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AIM: To evaluate whether pregnant individuals with pregestational diabetes who live in a food-insecure community have worse glycemic control compared to those who do not live in a food-insecure community. METHODS: A retrospective analysis of pregnant individuals with pregestational diabetes enrolled in a multidisciplinary prenatal and diabetes care program. The exposure was community-level food insecurity per the Food Access Research Atlas. The outcomes were hemoglobin A1c (A1c) < 6.0 % in early and late pregnancy, and an absolute decrease in A1c ≥ 2.0 % and mean change in A1c across pregnancy. RESULTS: Among 418 assessed pregnant individuals with pregestational diabetes, those living in a food-insecure community were less likely to have an A1c < 6.0 % in early pregnancy compared to those living in a community without food insecurity [16 % vs. 30 %; adjusted risk ratio (aRR): 0.55; 95 % CI: 0.33–0.92]. Individuals living in a food-insecure community were more likely to achieve a decrease in A1c ≥ 2.0 % [35 % vs. 21 %; aRR: 1.55; 95 % CI: 1.06–2.28] and a larger mean decrease in A1c across pregnancy [mean: 1.46 vs. 1.00; adjusted beta: 0.47; 95 % CI: 0.06–0.87)]. CONCLUSIONS: Pregnant individuals with pregestational diabetes who lived in a food-insecure community were less likely to enter pregnancy with glycemic control, but were more likely to have a reduction in A1c and achieve similar A1c status compared to those who lived in a community without food insecurity. Whether interventions that address food insecurity improve glycemic control and consequent perinatal outcomes remains to be studied.

Objective The aim of this study was to evaluate the association of mild gestational diabetes mellitus (GDM) and obesity with metabolic and cardiovascular markers 5 to 10 years after pregnancy. Study Design This was a secondary analysis of 5- to 10-year follow-up study of a mild GDM treatment trial and concurrent observational cohort of participants ineligible for the trial with abnormal 1-hour glucose challenge test only. Participants with 2-hour glucose tolerance test at follow-up were included. The primary exposures were mild GDM and obesity. The outcomes were insulinogenic index (IGI), 1/homeostatic model assessment of insulin resistance (HOMA-IR), and cardiovascular markers vascular endothelial growth factor, (VEGF), vascular cell adhesion molecule 1 (VCAM-1), cluster of differentiation 40 ligand (CD40L), growth differentiation factor 15 (GDF-15), and suppression of tumorgenesis 2 (ST-2). Multivariable linear regression estimated the association of GDM and obesity with biomarkers. Results Of 951 participants in the parent study, 642 (68%) were included. Lower 1/HOMA-IR were observed in treated and untreated GDM groups, compared with non-GDM (mean differences, −0.24 and −0.15; 95% confidence intervals [CIs], −0.36 to −0.12 and −0.28 to −0.03, respectively). Lower VCAM-1 (angiogenesis) was observed in treated GDM group (mean difference, −0.11; 95% CI, −0.19 to −0.03). GDM was not associated with IGI or other biomarkers. Obesity was associated with lower 1/HOMA-IR (mean difference, −0.42; 95% CI, −0.52 to −0.32), but not other biomarkers. Conclusion Prior GDM and obesity are associated with more insulin resistance but not insulin secretion or consistent cardiovascular dysfunction 5 to 10 years after delivery. Key Points

ImportanceBirth in the periviable period between 22 weeks 0 days and 25 weeks 6 days’ gestation is a major source of neonatal morbidity and mortality, and the decision to initiate active life-saving treatment is challenging.ObjectiveTo assess whether the frequency of active treatment among live-born neonates in the periviable period has changed over time and whether active treatment differed by gestational age at birth and race and ethnicity.Design, Setting, and ParticipantsSerial cross-sectional descriptive study using National Center for Health Statistics natality data from 2014 to 2020 for 61 908 singleton live births without clinical anomalies between 22 weeks 0 days and 25 weeks 6 days in the US.ExposuresYear of delivery, gestational age at birth, and race and ethnicity of the pregnant individual, stratified as non-Hispanic Asian/Pacific Islander, non-Hispanic Black, Hispanic/Latina, and non-Hispanic White.Main Outcomes and MeasuresActive treatment, determined by whether there was an attempt to treat the neonate and defined as a composite of surfactant therapy, immediate assisted ventilation at birth, assisted ventilation more than 6 hours in duration, and/or antibiotic therapy. Frequencies, mean annual percent change (APC), and adjusted risk ratios (aRRs) were estimated.ResultsOf 26 986 716 live births, 61 908 (0.2%) were periviable live births included in this study: 5% were Asian/Pacific Islander, 37% Black, 24% Hispanic, and 34% White; and 14% were born at 22 weeks, 21% at 23 weeks, 30% at 24 weeks, and 34% at 25 weeks. Fifty-two percent of neonates received active treatment. From 2014 to 2020, the overall frequency (mean APC per year) of active treatment increased significantly (3.9% [95% CI, 3.0% to 4.9%]), as well as among all racial and ethnic subgroups (Asian/Pacific Islander: 3.4% [95% CI, 0.8% to 6.0%]); Black: 4.7% [95% CI, 3.4% to 5.9%]; Hispanic: 4.7% [95% CI, 3.4% to 5.9%]; and White: 3.1% [95% CI, 1.1% to 4.4%]) and among each gestational age range (22 weeks: 14.4% [95% CI, 11.1% to 17.7%] and 25 weeks: 2.9% [95% CI, 1.5% to 4.2%]). Compared with neonates born to White individuals (57.0%), neonates born to Asian/Pacific Islander (46.2%; risk difference [RD], −10.81 [95% CI, −12.75 to −8.88]; aRR, 0.82 [95% CI, [0.79-0.86]), Black (51.6%; RD, −5.42 [95% CI, −6.36 to −4.50]; aRR, 0.90 [95% CI, 0.89 to 0.92]), and Hispanic (48.0%; RD, −9.03 [95% CI, −10.07 to −7.99]; aRR, 0.83 [95% CI, 0.81 to 0.85]) individuals were significantly less likely to receive active treatment.Conclusions and RelevanceFrom 2014 to 2020 in the US, the frequency of active treatment among neonates born alive between 22 weeks 0 days and 25 weeks 6 days significantly increased, and there were differences in rates of active treatment by race and ethnicity.

Objective: To measure the association between hypertensive disorders of pregnancy (HDP) and long-term maternal metabolic and cardiovascular biomarkers. Study Design: Follow-up study of patients who completed glucose tolerance testing 5-10 years after enrollment in a mild GDM treatment trial or concurrent non-GDM cohort. Maternal serum insulin concentrations and cardiovascular markers VCAM-1, VEGF, CD40L, GDF-15 and ST-2 were measured, and insulinogenic index (IGI, pancreatic -cell function) and 1/HOMA (insulin resistance) were calculated. Biomarkers were compared by presence of HDP (gestational hypertension or preeclampsia) during pregnancy. Multivariable linear regression estimated the association of HDP with biomarkers, adjusting for GDM, baseline BMI, and years since pregnancy. Results: Of 642 patients, 66 (10%) had HDP: 42 with gestational hypertension and 24 with preeclampsia. Patients with HDP had higher baseline and follow-up BMI, higher baseline BP and more chronic hypertension at follow-up. HDP was not associated with metabolic or cardiovascular biomarkers at follow-up. However, when HDP type was evaluated, patients with preeclampsia had lower GDF-15 levels (oxidative stress/cardiac ischemia), compared to patients without HDP (adjusted mean difference -0.24, 95%CI -0.44, -0.03). There were no differences between gestational hypertension and no HDP. Conclusion: In this cohort, metabolic and cardiovascular biomarkers 5-10 years after pregnancies did not differ by HDP. Patients with preeclampsia may have less oxidative stress/cardiac ischemia postpartum; however, this may have been observed due to chance alone given multiple comparisons. Longitudinal studies are needed to define the impact of HDP during pregnancy and interventions postpartum.

To examine the association between initial COVID-19 vaccine hesitancy and subsequent vaccination among pregnant and postpartum individuals.Prospective cohort.A Midwestern tertiary-care academic medical center. Individuals completed a baseline vaccine hesitancy assessment from 22 March 2021 to 2 April 2021, with subsequent ascertainment of vaccination status at 3-6 months follow-up.We used multivariable Poisson regression to estimate the relative risk of vaccination by baseline vaccine hesitancy status, and then characteristics associated with vaccination.Self-report of COVID-19 vaccination, and secondarily, consideration of COVID-19 vaccination among those not vaccinated.Of 456 individuals (93% pregnant, 7% postpartum) initially surveyed, 290 individuals (64%; 23% pregnant, 77% postpartum) provided subsequent vaccination status (median = 17 weeks). Of these 290 individuals, 40% (116/290) reported COVID-19 vaccine hesitancy upon enrolment, of whom 52% reported subsequent vaccination at follow-up. Few individuals transitioned during the study period from vaccine hesitant to vaccinated (10%); in comparison, 80% of those who were not vaccine hesitant were vaccinated at follow-up (aRR 0.19, 95% CI 0.11-0.33). Among those who remained unvaccinated at follow-up, 38% who were vaccine hesitant at baseline were considering vaccination, compared with 71% who were not vaccine hesitant (aRR 0.48, 95% CI 0.33-0.67). Individuals who were older, parous, employed and of higher educational attainment were more likely to be vaccinated, and those who identified as non-Hispanic black, were Medicaid beneficiaries, and were still pregnant at follow-up were less likely to be vaccinated.COVID-19 vaccine hesitancy persisted over time in the peripartum period, and few individuals who reported hesitancy at baseline were later vaccinated. Interventions that address vaccine hesitancy in pregnancy are needed.

To assess the frequency and associated characteristics of COVID-19 vaccine hesitancy among pregnant and postpartum individuals.Cross-sectional study.Prenatal care at a single academic tertiary care centre.Pregnant and postpartum individuals enrolled in prenatal care at a single academic tertiary care centre from 22 March 2021 to 2 April 2021, concurrent with state guidelines recommending COVID-19 vaccination in pregnancy.We used logistic regression to identify characteristics associated with COVID-19 vaccine hesitancy, and adjusted for: age, parity, race, trimester of pregnancy, and chronic comorbidities.COVID-19 vaccine hesitancy, defined as uncertainty or refusal of the vaccine, despite the availability of vaccine services, in accordance with the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on vaccine hesitancy.Of the 485 individuals screened and approached, 456 (94%) enrolled and completed the survey (435/456, 95% pregnant). The frequency of COVID-19 vaccine hesitancy was 46% (95% CI 41%-51%). Sociodemographic characteristics, including non-Hispanic Black race, younger age, lower education, public health insurance receipt, parity1, and reported substance use, were associated with a higher odds of COVID-19 vaccine hesitancy, but not clinical risk conditions. Individuals who had a family or friend vaccinated for COVID-19, prior or planned vaccination for tetanus, diphtheria and acellular pertussis (Tdap) and/or influenza, and who perceived that vaccination benefited the baby were less likely to express COVID-19 vaccine hesitancy.COVID-19 vaccine hesitancy was frequent among pregnant and postpartum individuals. Those who may face barriers to accessing healthcare services were more likely to report vaccine hesitancy. These results can inform interventions to increase COVID-19 vaccine uptake in pregnancy.COVID-19 vaccination hesitancy is frequent among pregnant and postpartum individuals, and those who face barriers to accessing healthcare services are more likely to report COVID-19 vaccine hesitancy.

Objective We estimated the association between diabetes and shoulder dystocia by infant birth weight subgroups (4,500 g) in an era of prophylactic cesarean delivery for suspected macrosomia.Study Design A secondary analysis from the National Institute of Child Health and Human Development U.S. Consortium for Safe Labor of deliveries at ≥24 weeks with a nonanomalous, singleton fetus with vertex presentation undergoing a trial of labor. The exposure was either pregestational or gestational diabetes compared with no diabetes. The primary outcome was shoulder dystocia and secondarily, birth trauma with a shoulder dystocia. We calculated adjusted risk ratios (aRRs) with modified Poison's regression between diabetes and shoulder dystocia and the number needed to treat (NNT) to prevent a shoulder dystocia with cesarean delivery.Results Among 167,589 assessed deliveries (6% with diabetes), pregnant individuals with diabetes had a higher risk of shoulder dystocia at birth weight 4,500 g (aRR: 1.26; 95% CI: 0.87–1.82) versus those without diabetes. The risk of birth trauma with shoulder dystocia was higher with diabetes (aRR: 2.29; 95% CI: 1.54–3.45). The NNT to prevent a shoulder dystocia with diabetes was 11 and 6 at ≥4,000 and >4,500 g, versus without diabetes, 17 and 8 at ≥4,000 and >4,500 g, respectively.Conclusion Diabetes increased the risk of shoulder dystocia, even at lower birth weight thresholds than at which cesarean delivery is currently offered. Guidelines providing the option of cesarean delivery for suspected macrosomia may have decreased the risk of shoulder dystocia at higher birth weights.Key Points

OBJECTIVES To assess the association between aspirin and glycemic control in diabetic, pregnant patients, and the risk for aspirin resistance in those with poor glycemic control across gestation taking low-dose aspirin (LDA) for pre-eclampsia (PEC) prevention. STUDY DESIGN We performed a secondary analysis of samples collected during the Maternal-Fetal Medicine Units trial of LDA for PEC prevention. A subset of insulin-controlled diabetic patient samples on placebo or 60 mg aspirin daily were evaluated. Glycosylated hemoglobin was measured at randomization, mid-second trimester, and third trimester time points. Thromboxane B2 (TXB2) measurements were previously assessed as part of the original study. Primary outcome was the effect of LDA on glycosylated hemoglobin levels compared with placebo across gestation. RESULTS Levels of glycosylated hemoglobin increased across gestation in the placebo group (2,067.7 [interquartile range, IQR: 1,624.6-2,713.5 µg/mL] vs. 2,461.9 [1,767.0-3,209.9 µg/mL] vs. 3,244.3 [2,691.5-4,187.0 µg/mL]; p

Background LDA triggers biosynthesis of endogenous anti-inflammatory molecules, aspirin-triggered 15-epi-lipoxin A4 (15-epi-LXA4), which may counteract inflammatory process of preeclampsia (PE), and play role in LDA’s mechanism of action in PE prevention in high-risk patients. Objective Investigate the effects of daily LDA on levels of 15-epi-LXA4 in pregnancies at high-risk for developing PE. Materials and methods Secondary analysis of multi-centered randomized controlled trial investigating effects of daily LDA (60 mg) in high-risk pregnancies. Maternal samples were drawn at three points: before LDA initiation (13–26 weeks’ gestation), 24–28 weeks’ gestation (at least two weeks after LDA) and 34–36 weeks’ gestation. 15-epi-LXA4 levels were measured by ELISA. Results Analysis included 82 patients: 63 receiving daily LDA and 29 receiving daily placebo starting between 13 and 25 weeks gestation. Prior to randomization, baseline 15-epi-LXA4 levels were similar between both groups (75.9 pg/mL [IQR; 63.8–114.0] vs 136.2 pg/mL [52.4–476.2]; p = 0.10). Patients receiving daily LDA were noted to have significantly increased levels of 15-epi-LXA4 after LDA administration (136.2 pg/mL [IQR; 52.4–476.2] vs 1758.2 pg/mL [905.4–6638.5]; p Conclusion Daily LDA administration increases 15-epi-LXA4 levels in high-risk pregnancies for PE. In LDA group, pregnancies complicated by PE have lower levels of 15-epi-LXA4 compared to pregnancies without PE.

Treatment with monoclonal antibodies has been shown to significantly reduce the risk of hospitalization and disease progression among high-risk patients with coronavirus disease 2019 (COVID-19). Pregnant individuals were excluded from the original trials. In this single-center retrospective cohort study, we evaluated whether monoclonal antibody treatment in pregnant individuals is associated with decreased risk of hospitalization. Outcomes of patients who received the treatment were compared with those who were eligible but did not receive the treatment. Analyses were stratified by vaccination status. Unvaccinated pregnant patients with mild or moderate COVID-19 who received outpatient monoclonal antibodies were less likely to be admitted to the hospital (4.2% vs 15.7%, odds ratio 0.24, 95% CI 0.07-0.74), whereas among vaccinated patients, the treatment was not associated with a lower rate of hospitalization (2.3% vs 0%, P=.99).

OBJECTIVE This study aimed to investigate the association between excess and less than recommended gestational weight gain (GWG) and adverse maternal and neonatal outcomes in women with pregestational and gestational diabetes. STUDY DESIGN We conducted a secondary analysis of the National Institute of Child Health and Human Development (NICHD) Consortium on Safe Labor (CSL) study. We included deliveries >23 weeks of nonanomalous singletons with either pregestational or gestational diabetes. The exposure was GWG greater than or less than compared with the U.S. Institute of Medicine recommendations for total pregnancy weight gain per prepregnancy body mass index. Consistent with the 2020 Delphi outcome for diabetes in pregnancy, maternal outcomes included cesarean delivery and preeclampsia and neonatal outcomes included small for gestational age (SGA), large for gestational age (LGA), macrosomia >4,000 g, preterm birth

OBJECTIVE To evaluate differences between fasting and nonfasting bile acid levels in asymptomatic and symptomatic pregnant women. METHODS This is a report of two prospective cohort studies describing bile acid levels in the fasting and nonfasting state in pregnancy. The first cohort included asymptomatic women with singleton pregnancies. Women with a diagnosis of cholestasis, symptoms of cholestasis, or intolerance to components of a standardized meal were excluded. Bile acid levels were measured during the second and third trimesters after fasting and again 2 hours after a standardized meal. The second cohort included symptomatic women with singleton pregnancies in whom fasting and nonfasting bile acid levels were measured at the time of symptom evaluation. A cutoff of 10 micromoles/L was used for diagnosis. RESULTS A total of 27 women were included in the asymptomatic cohort. Median [interquartile range] fasting bile acid levels were significantly lower than nonfasting levels in both the second trimester (4.65 micromoles/L [1.02-29.57] vs 13.62 micromoles/L [2.03-40.26]; P

OBJECTIVE We aimed to assess the relationship between obstetric history and incidence of short cervical length (CL) at

Objective We sought to determine if there is an association between fibroblast growth factor 21 (FGF21) levels and a history of gestational diabetes mellitus (GDM) in women with and without metabolic dysfunction, defined as a diagnosis of metabolic syndrome or type 2 diabetes (T2DM), 5 to 10 years following participation in a multiple cohort GDM study. Study Design At 5 to 10 years after index pregnancy, women underwent a follow-up visit and were categorized as having no metabolic syndrome, metabolic syndrome, or T2DM. FGF21 levels were compared between women who did and did not have a history of GDM using multivariable linear regression. Results Among 1,889 women, 950 underwent follow-up and 796 had plasma samples analyzed (413 GDM and 383 non-GDM). Total 30.7% of women had been diagnosed with T2DM or metabolic syndrome. Overall, there was no difference in median FGF21 levels in pg/mL between the prior GDM and non-GDM groups (p = 0.12), and the lack of association was observed across all three metabolic categories at follow-up (p for interaction = 0.70). Conclusion There was no association between FGF21 levels and prior history of mild GDM in women with and without metabolic dysfunction 5 to 10 years after the index pregnancy (ClinicalTrials.gov number, NCT00069576, original trial).

Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points Pregnancy was excluded from past pandemic research. Pregnancy is being excluded from COVID-19 research. Exclusion of pregnant women is potentially harmful.

Despite current guidelines recommending universal vaccination, the frequency of vaccination in pregnancy for influenza and tetanus-diphtheria-acellular pertussis remains low.This study aimed to evaluate the association between community-level social vulnerability and influenza and anticipated tetanus-diphtheria-acellular pertussis vaccinations among pregnant and postpartum individuals.We conducted a cross-sectional survey of vaccine hesitancy in the peripartum period among pregnant and postpartum participants enrolled in prenatal care at a single tertiary care center from March 22, 2021, to April 02, 2021. Participant addresses were geocoded using ArcGIS and linked at the census tract level. The primary exposure was community-level social vulnerability as measured by the US Centers for Disease Control and Prevention's Social Vulnerability Index. This index incorporates 15 census variables to produce a composite score and subscores across 4 major thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). The scores range from 0 to 1, with higher values indicating greater social vulnerability. The primary outcomes were self-reported influenza vaccination during the current influenza season and having received or planning to receive the tetanus-diphtheria-acellular pertussis vaccination in pregnancy. We used multivariable logistic regression and adjusted for age, self-reported race and ethnicity, parity, trimester of pregnancy, and chronic comorbid conditions.Of 456 assessed individuals (95% pregnant individuals and 5% postpartum individuals), the frequency of influenza vaccination was 58% (95% confidence interval, 53-62), and the anticipated tetanus-diphtheria-acellular pertussis vaccination was 72% (95% confidence interval, 68-76). Individuals from communities with a higher Social Vulnerability Index were less likely to report vaccination in pregnancy than those from communities with a lower Social Vulnerability Index. Specifically, for each 0.1-unit increase in the Social Vulnerability Index, the odds of influenza vaccination (adjusted odds ratio, 0.23; 95% confidence interval, 0.11-0.46) and anticipated tetanus-diphtheria-acellular pertussis vaccination (adjusted odds ratio, 0.24; 95% confidence interval, 0.11-0.53) decreased by70%. By domain, the Social Vulnerability Index subscores of socioeconomic status (influenza adjusted odds ratio, 0.20 [95% confidence interval, 0.10-0.40]; tetanus-diphtheria-acellular pertussis adjusted odds ratio, 0.25 [95% confidence interval, 0.12-0.53]) and housing type and transportation (influenza adjusted odds ratio, 0.41 [95% confidence interval, 0.19-0.84; tetanus-diphtheria-acellular pertussis adjusted odds ratio, 0.39 [95% confidence interval, 0.18-0.87) were inversely associated with a lower odds of influenza and tetanus-diphtheria-acellular pertussis vaccinations.Pregnant and postpartum individuals living in areas with higher social vulnerability were less likely to report influenza and anticipated tetanus-diphtheria-acellular pertussis vaccinations in pregnancy. The Social Vulnerability Index could be used as a tool to improve vaccine equity and address disparities in vaccination in pregnancy.

The rate of gestational diabetes mellitus has increased over the past decade. An age, period, and cohort epidemiologic analysis can be used to understand how and why disease trends have changed over time.This study aimed to estimate the associations of age (at delivery), period (delivery year), and cohort (birth year) of the pregnant individual with trends in the incidence of gestational diabetes mellitus in the United States.We conducted an age, period, and cohort analysis of nulliparous pregnant adults aged 18 to 44 years with singleton live births from the National Vital Statistics System from 2011 to 2019. Generalized linear mixed models were used to calculate the adjusted rate ratios for the incidence of gestational diabetes mellitus for each 3-year maternal age span, period, and cohort group compared with the reference group for each. We repeated the analyses with stratification according to self-reported racial and ethnic group (non-Hispanic Asian-Pacific Islander, non-Hispanic Black, Hispanic, and non-Hispanic White) because of differences in the incidence of and risk factors for gestational diabetes mellitus by race and ethnicity.Among 11,897,766 pregnant individuals, 5.2% had gestational diabetes mellitus. The incidence of gestational diabetes mellitus was higher with increasing 3-year maternal age span, among those in the more recent delivery period, and among the younger birth cohort. For example, individuals aged 42 to 44 years at delivery had a 5-fold higher risk for gestational diabetes mellitus than those aged 18 to 20 years (adjusted rate ratio, 5.57; 95% confidence interval, 5.43-5.72) after adjusting for cohort and period. Individuals who delivered between 2017 and 2019 were at higher risk for gestational diabetes mellitus than those who delivered between 2011 and 2013 (adjusted rate ratio, 1.24; 95% confidence interval, 1.23-1.25) after adjusting for age and cohort. Individuals born between 1999 and 2001 had a 3-fold higher risk for gestational diabetes mellitus than those born between 1969 and 1971 (adjusted rate ratio, 3.12; 95% confidence interval, 2.87-3.39) after adjusting for age and period. Similar age, period, and cohort effects were observed for the assessed racial and ethnic groups, with the greatest period effects observed among Asian and Pacific Islander individuals.Period and birth cohort effects have contributed to the rising incidence of gestational diabetes mellitus in the United States from 2011 to 2019.

Objective To examine whether vaginal progesterone is noninferior to 17-α hydroxyprogesterone caproate (17OHP-C) in the prevention of recurrent preterm birth (PTB). Study Design This retrospective cohort study included singleton pregnancies among women with a history of spontaneous PTB who received prenatal care at a single tertiary center from 2011 to 2016. Pregnancies were excluded if progesterone was not initiated prior to 24 weeks or the fetus had a major congenital anomaly. The primary outcome was PTB Results Among 858 pregnancies, 41% (n = 353) received vaginal progesterone and 59% (n = 505) were given 17OHP-C. Vaginal progesterone use was more common later in the study period, and among women who established prenatal care later, had prior PTBs at later gestational ages, and whose race/ethnicity was neither non-Hispanic white nor non-Hispanic black. Vaginal progesterone did not meet noninferiority criteria compared with 17-OHPC in examining PTB Conclusion We could not conclude noninferiority of vaginal progesterone to 17OHP-C; however, women and providers may be willing to accept a larger difference (>9%) when considering the cost and availability of vaginal progesterone versus 17OHP-C. A well-designed randomized trial is needed. Key Points

To determine whether a net decline in glycosylated haemoglobin (HbAA retrospective analysis from 2012 to 2016 at a tertiary care centre. The exposure was the net change in HbAAmong 347 women with pregestational diabetes, HbAWomen with pregestational diabetes with a reduction in HbA

Objective The aim of the study is to evaluate whether values and the shape of the glucose curve during the oral glucose tolerance test (OGTT) in pregnancy identify women at risk of developing hypertension (HTN) later in life. Methods This category includes the secondary analysis of a follow-up from a mild gestational diabetes mellitus (GDM) study that included a treatment trial for mild GDM (n = 458) and an observational cohort of participants with abnormal 1-hour glucose loading test only (normal OGTT, n = 430). Participants were assessed at a median of 7 (IQR 6–8) years after their index pregnancy, and trained staff measured their blood pressure (systolic blood pressure [SBP]; diastolic blood pressure [DBP]). The association between values and the shape of the glucose curve during OGTT in the index pregnancy and the primary outcome defined as elevated BP (SBP ≥120, DBP ≥80 mm Hg, or receiving anti-HTN medications), and secondary outcome defined as stage 1 or higher (SBP ≥130, DBP ≥80 mm Hg, or receiving anti-HTN medications) at follow-up were evaluated using multivariable regression, adjusting for maternal age, body mass index, and pregnancy-associated hypertension during the index pregnancy. Results There was no association between fasting, 1-hour OGTT, and the outcomes. However, the 2-hour OGTT value was positively associated (adjusted odds ratio [aRR] per 10-unit increase 1.04, 95% CI 1.01–1.08), and the 3-hour was inversely associated (aRR per 10-unit increase 0.96, 95% CI 0.93–0.99) with the primary outcome. When the shape of the OGTT curve was evaluated, a monophasic OGTT response (peak at 1 hour followed by a decline in glucose) was associated with increased risk of elevated BP (41.3vs. 23.5%, aRR 1.66, 95% CI 1.17–2.35) and stage 1 HTN or higher (28.5 vs. 14.7%, aRR 1.83, 95% CI 1.15–2.92), compared with a biphasic OGTT response. Conclusion Among persons with mild GDM or lesser degrees of glucose intolerance, the shape of the OGTT curve during pregnancy may help identify women who are at risk of HTN later in life, with biphasic shape to be associated with lower risk. Key Points

OBJECTIVE To define patterns of prescription and factors associated with choice of pharmacotherapy for gestational diabetes mellitus (GDM), namely metformin, glyburide and insulin, during a period of evolving professional guidelines. DESING Cross-sectional study. SETTING US commercial insurance beneficiaries from Market-Scan (late 2015 to 2018). STUDY DESIGN We included women with GDM, singleton gestations, 15-51 years of age on pharmacotherapy. The exposure was pharmacy claims for metformin, glyburide and insulin. MAIN OUTCOMES Pharmacotherapy for GDM with either oral agent, metformin or glyburide, compared with insulin as the reference, and secondarily, consequent treatment modification (addition and/or change) to metformin, glyburide or insulin. RESULTS Among 37 762 women with GDM, we analysed data from 10 407 (28%) with pharmacotherapy, 21% with metformin (n = 2147), 48% with glyburide (n = 4984) and 31% with insulin (n = 3276). From late 2015 to 2018, metformin use increased from 17 to 29%, as did insulin use from 26 to 44%, whereas glyburide use decreased from 58 to 27%. By 2018, insulin was the most common pharmacotherapy for GDM; metformin was more likely to be prescribed by 9% compared with late 2015/16, but glyburide was less likely by 45%. Treatment modification occurred in 20% of women prescribed metformin compared with 2% with insulin and 8% with glyburide. CONCLUSIONS Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for GDM among a privately insured US population during a time of evolving professional guidelines. Further evaluation of the relative effectiveness and safety of metformin compared with insulin is needed. TWEETABLE ABSTRACT Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for gestational diabetes mellitus in the USA.

OBJECTIVE: To compare breastfeeding (BF) initiation among 317 women with chronic hypertension (CHTN) and 106 women with CHTN superimposed on pregestational diabetes (CHTN-DM) who intended exclusive or partial BF. METHODS: Retrospective cohort study of women who delivered at≥34 weeks of gestation. At discharge, exclusive BF was defined by direct BF or BF complemented with expressed breast milk (EBM) while partial BF was defined by formula supplementation. RESULTS: CHTN and CHTN-DM groups were similar in prior BF experience (42 vs 52%), intention to BF exclusively (89 vs 79%) and intention to partially BF (11 vs 21%). Women in the CHTN group were younger (31 vs 33y), more likely primiparous (44 vs 27%), and delivered vaginally (59 vs 36%) at term (85 vs 75%). Women in the CHTN-DM group had higher repeat cesarean rates (32 vs 18%), preterm birth (25 vs 15%), neonatal hypoglycemia (42 vs 14%) and NICU admission (38 vs 16%). At discharge, exclusive BF rates among CHTN was higher (48 vs 19%), while rates of partial BF (34 vs 44%) and FF (18 vs 37%) were lower than in the CHTN-DM group. BF initiation (exclusive plus partial BF) occurred in 82%of CHTN and in 63% of CHTN-DM. CONCLUSION: Although intention to BF was similar, BF initiation rates were higher for the CHTN compared to the CHTN-DM group. Exclusive BF was low in the CHTN and even lower in the CHTN-DM group signaling the need for targeted interventions if BF initiation rates are to be improved.

Objective To compare exclusive breastfeeding (BF) and BF initiation among 185 women with Type 1 and 212 women with Type 2 pregestational diabetes who intended exclusive or partial BF and delivered at ≥34 weeks of gestation. Methods Retrospective cohort study. At discharge, exclusive BF is direct BF or BF complemented with expressed breast milk. BF initiation is defined by exclusive or partial BF. Results Type 1 and Type 2 groups were similar in prior BF experience (69 vs 67%) but were different in intention to BF exclusively (92 vs 78%) and partially (8 vs 22%). Women in the Type 1 group were younger (median age 30 vs 33y), likely to be primiparous (47 vs 25%), have a lower median BMI (32 vs 36 kg/m2) and deliver by primary cesarean (37 vs 26%). Infants born to Type 1 women were more likely to be admitted to the NICU (44 vs 18%) and to have hypoglycemia (59 vs 41%). At discharge, exclusive BF among Type 1 was higher (34 vs 23%), partial BF was similar (47 vs 46%) while FF (formula feeding) was lower (19 vs 31%) than in the Type 2 group. BF initiation occurred in 81% of Type 1 and 69% of Type 2 women. Conclusion Intention to BF exclusively was higher in Type 1 women compared to Type 2. At discharge, exclusive BF and BF initiation were lower and FF higher in the Type 2 group highlighting the need for different strategies if lactation in this special population is to be improved.

Objective The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes. Study Design This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy. Participants underwent blood pressure, height, weight, and anthropometric measurements by trained nursing personnel using a standardized approach. A nurse-assisted questionnaire regarding screening and treatment of diabetes or hypercholesterolemia, diet, and physical activity was completed. Laboratory evaluation included fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel. Subsequent diabetes, metabolic syndrome, obesity, and adiposity in those diagnosed with mild GDM and randomized to nutritional counseling and medical therapy (treated) were compared with those who underwent routine pregnancy management (untreated). Multivariable analyses were performed adjusting for race/ethnicity and years between randomization and follow-up visit. Results Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy. Baseline and follow-up characteristics were similar between treatment groups. Frequency of diabetes (9.2 vs. 8.5%, p =0.80), metabolic syndrome (32.2 vs. 34.3%, p =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3, p =0.11) and BMI (29.4 vs. 29.1 kg/m2, p =0.67) were also not different. Conclusion Identification and treatment of women with mild GDM during pregnancy had no discernible impact on subsequent diabetes, metabolic syndrome, or obesity 7 years after delivery.

Background To examine whether pregnant patients have higher risk of major 30-day postoperative complications compared with their non-pregnant counterparts after non-obstetric surgery. Methods A secondary analysis of the prospective National Surgical Quality Improvement Program (NSQIP) from 2005 to 2012 of pregnant patients 18–51 years old, without surgery in the preceding 30 days, and who underwent a non-obstetrical operation. The primary outcome was composite 30-day major postoperative complications. We used modified Poisson regression. Results Among 354,251 assessed patients, 3655 (1%) were pregnant. The overall incidence of 30-day major postoperative complication was 6%, and did not vary by pregnancy status. Pregnant patients were not at higher risk of 30-day major postoperative complications compared to non-pregnant patients following non-obstetric surgery. This held for most procedures, except pregnant patients were at a higher risk of complications with colorectal and hernia surgeries. Secondarily, pregnant patients were at higher risk of transfusion. Conclusions Pregnant patients are generally not at higher risk of major postoperative complications following non-obstetric surgery. This information can be used when counseling pregnant patients about the risks versus benefits of non-obstetric surgery.

To examine whether there are racial and ethnic differences in postoperative complications after nonobstetric surgery during pregnancy in the United States.We conducted a secondary analysis of the prospective ACS NSQIP (American College of Surgeons National Surgical Quality Improvement) program from 2005 to 2012. We assessed pregnant women 18-50 years without prior surgery in the preceding 30 days who underwent a nonobstetric surgery. Race and ethnicity were categorized as non-Hispanic Black, Hispanic, and non-Hispanic White (reference). The primary outcome was a composite of 30-day major postoperative complications inclusive of cardiovascular, pulmonary, and infectious complications, reoperation, unplanned readmission, blood transfusion, and death. We used modified Poisson regression to estimate the relative risk of complications.Among 3,093 pregnant women, 18% were non-Hispanic Black, 20% Hispanic, and 62% non-Hispanic White. The most common surgeries were appendectomy (36%) and cholecystectomy (19%). Black women (18%) were more likely to be assigned American Society of Anesthesiologists (ASA) physical status class III or higher than their White (12%) or Hispanic (9%) peers. Non-Hispanic Black pregnant women had a higher risk of 30-day major postoperative complications compared with their White peers (9% vs 6%; adjusted relative risk [aRR] 1.41, 95% CI 1.11-1.99). This difference persisted when limiting the analysis to apparently healthy women (ASA class I or II) (7% vs 4%; aRR 1.64, 95% CI 1.08-2.50), those who underwent appendectomy (10% vs 3%; aRR 2.36, 95% CI 1.13-4.96), and when appendectomy and cholecystectomy were performed by laparoscopy (7% vs 3%; aRR 2.62, 95% CI 1.22-5.58). Hispanic pregnant women were not at an increased risk of complications compared with non-Hispanic pregnant White women.Pregnant non-Hispanic Black women were at higher risk of major postoperative complications after nonobstetric surgery compared with their White counterparts.

BACKGROUND Pregnancies complicated by hypertensive disease of pregnancy often require labor induction. Rates of cesarean delivery range from 15% to 60% in this population. Nitric oxide deficiency has been shown to underlay the pathophysiology of preeclampsia, and nitric oxide promotes cervical ripening. OBJECTIVE We hypothesized that addition of vaginal isosorbide mononitrate for labor induction could decrease the rate of cesarean delivery in pregnancies with hypertensive disease of pregnancy. STUDY DESIGN This study was a double-blind, placebo-controlled, randomized trial of patients with singleton pregnancy at ≥24 weeks' gestation undergoing labor induction for hypertensive diseases of pregnancy between November 2017 and February 2020. Participants were eligible if their Bishop score was

LDA triggers biosynthesis of endogenous anti-inflammatory molecules, aspirin-triggered 15-epi-lipoxin AInvestigate the effects of daily LDA on levels of 15-epi-LXASecondary analysis of multi-centered randomized controlled trial investigating effects of daily LDA (60 mg) in high-risk pregnancies. Maternal samples were drawn at three points: before LDA initiation (13-26 weeks' gestation), 24-28 weeks' gestation (at least two weeks after LDA) and 34-36 weeks' gestation. 15-epi-LXAAnalysis included 82 patients: 63 receiving daily LDA and 29 receiving daily placebo starting between 13 and 25 weeks gestation. Prior to randomization, baseline 15-epi-LXADaily LDA administration increases 15-epi-LXA

IMPORTANCE: Gestational diabetes, which increases the risk of adverse pregnancy outcomes, has been increasing in frequency across all racial and ethnic subgroups in the US. OBJECTIVE: To assess whether the frequency of adverse pregnancy outcomes among those in the US with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity. DESIGN, SETTING, AND PARTICIPANTS: Exploratory serial, cross-sectional, descriptive study using US National Center for Health Statistics natality data for 1 560 822 individuals with gestational diabetes aged 15 to 44 years with singleton nonanomalous live births from 2014 to 2020 in the US. EXPOSURES: Year of delivery and race and ethnicity, as reported on the birth certificate, stratified as non-Hispanic American Indian, non-Hispanic Asian/Pacific Islander, non-Hispanic Black, Hispanic/Latina, and non-Hispanic White (reference group). MAIN OUTCOMES AND MEASURES: Maternal outcomes of interest included cesarean delivery, primary cesarean delivery, preeclampsia or gestational hypertension, intensive care unit (ICU) admission, and transfusion; neonatal outcomes included large for gestational age (LGA), macrosomia (>4000 g at birth), small for gestational age (SGA), preterm birth, and neonatal ICU (NICU) admission, as measured by the frequency (per 1000 live births) with estimation of mean annual percentage change (APC), disparity ratios, and adjusted risk ratios. RESULTS: Of 1 560 822 included pregnant individuals with gestational diabetes (mean [SD] age, 31 [5.5] years), 1% were American Indian, 13% were Asian/Pacific Islander, 12% were Black, 27% were Hispanic/Latina, and 48% were White. From 2014 to 2020, there was a statistically significant increase in the overall frequency (mean APC per year) of preeclampsia or gestational hypertension (4.2% [95% CI, 3.3% to 5.2%]), transfusion (8.0% [95% CI, 3.8% to 12.4%]), preterm birth at less than 37 weeks (0.9% [95% CI, 0.3% to 1.5%]), and NICU admission (1.0% [95% CI, 0.3% to 1.7%]). There was a significant decrease in cesarean delivery (−1.4% [95% CI, −1.7% to −1.1%]), primary cesarean delivery (−1.2% [95% CI, −1.5% to −0.9%]), LGA (−2.3% [95% CI, −2.8% to −1.8%]), and macrosomia (−4.7% [95% CI, −5.3% to −4.0%]). There was no significant change in maternal ICU admission and SGA. In comparison with White individuals, Black individuals were at significantly increased risk of all assessed outcomes, except LGA and macrosomia; American Indian individuals were at significantly increased risk of all assessed outcomes except cesarean delivery and SGA; and Hispanic/Latina and Asian/Pacific Islander individuals were at significantly increased risk of maternal ICU admission, preterm birth, NICU admission, and SGA. Differences in adverse outcomes by race and ethnicity persisted through these years. CONCLUSIONS AND RELEVANCE: From 2014 through 2020, the frequency of multiple adverse pregnancy outcomes in the US increased among pregnant individuals with gestational diabetes. Differences in adverse outcomes by race and ethnicity persisted.

Objective We aimed to describe changes in cesarean delivery (CD) rates after the change of the one-child policy in China by using the Robson classification in a large Chinese population. Study Design This retrospective cohort study included 91,015 women who delivered at ≥24 weeks of gestation at a large tertiary obstetric center in Shanghai, China from 2011 to 2016. We analyzed CD rate trend and CD contribution trend in each Robson group. Logistic regression was used to calculate the odds of CD while adjusting for confounding variables. Results The overall CD rate decreased from 49.0% in 2011 to 40.6% in 2016. In nulliparous women with singleton cephalic term pregnancy and planned CD, the CD contribution rate was reduced significantly from 29.3% in 2011 to 16.4% in 2016 (p Conclusion The rate of cesarean delivery in our Chinese population has declined significantly in the past few years.