Obstetrics

PHILADELPHIA – Women taking SSRIs may experience reduced fecundity and a lower live birth rate than women who were not exposed to antidepressants, Lindsey A. Sjaarda, PhD, reported at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

In addition, women in a subgroup receiving fluoxetine experienced a lower live birth rate and greater incidence of pregnancy loss than women taking other SSRIs, but the results were not statistically significant, said Dr. Sjaarda of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

“[It] is biologically plausible that fluoxetine might have some different effects,” she noted. “It does have some different interaction with [cytochrome] P-450 enzyme activity, and this translates to it having a much longer half-life as well. It’s different in terms of drug metabolism and in its interaction with the hormone biosynthesis pathway.”

Most of the research on antidepressants and SSRIs in pregnancy has focused on the safety of the agents, rather than the effect on pregnancy for women trying to conceive, explained Dr. Sjaarda. Previous research also has shown inconsistent findings for fecundability in women of reproductive age taking SSRIs, and the risk of specific SSRI compounds on pregnancy loss is unclear.

The researchers performed a longitudinal exposure assessment of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, which consisted of 1,228 women aged between 18 and 40 years trying to conceive. Patients were included if they had one to two prior pregnancy losses, up to two live births, and had been trying to become pregnant for six menstrual cycles; they were excluded if they had a severe history of mental illness. There were 1,035 women who had no preconception antidepressant exposure and 183 who did have preconception antidepressant exposure.

Patients provided longitudinal urine samples at various time points, including while trying to conceive and in early pregnancy, during the menses phase of each menstrual cycle and at their last menstrual cycle, and at 4 and 8 weeks’ gestation if they become pregnant. The urine samples were collected at home or in clinic; human chorionic gonadotropin levels were measured on the stored samples. The researchers defined pregnancy loss as any kind of loss measured after detecting human chorionic gonadotropin, and they used the patient’s medical record to determine live birth. The fecundability odds ratio was used to estimate the odds of conception in menstrual cycles.

Wavebreakmedia Ltd/Thinkstock

Aypical and tricyclic antidepressants and SSRIs such as sertraline, fluoxetine, and citalopram/escitalopram were analyzed, as well as use of opioids, cannabinoids, and benzodiazepines. In total, 172 women used SSRIs, which represented 94% of the patient group analyzed, said Dr. Sjaarda. “This cohort really represents women who are successfully controlled with first-line agents.”

Patients in both the SSRI and no-antidepressant groups had similar baseline characteristics, but there were differences with regard to body mass index (26 kg/m² vs. 28 kg/m²), employment status (77% vs. 67%), perceived stress (1.0 vs. 0.9), and opioid exposure (16% vs. 23%).

The researchers found use of any SSRI was associated with a 23% reduction in fecundability, with patients using fluoxetine, sertraline, and citalopram/escitalopram having a similar reduction in fecundability, compared with patients not using SSRIs.

Patients who received SSRIs also had approximately a 53% live birth rate overall. When analyzed by individual SSRI, however, there was a statistically significant reduction in the live birth rate for patients who were using fluoxetine, compared with patients using sertraline and citalopram/escitalopram. “This suggests that there was something besides just reduced fecundability going on with the fluoxetine-exposed women,” said Dr. Sjaarda.

When SSRI use was analyzed with regard to pregnancy loss, there was a generally null effect between women exposed to SSRIs overall versus those not exposed at the time before conception, at last menstrual period, and at 4 or 8 weeks’ gestation. But when grouped by specific SSRI, patients receiving fluoxetine had increased risk of pregnancy loss prior to conception, compared with patients not taking fluoxetine (34% vs. 24%; adjusted risk ratio, 1.41; 95% confidence interval, 0.94-2.12) , as well as at their last menstrual period (34% vs. 24%; adjusted RR, 1.48; 95% CI, 0.98-2.24) and at 4 weeks of pregnancy (31% vs. 22%; adjusted RR, 1.61; 95% CI, 0.94-2.78). “This was about a 40%-60% increase in pregnancy loss, even though the sample size is generally small when you divide it into these groups,” said Dr. Sjaarda.

Mental health care is an important public health and maternal health issue, and SSRIs as a drug class are essential for helping to appropriately manage mental health, noted Dr. Sjaarda.

Because “patients’ disease severities all vary and the reactions to different drugs vary, no one-size-fits-all recommendation can be made for people planning a pregnancy while using SSRIs,” concluded Dr. Sjaarda. “However, we’re hoping that women and their physicians can now consider these new data, which are based on objective and longitudinally measured exposure, as well as prospectively-assessed outcomes for these most common antidepressants and develop to a more informed and individualized plan for women who are trying to conceive and use SSRIs.”

Dr. Sjaarda reported no relevant conflicts of interest.

SOURCE: Sjaarda L et al. ASRM 2019, Abstract O-1.

PHILADELPHIA – Women taking SSRIs may experience reduced fecundity and a lower live birth rate than women who were not exposed to antidepressants, Lindsey A. Sjaarda, PhD, reported at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

In addition, women in a subgroup receiving fluoxetine experienced a lower live birth rate and greater incidence of pregnancy loss than women taking other SSRIs, but the results were not statistically significant, said Dr. Sjaarda of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

“[It] is biologically plausible that fluoxetine might have some different effects,” she noted. “It does have some different interaction with [cytochrome] P-450 enzyme activity, and this translates to it having a much longer half-life as well. It’s different in terms of drug metabolism and in its interaction with the hormone biosynthesis pathway.”

Most of the research on antidepressants and SSRIs in pregnancy has focused on the safety of the agents, rather than the effect on pregnancy for women trying to conceive, explained Dr. Sjaarda. Previous research also has shown inconsistent findings for fecundability in women of reproductive age taking SSRIs, and the risk of specific SSRI compounds on pregnancy loss is unclear.

The researchers performed a longitudinal exposure assessment of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, which consisted of 1,228 women aged between 18 and 40 years trying to conceive. Patients were included if they had one to two prior pregnancy losses, up to two live births, and had been trying to become pregnant for six menstrual cycles; they were excluded if they had a severe history of mental illness. There were 1,035 women who had no preconception antidepressant exposure and 183 who did have preconception antidepressant exposure.

Patients provided longitudinal urine samples at various time points, including while trying to conceive and in early pregnancy, during the menses phase of each menstrual cycle and at their last menstrual cycle, and at 4 and 8 weeks’ gestation if they become pregnant. The urine samples were collected at home or in clinic; human chorionic gonadotropin levels were measured on the stored samples. The researchers defined pregnancy loss as any kind of loss measured after detecting human chorionic gonadotropin, and they used the patient’s medical record to determine live birth. The fecundability odds ratio was used to estimate the odds of conception in menstrual cycles.

Wavebreakmedia Ltd/Thinkstock

Aypical and tricyclic antidepressants and SSRIs such as sertraline, fluoxetine, and citalopram/escitalopram were analyzed, as well as use of opioids, cannabinoids, and benzodiazepines. In total, 172 women used SSRIs, which represented 94% of the patient group analyzed, said Dr. Sjaarda. “This cohort really represents women who are successfully controlled with first-line agents.”

Patients in both the SSRI and no-antidepressant groups had similar baseline characteristics, but there were differences with regard to body mass index (26 kg/m² vs. 28 kg/m²), employment status (77% vs. 67%), perceived stress (1.0 vs. 0.9), and opioid exposure (16% vs. 23%).

The researchers found use of any SSRI was associated with a 23% reduction in fecundability, with patients using fluoxetine, sertraline, and citalopram/escitalopram having a similar reduction in fecundability, compared with patients not using SSRIs.

Patients who received SSRIs also had approximately a 53% live birth rate overall. When analyzed by individual SSRI, however, there was a statistically significant reduction in the live birth rate for patients who were using fluoxetine, compared with patients using sertraline and citalopram/escitalopram. “This suggests that there was something besides just reduced fecundability going on with the fluoxetine-exposed women,” said Dr. Sjaarda.

When SSRI use was analyzed with regard to pregnancy loss, there was a generally null effect between women exposed to SSRIs overall versus those not exposed at the time before conception, at last menstrual period, and at 4 or 8 weeks’ gestation. But when grouped by specific SSRI, patients receiving fluoxetine had increased risk of pregnancy loss prior to conception, compared with patients not taking fluoxetine (34% vs. 24%; adjusted risk ratio, 1.41; 95% confidence interval, 0.94-2.12) , as well as at their last menstrual period (34% vs. 24%; adjusted RR, 1.48; 95% CI, 0.98-2.24) and at 4 weeks of pregnancy (31% vs. 22%; adjusted RR, 1.61; 95% CI, 0.94-2.78). “This was about a 40%-60% increase in pregnancy loss, even though the sample size is generally small when you divide it into these groups,” said Dr. Sjaarda.

Mental health care is an important public health and maternal health issue, and SSRIs as a drug class are essential for helping to appropriately manage mental health, noted Dr. Sjaarda.

Because “patients’ disease severities all vary and the reactions to different drugs vary, no one-size-fits-all recommendation can be made for people planning a pregnancy while using SSRIs,” concluded Dr. Sjaarda. “However, we’re hoping that women and their physicians can now consider these new data, which are based on objective and longitudinally measured exposure, as well as prospectively-assessed outcomes for these most common antidepressants and develop to a more informed and individualized plan for women who are trying to conceive and use SSRIs.”

Dr. Sjaarda reported no relevant conflicts of interest.

SOURCE: Sjaarda L et al. ASRM 2019, Abstract O-1.

PHILADELPHIA – Women taking SSRIs may experience reduced fecundity and a lower live birth rate than women who were not exposed to antidepressants, Lindsey A. Sjaarda, PhD, reported at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

In addition, women in a subgroup receiving fluoxetine experienced a lower live birth rate and greater incidence of pregnancy loss than women taking other SSRIs, but the results were not statistically significant, said Dr. Sjaarda of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

“[It] is biologically plausible that fluoxetine might have some different effects,” she noted. “It does have some different interaction with [cytochrome] P-450 enzyme activity, and this translates to it having a much longer half-life as well. It’s different in terms of drug metabolism and in its interaction with the hormone biosynthesis pathway.”

Most of the research on antidepressants and SSRIs in pregnancy has focused on the safety of the agents, rather than the effect on pregnancy for women trying to conceive, explained Dr. Sjaarda. Previous research also has shown inconsistent findings for fecundability in women of reproductive age taking SSRIs, and the risk of specific SSRI compounds on pregnancy loss is unclear.

The researchers performed a longitudinal exposure assessment of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial, which consisted of 1,228 women aged between 18 and 40 years trying to conceive. Patients were included if they had one to two prior pregnancy losses, up to two live births, and had been trying to become pregnant for six menstrual cycles; they were excluded if they had a severe history of mental illness. There were 1,035 women who had no preconception antidepressant exposure and 183 who did have preconception antidepressant exposure.

Patients provided longitudinal urine samples at various time points, including while trying to conceive and in early pregnancy, during the menses phase of each menstrual cycle and at their last menstrual cycle, and at 4 and 8 weeks’ gestation if they become pregnant. The urine samples were collected at home or in clinic; human chorionic gonadotropin levels were measured on the stored samples. The researchers defined pregnancy loss as any kind of loss measured after detecting human chorionic gonadotropin, and they used the patient’s medical record to determine live birth. The fecundability odds ratio was used to estimate the odds of conception in menstrual cycles.

Wavebreakmedia Ltd/Thinkstock

Aypical and tricyclic antidepressants and SSRIs such as sertraline, fluoxetine, and citalopram/escitalopram were analyzed, as well as use of opioids, cannabinoids, and benzodiazepines. In total, 172 women used SSRIs, which represented 94% of the patient group analyzed, said Dr. Sjaarda. “This cohort really represents women who are successfully controlled with first-line agents.”

Patients in both the SSRI and no-antidepressant groups had similar baseline characteristics, but there were differences with regard to body mass index (26 kg/m² vs. 28 kg/m²), employment status (77% vs. 67%), perceived stress (1.0 vs. 0.9), and opioid exposure (16% vs. 23%).

The researchers found use of any SSRI was associated with a 23% reduction in fecundability, with patients using fluoxetine, sertraline, and citalopram/escitalopram having a similar reduction in fecundability, compared with patients not using SSRIs.

Patients who received SSRIs also had approximately a 53% live birth rate overall. When analyzed by individual SSRI, however, there was a statistically significant reduction in the live birth rate for patients who were using fluoxetine, compared with patients using sertraline and citalopram/escitalopram. “This suggests that there was something besides just reduced fecundability going on with the fluoxetine-exposed women,” said Dr. Sjaarda.

When SSRI use was analyzed with regard to pregnancy loss, there was a generally null effect between women exposed to SSRIs overall versus those not exposed at the time before conception, at last menstrual period, and at 4 or 8 weeks’ gestation. But when grouped by specific SSRI, patients receiving fluoxetine had increased risk of pregnancy loss prior to conception, compared with patients not taking fluoxetine (34% vs. 24%; adjusted risk ratio, 1.41; 95% confidence interval, 0.94-2.12) , as well as at their last menstrual period (34% vs. 24%; adjusted RR, 1.48; 95% CI, 0.98-2.24) and at 4 weeks of pregnancy (31% vs. 22%; adjusted RR, 1.61; 95% CI, 0.94-2.78). “This was about a 40%-60% increase in pregnancy loss, even though the sample size is generally small when you divide it into these groups,” said Dr. Sjaarda.

Mental health care is an important public health and maternal health issue, and SSRIs as a drug class are essential for helping to appropriately manage mental health, noted Dr. Sjaarda.

Because “patients’ disease severities all vary and the reactions to different drugs vary, no one-size-fits-all recommendation can be made for people planning a pregnancy while using SSRIs,” concluded Dr. Sjaarda. “However, we’re hoping that women and their physicians can now consider these new data, which are based on objective and longitudinally measured exposure, as well as prospectively-assessed outcomes for these most common antidepressants and develop to a more informed and individualized plan for women who are trying to conceive and use SSRIs.”

Dr. Sjaarda reported no relevant conflicts of interest.

SOURCE: Sjaarda L et al. ASRM 2019, Abstract O-1.

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.

The risk of major birth defects was lower for infants whose mothers had gastric bypass surgery prior to the pregnancy than it was for infants of matched controls, according to data from a cohort study of 2,921 women with a history of gastric bypass surgery and 30,573 matched controls.

“Obesity is associated with poor glucose control, which is teratogenic. Bariatric surgery results in weight loss and glucose normalization but is also associated with nutritional deficiencies and substance abuse, which could cause birth defects as hypothesized based on case series,” wrote Martin Neovius, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.

To determine the risk of birth defects for infants born to women after gastric bypass surgery, the researchers used the Swedish Medical Birth Register to identify singleton infants born between 2007 and 2014 to women who underwent Roux-en-Y gastric bypass surgery and matched controls. The findings were published in a research letter in JAMA.

In the surgery group, the mean interval from surgery to conception was 1.6 years, and the mean weight loss was 40 kg for these women. In addition, the use of diabetes drugs decreased from 10% before surgery to 2% during the 6 months before conception.

Overall, major birth defects occurred in 3% of infants in the gastric bypass groups versus 5% of infants in the control group (risk ratio, 0.67). No neural tube defects occurred in the surgery group and 20 cases of neural tube defects were noted in the control group.

The study was limited by several factors including the lack of data on pregnancy termination, exclusion of stillbirths, and inability to analyze individual birth defects because of small numbers, the researchers noted.

Nonetheless, the results suggest that “a mechanism could be that surgery-induced improvements in glucose metabolism, and potentially other beneficial physiologic changes, led to a reduction of major birth defect risk to a level similar to that of the general population,” they said.

Dr. Neovius disclosed advisory board fees from Itrim and Ethicon Johnson & Johnson. Three coauthors reported grants or other fees from a variety of pharmaceutical companies. The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, by the Swedish Research Council, and by the Swedish Research Council for Health, Working Life, and Welfare.
 

SOURCE: Neovius M et al. JAMA. 2019 Oct 15; 322:1515-17.

WASHINGTON – Daily treatment with valacyclovir for at least 6 weeks safely cut the cytomegalovirus (CMV) vertical transmission rate from mothers to fetuses in women with a primary CMV infection during the three weeks before conception through their first trimester. That finding emerged from a randomized, controlled, single-center Israeli study with 92 women.

The rate of congenital fetal infection with CMV was 11% among neonates born to 45 women treated with 8 g/day of valacyclovir, compared with a 30% rate among the infants born to 47 women who received placebo, a statistically significant difference, Keren Shahar-Nissan, MD, said at an annual scientific meeting on infectious diseases. The results also showed that the valacyclovir regimen was well tolerated, with no increase compared with placebo in adverse events and with no need for dosage adjustment regardless of a 16 pill/day regimen to deliver the 8 g/day of valacyclovir or placebo that participants received.

Dr. Shahar-Nissan said that she and her associates felt comfortable administering this amount of valacyclovir to pregnant woman given previous reports of the safety of this dosage for both women and their fetuses. These reports included 20 pregnant women safely treated for 7 weeks with 8 g/day during the late second or early third trimester (BJOG. 2007 Sept;114[9]:1113-21); more than 600 women in a Danish nationwide study treated with any dosage of valacyclovir during preconception, the first trimester, or the second or third trimesters with a prevalence of births defects not significantly different from unexposed pregnancies (JAMA. 2010 Aug 25;304[8]:859-66); and a prospective, open-label study of 8 g/day valacyclovir to treat 43 women carrying CMV-infected fetuses starting at a median 26 weeks gestation and continuing through delivery (Am J Obstet Gynecol. 2016 Oct;215[4]:462.e1-462.e10).

The study she ran enrolled women seen at Helen Schneider Hospital for Women in Petah Tikva, Israel, during November 2015-October 2018 who had a serologically-proven primary CMV infection that began at any time from 3 weeks before conception through the first trimester, excluding patients with renal dysfunction, liver disease, bone-marrow suppression, or acyclovir sensitivity. Screening for active CMV infection is common among newly-pregnant Israeli women, usually at the time of their first obstetrical consultation for a suspected pregnancy, noted Dr. Shahar-Nissan, a pediatrician at Schneider Children’s Medical Center of Israel in Petah Tikva. About a quarter of the enrolled women became infected during the 3 weeks prior to conception, and nearly two-thirds became infected during the first 8 weeks of pregnancy.

The valacyclovir intervention appeared to be effective specifically for preventing vertical transmission of infection acquired early during pregnancy. In this subgroup the transmission rate was 11% with valacyclovir treatment and 48% on placebo. Valacyclovir seemed to have no effect on vertical transmission of infections that began before conception, likely because treatment began too late to prevent transmission.

“I think this study is enough” to convince the U.S. Food and Drug Administration to add this treatment indication to the labeling of valacyclovir, a drug that has been available in generic formulations for many years, Dr. Shahar-Nissan said in an interview. Before approaching the FDA, her first goal is publishing the findings, she added.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Daily treatment with valacyclovir for at least 6 weeks safely cut the cytomegalovirus (CMV) vertical transmission rate from mothers to fetuses in women with a primary CMV infection during the three weeks before conception through their first trimester. That finding emerged from a randomized, controlled, single-center Israeli study with 92 women.

The rate of congenital fetal infection with CMV was 11% among neonates born to 45 women treated with 8 g/day of valacyclovir, compared with a 30% rate among the infants born to 47 women who received placebo, a statistically significant difference, Keren Shahar-Nissan, MD, said at an annual scientific meeting on infectious diseases. The results also showed that the valacyclovir regimen was well tolerated, with no increase compared with placebo in adverse events and with no need for dosage adjustment regardless of a 16 pill/day regimen to deliver the 8 g/day of valacyclovir or placebo that participants received.

Dr. Shahar-Nissan said that she and her associates felt comfortable administering this amount of valacyclovir to pregnant woman given previous reports of the safety of this dosage for both women and their fetuses. These reports included 20 pregnant women safely treated for 7 weeks with 8 g/day during the late second or early third trimester (BJOG. 2007 Sept;114[9]:1113-21); more than 600 women in a Danish nationwide study treated with any dosage of valacyclovir during preconception, the first trimester, or the second or third trimesters with a prevalence of births defects not significantly different from unexposed pregnancies (JAMA. 2010 Aug 25;304[8]:859-66); and a prospective, open-label study of 8 g/day valacyclovir to treat 43 women carrying CMV-infected fetuses starting at a median 26 weeks gestation and continuing through delivery (Am J Obstet Gynecol. 2016 Oct;215[4]:462.e1-462.e10).

The study she ran enrolled women seen at Helen Schneider Hospital for Women in Petah Tikva, Israel, during November 2015-October 2018 who had a serologically-proven primary CMV infection that began at any time from 3 weeks before conception through the first trimester, excluding patients with renal dysfunction, liver disease, bone-marrow suppression, or acyclovir sensitivity. Screening for active CMV infection is common among newly-pregnant Israeli women, usually at the time of their first obstetrical consultation for a suspected pregnancy, noted Dr. Shahar-Nissan, a pediatrician at Schneider Children’s Medical Center of Israel in Petah Tikva. About a quarter of the enrolled women became infected during the 3 weeks prior to conception, and nearly two-thirds became infected during the first 8 weeks of pregnancy.

The valacyclovir intervention appeared to be effective specifically for preventing vertical transmission of infection acquired early during pregnancy. In this subgroup the transmission rate was 11% with valacyclovir treatment and 48% on placebo. Valacyclovir seemed to have no effect on vertical transmission of infections that began before conception, likely because treatment began too late to prevent transmission.

“I think this study is enough” to convince the U.S. Food and Drug Administration to add this treatment indication to the labeling of valacyclovir, a drug that has been available in generic formulations for many years, Dr. Shahar-Nissan said in an interview. Before approaching the FDA, her first goal is publishing the findings, she added.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Daily treatment with valacyclovir for at least 6 weeks safely cut the cytomegalovirus (CMV) vertical transmission rate from mothers to fetuses in women with a primary CMV infection during the three weeks before conception through their first trimester. That finding emerged from a randomized, controlled, single-center Israeli study with 92 women.

The rate of congenital fetal infection with CMV was 11% among neonates born to 45 women treated with 8 g/day of valacyclovir, compared with a 30% rate among the infants born to 47 women who received placebo, a statistically significant difference, Keren Shahar-Nissan, MD, said at an annual scientific meeting on infectious diseases. The results also showed that the valacyclovir regimen was well tolerated, with no increase compared with placebo in adverse events and with no need for dosage adjustment regardless of a 16 pill/day regimen to deliver the 8 g/day of valacyclovir or placebo that participants received.

Dr. Shahar-Nissan said that she and her associates felt comfortable administering this amount of valacyclovir to pregnant woman given previous reports of the safety of this dosage for both women and their fetuses. These reports included 20 pregnant women safely treated for 7 weeks with 8 g/day during the late second or early third trimester (BJOG. 2007 Sept;114[9]:1113-21); more than 600 women in a Danish nationwide study treated with any dosage of valacyclovir during preconception, the first trimester, or the second or third trimesters with a prevalence of births defects not significantly different from unexposed pregnancies (JAMA. 2010 Aug 25;304[8]:859-66); and a prospective, open-label study of 8 g/day valacyclovir to treat 43 women carrying CMV-infected fetuses starting at a median 26 weeks gestation and continuing through delivery (Am J Obstet Gynecol. 2016 Oct;215[4]:462.e1-462.e10).

The study she ran enrolled women seen at Helen Schneider Hospital for Women in Petah Tikva, Israel, during November 2015-October 2018 who had a serologically-proven primary CMV infection that began at any time from 3 weeks before conception through the first trimester, excluding patients with renal dysfunction, liver disease, bone-marrow suppression, or acyclovir sensitivity. Screening for active CMV infection is common among newly-pregnant Israeli women, usually at the time of their first obstetrical consultation for a suspected pregnancy, noted Dr. Shahar-Nissan, a pediatrician at Schneider Children’s Medical Center of Israel in Petah Tikva. About a quarter of the enrolled women became infected during the 3 weeks prior to conception, and nearly two-thirds became infected during the first 8 weeks of pregnancy.

The valacyclovir intervention appeared to be effective specifically for preventing vertical transmission of infection acquired early during pregnancy. In this subgroup the transmission rate was 11% with valacyclovir treatment and 48% on placebo. Valacyclovir seemed to have no effect on vertical transmission of infections that began before conception, likely because treatment began too late to prevent transmission.

“I think this study is enough” to convince the U.S. Food and Drug Administration to add this treatment indication to the labeling of valacyclovir, a drug that has been available in generic formulations for many years, Dr. Shahar-Nissan said in an interview. Before approaching the FDA, her first goal is publishing the findings, she added.

[email protected]

On Twitter @mitchelzoler

Gov. Gavin Newsom (D-CA) signed into law three bills intended to lower drug prices and increase access to prescription drugs as part of a continuing health care initiative intended to benefit the residents of California.

doomu/Thinkstock

AB 824, the Pay for Delay bill, bans pharmaceutical companies from keeping cheaper generic drugs off the market. The bill prohibits agreements between brand name and generic drug manufacturers to delay the release of generic drugs, defining them as presumptively anticompetitive. A Federal Trade Commission study found that “these anticompetitive deals cost consumers and taxpayers $3.5 billion in higher drug costs every year,” according to a statement from the governor’s office.

The second bill, SB 464, is intended to improve black maternal health care. The bill is designed to reduce preventable maternal mortality among black women by requiring all perinatal health care providers to undergo implicit bias training to curb the effects of bias on maternal health and by improving data collection at the California Department of Public Health to better understand pregnancy-related deaths. “We know that black women have been dying at alarming rates during and after giving birth. The disproportionate effect of the maternal mortality rate on this community is a public health crisis and a major health equity issue. We must do everything in our power to take implicit bias out of the medical system – it is literally a matter of life and death,” said Gov. Newsom.

The third bill, SB 159, aims to facilitate the use of pre-exposure prophylaxis and postexposure prophylaxis against HIV infection. The bill allows pharmacists in the state to dispense PrEP and PEP without a physician’s prescription and prohibits insurance companies from requiring prior authorization for patients to obtain PrEP coverage. “All Californians deserve access to PrEP and PEP, two treatments that have transformed our fight against HIV and AIDS,” Gov. Newsom said in a statement.

[email protected]

Gov. Gavin Newsom (D-CA) signed into law three bills intended to lower drug prices and increase access to prescription drugs as part of a continuing health care initiative intended to benefit the residents of California.

doomu/Thinkstock

AB 824, the Pay for Delay bill, bans pharmaceutical companies from keeping cheaper generic drugs off the market. The bill prohibits agreements between brand name and generic drug manufacturers to delay the release of generic drugs, defining them as presumptively anticompetitive. A Federal Trade Commission study found that “these anticompetitive deals cost consumers and taxpayers $3.5 billion in higher drug costs every year,” according to a statement from the governor’s office.

The second bill, SB 464, is intended to improve black maternal health care. The bill is designed to reduce preventable maternal mortality among black women by requiring all perinatal health care providers to undergo implicit bias training to curb the effects of bias on maternal health and by improving data collection at the California Department of Public Health to better understand pregnancy-related deaths. “We know that black women have been dying at alarming rates during and after giving birth. The disproportionate effect of the maternal mortality rate on this community is a public health crisis and a major health equity issue. We must do everything in our power to take implicit bias out of the medical system – it is literally a matter of life and death,” said Gov. Newsom.

The third bill, SB 159, aims to facilitate the use of pre-exposure prophylaxis and postexposure prophylaxis against HIV infection. The bill allows pharmacists in the state to dispense PrEP and PEP without a physician’s prescription and prohibits insurance companies from requiring prior authorization for patients to obtain PrEP coverage. “All Californians deserve access to PrEP and PEP, two treatments that have transformed our fight against HIV and AIDS,” Gov. Newsom said in a statement.

[email protected]

Gov. Gavin Newsom (D-CA) signed into law three bills intended to lower drug prices and increase access to prescription drugs as part of a continuing health care initiative intended to benefit the residents of California.

doomu/Thinkstock

AB 824, the Pay for Delay bill, bans pharmaceutical companies from keeping cheaper generic drugs off the market. The bill prohibits agreements between brand name and generic drug manufacturers to delay the release of generic drugs, defining them as presumptively anticompetitive. A Federal Trade Commission study found that “these anticompetitive deals cost consumers and taxpayers $3.5 billion in higher drug costs every year,” according to a statement from the governor’s office.

The second bill, SB 464, is intended to improve black maternal health care. The bill is designed to reduce preventable maternal mortality among black women by requiring all perinatal health care providers to undergo implicit bias training to curb the effects of bias on maternal health and by improving data collection at the California Department of Public Health to better understand pregnancy-related deaths. “We know that black women have been dying at alarming rates during and after giving birth. The disproportionate effect of the maternal mortality rate on this community is a public health crisis and a major health equity issue. We must do everything in our power to take implicit bias out of the medical system – it is literally a matter of life and death,” said Gov. Newsom.

The third bill, SB 159, aims to facilitate the use of pre-exposure prophylaxis and postexposure prophylaxis against HIV infection. The bill allows pharmacists in the state to dispense PrEP and PEP without a physician’s prescription and prohibits insurance companies from requiring prior authorization for patients to obtain PrEP coverage. “All Californians deserve access to PrEP and PEP, two treatments that have transformed our fight against HIV and AIDS,” Gov. Newsom said in a statement.

[email protected]

One of the nation’s most preventable diseases is killing newborns in ever-increasing numbers.

Christoph Burgstedt/iStock/Getty Images Plus

Nationwide, 1,306 infants acquired syphilis from their mother in 2018, a 40% rise over 2017, according to federal data released Oct. 8. Seventy-eight of those babies were stillborn, and 16 died after birth.

In California, cases of congenital syphilis – the term used when a mother passes the infection to her baby during pregnancy – continued a stark 7-year climb, to 332 cases, an 18.1% increase from 2017, according to the federal data. Only Texas, Nevada, Louisiana, and Arizona had congenital syphilis rates higher than California’s. Those five states combined made up nearly two-thirds of total cases, although all but 17 states saw increases in their congenital syphilis rates.

The state-by-state numbers were released as part of a broader report from the Centers for Disease Control and Prevention tracking trends in sexually transmitted diseases. Cases of syphilis, gonorrhea, and chlamydia combined reached an all-time high in 2018. Cases of the most infectious stage of syphilis rose 14% to more than 35,000 cases; gonorrhea increased 5% to more than 580,000 cases; and chlamydia increased 3% to more than 1.7 million cases.

For veteran public health workers, the upward trend in congenital syphilis numbers is particularly disturbing because the condition is so easy to prevent. Blood tests can identify infection in pregnant women. The treatment is relatively simple and effective. When caught during pregnancy, transmission from mother to baby generally can be stopped.

“When we see a case of congenital syphilis, it is a hallmark of a health system and a health care failure,” said Virginia Bowen, PhD, an epidemiologist with the CDC and an author of the report.

It takes just a few shots of antibiotics to prevent a baby from getting syphilis from its mother. Left untreated, Treponema pallidum, the corkscrew-shaped organism that causes syphilis, can wiggle its way through a mother’s placenta and into a fetus. Once there, it can multiply furiously, invading every part of the body.

The effects on a newborn can be devastating. Philip Cheng, MD, is a neonatologist at St. Joseph’s Medical Center in Stockton, a city in San Joaquin County in California’s Central Valley. Twenty-six babies were infected last year in San Joaquin County, according to state data.

The brain of one of Cheng’s patients didn’t develop properly and the baby died shortly after birth. Other young patients survive but battle blood abnormalities, bone deformities, and organ damage. Congenital syphilis can cause blindness and excruciating pain.

Public health departments across the Central Valley, a largely rural expanse, report similar experiences. Following the release of the CDC report Tuesday, the California Department of Public Health released its county-by-county numbers for 2018. The report showed syphilis, gonorrhea, and chlamydia levels at their highest in 30 years, and attributed 22 stillbirths or neonatal deaths to congenital syphilis.

For the past several years, Fresno County, which had 63 cases of congenital syphilis in 2017, had the highest rate in California. In 2018, Fresno fell to fourth, behind Yuba, Kern, and San Joaquin counties. But the epidemic is far from under control. “I couldn’t even tell you how soon I think we’re going to see a decrease,” said Jena Adams, who oversees HIV and STD programs for Fresno County.

Syphilis was once a prolific and widely feared STD. But by the 1940s, penicillin was found to have a near-perfect cure rate for the disease. By 2000, syphilis rates were so low in the U.S. that the federal government launched a plan to eliminate the disease. Today, that goal is a distant memory.

Health departments once tracked down every person who tested positive for chlamydia, gonorrhea, or syphilis, to make sure they and their partners got treatment. With limited funds and climbing caseloads, many states now devote resources only to tracking syphilis. The caseloads are so high in some California counties that they track only women of childbearing age or just pregnant women.

“A lot of the funding for day-to-day public health work isn’t there,” said Jeffrey Klausner, MD, a professor at the University of California-Los Angeles who ran San Francisco’s STD program for more than a decade.

The bulk of STD prevention funding is appropriated by Congress to the CDC, which passes it on to states. That funding has been largely flat since 2003, according to data from the National Coalition of STD Directors, which represents health departments across the country. Take into account inflation and the growing caseloads, and the money is spread thinner. “It takes money, it takes training, it takes resources,” Dr. Klausner said, “and policymakers have just not prioritized that.”

A report this year by Trust for America’s Health, a public health policy research and advocacy group, estimated that 55,000 jobs were cut from local public health departments from 2008 to 2017. “We have our hands tied as much as [states] do,” said Dr. Bowen of the CDC. “We take what we’re given and try to distribute it as fairly as we can.”

San Joaquin County health officials have reorganized the department and applied for grants to increase the number of investigators available while congenital syphilis has spiked, said Hemal Parikh, county coordinator for STD control. But even with new hires and cutting back to tracking only women of childbearing age with syphilis, an investigator can have anywhere from 20 to 30 open cases at a time. In other counties, the caseload can be double that.

In 2018, Jennifer Wagman, PhD, a UCLA professor who studies infectious diseases and gender inequality, was part of a group that received CDC funding to look into what is causing the spike in congenital syphilis in California’s Central Valley.

Dr. Wagman said that, after years of studying health systems in other countries, she was shocked to see how much basic public health infrastructure has crumbled in California. In many parts of the Central Valley, county walk-in clinics that tested for and treated STDs were shuttered in the wake of the recession. That left few places for drop-in care, and investigators with no place to take someone for immediate treatment. Investigators or their patients must make appointments at one of the few providers who carry the right kind of treatment and hope the patients can keep the appointment when the time comes.

In focus groups, women told Dr. Wagman that working hourly jobs, or dealing with chaotic lives involving homelessness, abusive partners, and drug use, can make it all but impossible to stick to the appointments required at private clinics.

Dr. Wagman found that women in these high-risk groups were seeking care, though sometimes late in their pregnancy. They were just more likely to visit an emergency room, urgent care, or even a methadone clinic – places that take drop-ins but don’t necessarily routinely test for or treat syphilis.

“These people already have a million barriers,” said Jenny Malone, the public health nurse for San Joaquin County. “Now there are more.”

The most challenging cases in California are wrapped up with the state’s growing housing crisis and a methamphetamine epidemic with few treatment options. Women who are homeless often have unreliable contact information and are unlikely to have a primary care doctor. That makes them tough to track down to give a positive diagnosis or to follow up on a treatment plan.

Louisiana had the highest rate of congenital syphilis in the country for several years – until 2018. After a 22% drop in its rate, combined with increases in other states, Louisiana now ranks behind Texas and Nevada. That drop is the direct result of $550 million in temporary supplemental funding that the CDC gave the state to combat the epidemic, said Chaquetta Johnson, DNP, deputy director of operations for the state’s STD/HIV/hepatitis program. The money helped bolster the state’s lagging public health infrastructure. It was used to host two conferences for providers in the hardest-hit areas, hire two case managers and a nurse educator, create a program for in-home treatment, and improve data systems to track cases, among other things.

In California, more than 40% of pregnant women with syphilis passed it on to their baby in 2016, the most recent year for which data is available. Gov. Gavin Newsom (D) made additional funding available this year, but it’s a “drop in the bucket,” said Sergio Morales of Essential Access Health, a nonprofit that focuses on sexual and reproductive health and is working with Kern County on congenital syphilis. “We are seeing the results of years of inaction and a lack of prioritization of STD prevention, and we’re now paying the price.”
 

This KHN story first published on California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

[Update: This story was revised at 6:50 p.m. ET on Oct. 8 to reflect news developments.]
 

One of the nation’s most preventable diseases is killing newborns in ever-increasing numbers.

Christoph Burgstedt/iStock/Getty Images Plus

Nationwide, 1,306 infants acquired syphilis from their mother in 2018, a 40% rise over 2017, according to federal data released Oct. 8. Seventy-eight of those babies were stillborn, and 16 died after birth.

In California, cases of congenital syphilis – the term used when a mother passes the infection to her baby during pregnancy – continued a stark 7-year climb, to 332 cases, an 18.1% increase from 2017, according to the federal data. Only Texas, Nevada, Louisiana, and Arizona had congenital syphilis rates higher than California’s. Those five states combined made up nearly two-thirds of total cases, although all but 17 states saw increases in their congenital syphilis rates.

The state-by-state numbers were released as part of a broader report from the Centers for Disease Control and Prevention tracking trends in sexually transmitted diseases. Cases of syphilis, gonorrhea, and chlamydia combined reached an all-time high in 2018. Cases of the most infectious stage of syphilis rose 14% to more than 35,000 cases; gonorrhea increased 5% to more than 580,000 cases; and chlamydia increased 3% to more than 1.7 million cases.

For veteran public health workers, the upward trend in congenital syphilis numbers is particularly disturbing because the condition is so easy to prevent. Blood tests can identify infection in pregnant women. The treatment is relatively simple and effective. When caught during pregnancy, transmission from mother to baby generally can be stopped.

“When we see a case of congenital syphilis, it is a hallmark of a health system and a health care failure,” said Virginia Bowen, PhD, an epidemiologist with the CDC and an author of the report.

It takes just a few shots of antibiotics to prevent a baby from getting syphilis from its mother. Left untreated, Treponema pallidum, the corkscrew-shaped organism that causes syphilis, can wiggle its way through a mother’s placenta and into a fetus. Once there, it can multiply furiously, invading every part of the body.

The effects on a newborn can be devastating. Philip Cheng, MD, is a neonatologist at St. Joseph’s Medical Center in Stockton, a city in San Joaquin County in California’s Central Valley. Twenty-six babies were infected last year in San Joaquin County, according to state data.

The brain of one of Cheng’s patients didn’t develop properly and the baby died shortly after birth. Other young patients survive but battle blood abnormalities, bone deformities, and organ damage. Congenital syphilis can cause blindness and excruciating pain.

Public health departments across the Central Valley, a largely rural expanse, report similar experiences. Following the release of the CDC report Tuesday, the California Department of Public Health released its county-by-county numbers for 2018. The report showed syphilis, gonorrhea, and chlamydia levels at their highest in 30 years, and attributed 22 stillbirths or neonatal deaths to congenital syphilis.

For the past several years, Fresno County, which had 63 cases of congenital syphilis in 2017, had the highest rate in California. In 2018, Fresno fell to fourth, behind Yuba, Kern, and San Joaquin counties. But the epidemic is far from under control. “I couldn’t even tell you how soon I think we’re going to see a decrease,” said Jena Adams, who oversees HIV and STD programs for Fresno County.

Syphilis was once a prolific and widely feared STD. But by the 1940s, penicillin was found to have a near-perfect cure rate for the disease. By 2000, syphilis rates were so low in the U.S. that the federal government launched a plan to eliminate the disease. Today, that goal is a distant memory.

Health departments once tracked down every person who tested positive for chlamydia, gonorrhea, or syphilis, to make sure they and their partners got treatment. With limited funds and climbing caseloads, many states now devote resources only to tracking syphilis. The caseloads are so high in some California counties that they track only women of childbearing age or just pregnant women.

“A lot of the funding for day-to-day public health work isn’t there,” said Jeffrey Klausner, MD, a professor at the University of California-Los Angeles who ran San Francisco’s STD program for more than a decade.

The bulk of STD prevention funding is appropriated by Congress to the CDC, which passes it on to states. That funding has been largely flat since 2003, according to data from the National Coalition of STD Directors, which represents health departments across the country. Take into account inflation and the growing caseloads, and the money is spread thinner. “It takes money, it takes training, it takes resources,” Dr. Klausner said, “and policymakers have just not prioritized that.”

A report this year by Trust for America’s Health, a public health policy research and advocacy group, estimated that 55,000 jobs were cut from local public health departments from 2008 to 2017. “We have our hands tied as much as [states] do,” said Dr. Bowen of the CDC. “We take what we’re given and try to distribute it as fairly as we can.”

San Joaquin County health officials have reorganized the department and applied for grants to increase the number of investigators available while congenital syphilis has spiked, said Hemal Parikh, county coordinator for STD control. But even with new hires and cutting back to tracking only women of childbearing age with syphilis, an investigator can have anywhere from 20 to 30 open cases at a time. In other counties, the caseload can be double that.

In 2018, Jennifer Wagman, PhD, a UCLA professor who studies infectious diseases and gender inequality, was part of a group that received CDC funding to look into what is causing the spike in congenital syphilis in California’s Central Valley.

Dr. Wagman said that, after years of studying health systems in other countries, she was shocked to see how much basic public health infrastructure has crumbled in California. In many parts of the Central Valley, county walk-in clinics that tested for and treated STDs were shuttered in the wake of the recession. That left few places for drop-in care, and investigators with no place to take someone for immediate treatment. Investigators or their patients must make appointments at one of the few providers who carry the right kind of treatment and hope the patients can keep the appointment when the time comes.

In focus groups, women told Dr. Wagman that working hourly jobs, or dealing with chaotic lives involving homelessness, abusive partners, and drug use, can make it all but impossible to stick to the appointments required at private clinics.

Dr. Wagman found that women in these high-risk groups were seeking care, though sometimes late in their pregnancy. They were just more likely to visit an emergency room, urgent care, or even a methadone clinic – places that take drop-ins but don’t necessarily routinely test for or treat syphilis.

“These people already have a million barriers,” said Jenny Malone, the public health nurse for San Joaquin County. “Now there are more.”

The most challenging cases in California are wrapped up with the state’s growing housing crisis and a methamphetamine epidemic with few treatment options. Women who are homeless often have unreliable contact information and are unlikely to have a primary care doctor. That makes them tough to track down to give a positive diagnosis or to follow up on a treatment plan.

Louisiana had the highest rate of congenital syphilis in the country for several years – until 2018. After a 22% drop in its rate, combined with increases in other states, Louisiana now ranks behind Texas and Nevada. That drop is the direct result of $550 million in temporary supplemental funding that the CDC gave the state to combat the epidemic, said Chaquetta Johnson, DNP, deputy director of operations for the state’s STD/HIV/hepatitis program. The money helped bolster the state’s lagging public health infrastructure. It was used to host two conferences for providers in the hardest-hit areas, hire two case managers and a nurse educator, create a program for in-home treatment, and improve data systems to track cases, among other things.

In California, more than 40% of pregnant women with syphilis passed it on to their baby in 2016, the most recent year for which data is available. Gov. Gavin Newsom (D) made additional funding available this year, but it’s a “drop in the bucket,” said Sergio Morales of Essential Access Health, a nonprofit that focuses on sexual and reproductive health and is working with Kern County on congenital syphilis. “We are seeing the results of years of inaction and a lack of prioritization of STD prevention, and we’re now paying the price.”
 

This KHN story first published on California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

[Update: This story was revised at 6:50 p.m. ET on Oct. 8 to reflect news developments.]
 

One of the nation’s most preventable diseases is killing newborns in ever-increasing numbers.

Christoph Burgstedt/iStock/Getty Images Plus

Nationwide, 1,306 infants acquired syphilis from their mother in 2018, a 40% rise over 2017, according to federal data released Oct. 8. Seventy-eight of those babies were stillborn, and 16 died after birth.

In California, cases of congenital syphilis – the term used when a mother passes the infection to her baby during pregnancy – continued a stark 7-year climb, to 332 cases, an 18.1% increase from 2017, according to the federal data. Only Texas, Nevada, Louisiana, and Arizona had congenital syphilis rates higher than California’s. Those five states combined made up nearly two-thirds of total cases, although all but 17 states saw increases in their congenital syphilis rates.

The state-by-state numbers were released as part of a broader report from the Centers for Disease Control and Prevention tracking trends in sexually transmitted diseases. Cases of syphilis, gonorrhea, and chlamydia combined reached an all-time high in 2018. Cases of the most infectious stage of syphilis rose 14% to more than 35,000 cases; gonorrhea increased 5% to more than 580,000 cases; and chlamydia increased 3% to more than 1.7 million cases.

For veteran public health workers, the upward trend in congenital syphilis numbers is particularly disturbing because the condition is so easy to prevent. Blood tests can identify infection in pregnant women. The treatment is relatively simple and effective. When caught during pregnancy, transmission from mother to baby generally can be stopped.

“When we see a case of congenital syphilis, it is a hallmark of a health system and a health care failure,” said Virginia Bowen, PhD, an epidemiologist with the CDC and an author of the report.

It takes just a few shots of antibiotics to prevent a baby from getting syphilis from its mother. Left untreated, Treponema pallidum, the corkscrew-shaped organism that causes syphilis, can wiggle its way through a mother’s placenta and into a fetus. Once there, it can multiply furiously, invading every part of the body.

The effects on a newborn can be devastating. Philip Cheng, MD, is a neonatologist at St. Joseph’s Medical Center in Stockton, a city in San Joaquin County in California’s Central Valley. Twenty-six babies were infected last year in San Joaquin County, according to state data.

The brain of one of Cheng’s patients didn’t develop properly and the baby died shortly after birth. Other young patients survive but battle blood abnormalities, bone deformities, and organ damage. Congenital syphilis can cause blindness and excruciating pain.

Public health departments across the Central Valley, a largely rural expanse, report similar experiences. Following the release of the CDC report Tuesday, the California Department of Public Health released its county-by-county numbers for 2018. The report showed syphilis, gonorrhea, and chlamydia levels at their highest in 30 years, and attributed 22 stillbirths or neonatal deaths to congenital syphilis.

For the past several years, Fresno County, which had 63 cases of congenital syphilis in 2017, had the highest rate in California. In 2018, Fresno fell to fourth, behind Yuba, Kern, and San Joaquin counties. But the epidemic is far from under control. “I couldn’t even tell you how soon I think we’re going to see a decrease,” said Jena Adams, who oversees HIV and STD programs for Fresno County.

Syphilis was once a prolific and widely feared STD. But by the 1940s, penicillin was found to have a near-perfect cure rate for the disease. By 2000, syphilis rates were so low in the U.S. that the federal government launched a plan to eliminate the disease. Today, that goal is a distant memory.

Health departments once tracked down every person who tested positive for chlamydia, gonorrhea, or syphilis, to make sure they and their partners got treatment. With limited funds and climbing caseloads, many states now devote resources only to tracking syphilis. The caseloads are so high in some California counties that they track only women of childbearing age or just pregnant women.

“A lot of the funding for day-to-day public health work isn’t there,” said Jeffrey Klausner, MD, a professor at the University of California-Los Angeles who ran San Francisco’s STD program for more than a decade.

The bulk of STD prevention funding is appropriated by Congress to the CDC, which passes it on to states. That funding has been largely flat since 2003, according to data from the National Coalition of STD Directors, which represents health departments across the country. Take into account inflation and the growing caseloads, and the money is spread thinner. “It takes money, it takes training, it takes resources,” Dr. Klausner said, “and policymakers have just not prioritized that.”

A report this year by Trust for America’s Health, a public health policy research and advocacy group, estimated that 55,000 jobs were cut from local public health departments from 2008 to 2017. “We have our hands tied as much as [states] do,” said Dr. Bowen of the CDC. “We take what we’re given and try to distribute it as fairly as we can.”

San Joaquin County health officials have reorganized the department and applied for grants to increase the number of investigators available while congenital syphilis has spiked, said Hemal Parikh, county coordinator for STD control. But even with new hires and cutting back to tracking only women of childbearing age with syphilis, an investigator can have anywhere from 20 to 30 open cases at a time. In other counties, the caseload can be double that.

In 2018, Jennifer Wagman, PhD, a UCLA professor who studies infectious diseases and gender inequality, was part of a group that received CDC funding to look into what is causing the spike in congenital syphilis in California’s Central Valley.

Dr. Wagman said that, after years of studying health systems in other countries, she was shocked to see how much basic public health infrastructure has crumbled in California. In many parts of the Central Valley, county walk-in clinics that tested for and treated STDs were shuttered in the wake of the recession. That left few places for drop-in care, and investigators with no place to take someone for immediate treatment. Investigators or their patients must make appointments at one of the few providers who carry the right kind of treatment and hope the patients can keep the appointment when the time comes.

In focus groups, women told Dr. Wagman that working hourly jobs, or dealing with chaotic lives involving homelessness, abusive partners, and drug use, can make it all but impossible to stick to the appointments required at private clinics.

Dr. Wagman found that women in these high-risk groups were seeking care, though sometimes late in their pregnancy. They were just more likely to visit an emergency room, urgent care, or even a methadone clinic – places that take drop-ins but don’t necessarily routinely test for or treat syphilis.

“These people already have a million barriers,” said Jenny Malone, the public health nurse for San Joaquin County. “Now there are more.”

The most challenging cases in California are wrapped up with the state’s growing housing crisis and a methamphetamine epidemic with few treatment options. Women who are homeless often have unreliable contact information and are unlikely to have a primary care doctor. That makes them tough to track down to give a positive diagnosis or to follow up on a treatment plan.

Louisiana had the highest rate of congenital syphilis in the country for several years – until 2018. After a 22% drop in its rate, combined with increases in other states, Louisiana now ranks behind Texas and Nevada. That drop is the direct result of $550 million in temporary supplemental funding that the CDC gave the state to combat the epidemic, said Chaquetta Johnson, DNP, deputy director of operations for the state’s STD/HIV/hepatitis program. The money helped bolster the state’s lagging public health infrastructure. It was used to host two conferences for providers in the hardest-hit areas, hire two case managers and a nurse educator, create a program for in-home treatment, and improve data systems to track cases, among other things.

In California, more than 40% of pregnant women with syphilis passed it on to their baby in 2016, the most recent year for which data is available. Gov. Gavin Newsom (D) made additional funding available this year, but it’s a “drop in the bucket,” said Sergio Morales of Essential Access Health, a nonprofit that focuses on sexual and reproductive health and is working with Kern County on congenital syphilis. “We are seeing the results of years of inaction and a lack of prioritization of STD prevention, and we’re now paying the price.”
 

This KHN story first published on California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

[Update: This story was revised at 6:50 p.m. ET on Oct. 8 to reflect news developments.]
 

A little over half of pregnant women get the Tdap vaccine during pregnancy or the influenza vaccine before or during pregnancy, but only 35% get both, according to a Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention.

AvailableLight/istockphoto.com

The CDC recommends that all pregnant women receive the Tdap vaccine, preferably between 27 and 36 weeks’ gestation. The flu vaccine is recommended for all women at any point in pregnancy if the pregnancy falls within flu season. Women do not need a second flu shot if they received the vaccine before pregnancy in the same influenza season. Both vaccines provide protection to infants after birth.

“Clinicians caring for women who are pregnant have a huge role in helping women understand risks and benefits and the value of vaccines,” Anne Schuchat, MD, principal deputy director of the CDC, Atlanta, said in a telebriefing about the new report. “A lot of women are worried about taking any extra medicine or getting shots during pregnancy, and clinicians can let them know about the large data available showing the safety of the vaccine as well as the effectiveness. We also think it’s important to let people know about the risk of not vaccinating.”

Pregnant women are at higher risk for influenza complications and represent a disproportionate number of flu-related hospitalizations. From the 2010-2011 to 2017-2018 influenza seasons, 24%-34% of influenza hospitalizations each season were pregnant women aged 15-44, yet only 9% of women in this age group are pregnant at any point each year, according to the report.

Similarly, infants under 6 months have the greatest risk of hospitalization from influenza, and half of pertussis hospitalizations and 69% of pertussis deaths occur in infants under 2 months old. But a fetus receives protective maternal antibodies from flu and pertussis vaccines about 2 weeks after the mother is vaccinated.

Influenza hospitalization is 40% lower among pregnant women vaccinated against flu and 72% lower in infants under 6 months who received maternal influenza antibodies during gestation. Similarly, Tdap vaccination during the third trimester of pregnancy reduces pertussis infection risk by 78% and pertussis hospitalization by 91% in infants under 2 months.

“Infant protection can motivate pregnant women to receive recommended vaccines, and intention to vaccinate is higher among women who perceive more serious consequences of influenza or pertussis disease for their own or their infant’s health,” Megan C. Lindley, MPH, of the CDC’s Immunization Services Division, and colleagues wrote in the MMWR report.

In March-April 2019, Ms. Lindley and associates conducted an Internet survey about flu and Tdap immunizations among women aged 18-49 who had been pregnant at any point since August 1, 2018. A total of 2,626 women completed the survey of 2,762 invitations (95% response rate).

Among 817 women who knew their Tdap status during pregnancy, 55% received the Tdap vaccine. Among 2,097 women who reported a pregnancy between October 2018 and January 2019, 54% received the flu vaccine before or during pregnancy.

But many women received one vaccine without the other: 65% of women surveyed had not received both vaccines during pregnancy. Higher immunization rates occurred among women whose clinicians recommended the vaccines: 66% received a flu shot and 71% received Tdap.

“We’re learning a lot about improved communication between clinicians and patients. One thing we suggest is to begin the conversations early.” Dr Schuchat said. “If you begin talking early in the pregnancy about the things you’ll be looking forward to and provide information, by the time it is flu season or it is that third trimester, they’re prepared to make a good choice.”

Most women surveyed (75%) said their providers did offer a flu or Tdap vaccine in the office or a referral for one. Yet more than 30% of these women did not get the recommended vaccine.

The most common reason for not getting the Tdap during pregnancy, cited by 38% of women who didn’t receive it, was not knowing about the recommendation. Those who did not receive flu vaccination, however, cited concerns about effectiveness (18%) or safety for the baby (16%). A similar proportion of women cited safety concerns for not getting the Tdap (17%).

Sharing information early and engaging respectfully with patients are key to successful provider recommendations, Dr Schuchat said.

“It’s really important for clinicians to begin by listening to women, asking, ‘Can I answer your questions? What are the concerns that you have?’ ” she said. “We find that, when a clinician validates a patient’s concerns and really shows that they’re listening, they can build trust and respect.”

Providers’ sharing their personal experience can help as well, Dr Schuchat added. Clinicians can let patients know if they themselves, or their partner, received the vaccines during pregnancy.

Rates for turning down vaccines were higher for black women: 47% received the flu vaccine after a recommendation, compared with 69% of white women. Among those receiving a Tdap recommendation, 53% of black women accepted it, compared with 77% of white women and 66% of Latina women. The authors noted a past study showing black adults had a higher distrust of flu vaccination, their doctor, and CDC information than white adults.

“Differential effects of provider vaccination offers or referrals might also be explained by less patient-centered provider communication with black patients,” Ms. Lindley and associates wrote.

SOURCE: Lindley MC. MMWR Morb Mortal Wkly Rep. 2019 Oct 8. doi: 10.15585/mmwr.mm6840e1.

A little over half of pregnant women get the Tdap vaccine during pregnancy or the influenza vaccine before or during pregnancy, but only 35% get both, according to a Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention.

AvailableLight/istockphoto.com

The CDC recommends that all pregnant women receive the Tdap vaccine, preferably between 27 and 36 weeks’ gestation. The flu vaccine is recommended for all women at any point in pregnancy if the pregnancy falls within flu season. Women do not need a second flu shot if they received the vaccine before pregnancy in the same influenza season. Both vaccines provide protection to infants after birth.

“Clinicians caring for women who are pregnant have a huge role in helping women understand risks and benefits and the value of vaccines,” Anne Schuchat, MD, principal deputy director of the CDC, Atlanta, said in a telebriefing about the new report. “A lot of women are worried about taking any extra medicine or getting shots during pregnancy, and clinicians can let them know about the large data available showing the safety of the vaccine as well as the effectiveness. We also think it’s important to let people know about the risk of not vaccinating.”

Pregnant women are at higher risk for influenza complications and represent a disproportionate number of flu-related hospitalizations. From the 2010-2011 to 2017-2018 influenza seasons, 24%-34% of influenza hospitalizations each season were pregnant women aged 15-44, yet only 9% of women in this age group are pregnant at any point each year, according to the report.

Similarly, infants under 6 months have the greatest risk of hospitalization from influenza, and half of pertussis hospitalizations and 69% of pertussis deaths occur in infants under 2 months old. But a fetus receives protective maternal antibodies from flu and pertussis vaccines about 2 weeks after the mother is vaccinated.

Influenza hospitalization is 40% lower among pregnant women vaccinated against flu and 72% lower in infants under 6 months who received maternal influenza antibodies during gestation. Similarly, Tdap vaccination during the third trimester of pregnancy reduces pertussis infection risk by 78% and pertussis hospitalization by 91% in infants under 2 months.

“Infant protection can motivate pregnant women to receive recommended vaccines, and intention to vaccinate is higher among women who perceive more serious consequences of influenza or pertussis disease for their own or their infant’s health,” Megan C. Lindley, MPH, of the CDC’s Immunization Services Division, and colleagues wrote in the MMWR report.

In March-April 2019, Ms. Lindley and associates conducted an Internet survey about flu and Tdap immunizations among women aged 18-49 who had been pregnant at any point since August 1, 2018. A total of 2,626 women completed the survey of 2,762 invitations (95% response rate).

Among 817 women who knew their Tdap status during pregnancy, 55% received the Tdap vaccine. Among 2,097 women who reported a pregnancy between October 2018 and January 2019, 54% received the flu vaccine before or during pregnancy.

But many women received one vaccine without the other: 65% of women surveyed had not received both vaccines during pregnancy. Higher immunization rates occurred among women whose clinicians recommended the vaccines: 66% received a flu shot and 71% received Tdap.

“We’re learning a lot about improved communication between clinicians and patients. One thing we suggest is to begin the conversations early.” Dr Schuchat said. “If you begin talking early in the pregnancy about the things you’ll be looking forward to and provide information, by the time it is flu season or it is that third trimester, they’re prepared to make a good choice.”

Most women surveyed (75%) said their providers did offer a flu or Tdap vaccine in the office or a referral for one. Yet more than 30% of these women did not get the recommended vaccine.

The most common reason for not getting the Tdap during pregnancy, cited by 38% of women who didn’t receive it, was not knowing about the recommendation. Those who did not receive flu vaccination, however, cited concerns about effectiveness (18%) or safety for the baby (16%). A similar proportion of women cited safety concerns for not getting the Tdap (17%).

Sharing information early and engaging respectfully with patients are key to successful provider recommendations, Dr Schuchat said.

“It’s really important for clinicians to begin by listening to women, asking, ‘Can I answer your questions? What are the concerns that you have?’ ” she said. “We find that, when a clinician validates a patient’s concerns and really shows that they’re listening, they can build trust and respect.”

Providers’ sharing their personal experience can help as well, Dr Schuchat added. Clinicians can let patients know if they themselves, or their partner, received the vaccines during pregnancy.

Rates for turning down vaccines were higher for black women: 47% received the flu vaccine after a recommendation, compared with 69% of white women. Among those receiving a Tdap recommendation, 53% of black women accepted it, compared with 77% of white women and 66% of Latina women. The authors noted a past study showing black adults had a higher distrust of flu vaccination, their doctor, and CDC information than white adults.

“Differential effects of provider vaccination offers or referrals might also be explained by less patient-centered provider communication with black patients,” Ms. Lindley and associates wrote.

SOURCE: Lindley MC. MMWR Morb Mortal Wkly Rep. 2019 Oct 8. doi: 10.15585/mmwr.mm6840e1.

A little over half of pregnant women get the Tdap vaccine during pregnancy or the influenza vaccine before or during pregnancy, but only 35% get both, according to a Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention.

AvailableLight/istockphoto.com

The CDC recommends that all pregnant women receive the Tdap vaccine, preferably between 27 and 36 weeks’ gestation. The flu vaccine is recommended for all women at any point in pregnancy if the pregnancy falls within flu season. Women do not need a second flu shot if they received the vaccine before pregnancy in the same influenza season. Both vaccines provide protection to infants after birth.

“Clinicians caring for women who are pregnant have a huge role in helping women understand risks and benefits and the value of vaccines,” Anne Schuchat, MD, principal deputy director of the CDC, Atlanta, said in a telebriefing about the new report. “A lot of women are worried about taking any extra medicine or getting shots during pregnancy, and clinicians can let them know about the large data available showing the safety of the vaccine as well as the effectiveness. We also think it’s important to let people know about the risk of not vaccinating.”

Pregnant women are at higher risk for influenza complications and represent a disproportionate number of flu-related hospitalizations. From the 2010-2011 to 2017-2018 influenza seasons, 24%-34% of influenza hospitalizations each season were pregnant women aged 15-44, yet only 9% of women in this age group are pregnant at any point each year, according to the report.

Similarly, infants under 6 months have the greatest risk of hospitalization from influenza, and half of pertussis hospitalizations and 69% of pertussis deaths occur in infants under 2 months old. But a fetus receives protective maternal antibodies from flu and pertussis vaccines about 2 weeks after the mother is vaccinated.

Influenza hospitalization is 40% lower among pregnant women vaccinated against flu and 72% lower in infants under 6 months who received maternal influenza antibodies during gestation. Similarly, Tdap vaccination during the third trimester of pregnancy reduces pertussis infection risk by 78% and pertussis hospitalization by 91% in infants under 2 months.

“Infant protection can motivate pregnant women to receive recommended vaccines, and intention to vaccinate is higher among women who perceive more serious consequences of influenza or pertussis disease for their own or their infant’s health,” Megan C. Lindley, MPH, of the CDC’s Immunization Services Division, and colleagues wrote in the MMWR report.

In March-April 2019, Ms. Lindley and associates conducted an Internet survey about flu and Tdap immunizations among women aged 18-49 who had been pregnant at any point since August 1, 2018. A total of 2,626 women completed the survey of 2,762 invitations (95% response rate).

Among 817 women who knew their Tdap status during pregnancy, 55% received the Tdap vaccine. Among 2,097 women who reported a pregnancy between October 2018 and January 2019, 54% received the flu vaccine before or during pregnancy.

But many women received one vaccine without the other: 65% of women surveyed had not received both vaccines during pregnancy. Higher immunization rates occurred among women whose clinicians recommended the vaccines: 66% received a flu shot and 71% received Tdap.

“We’re learning a lot about improved communication between clinicians and patients. One thing we suggest is to begin the conversations early.” Dr Schuchat said. “If you begin talking early in the pregnancy about the things you’ll be looking forward to and provide information, by the time it is flu season or it is that third trimester, they’re prepared to make a good choice.”

Most women surveyed (75%) said their providers did offer a flu or Tdap vaccine in the office or a referral for one. Yet more than 30% of these women did not get the recommended vaccine.

The most common reason for not getting the Tdap during pregnancy, cited by 38% of women who didn’t receive it, was not knowing about the recommendation. Those who did not receive flu vaccination, however, cited concerns about effectiveness (18%) or safety for the baby (16%). A similar proportion of women cited safety concerns for not getting the Tdap (17%).

Sharing information early and engaging respectfully with patients are key to successful provider recommendations, Dr Schuchat said.

“It’s really important for clinicians to begin by listening to women, asking, ‘Can I answer your questions? What are the concerns that you have?’ ” she said. “We find that, when a clinician validates a patient’s concerns and really shows that they’re listening, they can build trust and respect.”

Providers’ sharing their personal experience can help as well, Dr Schuchat added. Clinicians can let patients know if they themselves, or their partner, received the vaccines during pregnancy.

Rates for turning down vaccines were higher for black women: 47% received the flu vaccine after a recommendation, compared with 69% of white women. Among those receiving a Tdap recommendation, 53% of black women accepted it, compared with 77% of white women and 66% of Latina women. The authors noted a past study showing black adults had a higher distrust of flu vaccination, their doctor, and CDC information than white adults.

“Differential effects of provider vaccination offers or referrals might also be explained by less patient-centered provider communication with black patients,” Ms. Lindley and associates wrote.

SOURCE: Lindley MC. MMWR Morb Mortal Wkly Rep. 2019 Oct 8. doi: 10.15585/mmwr.mm6840e1.

Pregnant women taking oral corticosteroids for rheumatoid arthritis may be at increased risk of preterm birth, according to research published online Sept. 30 in Rheumatology.

Antonio_Diaz/Thinkstock

A study of 528 pregnant women with rheumatoid arthritis enrolled in the MotherToBaby Pregnancy Studies found that those taking a daily dose of 10 mg or more of prednisone equivalent – representing a mean cumulative dose of 2,208.6 mg over the first 139 days of pregnancy – had 4.77-fold higher odds of preterm birth, compared with those not taking oral corticosteroids. Women on medium doses – with a mean cumulative dose of 883 mg – had 81% higher odds of preterm birth, while those on low cumulative doses of 264.9 mg showed a nonsignificant 38% increase in preterm birth risk.

Women who did not use oral corticosteroids before day 140 of pregnancy had a 2.2% risk of early preterm birth. Among women with low use of oral corticosteroids, the risk was 3.4%, among those with medium use the risk was 3.3%, but among those with high use the risk was 26.7%.

After day 140 of gestation, there was a nonsignificant 64% increase in the risk for preterm birth with any use of oral corticosteroids, compared with no use. But among women taking 10 mg or more of prednisone equivalent per day, the risk was 2.45-fold higher, whereas those taking under 10 mg showed no significant increase in risk.

“Systemic corticosteroid use has been associated with serious infection in pregnant women and serious and nonserious infection in individuals with autoimmune diseases, independent of other immunosuppressive medications, especially for doses of 10 mg of prednisone equivalent per day and greater,” wrote Kristin Palmsten, ScD, a research investigator with HealthPartners Institute in Minneapolis, Minn., and coauthors.

Given that intrauterine infection is believed to contribute to preterm birth, some have suggested that the immunosuppressive effects of oral corticosteroids could be associated with an increased risk of preterm birth because of subclinical intra-amniotic infection, they wrote.

However, they noted that there was a lack of information on the effect of dose and timing of oral corticosteroids during pregnancy on the risk of preterm birth.

The authors acknowledged that dosage of oral corticosteroids during pregnancy was linked to disease activity, which was itself associated with preterm birth risk. They adjusted for self-assessed rheumatoid arthritis severity at enrollment, which was generally during the first trimester, and found that this did attenuate the association with preterm birth.

“Ideally, we would have measures of disease severity at the time of every medication start, stop, or dose change to account for time-varying confounding later in pregnancy,” they wrote.

The study did not find any effect of biologic or nonbiologic disease-modifying antirheumatic drugs, either before or after the first 140 days of gestation.

The authors also looked at pregnancy outcomes among women with inflammatory bowel disease and asthma who were taking corticosteroids for those conditions.

While noting that these estimates were “imprecise,” they did see the suggestion of an increase in preterm birth among women taking oral corticosteroids for asthma, especially when used in the first half of pregnancy. There was also a suggestion of increased preterm birth risk associated with high oral corticosteroid use for inflammatory bowel disease, but these estimates were unadjusted, they noted.

“Overall, IBD and asthma exploratory analyses align with the direction of the associations in the RA analysis despite limitations of precision and inability to adjust for IBD severity,” they wrote.

The conclusions to be drawn from the study are limited by its small size, the investigators noted, as well as a lack of information on the type of rheumatoid arthritis and longitudinal disease severity. They added that while the hypothesized mechanism of action linking oral corticosteroid use to preterm birth was subclinical intrauterine infection, they did not have access to placental pathology to confirm this.

The study was supported by the National Institutes of Health, and the MotherToBaby Pregnancy Studies are supported by research grants from a number of pharmaceutical companies. No other conflicts of interest were declared.

SOURCE: Palmsten K et al. Rheumatology 2019 Sep 30. doi: 10.1093/rheumatology/kez405.

Pregnant women taking oral corticosteroids for rheumatoid arthritis may be at increased risk of preterm birth, according to research published online Sept. 30 in Rheumatology.

Antonio_Diaz/Thinkstock

A study of 528 pregnant women with rheumatoid arthritis enrolled in the MotherToBaby Pregnancy Studies found that those taking a daily dose of 10 mg or more of prednisone equivalent – representing a mean cumulative dose of 2,208.6 mg over the first 139 days of pregnancy – had 4.77-fold higher odds of preterm birth, compared with those not taking oral corticosteroids. Women on medium doses – with a mean cumulative dose of 883 mg – had 81% higher odds of preterm birth, while those on low cumulative doses of 264.9 mg showed a nonsignificant 38% increase in preterm birth risk.

Women who did not use oral corticosteroids before day 140 of pregnancy had a 2.2% risk of early preterm birth. Among women with low use of oral corticosteroids, the risk was 3.4%, among those with medium use the risk was 3.3%, but among those with high use the risk was 26.7%.

After day 140 of gestation, there was a nonsignificant 64% increase in the risk for preterm birth with any use of oral corticosteroids, compared with no use. But among women taking 10 mg or more of prednisone equivalent per day, the risk was 2.45-fold higher, whereas those taking under 10 mg showed no significant increase in risk.

“Systemic corticosteroid use has been associated with serious infection in pregnant women and serious and nonserious infection in individuals with autoimmune diseases, independent of other immunosuppressive medications, especially for doses of 10 mg of prednisone equivalent per day and greater,” wrote Kristin Palmsten, ScD, a research investigator with HealthPartners Institute in Minneapolis, Minn., and coauthors.

Given that intrauterine infection is believed to contribute to preterm birth, some have suggested that the immunosuppressive effects of oral corticosteroids could be associated with an increased risk of preterm birth because of subclinical intra-amniotic infection, they wrote.

However, they noted that there was a lack of information on the effect of dose and timing of oral corticosteroids during pregnancy on the risk of preterm birth.

The authors acknowledged that dosage of oral corticosteroids during pregnancy was linked to disease activity, which was itself associated with preterm birth risk. They adjusted for self-assessed rheumatoid arthritis severity at enrollment, which was generally during the first trimester, and found that this did attenuate the association with preterm birth.

“Ideally, we would have measures of disease severity at the time of every medication start, stop, or dose change to account for time-varying confounding later in pregnancy,” they wrote.

The study did not find any effect of biologic or nonbiologic disease-modifying antirheumatic drugs, either before or after the first 140 days of gestation.

The authors also looked at pregnancy outcomes among women with inflammatory bowel disease and asthma who were taking corticosteroids for those conditions.

While noting that these estimates were “imprecise,” they did see the suggestion of an increase in preterm birth among women taking oral corticosteroids for asthma, especially when used in the first half of pregnancy. There was also a suggestion of increased preterm birth risk associated with high oral corticosteroid use for inflammatory bowel disease, but these estimates were unadjusted, they noted.

“Overall, IBD and asthma exploratory analyses align with the direction of the associations in the RA analysis despite limitations of precision and inability to adjust for IBD severity,” they wrote.

The conclusions to be drawn from the study are limited by its small size, the investigators noted, as well as a lack of information on the type of rheumatoid arthritis and longitudinal disease severity. They added that while the hypothesized mechanism of action linking oral corticosteroid use to preterm birth was subclinical intrauterine infection, they did not have access to placental pathology to confirm this.

The study was supported by the National Institutes of Health, and the MotherToBaby Pregnancy Studies are supported by research grants from a number of pharmaceutical companies. No other conflicts of interest were declared.

SOURCE: Palmsten K et al. Rheumatology 2019 Sep 30. doi: 10.1093/rheumatology/kez405.

Pregnant women taking oral corticosteroids for rheumatoid arthritis may be at increased risk of preterm birth, according to research published online Sept. 30 in Rheumatology.

Antonio_Diaz/Thinkstock

A study of 528 pregnant women with rheumatoid arthritis enrolled in the MotherToBaby Pregnancy Studies found that those taking a daily dose of 10 mg or more of prednisone equivalent – representing a mean cumulative dose of 2,208.6 mg over the first 139 days of pregnancy – had 4.77-fold higher odds of preterm birth, compared with those not taking oral corticosteroids. Women on medium doses – with a mean cumulative dose of 883 mg – had 81% higher odds of preterm birth, while those on low cumulative doses of 264.9 mg showed a nonsignificant 38% increase in preterm birth risk.

Women who did not use oral corticosteroids before day 140 of pregnancy had a 2.2% risk of early preterm birth. Among women with low use of oral corticosteroids, the risk was 3.4%, among those with medium use the risk was 3.3%, but among those with high use the risk was 26.7%.

After day 140 of gestation, there was a nonsignificant 64% increase in the risk for preterm birth with any use of oral corticosteroids, compared with no use. But among women taking 10 mg or more of prednisone equivalent per day, the risk was 2.45-fold higher, whereas those taking under 10 mg showed no significant increase in risk.

“Systemic corticosteroid use has been associated with serious infection in pregnant women and serious and nonserious infection in individuals with autoimmune diseases, independent of other immunosuppressive medications, especially for doses of 10 mg of prednisone equivalent per day and greater,” wrote Kristin Palmsten, ScD, a research investigator with HealthPartners Institute in Minneapolis, Minn., and coauthors.

Given that intrauterine infection is believed to contribute to preterm birth, some have suggested that the immunosuppressive effects of oral corticosteroids could be associated with an increased risk of preterm birth because of subclinical intra-amniotic infection, they wrote.

However, they noted that there was a lack of information on the effect of dose and timing of oral corticosteroids during pregnancy on the risk of preterm birth.

The authors acknowledged that dosage of oral corticosteroids during pregnancy was linked to disease activity, which was itself associated with preterm birth risk. They adjusted for self-assessed rheumatoid arthritis severity at enrollment, which was generally during the first trimester, and found that this did attenuate the association with preterm birth.

“Ideally, we would have measures of disease severity at the time of every medication start, stop, or dose change to account for time-varying confounding later in pregnancy,” they wrote.

The study did not find any effect of biologic or nonbiologic disease-modifying antirheumatic drugs, either before or after the first 140 days of gestation.

The authors also looked at pregnancy outcomes among women with inflammatory bowel disease and asthma who were taking corticosteroids for those conditions.

While noting that these estimates were “imprecise,” they did see the suggestion of an increase in preterm birth among women taking oral corticosteroids for asthma, especially when used in the first half of pregnancy. There was also a suggestion of increased preterm birth risk associated with high oral corticosteroid use for inflammatory bowel disease, but these estimates were unadjusted, they noted.

“Overall, IBD and asthma exploratory analyses align with the direction of the associations in the RA analysis despite limitations of precision and inability to adjust for IBD severity,” they wrote.

The conclusions to be drawn from the study are limited by its small size, the investigators noted, as well as a lack of information on the type of rheumatoid arthritis and longitudinal disease severity. They added that while the hypothesized mechanism of action linking oral corticosteroid use to preterm birth was subclinical intrauterine infection, they did not have access to placental pathology to confirm this.

The study was supported by the National Institutes of Health, and the MotherToBaby Pregnancy Studies are supported by research grants from a number of pharmaceutical companies. No other conflicts of interest were declared.

SOURCE: Palmsten K et al. Rheumatology 2019 Sep 30. doi: 10.1093/rheumatology/kez405.

The recent drop in U.S. twin birthrates after more than three decades of increases was not distributed evenly among demographic groups, according to the National Center for Health Statistics.

The twin birthrate, which had increased by 79% during 1980-2014, fell by 4% during 2014-2018, but that decline was “not universal across maternal age and race and Hispanic-origin groups,” the NCHS investigators said.

Twin birthrates fell by at least 10% for mothers aged 30 years and older from 2014 to 2018 but held steady for women in their twenties. Over that same period, the twin birthrate fell by a significant 7% among non-Hispanic white women (36.7 to 34.3 per 1,000 total births) but increased just slightly for non-Hispanic black women (40.0 to 40.5 per 1,000) and Hispanic women (24.1 to 24.4), the investigators reported.

For women 30 years and older, the drops in twin births got larger as age increased and were significant for each age group. The rate for women aged 30-34 years fell 10% as it went from 40.3 per 1,000 total births in 2014 to 36.2 per 1,000. The decrease was 12% (from 48.6 per 1,000 to 42.8) for women aged 35-39 and 23% (from 66.0 to 51.1) for those aged 40 years and older, they said based on data from the National Vital Statistics System.

The rates were basically unchanged for women in their 20s, from 23.0 to 23.2 in 20- to 24-year-olds and 30.5 to 30.4 in 25- to 29-year-olds – but there was a significant increase for the youngest group with rates among those younger than 20 years going from 16.0 to 17.1 per 1,000, the report showed.

[email protected]

The recent drop in U.S. twin birthrates after more than three decades of increases was not distributed evenly among demographic groups, according to the National Center for Health Statistics.

The twin birthrate, which had increased by 79% during 1980-2014, fell by 4% during 2014-2018, but that decline was “not universal across maternal age and race and Hispanic-origin groups,” the NCHS investigators said.

Twin birthrates fell by at least 10% for mothers aged 30 years and older from 2014 to 2018 but held steady for women in their twenties. Over that same period, the twin birthrate fell by a significant 7% among non-Hispanic white women (36.7 to 34.3 per 1,000 total births) but increased just slightly for non-Hispanic black women (40.0 to 40.5 per 1,000) and Hispanic women (24.1 to 24.4), the investigators reported.

For women 30 years and older, the drops in twin births got larger as age increased and were significant for each age group. The rate for women aged 30-34 years fell 10% as it went from 40.3 per 1,000 total births in 2014 to 36.2 per 1,000. The decrease was 12% (from 48.6 per 1,000 to 42.8) for women aged 35-39 and 23% (from 66.0 to 51.1) for those aged 40 years and older, they said based on data from the National Vital Statistics System.

The rates were basically unchanged for women in their 20s, from 23.0 to 23.2 in 20- to 24-year-olds and 30.5 to 30.4 in 25- to 29-year-olds – but there was a significant increase for the youngest group with rates among those younger than 20 years going from 16.0 to 17.1 per 1,000, the report showed.

[email protected]

The recent drop in U.S. twin birthrates after more than three decades of increases was not distributed evenly among demographic groups, according to the National Center for Health Statistics.

The twin birthrate, which had increased by 79% during 1980-2014, fell by 4% during 2014-2018, but that decline was “not universal across maternal age and race and Hispanic-origin groups,” the NCHS investigators said.

Twin birthrates fell by at least 10% for mothers aged 30 years and older from 2014 to 2018 but held steady for women in their twenties. Over that same period, the twin birthrate fell by a significant 7% among non-Hispanic white women (36.7 to 34.3 per 1,000 total births) but increased just slightly for non-Hispanic black women (40.0 to 40.5 per 1,000) and Hispanic women (24.1 to 24.4), the investigators reported.

For women 30 years and older, the drops in twin births got larger as age increased and were significant for each age group. The rate for women aged 30-34 years fell 10% as it went from 40.3 per 1,000 total births in 2014 to 36.2 per 1,000. The decrease was 12% (from 48.6 per 1,000 to 42.8) for women aged 35-39 and 23% (from 66.0 to 51.1) for those aged 40 years and older, they said based on data from the National Vital Statistics System.

The rates were basically unchanged for women in their 20s, from 23.0 to 23.2 in 20- to 24-year-olds and 30.5 to 30.4 in 25- to 29-year-olds – but there was a significant increase for the youngest group with rates among those younger than 20 years going from 16.0 to 17.1 per 1,000, the report showed.

[email protected]

Sleeping supine during late pregnancy was independently associated with lower birth weight, but the number of women in this subgroup was small in the study.

Data from previous studies suggest that impaired uteroplacental flow can affect fetal growth, wrote Ngaire H. Anderson, PhD, of the University of Auckland, N.Z., and colleagues.

“The initial going-to-sleep position is the sleep position that women maintain for the longest duration throughout the night; therefore, going-to-sleep position is likely to have the greatest impact on blood flow to the developing fetus,” they said.

In a study published in JAMA Network Open, the researchers interviewed women with ongoing pregnancies at 28 weeks’ gestation or later to determine their sleeping positions. The mean age of the participants was 30 years. Of the 1,760 women, 3% reported that they usually slept supine during the past 1-4 weeks.

The adjusted mean birth weight was 3,410 g among supine sleepers and 3,554 g among nonsupine sleepers. The primary outcome was an adjusted mean difference in birth weight between infants of supine sleepers and nonsupine sleepers, which was a statistically significant 144 g (P = .009).

The study findings were limited by several factors including the small number of women who were reported supine sleepers, as well as the reliance on self-reports of sleep position, the researchers said.

However, women who had going-to-sleep data for the previous night and the previous month suggest that most women are consistent in their going-to-sleep position, they noted. “It is also biologically plausible that the association of decreased maternal blood flow on birth size with supine maternal position is cumulative over time,” but the researchers were not able to investigate how the duration of supine sleeping might further affect birth weight.

Although it might make additional studies more difficult, a public health campaign to encourage pregnant women to sleep on their side during the third trimester is a safe and easy opportunity to potentially optimize birth weight, they added.

The study was important because of the limited number of high-quality studies on the effects of maternal sleep on perinatal outcomes, Martina Badell, MD of Emory University in Atlanta said in an interview.

“The overall findings suggested a possible small increased risk of small-for-gestational-age babies with supine maternal sleeping, however, the absolute gram difference of 144 grams at term may not be clinically relevant,” she said. In addition, the relatively small number of women who reported supine sleep in late pregnancy suggests that broad public health campaigns or recommendations may not be indicated at this time.

“Also, the percentage of women who are supine sleepers at term is only approximately 3%, and this study didn’t assess reasons for supine sleeping in this small subset of women,” she said. “Further research is needed to assess whether there are specific maternal factors associated with supine sleeping, such as GI symptoms or respiratory difficulties, which could contribute to smaller fetal size rather than the sleep position itself.”

The study was supported by a Trans-Tasman Research Funding Grant by Cure Kids and Red Nose Australia. Six coauthors reported receiving numerous grants from a variety of organizations. Dr. Anderson and the remaining coauthors had no financial conflicts to disclose. Dr. Badell had no relevant financial disclosures.

SOURCE: Anderson NH et al. JAMA Network Open. 2019 Oct 2. doi: 10.1001/jamanetworkopen.2019.12614.

Sleeping supine during late pregnancy was independently associated with lower birth weight, but the number of women in this subgroup was small in the study.

Data from previous studies suggest that impaired uteroplacental flow can affect fetal growth, wrote Ngaire H. Anderson, PhD, of the University of Auckland, N.Z., and colleagues.

“The initial going-to-sleep position is the sleep position that women maintain for the longest duration throughout the night; therefore, going-to-sleep position is likely to have the greatest impact on blood flow to the developing fetus,” they said.

In a study published in JAMA Network Open, the researchers interviewed women with ongoing pregnancies at 28 weeks’ gestation or later to determine their sleeping positions. The mean age of the participants was 30 years. Of the 1,760 women, 3% reported that they usually slept supine during the past 1-4 weeks.

The adjusted mean birth weight was 3,410 g among supine sleepers and 3,554 g among nonsupine sleepers. The primary outcome was an adjusted mean difference in birth weight between infants of supine sleepers and nonsupine sleepers, which was a statistically significant 144 g (P = .009).

The study findings were limited by several factors including the small number of women who were reported supine sleepers, as well as the reliance on self-reports of sleep position, the researchers said.

However, women who had going-to-sleep data for the previous night and the previous month suggest that most women are consistent in their going-to-sleep position, they noted. “It is also biologically plausible that the association of decreased maternal blood flow on birth size with supine maternal position is cumulative over time,” but the researchers were not able to investigate how the duration of supine sleeping might further affect birth weight.

Although it might make additional studies more difficult, a public health campaign to encourage pregnant women to sleep on their side during the third trimester is a safe and easy opportunity to potentially optimize birth weight, they added.

The study was important because of the limited number of high-quality studies on the effects of maternal sleep on perinatal outcomes, Martina Badell, MD of Emory University in Atlanta said in an interview.

“The overall findings suggested a possible small increased risk of small-for-gestational-age babies with supine maternal sleeping, however, the absolute gram difference of 144 grams at term may not be clinically relevant,” she said. In addition, the relatively small number of women who reported supine sleep in late pregnancy suggests that broad public health campaigns or recommendations may not be indicated at this time.

“Also, the percentage of women who are supine sleepers at term is only approximately 3%, and this study didn’t assess reasons for supine sleeping in this small subset of women,” she said. “Further research is needed to assess whether there are specific maternal factors associated with supine sleeping, such as GI symptoms or respiratory difficulties, which could contribute to smaller fetal size rather than the sleep position itself.”

The study was supported by a Trans-Tasman Research Funding Grant by Cure Kids and Red Nose Australia. Six coauthors reported receiving numerous grants from a variety of organizations. Dr. Anderson and the remaining coauthors had no financial conflicts to disclose. Dr. Badell had no relevant financial disclosures.

SOURCE: Anderson NH et al. JAMA Network Open. 2019 Oct 2. doi: 10.1001/jamanetworkopen.2019.12614.

Sleeping supine during late pregnancy was independently associated with lower birth weight, but the number of women in this subgroup was small in the study.

Data from previous studies suggest that impaired uteroplacental flow can affect fetal growth, wrote Ngaire H. Anderson, PhD, of the University of Auckland, N.Z., and colleagues.

“The initial going-to-sleep position is the sleep position that women maintain for the longest duration throughout the night; therefore, going-to-sleep position is likely to have the greatest impact on blood flow to the developing fetus,” they said.

In a study published in JAMA Network Open, the researchers interviewed women with ongoing pregnancies at 28 weeks’ gestation or later to determine their sleeping positions. The mean age of the participants was 30 years. Of the 1,760 women, 3% reported that they usually slept supine during the past 1-4 weeks.

The adjusted mean birth weight was 3,410 g among supine sleepers and 3,554 g among nonsupine sleepers. The primary outcome was an adjusted mean difference in birth weight between infants of supine sleepers and nonsupine sleepers, which was a statistically significant 144 g (P = .009).

The study findings were limited by several factors including the small number of women who were reported supine sleepers, as well as the reliance on self-reports of sleep position, the researchers said.

However, women who had going-to-sleep data for the previous night and the previous month suggest that most women are consistent in their going-to-sleep position, they noted. “It is also biologically plausible that the association of decreased maternal blood flow on birth size with supine maternal position is cumulative over time,” but the researchers were not able to investigate how the duration of supine sleeping might further affect birth weight.

Although it might make additional studies more difficult, a public health campaign to encourage pregnant women to sleep on their side during the third trimester is a safe and easy opportunity to potentially optimize birth weight, they added.

The study was important because of the limited number of high-quality studies on the effects of maternal sleep on perinatal outcomes, Martina Badell, MD of Emory University in Atlanta said in an interview.

“The overall findings suggested a possible small increased risk of small-for-gestational-age babies with supine maternal sleeping, however, the absolute gram difference of 144 grams at term may not be clinically relevant,” she said. In addition, the relatively small number of women who reported supine sleep in late pregnancy suggests that broad public health campaigns or recommendations may not be indicated at this time.

“Also, the percentage of women who are supine sleepers at term is only approximately 3%, and this study didn’t assess reasons for supine sleeping in this small subset of women,” she said. “Further research is needed to assess whether there are specific maternal factors associated with supine sleeping, such as GI symptoms or respiratory difficulties, which could contribute to smaller fetal size rather than the sleep position itself.”

The study was supported by a Trans-Tasman Research Funding Grant by Cure Kids and Red Nose Australia. Six coauthors reported receiving numerous grants from a variety of organizations. Dr. Anderson and the remaining coauthors had no financial conflicts to disclose. Dr. Badell had no relevant financial disclosures.

SOURCE: Anderson NH et al. JAMA Network Open. 2019 Oct 2. doi: 10.1001/jamanetworkopen.2019.12614.

Physician burnout has been labeled a public health crisis by the Harvard School of Public Health and other institutions.¹ A 2018 Physician’s Foundation survey found that 78% of physicians had symptoms of burnout,² which result from chronic workplace stress and include feeling depleted of energy or exhausted, mentally distanced from or cynical about one’s job, and problems getting one’s job done successfully.³ Among ObGyns, almost half (46%) report burnout.⁴ One-third of ObGyns responded on a recent Medscape Burnout Report that the computerization of practice is contributing to their burnout, and 54% said too many bureaucratic tasks, including charting, were adding to their burnout.⁵

Inefficient electronic medical records (EMRs) have been implicated as one reason for burnout, with improvements in efficiency cited as one of several potential resolutions to the problem. About 96% of hospitals have adopted EMRs today, compared with only 9% in 2008,⁶ and many physicians report recognizing value in the technology. For instance, 60% of participants in Stanford Medicine’s 2018 National Physician Poll said EMRs had led to improved patient care. At the same time, however, about as many (59%) said EMRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54%) as well as from their clinical effectiveness (49%).⁷

With this roundtable, we explore the concerns with hours spent on the EMR with several experts, and whether it is a problem that has been contributing to burnout among staff at their institutions. In addition, are there solutions that their institutions have implemented that they can share to help to cope with the problem?
 

OBG Management: ObGyns report that the computerization of practice and too many bureaucratic tasks, including charting, are contributing to burnout. Do you see this problem at your institution?

John J. Dougherty, MD, MBA: Yes, absolutely. There is not a day that goes by that I don’t hear about or experience “Epic Fails.” (We use Epic’s EMR product at our institution.) Too many clicks are needed to navigate even the simplest tasks—finding notes or results, documenting visits, and billing for services are all unnecessarily complex. In addition, we are being held accountable for achieving a long and growing list of “metrics” measures, education projects (HealthStream), and productivity goals. When do we have time to treat patients? And it is not just practicing physicians and clinicians. Our resident physicians spend an inordinate amount of time in front of the computer documenting, placing orders, and transferring patients using a system with a very inefficient user interface, to say the least.

Megan L. Evans, MD, MPH: I absolutely agree. Over the years, my institution has created a conglomerate of EMRs, requiring physicians across the hospital to be fluent in a multitude of systems. For example, you finish your clinic notes in one system, sign off on discharge summaries in another, and complete your operative notes in an entirely different system. As busy attendings, it is hard to keep ahead of all of these tasks, especially when the systems do not talk to one another. Fortunately, my hospital is changing our EMR to a single system within the next year. Until then, however, we will work in this piecemeal system.

Mark Woodland, MS, MD: EMR and computerization of medicine is the number 1 issue relating to dissatisfaction by ObGyn providers in our institution. Providers are earnest in their attempt to be compliant with EMR requirements, but the reality is that they are dealing with an automated system that does not have realistic expectations for management of results, follow-up tasks, and patient communications for a human provider. The actual charting, ordering of tests and consults, and communication between providers has been enhanced. However, the “in-basket” of tasks to be accomplished are extraordinary and much of it relies on the provider, which requires an inordinate amount of time. Additionally, while other members of the medical staff are stationary at a desk, physicians and other providers are not. They are mobile between inpatient units, labor and delivery, operating rooms, and emergency rooms. Time management does not always allow for providers to access computers from all of these areas to facilitate their managing the expectations of the EMR. This requires providers to access the EMR at off hours, extending their workload. Finally, the EMR is neither personal nor friendly. It is not designed with the clinician in mind, and it is not fun or engaging for a provider.

Continue to: OBG Management: What solutions have been instituted...

OBG Management: What solutions have been instituted in order to help physicians with data entry into the EMR?

Dr. Dougherty: When our institution compared EMR offerings, EMR companies put their best collective marketing feet forward. The general notion, at least with the Epic EMR, was that “you can customize Epic to your liking.” It did not take long for a bunch of motivated Epic users to create “smart” stuff (lists, phrases, and texts) in an effort to customize workflows and create fancy-looking electronic notes. Shortly thereafter, it was obvious that, as an institution, our reporting efforts kept coming up short—our reports lacked accuracy and meaning. Everyone was documenting in different ways and in different areas. Considering that reports are currently generated using (mostly) discrete data entries (data placed in specific fields within the EMR), it became obvious that our data entry paradigm needed to change. Therefore, standardization became the leading buzzword. Our institution recently initiated a project aimed at standardizing our workflows and documentation habits. In addition, we have incorporated a third-party information exchange product into our health system data aggregation and analysis workflow. Much more needs to be done, but it is a start.

Dr. Evans: At my institution, as a group, we have created templates for routine procedures and visits that also auto populate billing codes. I know that some departments have used scribes. From the hospital side, there has been improved access to the EMR from home. Some of my colleagues like this feature; however, others, like myself, believe this contributes to some of our burnout. I like to leave work at work. Having the ability to continue working at home is not a solution in my mind.

Dr. Woodland: At our institution, we have engaged our chaperones and medical assistants to help facilitate completion of the medical records during the office visit. Providers work with their assistants to accommodate documentation of history and physical findings while also listening to the provider as they are speaking in order to document patient care plans and orders. This saves the clinicians time in reviewing and editing the record as well as making sure the appropriate care plan is instituted. Our EMR provider recently has begun experimenting with personalization of color themes as well as pictures as part of the interface. Having said this, I still ask, “Why have medical professionals allowed non–clinical agencies and information technology groups to run this show?” It is also inconceivable to me that this unfunded mandate—that has increased cost, decreased clinical efficiency, and decreased clinician satisfaction—has not been addressed by national and international medical communities.

OBG Management: What changes do you feel your EMR system needs to undergo?

Dr. Woodland: I feel that we need to appropriately manage expectations of the EMR and the institution with relation to EMR and providers. By this I mean that we need to make the EMR more user-friendly and appropriate for different clinicians as well as patients. We also need to manage expectations of our patients. In a digital age where immediate contact is the norm, we need to address the issue that the EMR is not social media but rather a communication tool for routine contact and information transmission. Emergencies are not typically addressed well through the EMR platform; they are better handled with a more appropriate communication interface.

Dr. Dougherty: I feel that the biggest change needed is a competent, simple, and standard user-interface. Our old charting methods were great on a number of levels. For instance, if I wanted to add an order, I flipped to the ”Orders” tab and entered an order. If I needed to document a note, I flipped to the “Notes” tab and started writing, etc. Obviously, manual charting had its downsides—like trying to decipher handwriting art! EMRs could easily adopt the stuff that worked from our old methods of documentation, while leveraging the advantages that computerized workflows can bring to practitioners, including efficient transfer of records, meaningful reporting, simple electronic ordering, and interprofessional communication portals.

Dr. Evans: Our systems need to better communicate with one another. I am in an academic practice, and I should be able to see labs, consultant notes, imaging, all in one spot to improve efficiency and ease with patient visits. Minimizing clicks would be helpful as well. I try to write as much as I can while in the room with a patient to avoid after-hours note writing, but it takes away from my interaction with each patient.

Continue to: OBG Management: With an aim toward alleviating burnout...

OBG Management: With an aim toward alleviating burnout, are there any tips you can offer your colleagues on interfacing with the EMR?

Dr. Evans: When I first started as a new attending, it would take me hours to finish my notes, partly because of the level of detail I would write in my history of present illness (HPI) and assessment and plan. One great piece of advice I received was to be satisfied with good notes, not perfect notes. I worked to consolidate my thoughts and use preconstructed phrases/paragraphs on common problems I saw. This saved time to focus on other aspects of my academic job.

Dr. Dougherty: We need to refocus on the patient first, and mold our systems to meet that priority. Much too often, we have our backs to the patients or spend too much time interfacing with our EMR systems, and our patients are not happy about it (as many surveys have demonstrated). More importantly, a renewed focus on patient care, not EMR care, would allow our practitioners to do what they signed up for—treating patients. In the meantime, I would suggest that practitioners stay away from EMR gimmicks and go back to old-style documentation practices (like those established by the Centers for Medicare and Medicaid Services in 1997 and 1998), and ask the IT folks to help with molding the EMR systems to meet your own standards, not the standards established by EMR companies. I am also very hopeful that the consumer will drive most of the health care-related data collection in the near future, thereby marginalizing the current generation of EMR systems.

Dr. Woodland: I would add that providers need to manage the EMR and not let the EMR manage them. Set up task reminders at point times to handle results and communications from the EMR and set up time in your schedule where you can facilitate meeting these tasks. When providers are out on vacation, make sure to have an out-of-office reminder built into their EMR so that patients and others know timing of potential responses. Try to make the EMR as enjoyable as possible and focus on the good points of the EMR, such as legibility, order verification, safety, and documentation.
 

OBG Management: Do you feel that the EMR has led to improved patient care?

Dr. Evans: Yes and no. Yes, in that it can be much easier to follow a patient’s health care history from other provider notes or prior surgeries. Information is searchable and legible. If an EMR is built correctly, it can save time for providers, through smart phrases and templates, and it can help providers with proper billing codes and documentation requirements. No, in that it can take away from important patient interaction. We are required to see more patients in less time all while using, at times, a cumbersome EMR system.

Dr. Woodland: This is a tricky question because the EMR has both positive and negative attributes. Certainly, the legibility and order verification has improved, but the ease of accessing information in the EMR has changed. Additionally, there has been a drastic increase in provider dissatisfaction that has not been addressed. Provider dissatisfaction can lead to problems in patient care. If there was a clear-cut increased value for the cost, I do not think the EMR would be such a huge focus of negative attention. Providers need to take back control of their EMR and their profession so that they can utilize the EMR as the tool it was supposed to be and not the dissatisfier that it has become.

Dr. Dougherty: I do not believe patient care has been improved by EMR systems, for all of the reasons we have discussed, and then some. But there is an enormous amount of potential, if we get the interface between humans and EMR systems right!

Physician burnout has been labeled a public health crisis by the Harvard School of Public Health and other institutions.¹ A 2018 Physician’s Foundation survey found that 78% of physicians had symptoms of burnout,² which result from chronic workplace stress and include feeling depleted of energy or exhausted, mentally distanced from or cynical about one’s job, and problems getting one’s job done successfully.³ Among ObGyns, almost half (46%) report burnout.⁴ One-third of ObGyns responded on a recent Medscape Burnout Report that the computerization of practice is contributing to their burnout, and 54% said too many bureaucratic tasks, including charting, were adding to their burnout.⁵

Inefficient electronic medical records (EMRs) have been implicated as one reason for burnout, with improvements in efficiency cited as one of several potential resolutions to the problem. About 96% of hospitals have adopted EMRs today, compared with only 9% in 2008,⁶ and many physicians report recognizing value in the technology. For instance, 60% of participants in Stanford Medicine’s 2018 National Physician Poll said EMRs had led to improved patient care. At the same time, however, about as many (59%) said EMRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54%) as well as from their clinical effectiveness (49%).⁷

With this roundtable, we explore the concerns with hours spent on the EMR with several experts, and whether it is a problem that has been contributing to burnout among staff at their institutions. In addition, are there solutions that their institutions have implemented that they can share to help to cope with the problem?
 

OBG Management: ObGyns report that the computerization of practice and too many bureaucratic tasks, including charting, are contributing to burnout. Do you see this problem at your institution?

John J. Dougherty, MD, MBA: Yes, absolutely. There is not a day that goes by that I don’t hear about or experience “Epic Fails.” (We use Epic’s EMR product at our institution.) Too many clicks are needed to navigate even the simplest tasks—finding notes or results, documenting visits, and billing for services are all unnecessarily complex. In addition, we are being held accountable for achieving a long and growing list of “metrics” measures, education projects (HealthStream), and productivity goals. When do we have time to treat patients? And it is not just practicing physicians and clinicians. Our resident physicians spend an inordinate amount of time in front of the computer documenting, placing orders, and transferring patients using a system with a very inefficient user interface, to say the least.

Megan L. Evans, MD, MPH: I absolutely agree. Over the years, my institution has created a conglomerate of EMRs, requiring physicians across the hospital to be fluent in a multitude of systems. For example, you finish your clinic notes in one system, sign off on discharge summaries in another, and complete your operative notes in an entirely different system. As busy attendings, it is hard to keep ahead of all of these tasks, especially when the systems do not talk to one another. Fortunately, my hospital is changing our EMR to a single system within the next year. Until then, however, we will work in this piecemeal system.

Mark Woodland, MS, MD: EMR and computerization of medicine is the number 1 issue relating to dissatisfaction by ObGyn providers in our institution. Providers are earnest in their attempt to be compliant with EMR requirements, but the reality is that they are dealing with an automated system that does not have realistic expectations for management of results, follow-up tasks, and patient communications for a human provider. The actual charting, ordering of tests and consults, and communication between providers has been enhanced. However, the “in-basket” of tasks to be accomplished are extraordinary and much of it relies on the provider, which requires an inordinate amount of time. Additionally, while other members of the medical staff are stationary at a desk, physicians and other providers are not. They are mobile between inpatient units, labor and delivery, operating rooms, and emergency rooms. Time management does not always allow for providers to access computers from all of these areas to facilitate their managing the expectations of the EMR. This requires providers to access the EMR at off hours, extending their workload. Finally, the EMR is neither personal nor friendly. It is not designed with the clinician in mind, and it is not fun or engaging for a provider.

Continue to: OBG Management: What solutions have been instituted...

OBG Management: What solutions have been instituted in order to help physicians with data entry into the EMR?

Dr. Dougherty: When our institution compared EMR offerings, EMR companies put their best collective marketing feet forward. The general notion, at least with the Epic EMR, was that “you can customize Epic to your liking.” It did not take long for a bunch of motivated Epic users to create “smart” stuff (lists, phrases, and texts) in an effort to customize workflows and create fancy-looking electronic notes. Shortly thereafter, it was obvious that, as an institution, our reporting efforts kept coming up short—our reports lacked accuracy and meaning. Everyone was documenting in different ways and in different areas. Considering that reports are currently generated using (mostly) discrete data entries (data placed in specific fields within the EMR), it became obvious that our data entry paradigm needed to change. Therefore, standardization became the leading buzzword. Our institution recently initiated a project aimed at standardizing our workflows and documentation habits. In addition, we have incorporated a third-party information exchange product into our health system data aggregation and analysis workflow. Much more needs to be done, but it is a start.

Dr. Evans: At my institution, as a group, we have created templates for routine procedures and visits that also auto populate billing codes. I know that some departments have used scribes. From the hospital side, there has been improved access to the EMR from home. Some of my colleagues like this feature; however, others, like myself, believe this contributes to some of our burnout. I like to leave work at work. Having the ability to continue working at home is not a solution in my mind.

Dr. Woodland: At our institution, we have engaged our chaperones and medical assistants to help facilitate completion of the medical records during the office visit. Providers work with their assistants to accommodate documentation of history and physical findings while also listening to the provider as they are speaking in order to document patient care plans and orders. This saves the clinicians time in reviewing and editing the record as well as making sure the appropriate care plan is instituted. Our EMR provider recently has begun experimenting with personalization of color themes as well as pictures as part of the interface. Having said this, I still ask, “Why have medical professionals allowed non–clinical agencies and information technology groups to run this show?” It is also inconceivable to me that this unfunded mandate—that has increased cost, decreased clinical efficiency, and decreased clinician satisfaction—has not been addressed by national and international medical communities.

OBG Management: What changes do you feel your EMR system needs to undergo?

Dr. Woodland: I feel that we need to appropriately manage expectations of the EMR and the institution with relation to EMR and providers. By this I mean that we need to make the EMR more user-friendly and appropriate for different clinicians as well as patients. We also need to manage expectations of our patients. In a digital age where immediate contact is the norm, we need to address the issue that the EMR is not social media but rather a communication tool for routine contact and information transmission. Emergencies are not typically addressed well through the EMR platform; they are better handled with a more appropriate communication interface.

Dr. Dougherty: I feel that the biggest change needed is a competent, simple, and standard user-interface. Our old charting methods were great on a number of levels. For instance, if I wanted to add an order, I flipped to the ”Orders” tab and entered an order. If I needed to document a note, I flipped to the “Notes” tab and started writing, etc. Obviously, manual charting had its downsides—like trying to decipher handwriting art! EMRs could easily adopt the stuff that worked from our old methods of documentation, while leveraging the advantages that computerized workflows can bring to practitioners, including efficient transfer of records, meaningful reporting, simple electronic ordering, and interprofessional communication portals.

Dr. Evans: Our systems need to better communicate with one another. I am in an academic practice, and I should be able to see labs, consultant notes, imaging, all in one spot to improve efficiency and ease with patient visits. Minimizing clicks would be helpful as well. I try to write as much as I can while in the room with a patient to avoid after-hours note writing, but it takes away from my interaction with each patient.

Continue to: OBG Management: With an aim toward alleviating burnout...

OBG Management: With an aim toward alleviating burnout, are there any tips you can offer your colleagues on interfacing with the EMR?

Dr. Evans: When I first started as a new attending, it would take me hours to finish my notes, partly because of the level of detail I would write in my history of present illness (HPI) and assessment and plan. One great piece of advice I received was to be satisfied with good notes, not perfect notes. I worked to consolidate my thoughts and use preconstructed phrases/paragraphs on common problems I saw. This saved time to focus on other aspects of my academic job.

Dr. Dougherty: We need to refocus on the patient first, and mold our systems to meet that priority. Much too often, we have our backs to the patients or spend too much time interfacing with our EMR systems, and our patients are not happy about it (as many surveys have demonstrated). More importantly, a renewed focus on patient care, not EMR care, would allow our practitioners to do what they signed up for—treating patients. In the meantime, I would suggest that practitioners stay away from EMR gimmicks and go back to old-style documentation practices (like those established by the Centers for Medicare and Medicaid Services in 1997 and 1998), and ask the IT folks to help with molding the EMR systems to meet your own standards, not the standards established by EMR companies. I am also very hopeful that the consumer will drive most of the health care-related data collection in the near future, thereby marginalizing the current generation of EMR systems.

Dr. Woodland: I would add that providers need to manage the EMR and not let the EMR manage them. Set up task reminders at point times to handle results and communications from the EMR and set up time in your schedule where you can facilitate meeting these tasks. When providers are out on vacation, make sure to have an out-of-office reminder built into their EMR so that patients and others know timing of potential responses. Try to make the EMR as enjoyable as possible and focus on the good points of the EMR, such as legibility, order verification, safety, and documentation.
 

OBG Management: Do you feel that the EMR has led to improved patient care?

Dr. Evans: Yes and no. Yes, in that it can be much easier to follow a patient’s health care history from other provider notes or prior surgeries. Information is searchable and legible. If an EMR is built correctly, it can save time for providers, through smart phrases and templates, and it can help providers with proper billing codes and documentation requirements. No, in that it can take away from important patient interaction. We are required to see more patients in less time all while using, at times, a cumbersome EMR system.

Dr. Woodland: This is a tricky question because the EMR has both positive and negative attributes. Certainly, the legibility and order verification has improved, but the ease of accessing information in the EMR has changed. Additionally, there has been a drastic increase in provider dissatisfaction that has not been addressed. Provider dissatisfaction can lead to problems in patient care. If there was a clear-cut increased value for the cost, I do not think the EMR would be such a huge focus of negative attention. Providers need to take back control of their EMR and their profession so that they can utilize the EMR as the tool it was supposed to be and not the dissatisfier that it has become.

Dr. Dougherty: I do not believe patient care has been improved by EMR systems, for all of the reasons we have discussed, and then some. But there is an enormous amount of potential, if we get the interface between humans and EMR systems right!

Physician burnout has been labeled a public health crisis by the Harvard School of Public Health and other institutions.¹ A 2018 Physician’s Foundation survey found that 78% of physicians had symptoms of burnout,² which result from chronic workplace stress and include feeling depleted of energy or exhausted, mentally distanced from or cynical about one’s job, and problems getting one’s job done successfully.³ Among ObGyns, almost half (46%) report burnout.⁴ One-third of ObGyns responded on a recent Medscape Burnout Report that the computerization of practice is contributing to their burnout, and 54% said too many bureaucratic tasks, including charting, were adding to their burnout.⁵

Inefficient electronic medical records (EMRs) have been implicated as one reason for burnout, with improvements in efficiency cited as one of several potential resolutions to the problem. About 96% of hospitals have adopted EMRs today, compared with only 9% in 2008,⁶ and many physicians report recognizing value in the technology. For instance, 60% of participants in Stanford Medicine’s 2018 National Physician Poll said EMRs had led to improved patient care. At the same time, however, about as many (59%) said EMRs needed a “complete overhaul” and that the systems had detracted from their professional satisfaction (54%) as well as from their clinical effectiveness (49%).⁷

With this roundtable, we explore the concerns with hours spent on the EMR with several experts, and whether it is a problem that has been contributing to burnout among staff at their institutions. In addition, are there solutions that their institutions have implemented that they can share to help to cope with the problem?
 

OBG Management: ObGyns report that the computerization of practice and too many bureaucratic tasks, including charting, are contributing to burnout. Do you see this problem at your institution?

John J. Dougherty, MD, MBA: Yes, absolutely. There is not a day that goes by that I don’t hear about or experience “Epic Fails.” (We use Epic’s EMR product at our institution.) Too many clicks are needed to navigate even the simplest tasks—finding notes or results, documenting visits, and billing for services are all unnecessarily complex. In addition, we are being held accountable for achieving a long and growing list of “metrics” measures, education projects (HealthStream), and productivity goals. When do we have time to treat patients? And it is not just practicing physicians and clinicians. Our resident physicians spend an inordinate amount of time in front of the computer documenting, placing orders, and transferring patients using a system with a very inefficient user interface, to say the least.

Megan L. Evans, MD, MPH: I absolutely agree. Over the years, my institution has created a conglomerate of EMRs, requiring physicians across the hospital to be fluent in a multitude of systems. For example, you finish your clinic notes in one system, sign off on discharge summaries in another, and complete your operative notes in an entirely different system. As busy attendings, it is hard to keep ahead of all of these tasks, especially when the systems do not talk to one another. Fortunately, my hospital is changing our EMR to a single system within the next year. Until then, however, we will work in this piecemeal system.

Mark Woodland, MS, MD: EMR and computerization of medicine is the number 1 issue relating to dissatisfaction by ObGyn providers in our institution. Providers are earnest in their attempt to be compliant with EMR requirements, but the reality is that they are dealing with an automated system that does not have realistic expectations for management of results, follow-up tasks, and patient communications for a human provider. The actual charting, ordering of tests and consults, and communication between providers has been enhanced. However, the “in-basket” of tasks to be accomplished are extraordinary and much of it relies on the provider, which requires an inordinate amount of time. Additionally, while other members of the medical staff are stationary at a desk, physicians and other providers are not. They are mobile between inpatient units, labor and delivery, operating rooms, and emergency rooms. Time management does not always allow for providers to access computers from all of these areas to facilitate their managing the expectations of the EMR. This requires providers to access the EMR at off hours, extending their workload. Finally, the EMR is neither personal nor friendly. It is not designed with the clinician in mind, and it is not fun or engaging for a provider.

Continue to: OBG Management: What solutions have been instituted...

OBG Management: What solutions have been instituted in order to help physicians with data entry into the EMR?

Dr. Dougherty: When our institution compared EMR offerings, EMR companies put their best collective marketing feet forward. The general notion, at least with the Epic EMR, was that “you can customize Epic to your liking.” It did not take long for a bunch of motivated Epic users to create “smart” stuff (lists, phrases, and texts) in an effort to customize workflows and create fancy-looking electronic notes. Shortly thereafter, it was obvious that, as an institution, our reporting efforts kept coming up short—our reports lacked accuracy and meaning. Everyone was documenting in different ways and in different areas. Considering that reports are currently generated using (mostly) discrete data entries (data placed in specific fields within the EMR), it became obvious that our data entry paradigm needed to change. Therefore, standardization became the leading buzzword. Our institution recently initiated a project aimed at standardizing our workflows and documentation habits. In addition, we have incorporated a third-party information exchange product into our health system data aggregation and analysis workflow. Much more needs to be done, but it is a start.

Dr. Evans: At my institution, as a group, we have created templates for routine procedures and visits that also auto populate billing codes. I know that some departments have used scribes. From the hospital side, there has been improved access to the EMR from home. Some of my colleagues like this feature; however, others, like myself, believe this contributes to some of our burnout. I like to leave work at work. Having the ability to continue working at home is not a solution in my mind.

Dr. Woodland: At our institution, we have engaged our chaperones and medical assistants to help facilitate completion of the medical records during the office visit. Providers work with their assistants to accommodate documentation of history and physical findings while also listening to the provider as they are speaking in order to document patient care plans and orders. This saves the clinicians time in reviewing and editing the record as well as making sure the appropriate care plan is instituted. Our EMR provider recently has begun experimenting with personalization of color themes as well as pictures as part of the interface. Having said this, I still ask, “Why have medical professionals allowed non–clinical agencies and information technology groups to run this show?” It is also inconceivable to me that this unfunded mandate—that has increased cost, decreased clinical efficiency, and decreased clinician satisfaction—has not been addressed by national and international medical communities.

OBG Management: What changes do you feel your EMR system needs to undergo?

Dr. Woodland: I feel that we need to appropriately manage expectations of the EMR and the institution with relation to EMR and providers. By this I mean that we need to make the EMR more user-friendly and appropriate for different clinicians as well as patients. We also need to manage expectations of our patients. In a digital age where immediate contact is the norm, we need to address the issue that the EMR is not social media but rather a communication tool for routine contact and information transmission. Emergencies are not typically addressed well through the EMR platform; they are better handled with a more appropriate communication interface.

Dr. Dougherty: I feel that the biggest change needed is a competent, simple, and standard user-interface. Our old charting methods were great on a number of levels. For instance, if I wanted to add an order, I flipped to the ”Orders” tab and entered an order. If I needed to document a note, I flipped to the “Notes” tab and started writing, etc. Obviously, manual charting had its downsides—like trying to decipher handwriting art! EMRs could easily adopt the stuff that worked from our old methods of documentation, while leveraging the advantages that computerized workflows can bring to practitioners, including efficient transfer of records, meaningful reporting, simple electronic ordering, and interprofessional communication portals.

Dr. Evans: Our systems need to better communicate with one another. I am in an academic practice, and I should be able to see labs, consultant notes, imaging, all in one spot to improve efficiency and ease with patient visits. Minimizing clicks would be helpful as well. I try to write as much as I can while in the room with a patient to avoid after-hours note writing, but it takes away from my interaction with each patient.

Continue to: OBG Management: With an aim toward alleviating burnout...

OBG Management: With an aim toward alleviating burnout, are there any tips you can offer your colleagues on interfacing with the EMR?

Dr. Evans: When I first started as a new attending, it would take me hours to finish my notes, partly because of the level of detail I would write in my history of present illness (HPI) and assessment and plan. One great piece of advice I received was to be satisfied with good notes, not perfect notes. I worked to consolidate my thoughts and use preconstructed phrases/paragraphs on common problems I saw. This saved time to focus on other aspects of my academic job.

Dr. Dougherty: We need to refocus on the patient first, and mold our systems to meet that priority. Much too often, we have our backs to the patients or spend too much time interfacing with our EMR systems, and our patients are not happy about it (as many surveys have demonstrated). More importantly, a renewed focus on patient care, not EMR care, would allow our practitioners to do what they signed up for—treating patients. In the meantime, I would suggest that practitioners stay away from EMR gimmicks and go back to old-style documentation practices (like those established by the Centers for Medicare and Medicaid Services in 1997 and 1998), and ask the IT folks to help with molding the EMR systems to meet your own standards, not the standards established by EMR companies. I am also very hopeful that the consumer will drive most of the health care-related data collection in the near future, thereby marginalizing the current generation of EMR systems.

Dr. Woodland: I would add that providers need to manage the EMR and not let the EMR manage them. Set up task reminders at point times to handle results and communications from the EMR and set up time in your schedule where you can facilitate meeting these tasks. When providers are out on vacation, make sure to have an out-of-office reminder built into their EMR so that patients and others know timing of potential responses. Try to make the EMR as enjoyable as possible and focus on the good points of the EMR, such as legibility, order verification, safety, and documentation.
 

OBG Management: Do you feel that the EMR has led to improved patient care?

Dr. Evans: Yes and no. Yes, in that it can be much easier to follow a patient’s health care history from other provider notes or prior surgeries. Information is searchable and legible. If an EMR is built correctly, it can save time for providers, through smart phrases and templates, and it can help providers with proper billing codes and documentation requirements. No, in that it can take away from important patient interaction. We are required to see more patients in less time all while using, at times, a cumbersome EMR system.

Dr. Woodland: This is a tricky question because the EMR has both positive and negative attributes. Certainly, the legibility and order verification has improved, but the ease of accessing information in the EMR has changed. Additionally, there has been a drastic increase in provider dissatisfaction that has not been addressed. Provider dissatisfaction can lead to problems in patient care. If there was a clear-cut increased value for the cost, I do not think the EMR would be such a huge focus of negative attention. Providers need to take back control of their EMR and their profession so that they can utilize the EMR as the tool it was supposed to be and not the dissatisfier that it has become.

Dr. Dougherty: I do not believe patient care has been improved by EMR systems, for all of the reasons we have discussed, and then some. But there is an enormous amount of potential, if we get the interface between humans and EMR systems right!