Ob.Gyn. News

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

koakes@mdedge.com

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

koakes@mdedge.com

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

GRAPEVINE, TEX. – College education and high socioeconomic status do not erase U.S. racial disparities in birth outcomes, according to a new analysis of all U.S. live births from 2015-2017.

Very early preterm birth – birth before 28 weeks gestational age – was five times more likely to occur in non-Hispanic black women of high socioeconomic status as similarly situated white women, even after statistical adjustment for a host of potentially confounding factors.

Being of non-Hispanic black race was the single strongest predictor of preterm birth (PTB) at less than 28 weeks’ gestation. The adjusted odds ratio (aOR) of 4.99 surpassed an interpregnancy interval under 1 year (aOR, 4.47), chronic hypertension (aOR, 2.84), and prior history of preterm birth (aOR, 2.81).

koakes@mdedge.com

SOURCE: Johnson J et al. Obstet Gynecol. 2020 Jan;222(1):S-37-8, Abstract 44.

Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.

The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.

“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.

That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.

The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.

The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.

Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.

Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.

Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.

Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.

Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.

Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.

The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).

The next steps, according to report authors, will be to figure out how the symptom and function constructs align with typical primary endpoints of glioma clinical trials, such as time to recurrence or survival.

“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.

Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.

Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.

The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.

“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.

That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.

The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.

The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.

Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.

Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.

Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.

Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.

Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.

Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.

The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).

The next steps, according to report authors, will be to figure out how the symptom and function constructs align with typical primary endpoints of glioma clinical trials, such as time to recurrence or survival.

“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.

Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.

Glioma treatment goals traditionally have focused on tumor shrinkage or prolonging survival, but it’s time for those endpoints to be supplemented by clinical outcomes that are meaningful to the patient, according to a recently published report from a neuro-oncology working group.

The group, which includes representatives of previous oncology working groups, the Food and Drug Administration, and observers from the European Medicines Agency, has established a core set of symptoms and functional points that they say could be used in clinical trials and clinical care for patients with high-grade gliomas.

“Patients want to live longer, but they also want to continue to function as well as possible for as long as possible,” said Terri S. Armstrong, PhD, of the National Cancer Institute (NCI), and coauthors in a report that sums up the work to date of the Fast Track COA Group.

That work, while specific to gliomas, echoes results from broader initiatives that seek to standardize patient-reported outcomes in oncology trials, Dr. Armstrong and coauthors wrote. The report was published in the Lancet Oncology.

The core set of symptom constructs and functional issues identified by the work group are represented already in patient-reported outcome measures, according to the authors.

The symptoms worth measuring fall into five categories, including pain, difficulty communicating, perceived cognition, seizures, and symptomatic adverse events. The functional issues were divided into two categories, physical functioning, including weakness or walking, and role functioning, which they defined as the ability to work or participate in social or leisure activities.

Some of those outcomes can be challenging or cumbersome to track, Dr. Armstrong and coauthors said.

Pain has “many dimensions“ and is important to track, the group wrote. Likewise, patients’ concerns related to language function also are important, but are very “noisy“ as a variable and can be specific to tumor location.

Collecting data on seizure frequency and severity is important yet complicated, because of the variability in seizures and considerable difference between focal and generalized seizures. Assessment of cognitive functioning can be lengthy and burdensome to patients.

Adverse events of relevance will vary, depending on the drug used, its mechanism of action, and available data, though some allowance needs to be made for the possibility of “overlap“ with disease-related symptoms, the report said.

Physical functioning, including walking and weakness, should be evaluated. It also would be useful to distinguish the duration of time that patients have deficits in physical functioning in the later stages of their disease progression, authors said.

Role and social functioning should be assessed in most patients with high-grade gliomas, who will have symptoms and deficits that prevent returning to a job. “Patients might spend a substantial portion of their lives feeling ill, unable to do usual activities, or meet occupational, social, financial, and family obligations,” said Dr. Armstrong and coauthors in the report.

The scales and tools used to measure symptoms and functional concerns need to be those that best fit a particular clinical trial or clinical practice scenario. Several instruments that would be appropriate are discussed in the report, including the NCI Patient-Reported Outcome of the Common Toxicity Criteria Adverse Events (NCI PRO-CTCAE) and symptom and function scales or items in the Patient-Reported Outcomes Measurement System (PROMIS).

The next steps, according to report authors, will be to figure out how the symptom and function constructs align with typical primary endpoints of glioma clinical trials, such as time to recurrence or survival.

“Strategies for introducing these constructs to clinical trial cooperative groups and sponsors will be necessary,” they concluded.

Dr. Armstrong reported employment as a senior investigator and deputy chief of the neuro-oncology branch of the Center for Cancer Research at the NCI. His coauthors reported disclosures related to several companies and interests, including AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Taiho, and Tocagen.

SOURCE: Armstrong TS et al. Lancet Oncol. 2020;21(2):e97-103.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

aotto@mdedge.com

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

aotto@mdedge.com

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

The median highest pain score in a randomized trial of 38 women undergoing vulvar biopsies was 25.7 mm lower, on a 100 mm visual analogue scale, when they received 5% lidocaine-prilocaine cream instead of a 1% lidocaine injection, according to a report from Duke University, in Durham, N.C.

“In the current study, we found that application of lidocaine-prilocaine cream, alone, for a minimum of 10 minutes before vulvar biopsy on a non–hair-bearing surface results in a significantly lower maximum pain score and a significantly better patient rating of the biopsy experience,” said investigators led by Logan K. Williams, MD, of the department of obstetrics and gynecology at Duke University, Durham, N.C.

Given the “clear advantage” of the cream, it “should be considered as an anesthetic method for vulvar biopsy in a non-hair-bearing area,” Dr. Williams and colleagues concluded (Obstet Gynecol. 2020 Feb;135{2]:311-8).

Studies have pitted the cream against the injection before, but they did not compare patients’ maximal pain scores. The team wanted to do that because “comparing the highest score allows us to consider the possibility that the pain of anesthesia application” – injection versus cream – “may be greater than the pain of any other portion of the biopsy procedure.”

They randomized 19 women to the cream, approximately 5 g at the site of biopsy at least 10 minutes beforehand, and 18 others to the injection, 2 mL using a 27-gauge needle, at least 1 minute prior.

The median highest pain score in the lidocaine-prilocaine group was 20 mm, but 56.5 mm in the injection group. Patients randomized to lidocaine-prilocaine also had a significantly better (P = 0.02) experience than those receiving injected lidocaine, also assessed by visual analog scale (VAS). The median baseline pain level was 0 mm.

Anxiety was assessed after patients knew whether they were going to get the cream or the injection, but before the biopsy. The median score in the cream group was of 19 mm on another VAS, compared with 31.5 mm.

The team had planned to enroll 106 women, but given the results on interim analysis, they stopped the trial early.

Participants were 60 years old on average, and almost all had prior vulvar biopsies. Two in the cream group and three in the injection group had punch biopsies; cervical biopsy forceps were used for the rest. More than half the women had benign findings, and most of the others had vulvar intraepithelial neoplasia, but there was one invasive cancer. At Duke, the cost of the injection was $0.99, compared with $7.36 for the cream.

Dr. Williams and colleagues cited a few limitations. One is that the patients and clinicians in the study were not blinded. Another is that most of the patients had undergone vulvar biopsy before, possibly predisposing them to bias.

“In the future, consideration could be taken to studying lidocaine-prilocaine cream applications to hair-bearing surfaces, which were excluded in this study.” Also, “there is a question of the histologic effect of lidocaine-prilocaine on tissues and whether this could affect pathologic diagnoses.

“We are conducting a separate ancillary study in conjunction with our dermatopathology colleagues to investigate this question,” the investigators said.

The work was funded by Duke and the National Institutes of Health. Dr. Williams had no disclosures.

aotto@mdedge.com

SOURCE: Williams LK et al. Obstet Gynecol. 2020 Feb;135(2):311-8.

GRAPEVINE, TEX. – Blood pressure categories created by the American College of Cardiology (ACC) and American Heart Association (AHA) in 2017 identify patients with increased risk of preeclampsia, preterm birth, and perinatal death when applied to the first 20 weeks of pregnancy, according to a retrospective study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The absolute risk increases are small, and it is unknown whether treating these patients differently would be beneficial, said study author Martha Tesfalul, MD, maternal-fetal medicine clinical fellow at University of California, San Francisco. Nevertheless, the associations suggest that patients with hypertension during the first 20 weeks may benefit from additional monitoring and counseling, Dr. Tesfalul said.

Cutoffs with unclear implications

The ACC/AHA in November 2017 reclassified blood pressure in nonpregnant adults, but “implications of these categories in pregnancy are still unclear,” Dr. Tesfalul and colleagues said. Under the guidelines, normal blood pressure is systolic blood pressure less than 120 mm Hg and diastolic blood pressure less than 80 mm Hg. Elevated blood pressure is defined as systolic blood pressure between 120 and 129 mm Hg and diastolic blood pressure less than 80 mm Hg. Stage 1 hypertension is systolic blood pressure between 130 and 139 mm Hg or diastolic blood pressure between 80 and 89 mm Hg. And stage 2 hypertension is systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg.

For the present analysis, the researchers retrospectively compared obstetric and perinatal outcomes for approximately 6,000 pregnancies at an academic center for which they had at least one blood pressure measurement prior to 20 weeks. The highest measurement was used to identify women with normal blood pressure, elevated blood pressure, or stage 1 hypertension according to the 2017 thresholds.

The researchers included singleton pregnancies with delivery between January 2014 and October 2017. They excluded patients with a prior diagnosis of chronic hypertension, autoimmune or chronic renal disease, or fetal anomalies. They examined rates of gestational hypertension, preeclampsia, preterm birth, neonatal intensive care admission, and perinatal death.

Adjusted relative risks

Dr. Tesfalul and colleagues identified about 3,500 pregnancies with normal blood pressure, more than 1,300 pregnancies with elevated blood pressure, and nearly 1,100 pregnancies with stage 1 hypertension.

After adjusting for relevant covariates – maternal age, nulliparity, race, body mass index, in vitro fertilization, tobacco use, pregestational diabetes, and aspirin use – elevated blood pressure and stage 1 hypertension were associated with a higher risk of preeclampsia and severe preeclampsia, relative to normal blood pressure. The proportion of patients with preeclampsia was 5.7% in the normal blood pressure group, 11.7% in the elevated blood pressure group (adjusted relative risk, 1.8), and 15% in the stage 1 hypertension group (adjusted RR, 2.1). The proportion with preeclampsia with severe features was 3.1% in the normal blood pressure group, 5.7% in the elevated blood pressure group (adjusted RR, 1.6), and 6.8% in the stage 1 hypertension group (adjusted RR, 1.8).

In addition, stage 1 hypertension, compared with normal blood pressure, was associated with increased odds of preterm birth at less than 37 weeks (7.9% vs. 5.1%; adjusted RR, 1.4) and perinatal death (0.7% vs. 0.4%; adjusted RR, 2.8).

“Patients with elevated blood pressure and stage 1 hypertension prior to 20 weeks are at increased risk of adverse outcomes,” the authors concluded. “Further research [is] needed to determine optimal care of patients with elevated blood pressure and stage 1 hypertension in pregnancy.”

Dr. Tesfalul receives support from the Foundation for SMFM.

jremaly@mdedge.com

SOURCE: Tesfalul M et al. Am J Obstet Gynecol. 2020 Jan;222(1):S92-3, Abstract 119.

GRAPEVINE, TEX. – Blood pressure categories created by the American College of Cardiology (ACC) and American Heart Association (AHA) in 2017 identify patients with increased risk of preeclampsia, preterm birth, and perinatal death when applied to the first 20 weeks of pregnancy, according to a retrospective study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The absolute risk increases are small, and it is unknown whether treating these patients differently would be beneficial, said study author Martha Tesfalul, MD, maternal-fetal medicine clinical fellow at University of California, San Francisco. Nevertheless, the associations suggest that patients with hypertension during the first 20 weeks may benefit from additional monitoring and counseling, Dr. Tesfalul said.

Cutoffs with unclear implications

The ACC/AHA in November 2017 reclassified blood pressure in nonpregnant adults, but “implications of these categories in pregnancy are still unclear,” Dr. Tesfalul and colleagues said. Under the guidelines, normal blood pressure is systolic blood pressure less than 120 mm Hg and diastolic blood pressure less than 80 mm Hg. Elevated blood pressure is defined as systolic blood pressure between 120 and 129 mm Hg and diastolic blood pressure less than 80 mm Hg. Stage 1 hypertension is systolic blood pressure between 130 and 139 mm Hg or diastolic blood pressure between 80 and 89 mm Hg. And stage 2 hypertension is systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg.

For the present analysis, the researchers retrospectively compared obstetric and perinatal outcomes for approximately 6,000 pregnancies at an academic center for which they had at least one blood pressure measurement prior to 20 weeks. The highest measurement was used to identify women with normal blood pressure, elevated blood pressure, or stage 1 hypertension according to the 2017 thresholds.

The researchers included singleton pregnancies with delivery between January 2014 and October 2017. They excluded patients with a prior diagnosis of chronic hypertension, autoimmune or chronic renal disease, or fetal anomalies. They examined rates of gestational hypertension, preeclampsia, preterm birth, neonatal intensive care admission, and perinatal death.

Adjusted relative risks

Dr. Tesfalul and colleagues identified about 3,500 pregnancies with normal blood pressure, more than 1,300 pregnancies with elevated blood pressure, and nearly 1,100 pregnancies with stage 1 hypertension.

After adjusting for relevant covariates – maternal age, nulliparity, race, body mass index, in vitro fertilization, tobacco use, pregestational diabetes, and aspirin use – elevated blood pressure and stage 1 hypertension were associated with a higher risk of preeclampsia and severe preeclampsia, relative to normal blood pressure. The proportion of patients with preeclampsia was 5.7% in the normal blood pressure group, 11.7% in the elevated blood pressure group (adjusted relative risk, 1.8), and 15% in the stage 1 hypertension group (adjusted RR, 2.1). The proportion with preeclampsia with severe features was 3.1% in the normal blood pressure group, 5.7% in the elevated blood pressure group (adjusted RR, 1.6), and 6.8% in the stage 1 hypertension group (adjusted RR, 1.8).

In addition, stage 1 hypertension, compared with normal blood pressure, was associated with increased odds of preterm birth at less than 37 weeks (7.9% vs. 5.1%; adjusted RR, 1.4) and perinatal death (0.7% vs. 0.4%; adjusted RR, 2.8).

“Patients with elevated blood pressure and stage 1 hypertension prior to 20 weeks are at increased risk of adverse outcomes,” the authors concluded. “Further research [is] needed to determine optimal care of patients with elevated blood pressure and stage 1 hypertension in pregnancy.”

Dr. Tesfalul receives support from the Foundation for SMFM.

jremaly@mdedge.com

SOURCE: Tesfalul M et al. Am J Obstet Gynecol. 2020 Jan;222(1):S92-3, Abstract 119.

GRAPEVINE, TEX. – Blood pressure categories created by the American College of Cardiology (ACC) and American Heart Association (AHA) in 2017 identify patients with increased risk of preeclampsia, preterm birth, and perinatal death when applied to the first 20 weeks of pregnancy, according to a retrospective study presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

The absolute risk increases are small, and it is unknown whether treating these patients differently would be beneficial, said study author Martha Tesfalul, MD, maternal-fetal medicine clinical fellow at University of California, San Francisco. Nevertheless, the associations suggest that patients with hypertension during the first 20 weeks may benefit from additional monitoring and counseling, Dr. Tesfalul said.

Cutoffs with unclear implications

The ACC/AHA in November 2017 reclassified blood pressure in nonpregnant adults, but “implications of these categories in pregnancy are still unclear,” Dr. Tesfalul and colleagues said. Under the guidelines, normal blood pressure is systolic blood pressure less than 120 mm Hg and diastolic blood pressure less than 80 mm Hg. Elevated blood pressure is defined as systolic blood pressure between 120 and 129 mm Hg and diastolic blood pressure less than 80 mm Hg. Stage 1 hypertension is systolic blood pressure between 130 and 139 mm Hg or diastolic blood pressure between 80 and 89 mm Hg. And stage 2 hypertension is systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at least 90 mm Hg.

For the present analysis, the researchers retrospectively compared obstetric and perinatal outcomes for approximately 6,000 pregnancies at an academic center for which they had at least one blood pressure measurement prior to 20 weeks. The highest measurement was used to identify women with normal blood pressure, elevated blood pressure, or stage 1 hypertension according to the 2017 thresholds.

The researchers included singleton pregnancies with delivery between January 2014 and October 2017. They excluded patients with a prior diagnosis of chronic hypertension, autoimmune or chronic renal disease, or fetal anomalies. They examined rates of gestational hypertension, preeclampsia, preterm birth, neonatal intensive care admission, and perinatal death.

Adjusted relative risks

Dr. Tesfalul and colleagues identified about 3,500 pregnancies with normal blood pressure, more than 1,300 pregnancies with elevated blood pressure, and nearly 1,100 pregnancies with stage 1 hypertension.

After adjusting for relevant covariates – maternal age, nulliparity, race, body mass index, in vitro fertilization, tobacco use, pregestational diabetes, and aspirin use – elevated blood pressure and stage 1 hypertension were associated with a higher risk of preeclampsia and severe preeclampsia, relative to normal blood pressure. The proportion of patients with preeclampsia was 5.7% in the normal blood pressure group, 11.7% in the elevated blood pressure group (adjusted relative risk, 1.8), and 15% in the stage 1 hypertension group (adjusted RR, 2.1). The proportion with preeclampsia with severe features was 3.1% in the normal blood pressure group, 5.7% in the elevated blood pressure group (adjusted RR, 1.6), and 6.8% in the stage 1 hypertension group (adjusted RR, 1.8).

In addition, stage 1 hypertension, compared with normal blood pressure, was associated with increased odds of preterm birth at less than 37 weeks (7.9% vs. 5.1%; adjusted RR, 1.4) and perinatal death (0.7% vs. 0.4%; adjusted RR, 2.8).

“Patients with elevated blood pressure and stage 1 hypertension prior to 20 weeks are at increased risk of adverse outcomes,” the authors concluded. “Further research [is] needed to determine optimal care of patients with elevated blood pressure and stage 1 hypertension in pregnancy.”

Dr. Tesfalul receives support from the Foundation for SMFM.

jremaly@mdedge.com

SOURCE: Tesfalul M et al. Am J Obstet Gynecol. 2020 Jan;222(1):S92-3, Abstract 119.

GRAPEVINE, TEX. – The amount of opioids prescribed post partum may decline over time without affecting levels of pain control satisfaction, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Data from a large center indicate that trends in opioid use significantly declined from 2017 to 2019, but not at the expense of adequate pain control, said Nevert Badreldin, MD, assistant professor of obstetrics and gynecology at Northwestern University in Chicago. Patients consistently reported that they were satisfied with inpatient pain control, while opioid use per inpatient day decreased from about 30 morphine milligram equivalents (MME) to less than 20 MME during that time.

To assess trends in postpartum opioid prescribing, opioid use, and pain control satisfaction, Dr. Badreldin and colleagues evaluated data from a prospective observational study. Their analysis included data from women who used an opioid during postpartum hospitalization between May 2017 and July 2019. The researchers excluded women with NSAID or morphine allergies or recent opioid use, as well as those who received general anesthesia without concurrent neuraxial anesthesia, those who underwent peripartum hysterectomy, and women admitted to the ICU.

The investigators used nonparametric tests of trend to assess the difference over time in the proportion of patients who received an opioid prescription at discharge and in the total MME prescribed post partum.

Of 2,470 women screened, 60.2% did not use an opioid during inpatient hospitalization, and the proportion of women who did use an opioid during inpatient hospitalization significantly declined over time. Of 900 women with inpatient opioid use, 471 agreed to be followed after discharge. In that group, the amount of opioid use per inpatient day significantly declined. In addition, the percentage who received an opioid prescription at discharge significantly declined, as did the total MME prescribed at discharge.

“Both inpatient and outpatient satisfaction with pain control were unchanged,” the researchers reported. “In this population, both the frequency and amount of opioid use in the postpartum period declined from 2017 to 2019, without any change in satisfaction with pain control.”

The study was supported by the Society for Maternal-Fetal Medicine/AMAG 2017 Health Policy Award, and a coauthor received support from the National Institute of Child Health and Human Development.

jremaly@mdedge.com

Source: Badreldin N et al. Am J Obstet Gynecol. 2020 Jan;222(1):S93, Abstract 120.

GRAPEVINE, TEX. – The amount of opioids prescribed post partum may decline over time without affecting levels of pain control satisfaction, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Data from a large center indicate that trends in opioid use significantly declined from 2017 to 2019, but not at the expense of adequate pain control, said Nevert Badreldin, MD, assistant professor of obstetrics and gynecology at Northwestern University in Chicago. Patients consistently reported that they were satisfied with inpatient pain control, while opioid use per inpatient day decreased from about 30 morphine milligram equivalents (MME) to less than 20 MME during that time.

To assess trends in postpartum opioid prescribing, opioid use, and pain control satisfaction, Dr. Badreldin and colleagues evaluated data from a prospective observational study. Their analysis included data from women who used an opioid during postpartum hospitalization between May 2017 and July 2019. The researchers excluded women with NSAID or morphine allergies or recent opioid use, as well as those who received general anesthesia without concurrent neuraxial anesthesia, those who underwent peripartum hysterectomy, and women admitted to the ICU.

The investigators used nonparametric tests of trend to assess the difference over time in the proportion of patients who received an opioid prescription at discharge and in the total MME prescribed post partum.

Of 2,470 women screened, 60.2% did not use an opioid during inpatient hospitalization, and the proportion of women who did use an opioid during inpatient hospitalization significantly declined over time. Of 900 women with inpatient opioid use, 471 agreed to be followed after discharge. In that group, the amount of opioid use per inpatient day significantly declined. In addition, the percentage who received an opioid prescription at discharge significantly declined, as did the total MME prescribed at discharge.

“Both inpatient and outpatient satisfaction with pain control were unchanged,” the researchers reported. “In this population, both the frequency and amount of opioid use in the postpartum period declined from 2017 to 2019, without any change in satisfaction with pain control.”

The study was supported by the Society for Maternal-Fetal Medicine/AMAG 2017 Health Policy Award, and a coauthor received support from the National Institute of Child Health and Human Development.

jremaly@mdedge.com

Source: Badreldin N et al. Am J Obstet Gynecol. 2020 Jan;222(1):S93, Abstract 120.

GRAPEVINE, TEX. – The amount of opioids prescribed post partum may decline over time without affecting levels of pain control satisfaction, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Data from a large center indicate that trends in opioid use significantly declined from 2017 to 2019, but not at the expense of adequate pain control, said Nevert Badreldin, MD, assistant professor of obstetrics and gynecology at Northwestern University in Chicago. Patients consistently reported that they were satisfied with inpatient pain control, while opioid use per inpatient day decreased from about 30 morphine milligram equivalents (MME) to less than 20 MME during that time.

To assess trends in postpartum opioid prescribing, opioid use, and pain control satisfaction, Dr. Badreldin and colleagues evaluated data from a prospective observational study. Their analysis included data from women who used an opioid during postpartum hospitalization between May 2017 and July 2019. The researchers excluded women with NSAID or morphine allergies or recent opioid use, as well as those who received general anesthesia without concurrent neuraxial anesthesia, those who underwent peripartum hysterectomy, and women admitted to the ICU.

The investigators used nonparametric tests of trend to assess the difference over time in the proportion of patients who received an opioid prescription at discharge and in the total MME prescribed post partum.

Of 2,470 women screened, 60.2% did not use an opioid during inpatient hospitalization, and the proportion of women who did use an opioid during inpatient hospitalization significantly declined over time. Of 900 women with inpatient opioid use, 471 agreed to be followed after discharge. In that group, the amount of opioid use per inpatient day significantly declined. In addition, the percentage who received an opioid prescription at discharge significantly declined, as did the total MME prescribed at discharge.

“Both inpatient and outpatient satisfaction with pain control were unchanged,” the researchers reported. “In this population, both the frequency and amount of opioid use in the postpartum period declined from 2017 to 2019, without any change in satisfaction with pain control.”

The study was supported by the Society for Maternal-Fetal Medicine/AMAG 2017 Health Policy Award, and a coauthor received support from the National Institute of Child Health and Human Development.

jremaly@mdedge.com

Source: Badreldin N et al. Am J Obstet Gynecol. 2020 Jan;222(1):S93, Abstract 120.

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

The Centers for Medicare & Medicaid Services’ latest maneuver to combat rising drug prices is the proposed addition of a second specialty drug tier for the Medicare Part D prescription drug benefit.

The proposal is part of a broader proposed update to Medicare Parts C and D for contract years 2021 and 2022.

Gurzzza/Thinkstock

A randomized, controlled trial of Gilead’s antiviral drug remdesivir is currently underway in China in hopes that it will be an effective treatment for the 2019 Novel Coronavirus (2019-nCoV).

dbrunk@mdedge.com

A randomized, controlled trial of Gilead’s antiviral drug remdesivir is currently underway in China in hopes that it will be an effective treatment for the 2019 Novel Coronavirus (2019-nCoV).

dbrunk@mdedge.com

A randomized, controlled trial of Gilead’s antiviral drug remdesivir is currently underway in China in hopes that it will be an effective treatment for the 2019 Novel Coronavirus (2019-nCoV).

dbrunk@mdedge.com

GRAPEVINE, TEX.* – Pregnant women with type 2 diabetes or prediabetes had significantly less gestational weight gain if they had metformin exposure at any point in their pregnancies, with no differences in infant birth weight or postnatal infant hypoglycemia, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/MDedge News

In a retrospective single-center review of 284 women without metformin exposure and 227 with metformin exposure in pregnancy, metformin exposure at any point in pregnancy was associated with a significantly greater chance of appropriate – rather than excessive – weight gain.

The relationship held true for the 169 women who had metformin in their first trimester of pregnancy. Here, 69% of women had appropriate weight gain using Institute of Medicine and American College of Obstetricians and Gynecologists standards, compared with 54% of the 282 women who had no metformin exposure (adjusted odds ratio 1.92, P = .003). A further 22% of women receiving metformin in their first trimester of pregnancy lost weight, compared with 9% of women without metformin exposure (aOR 2.11, P = .019). There was no significant difference between the two groups in infant birth weight.

Separately, study author Jacquelyn Adams, MD, and her colleagues analyzed outcomes for the full cohort of 227 women who received metformin at any point in their pregnancy, comparing them again to the 282 women who had not received metformin. Most women (85%) were on 2 g of metformin at the time of delivery. These results again showed a greater likelihood of appropriate weight gain in the metformin group (69%; aOR 1.85; P = .002). Maternal weight loss was seen in 20% of this group (aOR 1.98, P = .018). Infant birth weights were not significantly different between these two groups.

“We found that women who had been on metformin at any point in their pregnancy had more appropriate weight gain and less excessive weight gain,” said Dr. Adams, a maternal-fetal medicine fellow at the University of Wisconsin–Madison. “Actually, some women on metformin had even had a little bit of weight loss, with no difference in their baby’s birth weight. So that’s really exciting, because our starting prepregnancy body mass index was 33-36 [kg/m²], which is considered obese,” she said in an interview.

This is an important finding, said Dr. Adams, because previous work has shown that less weight gain in pregnancy is associated with lower risk for hypertension and preeclampsia, and lower rates of fetal macrosomia.

What about infant outcomes? Dr. Adams said that there were many concerns about metformin: “Would it affect baby outcome? Were those babies more likely to be hypoglycemic? Were they more likely to be growth restricted? Were they more likely to have issues in the NICU? And the answer was really, ‘No.’ ”

“So we can both help these women have appropriate weight gain and not have any negative effects on these babies,” she added.

Specifically, Dr. Adams and her coinvestigators found no significant differences between the groups in gestational age at birth, likelihood of neonatal ICU admission, Apgar scores, neonatal hypoglycemia, respiratory distress syndrome, or fetal death. Fetal growth restriction and anomalies occurred at a low and similar rate between the groups.

Dr. Adams said that she was not surprised to see that metformin was associated with less weight gain in pregnancy, but she was surprised at how highly significant the differences were with metformin use. “Metformin is first-line for diabetes in nonpregnant individuals because it’s associated with things like weight loss, and because of ease of use and lack of hypoglycemia – so I was really hoping to see this kind of result.”

Women receiving metformin were a mean 34 years old, while those who didn’t get metformin were 32 years old, a significant difference. Prepregnancy body mass index also was higher in those receiving metformin, and they were more likely to have a type 2 diabetes diagnosis. A similar proportion of both groups – about two-thirds – were white, and about 20% were Hispanic.

The lower weight gain seen in metformin-takers also might smooth the way post partum, said Dr. Adams. “My perception is that, when these women leave us, they might not have any primary care follow-up; they might not have anybody following their diabetes; and metformin is a very viable way to help them in their life outside of pregnancy.

“Not to mention that all the weight you gain in pregnancy, you do eventually have to lose post partum,” she added, “so having less pregnancy weight gain kind of sets them up for success in their postpregnancy life as well.”

Asked whether these results inform the ongoing question of whether insulin or metformin is the most appropriate first-line treatment for gestational diabetes, Dr. Adams first noted that “there’s a lot of crossover,” pointing out that over 60% of the participants in her study eventually also required insulin.

“It’s a question I would love to address in a head-to-head trial,” she said, adding that questions about metformin’s effects on the placenta and the potential for later deleterious effects require more study.

In her practice, Dr. Adams said that patients generally are discharged with a metformin prescription, and then meet with a diabetes educator 1 week after delivery to assess blood glucose levels and adjust medical management. Following that, a warm hand-off to a primary care practice who can continue management and education is optimal, she said.

In terms of next steps, “We would really love to look at metformin in the postpartum period,” said Dr. Adams. Ideally, future work could look for outcomes that extend beyond the 6- to 8-week postpartum follow-up visit. For example, she said, there are indications that women with insulin insensitivity might benefit from metformin while breastfeeding; it’s also possible that metformin might reduce the risk of postpartum preeclampsia.

Dr. Adams reported that she had no conflicts of interest and no outside sources of funding.

koakes@mdedge.com

SOURCE: Adams J et al. SMFM 2020, Abstract 335.

*This story was updated 2/10/2020.

GRAPEVINE, TEX.* – Pregnant women with type 2 diabetes or prediabetes had significantly less gestational weight gain if they had metformin exposure at any point in their pregnancies, with no differences in infant birth weight or postnatal infant hypoglycemia, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/MDedge News

In a retrospective single-center review of 284 women without metformin exposure and 227 with metformin exposure in pregnancy, metformin exposure at any point in pregnancy was associated with a significantly greater chance of appropriate – rather than excessive – weight gain.

The relationship held true for the 169 women who had metformin in their first trimester of pregnancy. Here, 69% of women had appropriate weight gain using Institute of Medicine and American College of Obstetricians and Gynecologists standards, compared with 54% of the 282 women who had no metformin exposure (adjusted odds ratio 1.92, P = .003). A further 22% of women receiving metformin in their first trimester of pregnancy lost weight, compared with 9% of women without metformin exposure (aOR 2.11, P = .019). There was no significant difference between the two groups in infant birth weight.

Separately, study author Jacquelyn Adams, MD, and her colleagues analyzed outcomes for the full cohort of 227 women who received metformin at any point in their pregnancy, comparing them again to the 282 women who had not received metformin. Most women (85%) were on 2 g of metformin at the time of delivery. These results again showed a greater likelihood of appropriate weight gain in the metformin group (69%; aOR 1.85; P = .002). Maternal weight loss was seen in 20% of this group (aOR 1.98, P = .018). Infant birth weights were not significantly different between these two groups.

“We found that women who had been on metformin at any point in their pregnancy had more appropriate weight gain and less excessive weight gain,” said Dr. Adams, a maternal-fetal medicine fellow at the University of Wisconsin–Madison. “Actually, some women on metformin had even had a little bit of weight loss, with no difference in their baby’s birth weight. So that’s really exciting, because our starting prepregnancy body mass index was 33-36 [kg/m²], which is considered obese,” she said in an interview.

This is an important finding, said Dr. Adams, because previous work has shown that less weight gain in pregnancy is associated with lower risk for hypertension and preeclampsia, and lower rates of fetal macrosomia.

What about infant outcomes? Dr. Adams said that there were many concerns about metformin: “Would it affect baby outcome? Were those babies more likely to be hypoglycemic? Were they more likely to be growth restricted? Were they more likely to have issues in the NICU? And the answer was really, ‘No.’ ”

“So we can both help these women have appropriate weight gain and not have any negative effects on these babies,” she added.

Specifically, Dr. Adams and her coinvestigators found no significant differences between the groups in gestational age at birth, likelihood of neonatal ICU admission, Apgar scores, neonatal hypoglycemia, respiratory distress syndrome, or fetal death. Fetal growth restriction and anomalies occurred at a low and similar rate between the groups.

Dr. Adams said that she was not surprised to see that metformin was associated with less weight gain in pregnancy, but she was surprised at how highly significant the differences were with metformin use. “Metformin is first-line for diabetes in nonpregnant individuals because it’s associated with things like weight loss, and because of ease of use and lack of hypoglycemia – so I was really hoping to see this kind of result.”

Women receiving metformin were a mean 34 years old, while those who didn’t get metformin were 32 years old, a significant difference. Prepregnancy body mass index also was higher in those receiving metformin, and they were more likely to have a type 2 diabetes diagnosis. A similar proportion of both groups – about two-thirds – were white, and about 20% were Hispanic.

The lower weight gain seen in metformin-takers also might smooth the way post partum, said Dr. Adams. “My perception is that, when these women leave us, they might not have any primary care follow-up; they might not have anybody following their diabetes; and metformin is a very viable way to help them in their life outside of pregnancy.

“Not to mention that all the weight you gain in pregnancy, you do eventually have to lose post partum,” she added, “so having less pregnancy weight gain kind of sets them up for success in their postpregnancy life as well.”

Asked whether these results inform the ongoing question of whether insulin or metformin is the most appropriate first-line treatment for gestational diabetes, Dr. Adams first noted that “there’s a lot of crossover,” pointing out that over 60% of the participants in her study eventually also required insulin.

“It’s a question I would love to address in a head-to-head trial,” she said, adding that questions about metformin’s effects on the placenta and the potential for later deleterious effects require more study.

In her practice, Dr. Adams said that patients generally are discharged with a metformin prescription, and then meet with a diabetes educator 1 week after delivery to assess blood glucose levels and adjust medical management. Following that, a warm hand-off to a primary care practice who can continue management and education is optimal, she said.

In terms of next steps, “We would really love to look at metformin in the postpartum period,” said Dr. Adams. Ideally, future work could look for outcomes that extend beyond the 6- to 8-week postpartum follow-up visit. For example, she said, there are indications that women with insulin insensitivity might benefit from metformin while breastfeeding; it’s also possible that metformin might reduce the risk of postpartum preeclampsia.

Dr. Adams reported that she had no conflicts of interest and no outside sources of funding.

koakes@mdedge.com

SOURCE: Adams J et al. SMFM 2020, Abstract 335.

*This story was updated 2/10/2020.

GRAPEVINE, TEX.* – Pregnant women with type 2 diabetes or prediabetes had significantly less gestational weight gain if they had metformin exposure at any point in their pregnancies, with no differences in infant birth weight or postnatal infant hypoglycemia, according to research presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/MDedge News

In a retrospective single-center review of 284 women without metformin exposure and 227 with metformin exposure in pregnancy, metformin exposure at any point in pregnancy was associated with a significantly greater chance of appropriate – rather than excessive – weight gain.

The relationship held true for the 169 women who had metformin in their first trimester of pregnancy. Here, 69% of women had appropriate weight gain using Institute of Medicine and American College of Obstetricians and Gynecologists standards, compared with 54% of the 282 women who had no metformin exposure (adjusted odds ratio 1.92, P = .003). A further 22% of women receiving metformin in their first trimester of pregnancy lost weight, compared with 9% of women without metformin exposure (aOR 2.11, P = .019). There was no significant difference between the two groups in infant birth weight.

Separately, study author Jacquelyn Adams, MD, and her colleagues analyzed outcomes for the full cohort of 227 women who received metformin at any point in their pregnancy, comparing them again to the 282 women who had not received metformin. Most women (85%) were on 2 g of metformin at the time of delivery. These results again showed a greater likelihood of appropriate weight gain in the metformin group (69%; aOR 1.85; P = .002). Maternal weight loss was seen in 20% of this group (aOR 1.98, P = .018). Infant birth weights were not significantly different between these two groups.

“We found that women who had been on metformin at any point in their pregnancy had more appropriate weight gain and less excessive weight gain,” said Dr. Adams, a maternal-fetal medicine fellow at the University of Wisconsin–Madison. “Actually, some women on metformin had even had a little bit of weight loss, with no difference in their baby’s birth weight. So that’s really exciting, because our starting prepregnancy body mass index was 33-36 [kg/m²], which is considered obese,” she said in an interview.

This is an important finding, said Dr. Adams, because previous work has shown that less weight gain in pregnancy is associated with lower risk for hypertension and preeclampsia, and lower rates of fetal macrosomia.

What about infant outcomes? Dr. Adams said that there were many concerns about metformin: “Would it affect baby outcome? Were those babies more likely to be hypoglycemic? Were they more likely to be growth restricted? Were they more likely to have issues in the NICU? And the answer was really, ‘No.’ ”

“So we can both help these women have appropriate weight gain and not have any negative effects on these babies,” she added.

Specifically, Dr. Adams and her coinvestigators found no significant differences between the groups in gestational age at birth, likelihood of neonatal ICU admission, Apgar scores, neonatal hypoglycemia, respiratory distress syndrome, or fetal death. Fetal growth restriction and anomalies occurred at a low and similar rate between the groups.

Dr. Adams said that she was not surprised to see that metformin was associated with less weight gain in pregnancy, but she was surprised at how highly significant the differences were with metformin use. “Metformin is first-line for diabetes in nonpregnant individuals because it’s associated with things like weight loss, and because of ease of use and lack of hypoglycemia – so I was really hoping to see this kind of result.”

Women receiving metformin were a mean 34 years old, while those who didn’t get metformin were 32 years old, a significant difference. Prepregnancy body mass index also was higher in those receiving metformin, and they were more likely to have a type 2 diabetes diagnosis. A similar proportion of both groups – about two-thirds – were white, and about 20% were Hispanic.

The lower weight gain seen in metformin-takers also might smooth the way post partum, said Dr. Adams. “My perception is that, when these women leave us, they might not have any primary care follow-up; they might not have anybody following their diabetes; and metformin is a very viable way to help them in their life outside of pregnancy.

“Not to mention that all the weight you gain in pregnancy, you do eventually have to lose post partum,” she added, “so having less pregnancy weight gain kind of sets them up for success in their postpregnancy life as well.”

Asked whether these results inform the ongoing question of whether insulin or metformin is the most appropriate first-line treatment for gestational diabetes, Dr. Adams first noted that “there’s a lot of crossover,” pointing out that over 60% of the participants in her study eventually also required insulin.

“It’s a question I would love to address in a head-to-head trial,” she said, adding that questions about metformin’s effects on the placenta and the potential for later deleterious effects require more study.

In her practice, Dr. Adams said that patients generally are discharged with a metformin prescription, and then meet with a diabetes educator 1 week after delivery to assess blood glucose levels and adjust medical management. Following that, a warm hand-off to a primary care practice who can continue management and education is optimal, she said.

In terms of next steps, “We would really love to look at metformin in the postpartum period,” said Dr. Adams. Ideally, future work could look for outcomes that extend beyond the 6- to 8-week postpartum follow-up visit. For example, she said, there are indications that women with insulin insensitivity might benefit from metformin while breastfeeding; it’s also possible that metformin might reduce the risk of postpartum preeclampsia.

Dr. Adams reported that she had no conflicts of interest and no outside sources of funding.

koakes@mdedge.com

SOURCE: Adams J et al. SMFM 2020, Abstract 335.

*This story was updated 2/10/2020.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.