The number of anomalies that are potentially amenable to treatment is a small percent of all pregnancies, but with more than 4 million U.S. births per year, it adds up to a fairly substantial number."

Fetal interventions "are accepted therapies; in the fetal community, I don’t think anyone thinks they are still investigational. But the number of cases is small, and a lot of the people who are diagnosing these may not be aware of how successful a lot of the procedures are," said Dr. Johnson.

"Obstetricians and maternal-fetal medicine physicians need to be more aware of what we can do. Our biggest challenge is to disseminate the information. The treatments are safe and effective, and families should at least have the option of going to centers to get more information and make informed decisions."

In addition, "screening ultrasound at between 18 to 20 weeks would be a great thing," he added.

"In the United States, ultrasound screening is becoming more the standard of care, but a lot of screening is not done until 22 or 23 weeks, often too late for patients to be referred to fetal treatment centers for evaluations before 24 weeks so that the option of termination is often no longer available to them. Also, with some anomalies irreversible damage has already occurred by 24 weeks so that fetal therapy would not help. In cases of lower urinary tract obstructions, well over half the cases we see are too late to offer therapy. It is recognized that screening at 19-20 weeks won’t pick up all anomalies, but it would pick up a lot of major anomalies," Dr. Johnson said.

A Fetal Surgery Checklist

Aside from myelomeningocele repair, placental laser ablation in cases of severe twin-twin transfusion syndrome is the fetal surgery with the best evidence base and, for now, it’s also the most frequently performed fetal surgery, although experts say it’s also underused.

"The success story of fetal surgery is laser ablation for TTTS," said Dr. Francois I. Luks, director of the Fetal Treatment Program at Hasbro Children’s Hospital in Providence, R.I. "Left untreated, severe TTTS leads to greater than 80% dual mortality. With laser surgery, survival of at least one twin is in excess of 80%."

First established as a good alternative to standard amnioreduction therapy in a 2004 randomized trial (N. Engl. J. Med. 2004;351:136-44), placental laser ablation has since become standard-of-care for TTTS.

"More and more groups are taking [laser ablation for TTTS] on because they believe they should provide it to patients," and it currently is available at about 30 U.S. centers, said Dr. Lim. "The maternal risk [from placental laser ablation] is acceptable and the outcomes are quite good. But some cases [of TTTS] are still being misdiagnosed," he said.

"Awareness is more widespread, but not at the rate it should be. We still have patients who are not referred until something bad happens," Dr. Lim said in an interview.

In Cincinnati alone, the program does more than 100 placental laser ablations each year, he added.

About 80 per year are performed at CHOP, and roughly 300-400 per year total at the 24 U.S. and Canadian centers that form the North American Fetal Therapy Network (NAFTNet), said Dr. Luks. (CHOP and Cincinnati Children’s are members of NAFTNet.) At least two other U.S. centers not in NAFTNet do more than 100 laser ablations each annually, and several other hospitals outside of NAFTNet do smaller numbers yearly, which means that while the current annual U.S. volume of these cases is uncertain it easily exceeds 500, Dr. Luks said.

All the other fetal surgeries each occur in fewer than about 50 U.S. cases a year, are available at fewer U.S. centers and, in some cases, have a checkered history of success and failure although today several are considered effective, relatively safe, and standard therapy.

The third most-common fetal surgery, based on NAFTNet records, are various types of selective umbilical cord occlusions in twin pregnancies, for reasons such as intrauterine growth retardation, placental insufficiency, and other situations in which problems with one twin puts a healthy twin at risk, said Dr. Johnson.

Dr. Johnson, Dr. Hirose, Dr. Adzick, Dr. Moldenhauer, Dr. Lee, Dr. Tulipan, Dr. Lim, and Dr. Evans all said that they had no relevant financial disclosures.

* This story was updated on 10/3/1012.

Publication of results from the landmark Management of Myelomeningocele Study last year established fetal surgery as a viable option, and possibly the best option for ameliorating the complications of spina bifida.

But the Management of Myelomeningocele Study (MOMS) also appears to have had farther-reaching effects. In the 18 months since the trial results appeared (N. Engl. J. Med. 2011;364:993-1004), myelomeningocele (MMC) repair in fetuses repositioned from investigational surgery performed at just three U.S. centers to arguably standard of care that could potentially be done at whichever centers gear up to offer it. Beyond that, the possibility of effective and reasonably safe fetal MMC repair that the MOMS results documented is also proving to be a catalyst in the transformation of the still-young field of fetal surgery from an investigational, niche specialty to a more mainstream intervention.

Courtesy Children's Hospital of Philadelphia

"For many of the other [fetal surgery] interventions, there are so few cases that having more than a few centers doing them did not make sense. To have a fetal center you need a dedicated, multidisciplinary team available 24/7/365 that does a certain number of cases per year to keep up its team’s skills. For fetal surgery to be successful, it will need to be regionalized so that there is access for all patients, but also focused at centers of excellence so there is enough volume to keep skills sharp," said Dr. Mark P. Johnson, obstetrical director of the Center for Fetal Diagnosis and Treatment at the Children’s Hospital of Philadelphia (CHOP).

The MOMS result "has already had a profound effect on the treatment of MMC, on reimbursement standards for fetal intervention, and has defined how fetal surgery centers should be organized and staffed across the United States," wrote Dr. Shinjiro Hirose, a fetal surgeon at the University of California, San Francisco (UCSF), and his associates in an article on maternal-fetal surgery that appeared in June (Clin. Perinatology 2012;39:269-78).

Growing fetal-intervention options also put unprecedented responsibility on the physicians who provide primary obstetrical care to identify pregnancies early that may have an anomaly that’s amenable to surgical intervention and make an appropriate referral so that the disorder can be confirmed and intervention offered if it is possible.

Growing Numbers of MMC Repairs and Other Fetal Surgeries

Although the exact number of fetal MMC repairs done in the United States during the 18 months since publication of the MOMS results is hard to pin down, experts estimate roughly 80 surgeries occurred during April 2011-March 2012. They project as many as 100 or more being done in 2012, with about eight U.S. centers now offering the surgery, including the three centers that participated in MOMS and another five or so that have begun performing the procedure since the results were announced.

The other "high volume" fetal surgery now done is fetoscopic laser ablation of communicating vessels on the placental chorionic plate in monochorionic twin pregnancies that develop Twin-Twin transfusion syndrome (TTTS), which first became established as standard of care in 2004 (N. Engl. J. Med. 2004;351:136-44). It is now widely accepted as the preferred option in these cases, done on upward of 500 U.S. pregnancies a year. When the annualized rate of 600+ MMC repairs and laser ablations for TTTS couples with various low-volume fetal surgeries done for selected, rare anomalies, U.S. fetal surgery is on track this year to treat some 700-1,000 cases, and this number will likely rise substantially in the near future. The current, annual U.S. incidence of spina bifida in fetuses is about 2,500 (with about 1,500 infants born with MMC each year), suggesting that as fetal MMC repair becomes more widely accepted and performed, the number of U.S. surgeries for this indication could eventually run into several hundred a year.

Planning for Fetal MMC Repairs After MOMS

Driven primarily by concerns about how the MOMS results would translate into routine practice, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the agency that sponsored MOMS, organized an expert panel with representatives from 11 U.S. professional and patient groups to come up with recommendations on which centers should perform fetal MMC repairs and the clinical issues that the teams at each center should address. Participants came from the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Institute of Ultrasound in Medicine, the Society for Maternal-Fetal Medicine, the Spina Bifida Association, and six other groups.

Formal publication of these recommendations had not occurred yet but was expected before the end of 2012. The article by Dr. Hirose and his coauthors provided a preview of some of the panel’s key recommendations, including a minimum annual volume of at least five MMC repairs as well as at least 30 fetuses with MMC evaluated for surgery; strict adherence to the MOMS protocol until improvements are proven better; comprehensive counseling that includes a reflective period for families of at least 24 hours; and participation in a national registry.

That article was removed from Clinics in Perinatology in early October at the request of the publication’s consulting editor.

According to a note on the publica­tion’s website, "It was learned after pub­lication that the guidelines for fetal repair of myelomeningocele that were pre­sented as being published by the NIH were neither supplied by the NIH nor published by them. To prevent this in­formation from being erroneously cit­ed, the article has been removed."

At press time, the article was still ac­cessible via the National Library of Med­icine’s PubMed.gov.*

Having a U.S. agency sponsor a major trial and then organize an expert panel to deliberate on how to best implement its results is unusual, but fetal MMC repair is unusual surgery, said Dr. Julie S. Moldenhauer, a maternal-fetal medicine physician and a representative to the NICHD panel appointed by the North American Fetal Therapy Network. "It is very high-risk surgery that is elective, it is an open procedure, not fetoscopic, and it depends on a very multidisciplinary team," she said in an interview. These are a combination of features that makes it unique, said Dr. Moldenhauer, who is an attending physician at the Center for Fetal Diagnosis and Treatment and the medical director of the special delivery unit, both at CHOP.

One other element of MOMS also adds to its special character: The trial lasted nearly 8 years and randomized just 183 patients, and during that time fetal MMC repair for U.S. patients was limited to three centers – CHOP, UCSF, and Vanderbilt University in Nashville, Tenn. Then, when the researchers reported their positive results last year, NICHD officials and others in this field faced the dilemma of how to make the surgery available elsewhere while ensuring that the results would be as good as in MOMS. "What the NICHD fears is that if MMC repair is offered uncontrolled, the outcomes won’t be what they were in MOMS," said Dr. Johnson.

Making Fetal MMC Repair Better

MMC repair is not easy and still has limitations, most notably the risk for extreme prematurity. "The risk of prematurity is the big obstacle to making it more mainstream," said Dr. Noel B. Tulipan, professor and director of pediatric neurosurgery at Vanderbilt University Medical Center.

Most fetuses treated in MOMS were delivered at 34 weeks’ gestation or later, and "these days, we almost don’t consider 34 weeks premature, because most of these babies do extremely well," Dr. Tulipan said in an interview. "But in MOMS, there was a 13% rate of extreme prematurity" with the infants delivered at less than 30 weeks.

This limitation is improving. The challenge, he said, is the incision and closure of the uterus. Dr. Tulipan and his colleagues have recently given increased attention to suturing the amniotic membranes to prevent them from separating from the uterine wall "With this change, our results have gotten substantially better. We’re getting to a rate that could make it mainstream. If the [extreme] prematurity rate was less than 5%, it would be hard to argue against this surgery."

Fetal MMC repair "will continue to grow, but not by an order of magnitude until there is a new technique that could be offered earlier in gestation and in a minimally-invasive way," said Dr. N. Scott Adzick, surgeon in chief and director of the Center for Fetal Diagnosis and Treatment at CHOP. Currently, MMC repairs are done at 20 weeks’-25 weeks’ 6 days gestation. His group at CHOP, as well as others, is also trying to perfect less-invasive approaches. "We are working on a tissue-engineering approach to seal the MMC defect before birth, and thus prevent exposure of the spinal cord to damaging amniotic fluid, and also prevent leakage of the cerebrospinal fluid from the spina bifida. CSF leakage is the underlying cause of hindbrain herniation and hydrocephalus seen with spina bifida. The goal is for this tissue-engineered component to be introduced through a single fetoscopic port or through an amniocentesis needle under sonographic guidance," Dr. Adzick said.

The risk of prematurity, as well as potential complications for the mother, means that centers offering fetal MMC repair provide extensive counseling for potential parents. "We are proud of the fact that over half of our families decide not to have prenatal surgery after the counseling," said Dr. Hanmin Lee, professor and chief of pediatric surgery at UCSF, and one of the leaders of that center’s MMC fetal repair program.

At CHOP, during the first year after the MOMS publication 238 pregnancies underwent evaluation, with 137 making it to a more extensive stage of assessment. Of these, 40 mothers (29%) underwent fetal MMC repair, Dr. Adzick said.

At Cincinnati Children’s Hospital, which began offering fetal MMC repairs following publication of the MOMS results, the winnowing was about as sharp as at CHOP. Since the program began, the Cincinnati team evaluated 53 pregnancies and performed 10 repairs, said Dr. Foong-Yen Lim, surgical director of the Fetal Care Center there. A handful of these patients who were first seen at Cincinnati decided to travel to Vanderbilt or CHOP instead for the surgery and thereby take advantage of the greater experience those centers offered.

That sentiment underscores a challenge faced by the programs that are trying to establish themselves as new options for fetal MMC repair, as the procedure rolls out post-MOMS.

"There is nothing wrong with patients going to a higher-volume center; they know that their outcome will be close to what is available today, compared with new centers that have not done as many of these procedures," Dr. Lim said in an interview. "Patients should hear the options and pick what’s best for them, not just whether to choose the procedure, but also to decide where to go. The reason why MOMS had such difficulty recruiting patients was that they had to uproot themselves to go to a MMC repair center, and a lot of patients decided not to go.

"Regionalization is the future. Spina bifida is one of the most common birth defects, so there is a large number of cases that could benefit" from fetal repair. But what does it mean to be a fetal surgery center, and what does it require," said CHOP’s Dr. Johnson. "These are the ideas that the fetal surgery community is struggling with and trying to address. The big question is which will be the centers of excellence. The first step toward answering this will be to see whether the new centers can replicate the MOMS results, he added.

Spreading the Word About Fetal Surgery

Another key element in growing fetal MMC repair, and fetal surgeries of all types, is boosting awareness of repair options among primary care obstetrical providers and making referrals more timely.

"The market is controlled by the number of physicians who are aware of surgical interventions," said Dr. Mark I. Evans, a clinical professor of obstetrics, gynecology, and reproductive services at Mount Sinai Medical Center in New York. "The number of anomalies that are potentially amenable to treatment is a small percent of all pregnancies, but with more than 4 million U.S. births per year, it adds up to a fairly substantial number."

Fetal interventions "are accepted therapies; in the fetal community, I don’t think anyone thinks they are still investigational. But the number of cases is small, and a lot of the people who are diagnosing these may not be aware of how successful a lot of the procedures are," said Dr. Johnson.

"Obstetricians and maternal-fetal medicine physicians need to be more aware of what we can do. Our biggest challenge is to disseminate the information. The treatments are safe and effective, and families should at least have the option of going to centers to get more information and make informed decisions."

In addition, "screening ultrasound at between 18 to 20 weeks would be a great thing," he added.

"In the United States, ultrasound screening is becoming more the standard of care, but a lot of screening is not done until 22 or 23 weeks, often too late for patients to be referred to fetal treatment centers for evaluations before 24 weeks so that the option of termination is often no longer available to them. Also, with some anomalies irreversible damage has already occurred by 24 weeks so that fetal therapy would not help. In cases of lower urinary tract obstructions, well over half the cases we see are too late to offer therapy. It is recognized that screening at 19-20 weeks won’t pick up all anomalies, but it would pick up a lot of major anomalies," Dr. Johnson said.

A Fetal Surgery Checklist

Aside from myelomeningocele repair, placental laser ablation in cases of severe twin-twin transfusion syndrome is the fetal surgery with the best evidence base and, for now, it’s also the most frequently performed fetal surgery, although experts say it’s also underused.

"The success story of fetal surgery is laser ablation for TTTS," said Dr. Francois I. Luks, director of the Fetal Treatment Program at Hasbro Children’s Hospital in Providence, R.I. "Left untreated, severe TTTS leads to greater than 80% dual mortality. With laser surgery, survival of at least one twin is in excess of 80%."

First established as a good alternative to standard amnioreduction therapy in a 2004 randomized trial (N. Engl. J. Med. 2004;351:136-44), placental laser ablation has since become standard-of-care for TTTS.

"More and more groups are taking [laser ablation for TTTS] on because they believe they should provide it to patients," and it currently is available at about 30 U.S. centers, said Dr. Lim. "The maternal risk [from placental laser ablation] is acceptable and the outcomes are quite good. But some cases [of TTTS] are still being misdiagnosed," he said.

"Awareness is more widespread, but not at the rate it should be. We still have patients who are not referred until something bad happens," Dr. Lim said in an interview.

In Cincinnati alone, the program does more than 100 placental laser ablations each year, he added.

About 80 per year are performed at CHOP, and roughly 300-400 per year total at the 24 U.S. and Canadian centers that form the North American Fetal Therapy Network (NAFTNet), said Dr. Luks. (CHOP and Cincinnati Children’s are members of NAFTNet.) At least two other U.S. centers not in NAFTNet do more than 100 laser ablations each annually, and several other hospitals outside of NAFTNet do smaller numbers yearly, which means that while the current annual U.S. volume of these cases is uncertain it easily exceeds 500, Dr. Luks said.

All the other fetal surgeries each occur in fewer than about 50 U.S. cases a year, are available at fewer U.S. centers and, in some cases, have a checkered history of success and failure although today several are considered effective, relatively safe, and standard therapy.

The third most-common fetal surgery, based on NAFTNet records, are various types of selective umbilical cord occlusions in twin pregnancies, for reasons such as intrauterine growth retardation, placental insufficiency, and other situations in which problems with one twin puts a healthy twin at risk, said Dr. Johnson.

Dr. Johnson, Dr. Hirose, Dr. Adzick, Dr. Moldenhauer, Dr. Lee, Dr. Tulipan, Dr. Lim, and Dr. Evans all said that they had no relevant financial disclosures.

* This story was updated on 10/3/1012.

Most women with heart disease can safely go through pregnancy, although striking differences in outcome were found by type of heart disease and between countries, a novel international registry shows.

Maternal mortality was 1%, but this was still 100 times higher than the mortality of 0.007% in the normal pregnant population. Seven of the 13 maternal deaths were due to cardiac events, three to thromboembolic events, and three to sepsis.

Maternal mortality was highest in women with cardiomyopathy at 2.4%, compared with 2.1% for those with valvular heart disease, 0.5% with congenital heart disease, and 0% for ischemic heart disease.

In addition, women with cardiomyopathy experienced higher rates of heart failure (24% vs. 18%, 8%, and 8%) and ventricular arrhythmias (11% vs. 0.6%, 1.6%, and 0%) than did those with valvular heart disease, congenital heart disease, and ischemic heart disease, cardiologist Dr. Jolien Roos-Hesselink and her associates reported (Eur. Heart J. 2012 [doi:10.1093/eurheartj/ehs270]).

Although cardiomyopathy is uncommon during pregnancy, it is difficult to manage in the context of left ventricular dysfunction or peripartum cardiomyopathy, with a high risk of an adverse outcome for both the mother and the baby, observed Dr. Roos-Hesselink of Erasmus Medical Center, Rotterdam, the Netherlands, and associates.

The analysis was based on 1,321 pregnant patients with structural or ischemic heart disease enrolled from 60 hospitals in 28 countries from 2008 to June 2011 in the European Registry on Pregnancy and Heart Disease, the world’s first registry to focus on this challenging clinical scenario.

The patients’ median age was 30 (range 16-53), median duration of pregnancy 38 weeks, 56% had one or more previous pregnancy, and 54% had undergone at least one prior cardiac intervention. About 50 patients were from the United States.

Most patients were New York Heart Association class I (70%), and only 0.3% were class IV. More women with cardiomyopathy were NYHA class III (8%), while those with ischemic heart disease were older, more likely to suffer from hypertension and diabetes, and more likely to be smokers.

Outcomes in women with congenital heart disease, the largest subgroup in the registry at 872 patients, were relatively good compared with other subgroups. The authors attributed this to the high rate of successful prior cardiac corrective surgery (66%), favorable NYHA class (76% class I and 21% class II) and low use of any medication (20%).

Even in this group, however, the rate of cesarean delivery was higher (38% vs. 23%) and mean birth weight was lower than in the background population (3,056 grams vs. 3,190 grams), Dr. Roos-Hesselink and associates noted.

Overall, 41% of the cohort had a cesarean delivery, with the highest rate in women with ischemic heart disease (60%) or cardiomyopathy (58%).

Cesarean delivery rates also varied widely between countries, with the highest rate reported in Italy, not the United States, she said in an interview.

"C-section rates are the product both of the background rates of a particular country and the numbers of women with severe heart disease, so that if the background rate was high and there were more women with severe heart disease in that group, then that country’s rates were higher," she explained.

During pregnancy, 338 patients (26%) were hospitalized, most (76%) only once. In all, 162 patients (12%) "had at least one period of heart failure during or after pregnancy, while this is rarely, if ever, seen in the general population," the investigators said.

Fetal mortality was significantly higher in the cohort than in the normal population (1.7% vs. 0.35%). In the cohort, 62% of the deaths were intrauterine fetal deaths with no further information, 21% were obviously due to the maternal condition, and 17% were because of structural fetal abnormalities. Neonatal death rates did not differ significantly between the cohort and the normal population (0.6% vs. 0.4%).

As for whether certain women with heart disease should avoid pregnancy, the data show there are certain groups of women who have a very high chance of experiencing an adverse outcome during pregnancy, but ultimately it is an individual’s choice whether to undergo a pregnancy, coauthor Dr. Mark R. Johnson, clinical chair in obstetrics at Imperial College, London, said in an interview.

The doctor’s job is to give advice about the risks," he said. One of the reasons the registry is so important is that "it gives us a more robust source to base our advice on."

Dr. Roos-Hesselink pointed out that guidelines published in Europe last year do consider some groups to be contraindicated for pregnancy including patients with pulmonary hypertension, patients with severe cyanosis, and patients with earlier peripartum cardiomyopathy and still diminished ventricular function.

"Some of these women do get pregnant against advice," she added. "Especially, we have seen this happen in Egypt," she said, noting that women who wanted a pregnancy for cultural reasons might not tell their husbands that they had heart defects.

Significant differences were found between developed and developing countries in maternal mortality (0.6% vs. 3.9%) and fetal death (0.9% vs. 6.5%), although the authors acknowledged that any between-country comparisons were "very fragile" because the size of the populations was "grossly unbalanced."

"Most women with adequate counseling and optimal care should not be discouraged and can go safely through pregnancy," the authors concluded.

In terms of counseling, Dr. Johnson said it’s important to give as accurate a picture as possible of the risks to which the woman would be exposing herself and her baby.

"In terms of management, the early recognition of a problem and its prompt management is really important, from things as simple as anemia or a urinary tract infection to the more severe situation of a cardiac arrhythmia or the development of heart failure," he said.

Dr. Roos-Hesselink said the standard at her clinic is to perform an echocardiogram and exercise test prepregnancy, with other tests such as magnetic resonance imaging done if needed. Symptomatic patients must be treated and a dilated aorta corrected prior to pregnancy.

"If the woman has a bad exercise capacity, this gives you an idea she will do badly during pregnancy," she added.

The study was supported by the European Society of Cardiology. The authors reported they have no conflicts of interest.

Most women with heart disease can safely go through pregnancy, although striking differences in outcome were found by type of heart disease and between countries, a novel international registry shows.

Maternal mortality was 1%, but this was still 100 times higher than the mortality of 0.007% in the normal pregnant population. Seven of the 13 maternal deaths were due to cardiac events, three to thromboembolic events, and three to sepsis.

Maternal mortality was highest in women with cardiomyopathy at 2.4%, compared with 2.1% for those with valvular heart disease, 0.5% with congenital heart disease, and 0% for ischemic heart disease.

In addition, women with cardiomyopathy experienced higher rates of heart failure (24% vs. 18%, 8%, and 8%) and ventricular arrhythmias (11% vs. 0.6%, 1.6%, and 0%) than did those with valvular heart disease, congenital heart disease, and ischemic heart disease, cardiologist Dr. Jolien Roos-Hesselink and her associates reported (Eur. Heart J. 2012 [doi:10.1093/eurheartj/ehs270]).

Although cardiomyopathy is uncommon during pregnancy, it is difficult to manage in the context of left ventricular dysfunction or peripartum cardiomyopathy, with a high risk of an adverse outcome for both the mother and the baby, observed Dr. Roos-Hesselink of Erasmus Medical Center, Rotterdam, the Netherlands, and associates.

The analysis was based on 1,321 pregnant patients with structural or ischemic heart disease enrolled from 60 hospitals in 28 countries from 2008 to June 2011 in the European Registry on Pregnancy and Heart Disease, the world’s first registry to focus on this challenging clinical scenario.

The patients’ median age was 30 (range 16-53), median duration of pregnancy 38 weeks, 56% had one or more previous pregnancy, and 54% had undergone at least one prior cardiac intervention. About 50 patients were from the United States.

Most patients were New York Heart Association class I (70%), and only 0.3% were class IV. More women with cardiomyopathy were NYHA class III (8%), while those with ischemic heart disease were older, more likely to suffer from hypertension and diabetes, and more likely to be smokers.

Outcomes in women with congenital heart disease, the largest subgroup in the registry at 872 patients, were relatively good compared with other subgroups. The authors attributed this to the high rate of successful prior cardiac corrective surgery (66%), favorable NYHA class (76% class I and 21% class II) and low use of any medication (20%).

Even in this group, however, the rate of cesarean delivery was higher (38% vs. 23%) and mean birth weight was lower than in the background population (3,056 grams vs. 3,190 grams), Dr. Roos-Hesselink and associates noted.

Overall, 41% of the cohort had a cesarean delivery, with the highest rate in women with ischemic heart disease (60%) or cardiomyopathy (58%).

Cesarean delivery rates also varied widely between countries, with the highest rate reported in Italy, not the United States, she said in an interview.

"C-section rates are the product both of the background rates of a particular country and the numbers of women with severe heart disease, so that if the background rate was high and there were more women with severe heart disease in that group, then that country’s rates were higher," she explained.

During pregnancy, 338 patients (26%) were hospitalized, most (76%) only once. In all, 162 patients (12%) "had at least one period of heart failure during or after pregnancy, while this is rarely, if ever, seen in the general population," the investigators said.

Fetal mortality was significantly higher in the cohort than in the normal population (1.7% vs. 0.35%). In the cohort, 62% of the deaths were intrauterine fetal deaths with no further information, 21% were obviously due to the maternal condition, and 17% were because of structural fetal abnormalities. Neonatal death rates did not differ significantly between the cohort and the normal population (0.6% vs. 0.4%).

As for whether certain women with heart disease should avoid pregnancy, the data show there are certain groups of women who have a very high chance of experiencing an adverse outcome during pregnancy, but ultimately it is an individual’s choice whether to undergo a pregnancy, coauthor Dr. Mark R. Johnson, clinical chair in obstetrics at Imperial College, London, said in an interview.

The doctor’s job is to give advice about the risks," he said. One of the reasons the registry is so important is that "it gives us a more robust source to base our advice on."

Dr. Roos-Hesselink pointed out that guidelines published in Europe last year do consider some groups to be contraindicated for pregnancy including patients with pulmonary hypertension, patients with severe cyanosis, and patients with earlier peripartum cardiomyopathy and still diminished ventricular function.

"Some of these women do get pregnant against advice," she added. "Especially, we have seen this happen in Egypt," she said, noting that women who wanted a pregnancy for cultural reasons might not tell their husbands that they had heart defects.

Significant differences were found between developed and developing countries in maternal mortality (0.6% vs. 3.9%) and fetal death (0.9% vs. 6.5%), although the authors acknowledged that any between-country comparisons were "very fragile" because the size of the populations was "grossly unbalanced."

"Most women with adequate counseling and optimal care should not be discouraged and can go safely through pregnancy," the authors concluded.

In terms of counseling, Dr. Johnson said it’s important to give as accurate a picture as possible of the risks to which the woman would be exposing herself and her baby.

"In terms of management, the early recognition of a problem and its prompt management is really important, from things as simple as anemia or a urinary tract infection to the more severe situation of a cardiac arrhythmia or the development of heart failure," he said.

Dr. Roos-Hesselink said the standard at her clinic is to perform an echocardiogram and exercise test prepregnancy, with other tests such as magnetic resonance imaging done if needed. Symptomatic patients must be treated and a dilated aorta corrected prior to pregnancy.

"If the woman has a bad exercise capacity, this gives you an idea she will do badly during pregnancy," she added.

The study was supported by the European Society of Cardiology. The authors reported they have no conflicts of interest.

Most women with heart disease can safely go through pregnancy, although striking differences in outcome were found by type of heart disease and between countries, a novel international registry shows.

Maternal mortality was 1%, but this was still 100 times higher than the mortality of 0.007% in the normal pregnant population. Seven of the 13 maternal deaths were due to cardiac events, three to thromboembolic events, and three to sepsis.

Maternal mortality was highest in women with cardiomyopathy at 2.4%, compared with 2.1% for those with valvular heart disease, 0.5% with congenital heart disease, and 0% for ischemic heart disease.

In addition, women with cardiomyopathy experienced higher rates of heart failure (24% vs. 18%, 8%, and 8%) and ventricular arrhythmias (11% vs. 0.6%, 1.6%, and 0%) than did those with valvular heart disease, congenital heart disease, and ischemic heart disease, cardiologist Dr. Jolien Roos-Hesselink and her associates reported (Eur. Heart J. 2012 [doi:10.1093/eurheartj/ehs270]).

Although cardiomyopathy is uncommon during pregnancy, it is difficult to manage in the context of left ventricular dysfunction or peripartum cardiomyopathy, with a high risk of an adverse outcome for both the mother and the baby, observed Dr. Roos-Hesselink of Erasmus Medical Center, Rotterdam, the Netherlands, and associates.

The analysis was based on 1,321 pregnant patients with structural or ischemic heart disease enrolled from 60 hospitals in 28 countries from 2008 to June 2011 in the European Registry on Pregnancy and Heart Disease, the world’s first registry to focus on this challenging clinical scenario.

The patients’ median age was 30 (range 16-53), median duration of pregnancy 38 weeks, 56% had one or more previous pregnancy, and 54% had undergone at least one prior cardiac intervention. About 50 patients were from the United States.

Most patients were New York Heart Association class I (70%), and only 0.3% were class IV. More women with cardiomyopathy were NYHA class III (8%), while those with ischemic heart disease were older, more likely to suffer from hypertension and diabetes, and more likely to be smokers.

Outcomes in women with congenital heart disease, the largest subgroup in the registry at 872 patients, were relatively good compared with other subgroups. The authors attributed this to the high rate of successful prior cardiac corrective surgery (66%), favorable NYHA class (76% class I and 21% class II) and low use of any medication (20%).

Even in this group, however, the rate of cesarean delivery was higher (38% vs. 23%) and mean birth weight was lower than in the background population (3,056 grams vs. 3,190 grams), Dr. Roos-Hesselink and associates noted.

Overall, 41% of the cohort had a cesarean delivery, with the highest rate in women with ischemic heart disease (60%) or cardiomyopathy (58%).

Cesarean delivery rates also varied widely between countries, with the highest rate reported in Italy, not the United States, she said in an interview.

"C-section rates are the product both of the background rates of a particular country and the numbers of women with severe heart disease, so that if the background rate was high and there were more women with severe heart disease in that group, then that country’s rates were higher," she explained.

During pregnancy, 338 patients (26%) were hospitalized, most (76%) only once. In all, 162 patients (12%) "had at least one period of heart failure during or after pregnancy, while this is rarely, if ever, seen in the general population," the investigators said.

Fetal mortality was significantly higher in the cohort than in the normal population (1.7% vs. 0.35%). In the cohort, 62% of the deaths were intrauterine fetal deaths with no further information, 21% were obviously due to the maternal condition, and 17% were because of structural fetal abnormalities. Neonatal death rates did not differ significantly between the cohort and the normal population (0.6% vs. 0.4%).

As for whether certain women with heart disease should avoid pregnancy, the data show there are certain groups of women who have a very high chance of experiencing an adverse outcome during pregnancy, but ultimately it is an individual’s choice whether to undergo a pregnancy, coauthor Dr. Mark R. Johnson, clinical chair in obstetrics at Imperial College, London, said in an interview.

The doctor’s job is to give advice about the risks," he said. One of the reasons the registry is so important is that "it gives us a more robust source to base our advice on."

Dr. Roos-Hesselink pointed out that guidelines published in Europe last year do consider some groups to be contraindicated for pregnancy including patients with pulmonary hypertension, patients with severe cyanosis, and patients with earlier peripartum cardiomyopathy and still diminished ventricular function.

"Some of these women do get pregnant against advice," she added. "Especially, we have seen this happen in Egypt," she said, noting that women who wanted a pregnancy for cultural reasons might not tell their husbands that they had heart defects.

Significant differences were found between developed and developing countries in maternal mortality (0.6% vs. 3.9%) and fetal death (0.9% vs. 6.5%), although the authors acknowledged that any between-country comparisons were "very fragile" because the size of the populations was "grossly unbalanced."

"Most women with adequate counseling and optimal care should not be discouraged and can go safely through pregnancy," the authors concluded.

In terms of counseling, Dr. Johnson said it’s important to give as accurate a picture as possible of the risks to which the woman would be exposing herself and her baby.

"In terms of management, the early recognition of a problem and its prompt management is really important, from things as simple as anemia or a urinary tract infection to the more severe situation of a cardiac arrhythmia or the development of heart failure," he said.

Dr. Roos-Hesselink said the standard at her clinic is to perform an echocardiogram and exercise test prepregnancy, with other tests such as magnetic resonance imaging done if needed. Symptomatic patients must be treated and a dilated aorta corrected prior to pregnancy.

"If the woman has a bad exercise capacity, this gives you an idea she will do badly during pregnancy," she added.

The study was supported by the European Society of Cardiology. The authors reported they have no conflicts of interest.

SAN ANTONIO – Education about appropriate weight gain, healthy eating, and exercise during pregnancy improves dietary restraint and self-weighing, and prevents postpartum weight retention, according to 12-month findings from the randomized, controlled Fit for Delivery study.

Benefits accrued even after the "pretty practical, low-intensity intervention" ended, suggesting that "pregnancy may be a teachable moment for promoting continued behavioral changes," Suzanne Phelan, Ph.D., of California Polytechnic State University, San Luis Obispo, reported at the annual meeting of the Obesity Society.

©Stephanie Horrocks/iStockphoto.com

Among 201 normal-weight study participants, 40% of those randomized to receive standard care plus a lifestyle modification intervention exceeded 1990 Institute of Medicine recommendations for weight gain during pregnancy, compared with 52% of those randomized to receive standard care as part of a control group.

No such difference was seen among 200 overweight or obese participants in the intervention and control groups (67% and 61%). Regardless of weight status at study entry, 31% of 201 women in the intervention group returned to their prepregnancy weight by 6 months post partum, compared with 19% of 200 women in the control group.

The 6-month results of the Fit for Delivery study were published last year in the American Journal of Clinical Nutrition (2011;93:772-9). Dr. Phelan’s presentation included findings at 12 months’ follow-up.

At 12 months post partum, 45% of normal-weight and overweight/obese participants in the intervention group and 35% in the control group reached their prepregnancy weight. The women in the intervention group may have been more successful because they exhibited significantly greater dietary restraint and were significantly more likely to monitor their weight throughout the study period. For example, the intervention group reduced calories consumed from soft drinks during pregnancy and until 6 months’ follow-up.

More sophisticated analyses to explore the complex relationships between potential mediators of treatment effects are underway, she added.

Fit for Delivery study participants were pregnant women recruited from six obstetrics practices between 2006 and 2008. At study entry, their mean age was 29 years and mean gestation was 13.5 weeks. Two-thirds were non-Hispanic white women and 77% were primiparous. Half were normal weight and half were overweight or obese.

Those in the intervention group had one 30-minute face-to-face visit, three phone calls throughout pregnancy (with more for those gaining more or less than the recommended amount of weight), and mail delivery of "challenge cards" highlighting key behavioral targets such as healthy eating and physical activity. The intervention group also received a scale, pedometer, and nutritional resources such as calorie-counting booklets.

A motivational approach to the intervention, which ended at delivery, aimed to teach participants to consider the impact of their behavior on the health of their growing baby, Dr. Phelan noted.

Participants in the control group had one face-to-face visit with a dietitian, and received general educational brochures and newsletters about pregnancy-related topics.

The final analysis excluded 6 women who experienced a miscarriage, 32 who developed gestational diabetes, 5 who became pregnant within 6 months of delivery, and an additional 36 who became pregnant within 12 months of delivery.

Excessive gestational weight gain is a major determinant of high postpartum weight retention as well as long-term obesity and several adverse maternal and offspring outcomes, Dr. Phelan said. About half of normal-weight women and 65% of overweight or obese women gain more weight than recommended during pregnancy.

This type of program could be useful in the clinical setting, she added, noting that additional research to evaluate the effects of higher-intensity programs is needed.

The Fit for Delivery study was supported by the National Institutes of Health. Dr. Phelan and her colleagues reported having no relevant financial disclosures.

SAN ANTONIO – Education about appropriate weight gain, healthy eating, and exercise during pregnancy improves dietary restraint and self-weighing, and prevents postpartum weight retention, according to 12-month findings from the randomized, controlled Fit for Delivery study.

Benefits accrued even after the "pretty practical, low-intensity intervention" ended, suggesting that "pregnancy may be a teachable moment for promoting continued behavioral changes," Suzanne Phelan, Ph.D., of California Polytechnic State University, San Luis Obispo, reported at the annual meeting of the Obesity Society.

©Stephanie Horrocks/iStockphoto.com

Among 201 normal-weight study participants, 40% of those randomized to receive standard care plus a lifestyle modification intervention exceeded 1990 Institute of Medicine recommendations for weight gain during pregnancy, compared with 52% of those randomized to receive standard care as part of a control group.

No such difference was seen among 200 overweight or obese participants in the intervention and control groups (67% and 61%). Regardless of weight status at study entry, 31% of 201 women in the intervention group returned to their prepregnancy weight by 6 months post partum, compared with 19% of 200 women in the control group.

The 6-month results of the Fit for Delivery study were published last year in the American Journal of Clinical Nutrition (2011;93:772-9). Dr. Phelan’s presentation included findings at 12 months’ follow-up.

At 12 months post partum, 45% of normal-weight and overweight/obese participants in the intervention group and 35% in the control group reached their prepregnancy weight. The women in the intervention group may have been more successful because they exhibited significantly greater dietary restraint and were significantly more likely to monitor their weight throughout the study period. For example, the intervention group reduced calories consumed from soft drinks during pregnancy and until 6 months’ follow-up.

More sophisticated analyses to explore the complex relationships between potential mediators of treatment effects are underway, she added.

Fit for Delivery study participants were pregnant women recruited from six obstetrics practices between 2006 and 2008. At study entry, their mean age was 29 years and mean gestation was 13.5 weeks. Two-thirds were non-Hispanic white women and 77% were primiparous. Half were normal weight and half were overweight or obese.

Those in the intervention group had one 30-minute face-to-face visit, three phone calls throughout pregnancy (with more for those gaining more or less than the recommended amount of weight), and mail delivery of "challenge cards" highlighting key behavioral targets such as healthy eating and physical activity. The intervention group also received a scale, pedometer, and nutritional resources such as calorie-counting booklets.

A motivational approach to the intervention, which ended at delivery, aimed to teach participants to consider the impact of their behavior on the health of their growing baby, Dr. Phelan noted.

Participants in the control group had one face-to-face visit with a dietitian, and received general educational brochures and newsletters about pregnancy-related topics.

The final analysis excluded 6 women who experienced a miscarriage, 32 who developed gestational diabetes, 5 who became pregnant within 6 months of delivery, and an additional 36 who became pregnant within 12 months of delivery.

Excessive gestational weight gain is a major determinant of high postpartum weight retention as well as long-term obesity and several adverse maternal and offspring outcomes, Dr. Phelan said. About half of normal-weight women and 65% of overweight or obese women gain more weight than recommended during pregnancy.

This type of program could be useful in the clinical setting, she added, noting that additional research to evaluate the effects of higher-intensity programs is needed.

The Fit for Delivery study was supported by the National Institutes of Health. Dr. Phelan and her colleagues reported having no relevant financial disclosures.

SAN ANTONIO – Education about appropriate weight gain, healthy eating, and exercise during pregnancy improves dietary restraint and self-weighing, and prevents postpartum weight retention, according to 12-month findings from the randomized, controlled Fit for Delivery study.

Benefits accrued even after the "pretty practical, low-intensity intervention" ended, suggesting that "pregnancy may be a teachable moment for promoting continued behavioral changes," Suzanne Phelan, Ph.D., of California Polytechnic State University, San Luis Obispo, reported at the annual meeting of the Obesity Society.

©Stephanie Horrocks/iStockphoto.com

Among 201 normal-weight study participants, 40% of those randomized to receive standard care plus a lifestyle modification intervention exceeded 1990 Institute of Medicine recommendations for weight gain during pregnancy, compared with 52% of those randomized to receive standard care as part of a control group.

No such difference was seen among 200 overweight or obese participants in the intervention and control groups (67% and 61%). Regardless of weight status at study entry, 31% of 201 women in the intervention group returned to their prepregnancy weight by 6 months post partum, compared with 19% of 200 women in the control group.

The 6-month results of the Fit for Delivery study were published last year in the American Journal of Clinical Nutrition (2011;93:772-9). Dr. Phelan’s presentation included findings at 12 months’ follow-up.

At 12 months post partum, 45% of normal-weight and overweight/obese participants in the intervention group and 35% in the control group reached their prepregnancy weight. The women in the intervention group may have been more successful because they exhibited significantly greater dietary restraint and were significantly more likely to monitor their weight throughout the study period. For example, the intervention group reduced calories consumed from soft drinks during pregnancy and until 6 months’ follow-up.

More sophisticated analyses to explore the complex relationships between potential mediators of treatment effects are underway, she added.

Fit for Delivery study participants were pregnant women recruited from six obstetrics practices between 2006 and 2008. At study entry, their mean age was 29 years and mean gestation was 13.5 weeks. Two-thirds were non-Hispanic white women and 77% were primiparous. Half were normal weight and half were overweight or obese.

Those in the intervention group had one 30-minute face-to-face visit, three phone calls throughout pregnancy (with more for those gaining more or less than the recommended amount of weight), and mail delivery of "challenge cards" highlighting key behavioral targets such as healthy eating and physical activity. The intervention group also received a scale, pedometer, and nutritional resources such as calorie-counting booklets.

A motivational approach to the intervention, which ended at delivery, aimed to teach participants to consider the impact of their behavior on the health of their growing baby, Dr. Phelan noted.

Participants in the control group had one face-to-face visit with a dietitian, and received general educational brochures and newsletters about pregnancy-related topics.

The final analysis excluded 6 women who experienced a miscarriage, 32 who developed gestational diabetes, 5 who became pregnant within 6 months of delivery, and an additional 36 who became pregnant within 12 months of delivery.

Excessive gestational weight gain is a major determinant of high postpartum weight retention as well as long-term obesity and several adverse maternal and offspring outcomes, Dr. Phelan said. About half of normal-weight women and 65% of overweight or obese women gain more weight than recommended during pregnancy.

This type of program could be useful in the clinical setting, she added, noting that additional research to evaluate the effects of higher-intensity programs is needed.

The Fit for Delivery study was supported by the National Institutes of Health. Dr. Phelan and her colleagues reported having no relevant financial disclosures.

BERLIN – Intermittent use of continuous glucose monitoring during pregnancy failed to improve glycemic control or cut the rate of neonatal macrosomia in a single-center, randomized study with 149 women with diabetes.

In fact, the rate of macrosomia was actually higher in the 76 women with diabetes who used continuous, real-time glucose monitoring during at least 5 weeks of their pregnancy, with a 45% rate, compared with a 34% rate among the 73 control women who used seven-per-day sessions of self-monitoring throughout their pregnancy, a difference that was not statistically significant, Dr. Anna L. Secher said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

The absence of any discernable benefit from real-time continuous monitoring for any of the measures examined set back the concept that pregnancy could benefit from continuous monitoring, as shown in a prior study of intermittent, continuous monitoring from other investigators (BMJ 2008;337:a1680).

"We were surprised and disappointed with the results," said Dr. Secher, a researcher with the center for pregnant women with diabetes at Rigshospitalet in Copenhagen. The absence of any significant effect from continuous monitoring on macrosomia, prematurity, or episodes of severe neonatal hypoglycemia may have resulted from a cautious control approach promoted by the center’s staff in an effort to minimize hypoglycemia events.

"By focusing on severe hypoglycemia, we might pay a price in hyperglycemic complications," she said.

Another flaw in the Danish study was that the study protocol specified continuous monitoring during only gestational weeks 8, 12, 21, 27, and 33, with each of these weeks culminating with a clinic visit and adjustments to insulin dosages and diet as dictated by the monitoring results. Women in the continuous-monitoring arm were "encouraged" to use continuous monitoring as often as they could during the rest of their pregnancy, but it was not mandatory.

"We made the design intermittent because we knew that limitations in the system would affect compliance," Dr. Secher said. In addition, "we were concerned that women who could use continuous monitoring would be a selected population with limited numbers."

The study enrolled women with type 1 or 2 diabetes at less than 14 weeks’ gestation with a singleton pregnancy. Their average hemoglobin A_1c at baseline was about 6.7%, their average body mass index was about 25 kg/m², and their average duration of diabetes was about 11 years. Eighty percent had type 1 diabetes.

The 76 women who completed the continuous-monitoring arm of the study used the Guardian monitor marketed by Medtronic.

The measurements taken during pregnancy showed identical average levels of HbA_1c in both treatment arms throughout the study. The rate of preterm delivery, severe neonatal hypoglycemia, or both was 29% in the continuous-monitoring women and 22% in those who always self-monitored.

A subgroup analysis that focused on the 80% of women with type 1 diabetes failed to change the outcomes. In addition, 22% of the women in the continuous-monitoring group also used an insulin pump, and for these women their pump was hooked up to their continuous monitor. An additional subgroup analysis that focused only on these women also failed to change the outcomes.

Dr. Secher said that she and her associates had no disclosures.

BERLIN – Intermittent use of continuous glucose monitoring during pregnancy failed to improve glycemic control or cut the rate of neonatal macrosomia in a single-center, randomized study with 149 women with diabetes.

In fact, the rate of macrosomia was actually higher in the 76 women with diabetes who used continuous, real-time glucose monitoring during at least 5 weeks of their pregnancy, with a 45% rate, compared with a 34% rate among the 73 control women who used seven-per-day sessions of self-monitoring throughout their pregnancy, a difference that was not statistically significant, Dr. Anna L. Secher said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

The absence of any discernable benefit from real-time continuous monitoring for any of the measures examined set back the concept that pregnancy could benefit from continuous monitoring, as shown in a prior study of intermittent, continuous monitoring from other investigators (BMJ 2008;337:a1680).

"We were surprised and disappointed with the results," said Dr. Secher, a researcher with the center for pregnant women with diabetes at Rigshospitalet in Copenhagen. The absence of any significant effect from continuous monitoring on macrosomia, prematurity, or episodes of severe neonatal hypoglycemia may have resulted from a cautious control approach promoted by the center’s staff in an effort to minimize hypoglycemia events.

"By focusing on severe hypoglycemia, we might pay a price in hyperglycemic complications," she said.

Another flaw in the Danish study was that the study protocol specified continuous monitoring during only gestational weeks 8, 12, 21, 27, and 33, with each of these weeks culminating with a clinic visit and adjustments to insulin dosages and diet as dictated by the monitoring results. Women in the continuous-monitoring arm were "encouraged" to use continuous monitoring as often as they could during the rest of their pregnancy, but it was not mandatory.

"We made the design intermittent because we knew that limitations in the system would affect compliance," Dr. Secher said. In addition, "we were concerned that women who could use continuous monitoring would be a selected population with limited numbers."

The study enrolled women with type 1 or 2 diabetes at less than 14 weeks’ gestation with a singleton pregnancy. Their average hemoglobin A_1c at baseline was about 6.7%, their average body mass index was about 25 kg/m², and their average duration of diabetes was about 11 years. Eighty percent had type 1 diabetes.

The 76 women who completed the continuous-monitoring arm of the study used the Guardian monitor marketed by Medtronic.

The measurements taken during pregnancy showed identical average levels of HbA_1c in both treatment arms throughout the study. The rate of preterm delivery, severe neonatal hypoglycemia, or both was 29% in the continuous-monitoring women and 22% in those who always self-monitored.

A subgroup analysis that focused on the 80% of women with type 1 diabetes failed to change the outcomes. In addition, 22% of the women in the continuous-monitoring group also used an insulin pump, and for these women their pump was hooked up to their continuous monitor. An additional subgroup analysis that focused only on these women also failed to change the outcomes.

Dr. Secher said that she and her associates had no disclosures.

BERLIN – Intermittent use of continuous glucose monitoring during pregnancy failed to improve glycemic control or cut the rate of neonatal macrosomia in a single-center, randomized study with 149 women with diabetes.

In fact, the rate of macrosomia was actually higher in the 76 women with diabetes who used continuous, real-time glucose monitoring during at least 5 weeks of their pregnancy, with a 45% rate, compared with a 34% rate among the 73 control women who used seven-per-day sessions of self-monitoring throughout their pregnancy, a difference that was not statistically significant, Dr. Anna L. Secher said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

The absence of any discernable benefit from real-time continuous monitoring for any of the measures examined set back the concept that pregnancy could benefit from continuous monitoring, as shown in a prior study of intermittent, continuous monitoring from other investigators (BMJ 2008;337:a1680).

"We were surprised and disappointed with the results," said Dr. Secher, a researcher with the center for pregnant women with diabetes at Rigshospitalet in Copenhagen. The absence of any significant effect from continuous monitoring on macrosomia, prematurity, or episodes of severe neonatal hypoglycemia may have resulted from a cautious control approach promoted by the center’s staff in an effort to minimize hypoglycemia events.

"By focusing on severe hypoglycemia, we might pay a price in hyperglycemic complications," she said.

Another flaw in the Danish study was that the study protocol specified continuous monitoring during only gestational weeks 8, 12, 21, 27, and 33, with each of these weeks culminating with a clinic visit and adjustments to insulin dosages and diet as dictated by the monitoring results. Women in the continuous-monitoring arm were "encouraged" to use continuous monitoring as often as they could during the rest of their pregnancy, but it was not mandatory.

"We made the design intermittent because we knew that limitations in the system would affect compliance," Dr. Secher said. In addition, "we were concerned that women who could use continuous monitoring would be a selected population with limited numbers."

The study enrolled women with type 1 or 2 diabetes at less than 14 weeks’ gestation with a singleton pregnancy. Their average hemoglobin A_1c at baseline was about 6.7%, their average body mass index was about 25 kg/m², and their average duration of diabetes was about 11 years. Eighty percent had type 1 diabetes.

The 76 women who completed the continuous-monitoring arm of the study used the Guardian monitor marketed by Medtronic.

The measurements taken during pregnancy showed identical average levels of HbA_1c in both treatment arms throughout the study. The rate of preterm delivery, severe neonatal hypoglycemia, or both was 29% in the continuous-monitoring women and 22% in those who always self-monitored.

A subgroup analysis that focused on the 80% of women with type 1 diabetes failed to change the outcomes. In addition, 22% of the women in the continuous-monitoring group also used an insulin pump, and for these women their pump was hooked up to their continuous monitor. An additional subgroup analysis that focused only on these women also failed to change the outcomes.

Dr. Secher said that she and her associates had no disclosures.

The American College of Obstetricians and Gynecologists (ACOG) has recommended dividing a woman's life cycle into four intervals—ages 13–18, 19–39, 40–64, and older than 65—in order to best organize the approach to primary and preventive health care.¹ This paradigm provides a structure for organizing the clinical approach to physical examination, laboratory testing, counseling, and immunizations. In addition, it helps to highlight the diseases and health problems most prevalent among women at each life-stage.

Different professional organizations—US Preventive Services Task Force (USPSTF), American Medical Association, American College of Physicians, ACOG, American Academy of Family Physicians, American Academy of Pediatrics, and Advisory Committee on Immunization Practices—have used varying analytical methods to determine recommended health services by age group; consequently, these organizations have somewhat divergent recommendations. However, the recommendations of most organizations share many similarities. In this comprehensive guide, I point out those similarities. Keep in mind that recommendations change over time, and it is important to use your professional judgment when approaching each patient.

TABLE

Physical examination and laboratory testing services according to a patient's age, based on ACOG recommendations¹

The adolescent: 13–18 years

Screen. Guide. Immunize. ACOG recommends that the first visit take place between 13 and 15 years of age, with annual visits thereafter. The purpose of the first, and subsequent, visits is to assess health status, including menstrual history and body mass index (BMI), and to provide health guidance, screening, and preventive health services. This initial visit generally does not include a pelvic examination. A physical examination is not required at every visit but is recommended to occur at least once during early, middle, and late adolescence.

Target your screening practices. Screen adolescents for the following conditions during clinical preventive services: hypertension; hyperlipidemia; obesity and eating disorders; physical, sexual, or emotional abuse; learning or school problems; substance use; depression and risk of suicide; sexual assault; sexual behavior that may lead to pregnancy or sexually transmitted disease (STD); and tuberculosis and HIV, unless the patient opts out (TABLE).

Anticipate. Then guide. Using anticipatory guidance, you can help adolescents understand their physical, psychosocial, and sexual development and motivate them to be involved in their health and health-care decisions. Issues relevant to adolescents include dietary habits; injury prevention, through the use of helmets and seatbelts; regular exercise; responsible sexual behaviors; avoidance of substances that can be abused; strategies for dealing with bullying; and avoidance of behaviors that might have negative consequences, such as vandalism, stealing, and sharing personal information with strangers.

Recommended immunizations. For this age group, immunizations, unless previously given, include:

• 1 or 2 doses of measles, mumps, and rubella
• 2 doses of varicella if not previously infected
• a booster dose of tetanus if ≥10 years have elapsed since the last dose
• human papillomavirus (HPV)
• annual influenza.

Other immunizations that may be warranted on the basis of medical condition, occupation, lifestyle, or other indications include: 3 doses of hepatitis B, 2 doses of hepatitis A, 1 or more doses of meningococcal, and 1 or 2 doses of pneumococcal.

Menses, an important "vital sign." Once menstruation begins, evaluating menstrual cycle characteristics is important. Patterns that may require evaluation include²:

• no menses within 3 years of thelarche
• no menses by age 13 with no sign of pubertal development
• no menses by age 14 with signs of hirsutism
• no menses by age 14 with indications of an eating disorder
• no menses by age 15
• history of regular menses that are now markedly irregular
• menses occur more frequently than 21 days or less frequently than every 45 days
• menses occur 90 days apart for one cycle
• menstrual bleeding that lasts more than 7 days
• frequent tampon/pad changes (more than 1 tampon/pad every 1 to 2 hours).

BMI predicts future disease. Overweight and obesity are important risk factors for diabetes mellitus, hyperlipidemia, hypertension, and various cancers. Eating disorders are common among adolescents and often occur in association with other mental health problems.

Non–sexually active teens and children

Gynecologic examination typically involves inspection of the genitalia and not instrumentation of the vagina. A careful explanation of the proposed examination is important. Ask young adolescents who they would like to have in the examination room with them. A hand mirror can be used to involve the patient in the genitalia inspection. If it's necessary to obtain magnification, use a hand lens, an otoscope without the speculum, or a colposcope. Record the configuration of the hymen, if present. If indicated, examination of the genitalia while the patient is in the knee-chest position often provides a good view of the vagina and sometimes the cervix, without instrumentation.

Sexually active teens

Effective contraception, including the use of emergency contraceptives, is an important health focus for sexually active teens. Vaginal speculum examination and bimanual gyn exam are not required prior to prescribing hormonal contraceptives to teens. Based on a review of the evidence and expert opinion,³ the current recommendation is that prior to prescribing a hormonal contraceptive, a medical history and blood pressure measurement are the only requirements; breast examination and a gyn exam (vaginal speculum and bimanual gyn exam) are not necessary. Testing for chlamydia and gonorrhea can be performed using a urine sample. A cervical cytology examination is not necessary until age 21 unless the patient is in a high-risk group, such as immunosuppressed or HIV-infected teens.

The young woman: 19–39 years

Focus on reproductive issues. Contraception, pregnancy, and cervical cancer screening are common reasons for visits among women in this age group. Gynecologic problems can include polycystic ovary syndrome (PCOS), endometriosis, fibroids, infertility, pelvic pain, vulvovaginal pain syndromes, vaginitis, adnexal masses, and STDs, including pelvic inflammatory diseases.

Offer effective contraception

Long-acting reversible contraceptives (LARCs) are the most clinically and cost-effective forms of reversible contraception. There are three LARC methods available in the United States: 1) the copper T380A intrauterine device (IUD; Paragard), 2) the levonorgestrel-releasing intrauterine system (Mirena), and 3) the single-rod etonogestrel implant (Implanon, Explanon).

The use of IUDs among American women has increased from about 2.4% of contracepting women of reproductive age in 2002 to 8.5% in 2009.⁴ In Norway and France, contracepting women of reproductive age use IUDs at a rate of 27% and 23%, respectively.⁵ Typical-use pregnancy rates for LARCs are lower and continuation rates are higher than observed with oral contraceptives (OCs).

In an economic analysis, the cost of LARCs was lower than almost all other forms of reversible contraception over a 5-year interval.⁶ When financial and access barriers are removed, most women starting a contraceptive will use a LARC, if offered.⁷

Be aware of STDs

STDs are common in this age group. In the United States, chlamydial genital infections reach a peak in women 18 to 25 years old, with a prevalence of about 4%.⁸

Counsel her about exercise and weight loss

Approximately 60% of women older than age 20 are overweight or obese.⁹ The rise in obesity is a key contributing factor to an increase in many diseases, including gestational diabetes, type 2 diabetes mellitus, and hypertension. Successful efforts to reduce the prevalence of obesity through diet and exercise could markedly improve population health.

Don't overlook autoimmune conditions

Many autoimmune diseases reach a peak incidence between ages 19 and 39, and, except for ankylosing spondylitis, are more of a concern for women than men. Systemic lupus erythematosus, lymphocytic thyroiditis, and rheumatoid arthritis occur much more frequently in women than in men, with ratios in the range of 7:1 observed during this age interval.

Keep her immunity up to date

Immunizations recommended in this age group include:

• one Tdap (tetanus toxoid, diphtheria, and pertussis)
• tetanus every 10 years
• influenza annually
• varicella if no evidence of immunity
• HPV for those aged 26 years or younger.

The mature woman: 40–64 years

Transition to postmenopause. The menstrual changes through perimenopause to postmenopause are often accompanied by changes in sleep patterns, vasomotor symptoms, and increasing vaginal dryness.

Open your eyes to a patient's insomnia

Perimenopausal and postmenopausal women report a much higher rate of insomnia than age-matched men.¹⁰ Women with moderate to severe vasomotor symptoms are more likely to report greater nighttime wakefulness and a greater number of nighttime long-awake episodes than women with mild vasomotor symptoms.¹¹ Insomnia can be associated with poor work performance and mood changes.

Hormone therapy: Be conservative

In the past, hormone therapy, with various estrogen and progestin combinations, was recommended to help prevent a number of diseases, including cardiovascular disease (CD) and osteoporosis. Based on clinical trial results, the current recommendation is to limit the use of hormone therapy in postmenopausal women to the treatment of vasomotor symptoms and vaginal symptoms caused by hypoestrogenism. To treat these problems, the lowest doses of hormones that are effective should be used for the shortest periods of time that achieve symptom resolution.

The older woman: 65+ years

Successful aging. Based on observational studies, behavioral and health factors associated with successful aging include more than 12 years of education; high socioeconomic status; absence of diabetes, asthma, stroke, and lower respiratory tract disease; absence of depression; presence of at least five close personal contacts; frequent walking; moderate use of alcohol; and nonsmoking status.¹²

Know her risks, and watch for them

Cardiovascular disease. Among women, CDs cause more deaths than malignant neoplasms, chronic lower respiratory disease, Alzheimer's disease, and accidents combined. Black women have rates of CD approximately 40% greater than white women. Hypertension, hypertriglyceridemia, obesity, and sedentary lifestyle among black women account for a part of this increased risk.

Effective lifestyle interventions for primary CD prevention in women include smoking cessation, a diet such as DASH (Dietary Approaches to Stop Hypertension) rich in fruits and vegetables, regular physical activity, and weight management.¹³

There are important gender differences in aspirin efficacy for primary prevention of stroke and myocardial infarction (MI) in men and women. Among women, aspirin used for primary prevention appears to reduce the risk of stroke but not MI.¹⁴ Among men, aspirin used for primary prevention appears to reduce the risk of MI but not stroke.^15,16 Based on these and other data, the USPSTF has recommended that aspirin not be used to prevent stroke in men but recommends aspirin to prevent stroke among women 55 to 79 years of age when benefits outweigh risks of gastrointestinal bleeding.¹⁷

Atrial fibrillation (AF), a risk factor for stroke, is more common in women than in men. In addition, women with AF who are not anticoagulated are at greater risk for stroke than men with AF who are not anticoagulated.¹⁸ The mechanisms that influence these gender differences are not well characterized.

Respiratory illness. Among women, the prevalence of chronic bronchitis and emphysema increased more than 2.8-fold from 1980 to 2000.¹⁹ These diseases are major contributors to physician office visits, hospitalizations, disability, and death. Tobacco use is the major risk factor that accounts for the marked increase in COPD among women during recent decades, although ambient pollutants in the environment, home, and workplace are also important contributors to COPD development.

Cognitive decline. Alzheimer's disease afflicts approximately twice as many women as men. Part of this difference is due to the greater longevity of women, but additional variables, such as gender differences in neurobiology, are also contributory. The role of estradiol in the development of Alzheimer's disease remains controversial.

Osteoporosis. This disease occurs about five times more frequently in women than in men. Among Medicare patients, the cost of caring for a hip fracture is more than $40,000 in the first year postfracture. Hip fracture is associated with a high risk of rapid health decline. Interventions that successfully prevent hip fracture are associated with a reduced mortality rate.^20,21

A concern at any age

Domestic violence

Domestic violence is common; approximately 5% of women report one episode during the past year and 25% report at least one lifetime episode.²² Domestic violence involves two people: a perpetrator and a victim. In some relationships, a recurrent cycle of violence and reconciliation is observed. Routine, confidential, and private screening is required to detect most cases of domestic violence.

Ask the right question(s). The single question, "At any time, has a partner hit, kicked, or otherwise hurt or threatened you?" can increase the rate of detection. Alternatively, a set of three questions can be used to screen for domestic violence:

1. "Within the past year, have you been hit, slapped, kicked or otherwise physically hurt by someone?"
2. "Within the past year, has anyone forced you to have sexual activity?"
3. In pregnancy: "Since you have been pregnant, have you been hit, slapped, kicked, or otherwise physically hurt by someone?"

Follow-up and refer. If a woman reports that she has suffered or is at risk for domestic violence, document the finding in her medical record. Then try to assess her safety by asking: "Are there guns in the home?", "Have there been threats of suicide or homicide?", "Has there been violence toward children?" Choking, specifically, could be a sign of future escalated violence—as many perpetrators choke their victims prior to further, escalated violence occurring—and should be taken as a threat of homicide. Refer women who report domestic violence to a specialist; often, the best trained and most available experts are experienced social workers.

Sexual assault

About 25% of women report at least one lifetime sexual assault. Most women who report being raped initially receive care in a hospital-based emergency department from nurses who are credentialed in Sexual Assault Nurse Evaluation (SANE) skills.

The initial evaluation includes rapid access to treatment by a specialized clinical team, assessment and treatment of bodily injuries with a focus on genital trauma, psychological assessment and support, pregnancy assessment and prevention, preventive treatment of STDs, and collection of forensic data, including toxicology testing for the presence of date-rape drugs.

When sexual assault is reported, treat for an STD. The Centers for Disease Control and Prevention (CDC) recommends the following approach to prevent and treat STDs in victims of sexual assault²³:

• ceftriaxone 125 mg IM to prevent gonorrhea
• azithromycin 1 g orally as a single dose or doxycycline 100 mg twice daily for 7 days to prevent chlamydia
• metronidazole 2 g orally as a single dose to prevent trichomoniasis
• hepatitis B vaccination, for women not previously vaccinated. (The CDC recommends against the use of hepatitis B immune globulin as the costs are believed to outweigh the benefits.)
• HIV postexposure prophylaxis for 3 to 7 days, with a follow-up visit to consider pros and cons of continued prophylaxis. (The risk of HIV infection following a sexual assault is low.)
• postcoital contraception (for example, levonorgestrel 1.5 mg orally as a single dose).

An antiemetic also should be offered to reduce the risk that the multiple prescribed medications will cause vomiting and nullify prophylaxis efforts. Approximately 2 weeks after the sexual assault the patient should have a pregnancy test and be assessed for ongoing mental health needs. If she did not adhere to the medications or if she shows relevant symptoms, perform follow-up STD testing. Follow-up HIV and syphilis testing can be performed at 12 and 24 weeks following the assault.

Sexual dysfunction

Sexuality is an important part of the human experience. Sexual dysfunction is the inability to participate as desired in a sexual relationship. Problems of sexual dysfunction are best approached from a biopsychosocial framework that recognizes the important contributions of biological, psychological, and social-cultural factors in sexual health. Masters and Johnson posited four stages of sexual response: excitement, plateau, orgasm, and resolution. Building on this linear model, investigators later divided the excitement phase into desire and arousal.

Recent models of sexual response have emphasized a circular model, in which sequential responses overlap and build on previous stimuli. These models also emphasize the importance of emotional intimacy and the quality of the relationship in achieving optimal sexual health.

Approximately 40% of women and 30% of men report sexual dysfunction.²⁴ Common sexual problems reported by heterosexual women include:

• lack of interest in sex
• inability to achieve orgasm
• pain caused by sexual intercourse
• lack of pleasure with sex
• trouble lubricating.

The majority of men and women will not voluntarily report sexual dysfunction to their clinician. To elicit the presence of sexual concerns, you must initiate the conversation.²⁵ You can begin the sexual history by asking, "Do you have any concerns about your sex life?" Additional helpful, open-ended questions include: "Are you having sexual relations currently? With men or women or both?", "If you are not having sex, when did you last have intercourse?", "Are you satisfied with the frequency and quality of your sexual experiences?", "What is the emotional quality and intimacy of your relationship with your sex partner?"

The common sexual disorders in women are categorized as desire, arousal, orgasm, and pain disorders. There are two desire disorders: hypoactive sexual desire disorder and sexual aversion disorder. There are two arousal disorders: female sexual arousal disorder and persistent genital arousal disorder. There are four pain disorders: dyspareunia, vulvodynia, vaginismus, and noncoital nonsexual pain.

Most experts recommend that treatment of female sexual dysfunction include multiple modalities that reflect the complex biopsychosocial factors that cause the problem. For example, a treatment plan might include cognitive behavioral therapy, sex therapy, and appropriate medications.

Mental health issues

Depression, anxiety, bulimia, and anorexia nervosa are more common in women than men. For instance, the lifetime risk of depression in women is approximately 20%, compared with about 10% in men. The gender difference is first observed in adolescence and becomes minimal after age 60. The gender differences are observed across racial and ethnic groups.²⁶

It's on us

As leaders in women's health care, we are uniquely trained to guide, counsel, diagnose, and treat women across their entire lifetime, from adolescence to postmenopause. We are at the vanguard in the effort to continually improve the health of all women.

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

The American College of Obstetricians and Gynecologists (ACOG) has recommended dividing a woman's life cycle into four intervals—ages 13–18, 19–39, 40–64, and older than 65—in order to best organize the approach to primary and preventive health care.¹ This paradigm provides a structure for organizing the clinical approach to physical examination, laboratory testing, counseling, and immunizations. In addition, it helps to highlight the diseases and health problems most prevalent among women at each life-stage.

Different professional organizations—US Preventive Services Task Force (USPSTF), American Medical Association, American College of Physicians, ACOG, American Academy of Family Physicians, American Academy of Pediatrics, and Advisory Committee on Immunization Practices—have used varying analytical methods to determine recommended health services by age group; consequently, these organizations have somewhat divergent recommendations. However, the recommendations of most organizations share many similarities. In this comprehensive guide, I point out those similarities. Keep in mind that recommendations change over time, and it is important to use your professional judgment when approaching each patient.

TABLE

Physical examination and laboratory testing services according to a patient's age, based on ACOG recommendations¹

The adolescent: 13–18 years

Screen. Guide. Immunize. ACOG recommends that the first visit take place between 13 and 15 years of age, with annual visits thereafter. The purpose of the first, and subsequent, visits is to assess health status, including menstrual history and body mass index (BMI), and to provide health guidance, screening, and preventive health services. This initial visit generally does not include a pelvic examination. A physical examination is not required at every visit but is recommended to occur at least once during early, middle, and late adolescence.

Target your screening practices. Screen adolescents for the following conditions during clinical preventive services: hypertension; hyperlipidemia; obesity and eating disorders; physical, sexual, or emotional abuse; learning or school problems; substance use; depression and risk of suicide; sexual assault; sexual behavior that may lead to pregnancy or sexually transmitted disease (STD); and tuberculosis and HIV, unless the patient opts out (TABLE).

Anticipate. Then guide. Using anticipatory guidance, you can help adolescents understand their physical, psychosocial, and sexual development and motivate them to be involved in their health and health-care decisions. Issues relevant to adolescents include dietary habits; injury prevention, through the use of helmets and seatbelts; regular exercise; responsible sexual behaviors; avoidance of substances that can be abused; strategies for dealing with bullying; and avoidance of behaviors that might have negative consequences, such as vandalism, stealing, and sharing personal information with strangers.

Recommended immunizations. For this age group, immunizations, unless previously given, include:

• 1 or 2 doses of measles, mumps, and rubella
• 2 doses of varicella if not previously infected
• a booster dose of tetanus if ≥10 years have elapsed since the last dose
• human papillomavirus (HPV)
• annual influenza.

Other immunizations that may be warranted on the basis of medical condition, occupation, lifestyle, or other indications include: 3 doses of hepatitis B, 2 doses of hepatitis A, 1 or more doses of meningococcal, and 1 or 2 doses of pneumococcal.

Menses, an important "vital sign." Once menstruation begins, evaluating menstrual cycle characteristics is important. Patterns that may require evaluation include²:

• no menses within 3 years of thelarche
• no menses by age 13 with no sign of pubertal development
• no menses by age 14 with signs of hirsutism
• no menses by age 14 with indications of an eating disorder
• no menses by age 15
• history of regular menses that are now markedly irregular
• menses occur more frequently than 21 days or less frequently than every 45 days
• menses occur 90 days apart for one cycle
• menstrual bleeding that lasts more than 7 days
• frequent tampon/pad changes (more than 1 tampon/pad every 1 to 2 hours).

BMI predicts future disease. Overweight and obesity are important risk factors for diabetes mellitus, hyperlipidemia, hypertension, and various cancers. Eating disorders are common among adolescents and often occur in association with other mental health problems.

Non–sexually active teens and children

Gynecologic examination typically involves inspection of the genitalia and not instrumentation of the vagina. A careful explanation of the proposed examination is important. Ask young adolescents who they would like to have in the examination room with them. A hand mirror can be used to involve the patient in the genitalia inspection. If it's necessary to obtain magnification, use a hand lens, an otoscope without the speculum, or a colposcope. Record the configuration of the hymen, if present. If indicated, examination of the genitalia while the patient is in the knee-chest position often provides a good view of the vagina and sometimes the cervix, without instrumentation.

Sexually active teens

Effective contraception, including the use of emergency contraceptives, is an important health focus for sexually active teens. Vaginal speculum examination and bimanual gyn exam are not required prior to prescribing hormonal contraceptives to teens. Based on a review of the evidence and expert opinion,³ the current recommendation is that prior to prescribing a hormonal contraceptive, a medical history and blood pressure measurement are the only requirements; breast examination and a gyn exam (vaginal speculum and bimanual gyn exam) are not necessary. Testing for chlamydia and gonorrhea can be performed using a urine sample. A cervical cytology examination is not necessary until age 21 unless the patient is in a high-risk group, such as immunosuppressed or HIV-infected teens.

The young woman: 19–39 years

Focus on reproductive issues. Contraception, pregnancy, and cervical cancer screening are common reasons for visits among women in this age group. Gynecologic problems can include polycystic ovary syndrome (PCOS), endometriosis, fibroids, infertility, pelvic pain, vulvovaginal pain syndromes, vaginitis, adnexal masses, and STDs, including pelvic inflammatory diseases.

Offer effective contraception

Long-acting reversible contraceptives (LARCs) are the most clinically and cost-effective forms of reversible contraception. There are three LARC methods available in the United States: 1) the copper T380A intrauterine device (IUD; Paragard), 2) the levonorgestrel-releasing intrauterine system (Mirena), and 3) the single-rod etonogestrel implant (Implanon, Explanon).

The use of IUDs among American women has increased from about 2.4% of contracepting women of reproductive age in 2002 to 8.5% in 2009.⁴ In Norway and France, contracepting women of reproductive age use IUDs at a rate of 27% and 23%, respectively.⁵ Typical-use pregnancy rates for LARCs are lower and continuation rates are higher than observed with oral contraceptives (OCs).

In an economic analysis, the cost of LARCs was lower than almost all other forms of reversible contraception over a 5-year interval.⁶ When financial and access barriers are removed, most women starting a contraceptive will use a LARC, if offered.⁷

Be aware of STDs

STDs are common in this age group. In the United States, chlamydial genital infections reach a peak in women 18 to 25 years old, with a prevalence of about 4%.⁸

Counsel her about exercise and weight loss

Approximately 60% of women older than age 20 are overweight or obese.⁹ The rise in obesity is a key contributing factor to an increase in many diseases, including gestational diabetes, type 2 diabetes mellitus, and hypertension. Successful efforts to reduce the prevalence of obesity through diet and exercise could markedly improve population health.

Don't overlook autoimmune conditions

Many autoimmune diseases reach a peak incidence between ages 19 and 39, and, except for ankylosing spondylitis, are more of a concern for women than men. Systemic lupus erythematosus, lymphocytic thyroiditis, and rheumatoid arthritis occur much more frequently in women than in men, with ratios in the range of 7:1 observed during this age interval.

Keep her immunity up to date

Immunizations recommended in this age group include:

• one Tdap (tetanus toxoid, diphtheria, and pertussis)
• tetanus every 10 years
• influenza annually
• varicella if no evidence of immunity
• HPV for those aged 26 years or younger.

The mature woman: 40–64 years

Transition to postmenopause. The menstrual changes through perimenopause to postmenopause are often accompanied by changes in sleep patterns, vasomotor symptoms, and increasing vaginal dryness.

Open your eyes to a patient's insomnia

Perimenopausal and postmenopausal women report a much higher rate of insomnia than age-matched men.¹⁰ Women with moderate to severe vasomotor symptoms are more likely to report greater nighttime wakefulness and a greater number of nighttime long-awake episodes than women with mild vasomotor symptoms.¹¹ Insomnia can be associated with poor work performance and mood changes.

Hormone therapy: Be conservative

In the past, hormone therapy, with various estrogen and progestin combinations, was recommended to help prevent a number of diseases, including cardiovascular disease (CD) and osteoporosis. Based on clinical trial results, the current recommendation is to limit the use of hormone therapy in postmenopausal women to the treatment of vasomotor symptoms and vaginal symptoms caused by hypoestrogenism. To treat these problems, the lowest doses of hormones that are effective should be used for the shortest periods of time that achieve symptom resolution.

The older woman: 65+ years

Successful aging. Based on observational studies, behavioral and health factors associated with successful aging include more than 12 years of education; high socioeconomic status; absence of diabetes, asthma, stroke, and lower respiratory tract disease; absence of depression; presence of at least five close personal contacts; frequent walking; moderate use of alcohol; and nonsmoking status.¹²

Know her risks, and watch for them

Cardiovascular disease. Among women, CDs cause more deaths than malignant neoplasms, chronic lower respiratory disease, Alzheimer's disease, and accidents combined. Black women have rates of CD approximately 40% greater than white women. Hypertension, hypertriglyceridemia, obesity, and sedentary lifestyle among black women account for a part of this increased risk.

Effective lifestyle interventions for primary CD prevention in women include smoking cessation, a diet such as DASH (Dietary Approaches to Stop Hypertension) rich in fruits and vegetables, regular physical activity, and weight management.¹³

There are important gender differences in aspirin efficacy for primary prevention of stroke and myocardial infarction (MI) in men and women. Among women, aspirin used for primary prevention appears to reduce the risk of stroke but not MI.¹⁴ Among men, aspirin used for primary prevention appears to reduce the risk of MI but not stroke.^15,16 Based on these and other data, the USPSTF has recommended that aspirin not be used to prevent stroke in men but recommends aspirin to prevent stroke among women 55 to 79 years of age when benefits outweigh risks of gastrointestinal bleeding.¹⁷

Atrial fibrillation (AF), a risk factor for stroke, is more common in women than in men. In addition, women with AF who are not anticoagulated are at greater risk for stroke than men with AF who are not anticoagulated.¹⁸ The mechanisms that influence these gender differences are not well characterized.

Respiratory illness. Among women, the prevalence of chronic bronchitis and emphysema increased more than 2.8-fold from 1980 to 2000.¹⁹ These diseases are major contributors to physician office visits, hospitalizations, disability, and death. Tobacco use is the major risk factor that accounts for the marked increase in COPD among women during recent decades, although ambient pollutants in the environment, home, and workplace are also important contributors to COPD development.

Cognitive decline. Alzheimer's disease afflicts approximately twice as many women as men. Part of this difference is due to the greater longevity of women, but additional variables, such as gender differences in neurobiology, are also contributory. The role of estradiol in the development of Alzheimer's disease remains controversial.

Osteoporosis. This disease occurs about five times more frequently in women than in men. Among Medicare patients, the cost of caring for a hip fracture is more than $40,000 in the first year postfracture. Hip fracture is associated with a high risk of rapid health decline. Interventions that successfully prevent hip fracture are associated with a reduced mortality rate.^20,21

A concern at any age

Domestic violence

Domestic violence is common; approximately 5% of women report one episode during the past year and 25% report at least one lifetime episode.²² Domestic violence involves two people: a perpetrator and a victim. In some relationships, a recurrent cycle of violence and reconciliation is observed. Routine, confidential, and private screening is required to detect most cases of domestic violence.

Ask the right question(s). The single question, "At any time, has a partner hit, kicked, or otherwise hurt or threatened you?" can increase the rate of detection. Alternatively, a set of three questions can be used to screen for domestic violence:

1. "Within the past year, have you been hit, slapped, kicked or otherwise physically hurt by someone?"
2. "Within the past year, has anyone forced you to have sexual activity?"
3. In pregnancy: "Since you have been pregnant, have you been hit, slapped, kicked, or otherwise physically hurt by someone?"

Follow-up and refer. If a woman reports that she has suffered or is at risk for domestic violence, document the finding in her medical record. Then try to assess her safety by asking: "Are there guns in the home?", "Have there been threats of suicide or homicide?", "Has there been violence toward children?" Choking, specifically, could be a sign of future escalated violence—as many perpetrators choke their victims prior to further, escalated violence occurring—and should be taken as a threat of homicide. Refer women who report domestic violence to a specialist; often, the best trained and most available experts are experienced social workers.

Sexual assault

About 25% of women report at least one lifetime sexual assault. Most women who report being raped initially receive care in a hospital-based emergency department from nurses who are credentialed in Sexual Assault Nurse Evaluation (SANE) skills.

The initial evaluation includes rapid access to treatment by a specialized clinical team, assessment and treatment of bodily injuries with a focus on genital trauma, psychological assessment and support, pregnancy assessment and prevention, preventive treatment of STDs, and collection of forensic data, including toxicology testing for the presence of date-rape drugs.

When sexual assault is reported, treat for an STD. The Centers for Disease Control and Prevention (CDC) recommends the following approach to prevent and treat STDs in victims of sexual assault²³:

• ceftriaxone 125 mg IM to prevent gonorrhea
• azithromycin 1 g orally as a single dose or doxycycline 100 mg twice daily for 7 days to prevent chlamydia
• metronidazole 2 g orally as a single dose to prevent trichomoniasis
• hepatitis B vaccination, for women not previously vaccinated. (The CDC recommends against the use of hepatitis B immune globulin as the costs are believed to outweigh the benefits.)
• HIV postexposure prophylaxis for 3 to 7 days, with a follow-up visit to consider pros and cons of continued prophylaxis. (The risk of HIV infection following a sexual assault is low.)
• postcoital contraception (for example, levonorgestrel 1.5 mg orally as a single dose).

An antiemetic also should be offered to reduce the risk that the multiple prescribed medications will cause vomiting and nullify prophylaxis efforts. Approximately 2 weeks after the sexual assault the patient should have a pregnancy test and be assessed for ongoing mental health needs. If she did not adhere to the medications or if she shows relevant symptoms, perform follow-up STD testing. Follow-up HIV and syphilis testing can be performed at 12 and 24 weeks following the assault.

Sexual dysfunction

Sexuality is an important part of the human experience. Sexual dysfunction is the inability to participate as desired in a sexual relationship. Problems of sexual dysfunction are best approached from a biopsychosocial framework that recognizes the important contributions of biological, psychological, and social-cultural factors in sexual health. Masters and Johnson posited four stages of sexual response: excitement, plateau, orgasm, and resolution. Building on this linear model, investigators later divided the excitement phase into desire and arousal.

Recent models of sexual response have emphasized a circular model, in which sequential responses overlap and build on previous stimuli. These models also emphasize the importance of emotional intimacy and the quality of the relationship in achieving optimal sexual health.

Approximately 40% of women and 30% of men report sexual dysfunction.²⁴ Common sexual problems reported by heterosexual women include:

• lack of interest in sex
• inability to achieve orgasm
• pain caused by sexual intercourse
• lack of pleasure with sex
• trouble lubricating.

The majority of men and women will not voluntarily report sexual dysfunction to their clinician. To elicit the presence of sexual concerns, you must initiate the conversation.²⁵ You can begin the sexual history by asking, "Do you have any concerns about your sex life?" Additional helpful, open-ended questions include: "Are you having sexual relations currently? With men or women or both?", "If you are not having sex, when did you last have intercourse?", "Are you satisfied with the frequency and quality of your sexual experiences?", "What is the emotional quality and intimacy of your relationship with your sex partner?"

The common sexual disorders in women are categorized as desire, arousal, orgasm, and pain disorders. There are two desire disorders: hypoactive sexual desire disorder and sexual aversion disorder. There are two arousal disorders: female sexual arousal disorder and persistent genital arousal disorder. There are four pain disorders: dyspareunia, vulvodynia, vaginismus, and noncoital nonsexual pain.

Most experts recommend that treatment of female sexual dysfunction include multiple modalities that reflect the complex biopsychosocial factors that cause the problem. For example, a treatment plan might include cognitive behavioral therapy, sex therapy, and appropriate medications.

Mental health issues

Depression, anxiety, bulimia, and anorexia nervosa are more common in women than men. For instance, the lifetime risk of depression in women is approximately 20%, compared with about 10% in men. The gender difference is first observed in adolescence and becomes minimal after age 60. The gender differences are observed across racial and ethnic groups.²⁶

It's on us

As leaders in women's health care, we are uniquely trained to guide, counsel, diagnose, and treat women across their entire lifetime, from adolescence to postmenopause. We are at the vanguard in the effort to continually improve the health of all women.

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

The American College of Obstetricians and Gynecologists (ACOG) has recommended dividing a woman's life cycle into four intervals—ages 13–18, 19–39, 40–64, and older than 65—in order to best organize the approach to primary and preventive health care.¹ This paradigm provides a structure for organizing the clinical approach to physical examination, laboratory testing, counseling, and immunizations. In addition, it helps to highlight the diseases and health problems most prevalent among women at each life-stage.

Different professional organizations—US Preventive Services Task Force (USPSTF), American Medical Association, American College of Physicians, ACOG, American Academy of Family Physicians, American Academy of Pediatrics, and Advisory Committee on Immunization Practices—have used varying analytical methods to determine recommended health services by age group; consequently, these organizations have somewhat divergent recommendations. However, the recommendations of most organizations share many similarities. In this comprehensive guide, I point out those similarities. Keep in mind that recommendations change over time, and it is important to use your professional judgment when approaching each patient.

TABLE

Physical examination and laboratory testing services according to a patient's age, based on ACOG recommendations¹

The adolescent: 13–18 years

Screen. Guide. Immunize. ACOG recommends that the first visit take place between 13 and 15 years of age, with annual visits thereafter. The purpose of the first, and subsequent, visits is to assess health status, including menstrual history and body mass index (BMI), and to provide health guidance, screening, and preventive health services. This initial visit generally does not include a pelvic examination. A physical examination is not required at every visit but is recommended to occur at least once during early, middle, and late adolescence.

Target your screening practices. Screen adolescents for the following conditions during clinical preventive services: hypertension; hyperlipidemia; obesity and eating disorders; physical, sexual, or emotional abuse; learning or school problems; substance use; depression and risk of suicide; sexual assault; sexual behavior that may lead to pregnancy or sexually transmitted disease (STD); and tuberculosis and HIV, unless the patient opts out (TABLE).

Anticipate. Then guide. Using anticipatory guidance, you can help adolescents understand their physical, psychosocial, and sexual development and motivate them to be involved in their health and health-care decisions. Issues relevant to adolescents include dietary habits; injury prevention, through the use of helmets and seatbelts; regular exercise; responsible sexual behaviors; avoidance of substances that can be abused; strategies for dealing with bullying; and avoidance of behaviors that might have negative consequences, such as vandalism, stealing, and sharing personal information with strangers.

Recommended immunizations. For this age group, immunizations, unless previously given, include:

• 1 or 2 doses of measles, mumps, and rubella
• 2 doses of varicella if not previously infected
• a booster dose of tetanus if ≥10 years have elapsed since the last dose
• human papillomavirus (HPV)
• annual influenza.

Other immunizations that may be warranted on the basis of medical condition, occupation, lifestyle, or other indications include: 3 doses of hepatitis B, 2 doses of hepatitis A, 1 or more doses of meningococcal, and 1 or 2 doses of pneumococcal.

Menses, an important "vital sign." Once menstruation begins, evaluating menstrual cycle characteristics is important. Patterns that may require evaluation include²:

• no menses within 3 years of thelarche
• no menses by age 13 with no sign of pubertal development
• no menses by age 14 with signs of hirsutism
• no menses by age 14 with indications of an eating disorder
• no menses by age 15
• history of regular menses that are now markedly irregular
• menses occur more frequently than 21 days or less frequently than every 45 days
• menses occur 90 days apart for one cycle
• menstrual bleeding that lasts more than 7 days
• frequent tampon/pad changes (more than 1 tampon/pad every 1 to 2 hours).

BMI predicts future disease. Overweight and obesity are important risk factors for diabetes mellitus, hyperlipidemia, hypertension, and various cancers. Eating disorders are common among adolescents and often occur in association with other mental health problems.

Non–sexually active teens and children

Gynecologic examination typically involves inspection of the genitalia and not instrumentation of the vagina. A careful explanation of the proposed examination is important. Ask young adolescents who they would like to have in the examination room with them. A hand mirror can be used to involve the patient in the genitalia inspection. If it's necessary to obtain magnification, use a hand lens, an otoscope without the speculum, or a colposcope. Record the configuration of the hymen, if present. If indicated, examination of the genitalia while the patient is in the knee-chest position often provides a good view of the vagina and sometimes the cervix, without instrumentation.

Sexually active teens

Effective contraception, including the use of emergency contraceptives, is an important health focus for sexually active teens. Vaginal speculum examination and bimanual gyn exam are not required prior to prescribing hormonal contraceptives to teens. Based on a review of the evidence and expert opinion,³ the current recommendation is that prior to prescribing a hormonal contraceptive, a medical history and blood pressure measurement are the only requirements; breast examination and a gyn exam (vaginal speculum and bimanual gyn exam) are not necessary. Testing for chlamydia and gonorrhea can be performed using a urine sample. A cervical cytology examination is not necessary until age 21 unless the patient is in a high-risk group, such as immunosuppressed or HIV-infected teens.

The young woman: 19–39 years

Focus on reproductive issues. Contraception, pregnancy, and cervical cancer screening are common reasons for visits among women in this age group. Gynecologic problems can include polycystic ovary syndrome (PCOS), endometriosis, fibroids, infertility, pelvic pain, vulvovaginal pain syndromes, vaginitis, adnexal masses, and STDs, including pelvic inflammatory diseases.

Offer effective contraception

Long-acting reversible contraceptives (LARCs) are the most clinically and cost-effective forms of reversible contraception. There are three LARC methods available in the United States: 1) the copper T380A intrauterine device (IUD; Paragard), 2) the levonorgestrel-releasing intrauterine system (Mirena), and 3) the single-rod etonogestrel implant (Implanon, Explanon).

The use of IUDs among American women has increased from about 2.4% of contracepting women of reproductive age in 2002 to 8.5% in 2009.⁴ In Norway and France, contracepting women of reproductive age use IUDs at a rate of 27% and 23%, respectively.⁵ Typical-use pregnancy rates for LARCs are lower and continuation rates are higher than observed with oral contraceptives (OCs).

In an economic analysis, the cost of LARCs was lower than almost all other forms of reversible contraception over a 5-year interval.⁶ When financial and access barriers are removed, most women starting a contraceptive will use a LARC, if offered.⁷

Be aware of STDs

STDs are common in this age group. In the United States, chlamydial genital infections reach a peak in women 18 to 25 years old, with a prevalence of about 4%.⁸

Counsel her about exercise and weight loss

Approximately 60% of women older than age 20 are overweight or obese.⁹ The rise in obesity is a key contributing factor to an increase in many diseases, including gestational diabetes, type 2 diabetes mellitus, and hypertension. Successful efforts to reduce the prevalence of obesity through diet and exercise could markedly improve population health.

Don't overlook autoimmune conditions

Many autoimmune diseases reach a peak incidence between ages 19 and 39, and, except for ankylosing spondylitis, are more of a concern for women than men. Systemic lupus erythematosus, lymphocytic thyroiditis, and rheumatoid arthritis occur much more frequently in women than in men, with ratios in the range of 7:1 observed during this age interval.

Keep her immunity up to date

Immunizations recommended in this age group include:

• one Tdap (tetanus toxoid, diphtheria, and pertussis)
• tetanus every 10 years
• influenza annually
• varicella if no evidence of immunity
• HPV for those aged 26 years or younger.

The mature woman: 40–64 years

Transition to postmenopause. The menstrual changes through perimenopause to postmenopause are often accompanied by changes in sleep patterns, vasomotor symptoms, and increasing vaginal dryness.

Open your eyes to a patient's insomnia

Perimenopausal and postmenopausal women report a much higher rate of insomnia than age-matched men.¹⁰ Women with moderate to severe vasomotor symptoms are more likely to report greater nighttime wakefulness and a greater number of nighttime long-awake episodes than women with mild vasomotor symptoms.¹¹ Insomnia can be associated with poor work performance and mood changes.

Hormone therapy: Be conservative

In the past, hormone therapy, with various estrogen and progestin combinations, was recommended to help prevent a number of diseases, including cardiovascular disease (CD) and osteoporosis. Based on clinical trial results, the current recommendation is to limit the use of hormone therapy in postmenopausal women to the treatment of vasomotor symptoms and vaginal symptoms caused by hypoestrogenism. To treat these problems, the lowest doses of hormones that are effective should be used for the shortest periods of time that achieve symptom resolution.

The older woman: 65+ years

Successful aging. Based on observational studies, behavioral and health factors associated with successful aging include more than 12 years of education; high socioeconomic status; absence of diabetes, asthma, stroke, and lower respiratory tract disease; absence of depression; presence of at least five close personal contacts; frequent walking; moderate use of alcohol; and nonsmoking status.¹²

Know her risks, and watch for them

Cardiovascular disease. Among women, CDs cause more deaths than malignant neoplasms, chronic lower respiratory disease, Alzheimer's disease, and accidents combined. Black women have rates of CD approximately 40% greater than white women. Hypertension, hypertriglyceridemia, obesity, and sedentary lifestyle among black women account for a part of this increased risk.

Effective lifestyle interventions for primary CD prevention in women include smoking cessation, a diet such as DASH (Dietary Approaches to Stop Hypertension) rich in fruits and vegetables, regular physical activity, and weight management.¹³

There are important gender differences in aspirin efficacy for primary prevention of stroke and myocardial infarction (MI) in men and women. Among women, aspirin used for primary prevention appears to reduce the risk of stroke but not MI.¹⁴ Among men, aspirin used for primary prevention appears to reduce the risk of MI but not stroke.^15,16 Based on these and other data, the USPSTF has recommended that aspirin not be used to prevent stroke in men but recommends aspirin to prevent stroke among women 55 to 79 years of age when benefits outweigh risks of gastrointestinal bleeding.¹⁷

Atrial fibrillation (AF), a risk factor for stroke, is more common in women than in men. In addition, women with AF who are not anticoagulated are at greater risk for stroke than men with AF who are not anticoagulated.¹⁸ The mechanisms that influence these gender differences are not well characterized.

Respiratory illness. Among women, the prevalence of chronic bronchitis and emphysema increased more than 2.8-fold from 1980 to 2000.¹⁹ These diseases are major contributors to physician office visits, hospitalizations, disability, and death. Tobacco use is the major risk factor that accounts for the marked increase in COPD among women during recent decades, although ambient pollutants in the environment, home, and workplace are also important contributors to COPD development.

Cognitive decline. Alzheimer's disease afflicts approximately twice as many women as men. Part of this difference is due to the greater longevity of women, but additional variables, such as gender differences in neurobiology, are also contributory. The role of estradiol in the development of Alzheimer's disease remains controversial.

Osteoporosis. This disease occurs about five times more frequently in women than in men. Among Medicare patients, the cost of caring for a hip fracture is more than $40,000 in the first year postfracture. Hip fracture is associated with a high risk of rapid health decline. Interventions that successfully prevent hip fracture are associated with a reduced mortality rate.^20,21

A concern at any age

Domestic violence

Domestic violence is common; approximately 5% of women report one episode during the past year and 25% report at least one lifetime episode.²² Domestic violence involves two people: a perpetrator and a victim. In some relationships, a recurrent cycle of violence and reconciliation is observed. Routine, confidential, and private screening is required to detect most cases of domestic violence.

Ask the right question(s). The single question, "At any time, has a partner hit, kicked, or otherwise hurt or threatened you?" can increase the rate of detection. Alternatively, a set of three questions can be used to screen for domestic violence:

1. "Within the past year, have you been hit, slapped, kicked or otherwise physically hurt by someone?"
2. "Within the past year, has anyone forced you to have sexual activity?"
3. In pregnancy: "Since you have been pregnant, have you been hit, slapped, kicked, or otherwise physically hurt by someone?"

Follow-up and refer. If a woman reports that she has suffered or is at risk for domestic violence, document the finding in her medical record. Then try to assess her safety by asking: "Are there guns in the home?", "Have there been threats of suicide or homicide?", "Has there been violence toward children?" Choking, specifically, could be a sign of future escalated violence—as many perpetrators choke their victims prior to further, escalated violence occurring—and should be taken as a threat of homicide. Refer women who report domestic violence to a specialist; often, the best trained and most available experts are experienced social workers.

Sexual assault

About 25% of women report at least one lifetime sexual assault. Most women who report being raped initially receive care in a hospital-based emergency department from nurses who are credentialed in Sexual Assault Nurse Evaluation (SANE) skills.

The initial evaluation includes rapid access to treatment by a specialized clinical team, assessment and treatment of bodily injuries with a focus on genital trauma, psychological assessment and support, pregnancy assessment and prevention, preventive treatment of STDs, and collection of forensic data, including toxicology testing for the presence of date-rape drugs.

When sexual assault is reported, treat for an STD. The Centers for Disease Control and Prevention (CDC) recommends the following approach to prevent and treat STDs in victims of sexual assault²³:

• ceftriaxone 125 mg IM to prevent gonorrhea
• azithromycin 1 g orally as a single dose or doxycycline 100 mg twice daily for 7 days to prevent chlamydia
• metronidazole 2 g orally as a single dose to prevent trichomoniasis
• hepatitis B vaccination, for women not previously vaccinated. (The CDC recommends against the use of hepatitis B immune globulin as the costs are believed to outweigh the benefits.)
• HIV postexposure prophylaxis for 3 to 7 days, with a follow-up visit to consider pros and cons of continued prophylaxis. (The risk of HIV infection following a sexual assault is low.)
• postcoital contraception (for example, levonorgestrel 1.5 mg orally as a single dose).

An antiemetic also should be offered to reduce the risk that the multiple prescribed medications will cause vomiting and nullify prophylaxis efforts. Approximately 2 weeks after the sexual assault the patient should have a pregnancy test and be assessed for ongoing mental health needs. If she did not adhere to the medications or if she shows relevant symptoms, perform follow-up STD testing. Follow-up HIV and syphilis testing can be performed at 12 and 24 weeks following the assault.

Sexual dysfunction

Sexuality is an important part of the human experience. Sexual dysfunction is the inability to participate as desired in a sexual relationship. Problems of sexual dysfunction are best approached from a biopsychosocial framework that recognizes the important contributions of biological, psychological, and social-cultural factors in sexual health. Masters and Johnson posited four stages of sexual response: excitement, plateau, orgasm, and resolution. Building on this linear model, investigators later divided the excitement phase into desire and arousal.

Recent models of sexual response have emphasized a circular model, in which sequential responses overlap and build on previous stimuli. These models also emphasize the importance of emotional intimacy and the quality of the relationship in achieving optimal sexual health.

Approximately 40% of women and 30% of men report sexual dysfunction.²⁴ Common sexual problems reported by heterosexual women include:

• lack of interest in sex
• inability to achieve orgasm
• pain caused by sexual intercourse
• lack of pleasure with sex
• trouble lubricating.

The majority of men and women will not voluntarily report sexual dysfunction to their clinician. To elicit the presence of sexual concerns, you must initiate the conversation.²⁵ You can begin the sexual history by asking, "Do you have any concerns about your sex life?" Additional helpful, open-ended questions include: "Are you having sexual relations currently? With men or women or both?", "If you are not having sex, when did you last have intercourse?", "Are you satisfied with the frequency and quality of your sexual experiences?", "What is the emotional quality and intimacy of your relationship with your sex partner?"

The common sexual disorders in women are categorized as desire, arousal, orgasm, and pain disorders. There are two desire disorders: hypoactive sexual desire disorder and sexual aversion disorder. There are two arousal disorders: female sexual arousal disorder and persistent genital arousal disorder. There are four pain disorders: dyspareunia, vulvodynia, vaginismus, and noncoital nonsexual pain.

Most experts recommend that treatment of female sexual dysfunction include multiple modalities that reflect the complex biopsychosocial factors that cause the problem. For example, a treatment plan might include cognitive behavioral therapy, sex therapy, and appropriate medications.

Mental health issues

Depression, anxiety, bulimia, and anorexia nervosa are more common in women than men. For instance, the lifetime risk of depression in women is approximately 20%, compared with about 10% in men. The gender difference is first observed in adolescence and becomes minimal after age 60. The gender differences are observed across racial and ethnic groups.²⁶

It's on us

As leaders in women's health care, we are uniquely trained to guide, counsel, diagnose, and treat women across their entire lifetime, from adolescence to postmenopause. We are at the vanguard in the effort to continually improve the health of all women.

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

In contemporary obstetrics, electronic fetal monitoring (EFM) is used almost universally, and magnesium sulfate often is administered for seizure prophylaxis, tocolysis, or preterm neuroprotection. Given that magnesium crosses the placenta and is known to have both neurologic and cardiac effects and toxicities, it has been speculated that magnesium sulfate may change various characteristics of the fetal heart rate (FHR). Previous studies in small animals have failed to answer this common clinical question.

Details of the study

In this retrospective study from Washington University in St. Louis, Duffy and colleagues analyzed FHR tracings from 248 women who were exposed to magnesium sulfate, focusing on the 30 minutes just prior to delivery. These tracings were compared with those of 5,139 women who were not exposed to magnesium at all during the study.

All women in the study reached the second stage of labor, had at least 10 minutes of EFM recorded in the 30 minutes preceding delivery, and delivered at or beyond 37 weeks’ gestation. The groups were similar in regard to maternal race, mode of delivery, and tobacco and alcohol use. However, women exposed to magnesium were younger, had a higher body mass index and lower gravidity, and were more likely to be nulliparous and to have pregestational diabetes or gestational diabetes. In addition, women exposed to magnesium had a lower gestational age at delivery (38.4 [SD, 1.2] weeks vs 39.0 [SD, 1.2]weeks; P<.01), although no infants were born before 37 weeks.

Magnesium was given in accordance with the institution’s treatment guidelines for severe preeclampsia: a 6-g loading dose followed by a maintenance infusion of 2 g/hr, with monitoring for signs and symptoms of magnesium toxicity. (Magnesium was not given to women with mild preeclampsia.)

Two research nurses blinded to all exposure and outcome data used National Institute of Child Health and Human Development (NICHD) nomenclature to categorize FHR tracings. Magnesium exposure was associated with:

• a mean 3-beat difference in baseline FHR
• an increased likelihood of baseline FHR below 120 bpm
• greater likelihood that FHR variability was reduced or diminished.

The presence or number of accelerations or decelerations did not differ significantly between groups, but magnesium exposure was associated with fewer prolonged decelerations. These associations remained after excluding women who had adverse neonatal outcomes.

Fetal tachycardia was strongly associated with fetal acidemia and adverse neonatal outcomes in both groups. And prolonged decelerations were associated with an increased risk of fetal acidemia in women not exposed to magnesium and were present in all cases of fetal acidemia in exposed women.

The authors concluded that magnesium may mask signs of fetal distress.

Findings have little clinical utility

Despite the large numbers of women in this study and the rigorous methods utilized, the findings will be of little help to clinicians interpreting EFM tracings from fetuses whose mothers are receiving magnesium. The differences between groups were small, and the overwhelming majority of changes fell within the normal range.

More important than FHR changes is actual newborn condition. In a secondary analysis from the Beneficial Effects of Antenatal Magnesium trial from the Maternal-Fetal Medicine Units Network, Johnson and colleagues demonstrated that cord-blood magnesium levels did not predict the need for delivery room resuscitation.¹ In this trial, pediatricians were blinded as to whether the mother was receiving magnesium or placebo. These results cast real doubt on the hypothesis that maternal magnesium exposure alters the condition of the fetus or newborn in a clinically meaningful way.

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

In contemporary obstetrics, electronic fetal monitoring (EFM) is used almost universally, and magnesium sulfate often is administered for seizure prophylaxis, tocolysis, or preterm neuroprotection. Given that magnesium crosses the placenta and is known to have both neurologic and cardiac effects and toxicities, it has been speculated that magnesium sulfate may change various characteristics of the fetal heart rate (FHR). Previous studies in small animals have failed to answer this common clinical question.

Details of the study

In this retrospective study from Washington University in St. Louis, Duffy and colleagues analyzed FHR tracings from 248 women who were exposed to magnesium sulfate, focusing on the 30 minutes just prior to delivery. These tracings were compared with those of 5,139 women who were not exposed to magnesium at all during the study.

All women in the study reached the second stage of labor, had at least 10 minutes of EFM recorded in the 30 minutes preceding delivery, and delivered at or beyond 37 weeks’ gestation. The groups were similar in regard to maternal race, mode of delivery, and tobacco and alcohol use. However, women exposed to magnesium were younger, had a higher body mass index and lower gravidity, and were more likely to be nulliparous and to have pregestational diabetes or gestational diabetes. In addition, women exposed to magnesium had a lower gestational age at delivery (38.4 [SD, 1.2] weeks vs 39.0 [SD, 1.2]weeks; P<.01), although no infants were born before 37 weeks.

Magnesium was given in accordance with the institution’s treatment guidelines for severe preeclampsia: a 6-g loading dose followed by a maintenance infusion of 2 g/hr, with monitoring for signs and symptoms of magnesium toxicity. (Magnesium was not given to women with mild preeclampsia.)

Two research nurses blinded to all exposure and outcome data used National Institute of Child Health and Human Development (NICHD) nomenclature to categorize FHR tracings. Magnesium exposure was associated with:

• a mean 3-beat difference in baseline FHR
• an increased likelihood of baseline FHR below 120 bpm
• greater likelihood that FHR variability was reduced or diminished.

The presence or number of accelerations or decelerations did not differ significantly between groups, but magnesium exposure was associated with fewer prolonged decelerations. These associations remained after excluding women who had adverse neonatal outcomes.

Fetal tachycardia was strongly associated with fetal acidemia and adverse neonatal outcomes in both groups. And prolonged decelerations were associated with an increased risk of fetal acidemia in women not exposed to magnesium and were present in all cases of fetal acidemia in exposed women.

The authors concluded that magnesium may mask signs of fetal distress.

Findings have little clinical utility

Despite the large numbers of women in this study and the rigorous methods utilized, the findings will be of little help to clinicians interpreting EFM tracings from fetuses whose mothers are receiving magnesium. The differences between groups were small, and the overwhelming majority of changes fell within the normal range.

More important than FHR changes is actual newborn condition. In a secondary analysis from the Beneficial Effects of Antenatal Magnesium trial from the Maternal-Fetal Medicine Units Network, Johnson and colleagues demonstrated that cord-blood magnesium levels did not predict the need for delivery room resuscitation.¹ In this trial, pediatricians were blinded as to whether the mother was receiving magnesium or placebo. These results cast real doubt on the hypothesis that maternal magnesium exposure alters the condition of the fetus or newborn in a clinically meaningful way.

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

In contemporary obstetrics, electronic fetal monitoring (EFM) is used almost universally, and magnesium sulfate often is administered for seizure prophylaxis, tocolysis, or preterm neuroprotection. Given that magnesium crosses the placenta and is known to have both neurologic and cardiac effects and toxicities, it has been speculated that magnesium sulfate may change various characteristics of the fetal heart rate (FHR). Previous studies in small animals have failed to answer this common clinical question.

Details of the study

In this retrospective study from Washington University in St. Louis, Duffy and colleagues analyzed FHR tracings from 248 women who were exposed to magnesium sulfate, focusing on the 30 minutes just prior to delivery. These tracings were compared with those of 5,139 women who were not exposed to magnesium at all during the study.

All women in the study reached the second stage of labor, had at least 10 minutes of EFM recorded in the 30 minutes preceding delivery, and delivered at or beyond 37 weeks’ gestation. The groups were similar in regard to maternal race, mode of delivery, and tobacco and alcohol use. However, women exposed to magnesium were younger, had a higher body mass index and lower gravidity, and were more likely to be nulliparous and to have pregestational diabetes or gestational diabetes. In addition, women exposed to magnesium had a lower gestational age at delivery (38.4 [SD, 1.2] weeks vs 39.0 [SD, 1.2]weeks; P<.01), although no infants were born before 37 weeks.

Magnesium was given in accordance with the institution’s treatment guidelines for severe preeclampsia: a 6-g loading dose followed by a maintenance infusion of 2 g/hr, with monitoring for signs and symptoms of magnesium toxicity. (Magnesium was not given to women with mild preeclampsia.)

Two research nurses blinded to all exposure and outcome data used National Institute of Child Health and Human Development (NICHD) nomenclature to categorize FHR tracings. Magnesium exposure was associated with:

• a mean 3-beat difference in baseline FHR
• an increased likelihood of baseline FHR below 120 bpm
• greater likelihood that FHR variability was reduced or diminished.

The presence or number of accelerations or decelerations did not differ significantly between groups, but magnesium exposure was associated with fewer prolonged decelerations. These associations remained after excluding women who had adverse neonatal outcomes.

Fetal tachycardia was strongly associated with fetal acidemia and adverse neonatal outcomes in both groups. And prolonged decelerations were associated with an increased risk of fetal acidemia in women not exposed to magnesium and were present in all cases of fetal acidemia in exposed women.

The authors concluded that magnesium may mask signs of fetal distress.

Findings have little clinical utility

Despite the large numbers of women in this study and the rigorous methods utilized, the findings will be of little help to clinicians interpreting EFM tracings from fetuses whose mothers are receiving magnesium. The differences between groups were small, and the overwhelming majority of changes fell within the normal range.

More important than FHR changes is actual newborn condition. In a secondary analysis from the Beneficial Effects of Antenatal Magnesium trial from the Maternal-Fetal Medicine Units Network, Johnson and colleagues demonstrated that cord-blood magnesium levels did not predict the need for delivery room resuscitation.¹ In this trial, pediatricians were blinded as to whether the mother was receiving magnesium or placebo. These results cast real doubt on the hypothesis that maternal magnesium exposure alters the condition of the fetus or newborn in a clinically meaningful way.

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

Several studies have suggested that the risk of preterm birth increases after treatment for CIN. For example, a meta-analysis of 27 studies found a relative risk (RR) of preterm delivery of 1.70 after treatment for CIN (95% confidence interval [CI], 1.24–2.35).¹ Later studies from Nordic countries estimated the RR at 1.8 to 2.8.^2,3

In the United Kingdom, women who have abnormal findings at the time of cervical cancer screening are referred to clinics that specialize in the assessment and management of CIN. At these clinics, colposcopy and punch cervical biopsy are used to evaluate patients. When treatment is warranted, loop electrosurgical excision procedures (LEEP) are the most common intervention.

Details of the study

Investigators focused on two groups of women referred to large colposcopy clinics (more than 550 new patients annually) between 1987 and 2009:

• untreated group: those who underwent punch biopsy only
• treatment group: those who had an excisional procedure.

Women were followed both retrospectively (previous births) and prospectively (subsequent births) to assess gestational age at delivery. The risk of preterm birth (<37 weeks) was compared between groups.

Among women who delivered after colposcopy, the risk of preterm birth was significantly higher in the treatment group than in the untreated group (adjusted RR, 1.19; P<.05). However, when investigators focused on births prior to colposcopy, the risk of preterm delivery was significantly higher in women who were subsequently treated than in those who were untreated (RR, 1.31; P<.05).

Among untreated women who had a birth prior to evaluation for CIN, the risk of preterm delivery in the subsequent pregnancy was marginally, though significantly, higher than the risk associated with the delivery prior to biopsy (RR, 1.14; P<.05). However, among treated women, the risk of preterm delivery was marginally lower after treatment, compared with their risk in the pregnancy before treatment (RR, 0.94; P>.05).

Expertise of the physician may play a role
in the risk of preterm birth

This study’s finding of a higher risk of preterm birth after treatment, compared with before treatment, would seem to support earlier studies that show an increased risk of preterm birth after LEEP. However, the finding that women destined to undergo treatment of CIN had a higher rate of preterm delivery before that treatment is surprising. And the fact that women who gave birth both before and after treatment had no elevated risk of preterm delivery in the later pregnancy is even more startling.

So what are we to make of these data? They suggest that, at least among women receiving care at high-volume specialty clinics in England, the treatment of CIN does not increase the risk of preterm delivery. Castanon and colleagues hypothesize that the clinicians who work in these clinics may remove less tissue during treatment than other clinicians do, minimizing the risk of later preterm delivery.

A cervical cancer screening expert weighs in

Tom Cox, MD, is past president of ASCCP, the Society for Lower Genital Tract Disease, and a widely published expert on cervical cancer screening. He is also an OBG Management Contributing Editor. When asked for his take on the conclusions of Castanon and colleagues, he agreed that the data are highly credible.

“The findings are different than most of the world literature on this subject,” he continued, “and it may be indeed, as the authors suggest, due to less tissue being removed during surgical excision procedures in England, compared with other countries. If that is true, it may be because colposcopists in the United Kingdom receive a higher level of training and are subject to more rigorous quality control than we have in the United States and in other countries—although most of the studies demonstrating odds ratios of 2 to 3 for preterm birth following treatment have been conducted in Scandinavian countries known for their high-quality medical care.”

Castanon and colleagues are at work on Phase 2 of this study, and Dr. Cox anticipates that its findings will help determine why CIN treatment did not increase the risk of preterm delivery.

“Although colposcopy training is far less rigorous in the United States, and quality control is virtually lacking, it has been thought that, in general, the size of cervical excisions in the United States are likely to have been smaller than in the United Kingdom, where large loop excision of the T-zone (LLETZ), using larger loops than with LEEP, has been common. So it will be interesting to see the authors’ promised Phase 2 article, which compares the size of the excision with outcomes.

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

Several studies have suggested that the risk of preterm birth increases after treatment for CIN. For example, a meta-analysis of 27 studies found a relative risk (RR) of preterm delivery of 1.70 after treatment for CIN (95% confidence interval [CI], 1.24–2.35).¹ Later studies from Nordic countries estimated the RR at 1.8 to 2.8.^2,3

In the United Kingdom, women who have abnormal findings at the time of cervical cancer screening are referred to clinics that specialize in the assessment and management of CIN. At these clinics, colposcopy and punch cervical biopsy are used to evaluate patients. When treatment is warranted, loop electrosurgical excision procedures (LEEP) are the most common intervention.

Details of the study

Investigators focused on two groups of women referred to large colposcopy clinics (more than 550 new patients annually) between 1987 and 2009:

• untreated group: those who underwent punch biopsy only
• treatment group: those who had an excisional procedure.

Women were followed both retrospectively (previous births) and prospectively (subsequent births) to assess gestational age at delivery. The risk of preterm birth (<37 weeks) was compared between groups.

Among women who delivered after colposcopy, the risk of preterm birth was significantly higher in the treatment group than in the untreated group (adjusted RR, 1.19; P<.05). However, when investigators focused on births prior to colposcopy, the risk of preterm delivery was significantly higher in women who were subsequently treated than in those who were untreated (RR, 1.31; P<.05).

Among untreated women who had a birth prior to evaluation for CIN, the risk of preterm delivery in the subsequent pregnancy was marginally, though significantly, higher than the risk associated with the delivery prior to biopsy (RR, 1.14; P<.05). However, among treated women, the risk of preterm delivery was marginally lower after treatment, compared with their risk in the pregnancy before treatment (RR, 0.94; P>.05).

Expertise of the physician may play a role
in the risk of preterm birth

This study’s finding of a higher risk of preterm birth after treatment, compared with before treatment, would seem to support earlier studies that show an increased risk of preterm birth after LEEP. However, the finding that women destined to undergo treatment of CIN had a higher rate of preterm delivery before that treatment is surprising. And the fact that women who gave birth both before and after treatment had no elevated risk of preterm delivery in the later pregnancy is even more startling.

So what are we to make of these data? They suggest that, at least among women receiving care at high-volume specialty clinics in England, the treatment of CIN does not increase the risk of preterm delivery. Castanon and colleagues hypothesize that the clinicians who work in these clinics may remove less tissue during treatment than other clinicians do, minimizing the risk of later preterm delivery.

A cervical cancer screening expert weighs in

Tom Cox, MD, is past president of ASCCP, the Society for Lower Genital Tract Disease, and a widely published expert on cervical cancer screening. He is also an OBG Management Contributing Editor. When asked for his take on the conclusions of Castanon and colleagues, he agreed that the data are highly credible.

“The findings are different than most of the world literature on this subject,” he continued, “and it may be indeed, as the authors suggest, due to less tissue being removed during surgical excision procedures in England, compared with other countries. If that is true, it may be because colposcopists in the United Kingdom receive a higher level of training and are subject to more rigorous quality control than we have in the United States and in other countries—although most of the studies demonstrating odds ratios of 2 to 3 for preterm birth following treatment have been conducted in Scandinavian countries known for their high-quality medical care.”

Castanon and colleagues are at work on Phase 2 of this study, and Dr. Cox anticipates that its findings will help determine why CIN treatment did not increase the risk of preterm delivery.

“Although colposcopy training is far less rigorous in the United States, and quality control is virtually lacking, it has been thought that, in general, the size of cervical excisions in the United States are likely to have been smaller than in the United Kingdom, where large loop excision of the T-zone (LLETZ), using larger loops than with LEEP, has been common. So it will be interesting to see the authors’ promised Phase 2 article, which compares the size of the excision with outcomes.

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

Several studies have suggested that the risk of preterm birth increases after treatment for CIN. For example, a meta-analysis of 27 studies found a relative risk (RR) of preterm delivery of 1.70 after treatment for CIN (95% confidence interval [CI], 1.24–2.35).¹ Later studies from Nordic countries estimated the RR at 1.8 to 2.8.^2,3

In the United Kingdom, women who have abnormal findings at the time of cervical cancer screening are referred to clinics that specialize in the assessment and management of CIN. At these clinics, colposcopy and punch cervical biopsy are used to evaluate patients. When treatment is warranted, loop electrosurgical excision procedures (LEEP) are the most common intervention.

Details of the study

Investigators focused on two groups of women referred to large colposcopy clinics (more than 550 new patients annually) between 1987 and 2009:

• untreated group: those who underwent punch biopsy only
• treatment group: those who had an excisional procedure.

Women were followed both retrospectively (previous births) and prospectively (subsequent births) to assess gestational age at delivery. The risk of preterm birth (<37 weeks) was compared between groups.

Among women who delivered after colposcopy, the risk of preterm birth was significantly higher in the treatment group than in the untreated group (adjusted RR, 1.19; P<.05). However, when investigators focused on births prior to colposcopy, the risk of preterm delivery was significantly higher in women who were subsequently treated than in those who were untreated (RR, 1.31; P<.05).

Among untreated women who had a birth prior to evaluation for CIN, the risk of preterm delivery in the subsequent pregnancy was marginally, though significantly, higher than the risk associated with the delivery prior to biopsy (RR, 1.14; P<.05). However, among treated women, the risk of preterm delivery was marginally lower after treatment, compared with their risk in the pregnancy before treatment (RR, 0.94; P>.05).

Expertise of the physician may play a role
in the risk of preterm birth

This study’s finding of a higher risk of preterm birth after treatment, compared with before treatment, would seem to support earlier studies that show an increased risk of preterm birth after LEEP. However, the finding that women destined to undergo treatment of CIN had a higher rate of preterm delivery before that treatment is surprising. And the fact that women who gave birth both before and after treatment had no elevated risk of preterm delivery in the later pregnancy is even more startling.

So what are we to make of these data? They suggest that, at least among women receiving care at high-volume specialty clinics in England, the treatment of CIN does not increase the risk of preterm delivery. Castanon and colleagues hypothesize that the clinicians who work in these clinics may remove less tissue during treatment than other clinicians do, minimizing the risk of later preterm delivery.

A cervical cancer screening expert weighs in

Tom Cox, MD, is past president of ASCCP, the Society for Lower Genital Tract Disease, and a widely published expert on cervical cancer screening. He is also an OBG Management Contributing Editor. When asked for his take on the conclusions of Castanon and colleagues, he agreed that the data are highly credible.

“The findings are different than most of the world literature on this subject,” he continued, “and it may be indeed, as the authors suggest, due to less tissue being removed during surgical excision procedures in England, compared with other countries. If that is true, it may be because colposcopists in the United Kingdom receive a higher level of training and are subject to more rigorous quality control than we have in the United States and in other countries—although most of the studies demonstrating odds ratios of 2 to 3 for preterm birth following treatment have been conducted in Scandinavian countries known for their high-quality medical care.”

Castanon and colleagues are at work on Phase 2 of this study, and Dr. Cox anticipates that its findings will help determine why CIN treatment did not increase the risk of preterm delivery.

“Although colposcopy training is far less rigorous in the United States, and quality control is virtually lacking, it has been thought that, in general, the size of cervical excisions in the United States are likely to have been smaller than in the United Kingdom, where large loop excision of the T-zone (LLETZ), using larger loops than with LEEP, has been common. So it will be interesting to see the authors’ promised Phase 2 article, which compares the size of the excision with outcomes.

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