A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening.

BACKGROUND: Gestational diabetes mellitus is common and is associated with an increased risk of adverse maternal and perinatal outcomes. Although experts recommend universal screening for gestational diabetes, consensus is lacking about which of two recommended screening approaches should be used. METHODS: We performed a pragmatic, randomized trial comparing one-step screening (i.e., a glucose-tolerance test in which the blood glucose level was obtained after the oral administration of a 75-g glucose load in the fasting state) with two-step screening (a glucose challenge test in which the blood glucose level was obtained after the oral administration of a 50-g glucose load in the nonfasting state, followed, if positive, by an oral glucose-tolerance test with a 100-g glucose load in the fasting state) in all pregnant women who received care in two health systems. Guidelines for the treatment of gestational diabetes were consistent with the two screening approaches. The primary outcomes were a diagnosis of gestational diabetes, large-for-gestational-age infants, a perinatal composite outcome (stillbirth, neonatal death, shoulder dystocia, bone fracture, or any arm or hand nerve palsy related to birth injury), gestational hypertension or preeclampsia, and primary cesarean section. RESULTS: A total of 23,792 women underwent randomization; women with more than one pregnancy during the trial could have been assigned to more than one type of screening. A total of 66% of the women in the one-step group and 92% of those in the two-step group adhered to the assigned screening. Gestational diabetes was diagnosed in 16.5% of the women assigned to the one-step approach and in 8.5% of those assigned to the two-step approach (unadjusted relative risk, 1.94; 97.5% confidence interval [CI], 1.79 to 2.11). In intention-to-treat analyses, the respective incidences of the other primary outcomes were as follows: large-for-gestational-age infants, 8.9% and 9.2% (relative risk, 0.95; 97.5% CI, 0.87 to 1.05); perinatal composite outcome, 3.1% and 3.0% (relative risk, 1.04; 97.5% CI, 0.88 to 1.23); gestational hypertension or preeclampsia, 13.6% and 13.5% (relative risk, 1.00; 97.5% CI, 0.93 to 1.08); and primary cesarean section, 24.0% and 24.6% (relative risk, 0.98; 97.5% CI, 0.93 to 1.02). The results were materially unchanged in intention-to-treat analyses with inverse probability weighting to account for differential adherence to the screening approaches. CONCLUSIONS: Despite more diagnoses of gestational diabetes with the one-step approach than with the two-step approach, there were no significant between-group differences in the risks of the primary outcomes relating to perinatal and maternal complications. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ScreenR2GDM ClinicalTrials.gov number, NCT02266758.).

Postmenopausal bleeding after COVID-19 vaccination.

BACKGROUND: There is a growing literature base regarding menstrual changes following COVID-19 vaccination among premenopausal people. However, relatively little is known about uterine bleeding in postmenopausal people following COVID-19 vaccination. OBJECTIVE: This study aimed to examine trends in incident postmenopausal bleeding diagnoses over time before and after COVID-19 vaccine introduction, and to describe cases of new-onset postmenopausal bleeding after COVID-19 vaccination. STUDY DESIGN: For postmenopausal bleeding incidence calculations, monthly population-level cohorts consisted of female Kaiser Permanente Northwest members aged ≥45 years. Those diagnosed with incident postmenopausal bleeding in the electronic medical record were included in monthly numerators. Members with preexisting postmenopausal bleeding or abnormal uterine bleeding, or who were at increased risk of bleeding due to other health conditions, were excluded from monthly calculations. We used segmented regression analysis to estimate changes in the incidence of postmenopausal bleeding diagnoses from 2018 through 2021 in Kaiser Permanente Northwest members meeting the inclusion criteria, stratified by COVID-19 vaccination status in 2021. In addition, we identified all members with ≥1 COVID-19 vaccination between December 14, 2020 and August 14, 2021, who had an incident postmenopausal bleeding diagnosis within 60 days of vaccination. COVID-19 vaccination, diagnostic procedures, and presumed bleeding etiology were assessed through chart review and described. A temporal scan statistic was run on all cases without clear bleeding etiology. RESULTS: In a population of 75,530 to 82,693 individuals per month, there was no statistically significant difference in the rate of incident postmenopausal bleeding diagnoses before and after COVID-19 vaccine introduction (P=.59). A total of 104 individuals had incident postmenopausal bleeding diagnosed within 60 days following COVID-19 vaccination; 76% of cases (79/104) were confirmed as postvaccination postmenopausal bleeding after chart review. Median time from vaccination to bleeding onset was 21 days (range: 2-54 days). Among the 56 postmenopausal bleeding cases with a provider-attributed etiology, the common causes of bleeding were uterine or cervical lesions (50% [28/56]), hormone replacement therapy (13% [7/56]), and proliferative endometrium (13% [7/56]). Among the 23 cases without a clear etiology, there was no statistically significant clustering of postmenopausal bleeding onset following vaccination. CONCLUSION: Within this integrated health system, introduction of COVID-19 vaccines was not associated with an increase in incident postmenopausal bleeding diagnoses. Diagnosis of postmenopausal bleeding in the 60 days following receipt of a COVID-19 vaccination was rare.

Abnormal uterine bleeding diagnoses and care following COVID-19 vaccination.

BACKGROUND: There is evidence suggesting that COVID-19 vaccination may be associated with small, transitory effects on uterine bleeding, possibly including menstrual timing, flow, and duration, in some individuals. However, changes in health care seeking, diagnosis, and workup for abnormal uterine bleeding in the COVID-19 vaccine era are less clear. OBJECTIVE: This study aimed to assess the impact of COVID-19 vaccination on incident abnormal uterine bleeding diagnosis and diagnostic evaluation in a large integrated health system. STUDY DESIGN: Using segmented regression, we assessed whether the availability of COVID-19 vaccines was associated with changes in monthly, population-based rates of incident abnormal uterine bleeding diagnoses relative to the prepandemic period in health system members aged 16 to 44 years who were not menopausal. We also compared clinical and demographic characteristics of patients diagnosed with incident abnormal uterine bleeding between December 2020 and October 13, 2021 by vaccination status (never vaccinated, vaccinated in the 60 days before diagnosis, vaccinated >60 days before diagnosis). Furthermore, we conducted detailed chart review of patients diagnosed with abnormal uterine bleeding within 1 to 60 days of COVID-19 vaccination in the same time period. RESULTS: In monthly populations ranging from 79,000 to 85,000 female health system members, incidence of abnormal uterine bleeding diagnosis per 100,000 person-days ranged from 8.97 to 19.19. There was no significant change in the level or trend in the incidence of abnormal uterine bleeding diagnoses between the prepandemic (January 2019-January 2020) and post-COVID-19 vaccine (December 2020-December 2021) periods. A comparison of clinical characteristics of 2717 abnormal uterine bleeding cases by vaccination status suggested that abnormal bleeding among recently vaccinated patients was similar or less severe than abnormal bleeding among patients who had never been vaccinated or those vaccinated >60 days before. There were also significant differences in age and race of patients with incident abnormal uterine bleeding diagnoses by vaccination status (Ps<.02). Never-vaccinated patients were the youngest and those vaccinated >60 days before were the oldest. The proportion of patients who were Black/African American was highest among never-vaccinated patients, and the proportion of Asian patients was higher among vaccinated patients. Chart review of 114 confirmed postvaccination abnormal uterine bleeding cases diagnosed from December 2020 through October 13, 2021 found that the most common symptoms reported were changes in timing, duration, and volume of bleeding. Approximately one-third of cases received no diagnostic workup; 57% had no etiology for the bleeding documented in the electronic health record. In 12% of cases, the patient mentioned or asked about a possible link between their bleeding and their recent COVID-19 vaccine. CONCLUSION: The availability of COVID-19 vaccination was not associated with a change in incidence of medically attended abnormal uterine bleeding in our population of over 79,000 female patients of reproductive age. In addition, among 2717 patients with abnormal uterine bleeding diagnoses in the period following COVID-19 vaccine availability, receipt of the vaccine was not associated with greater bleeding severity.

Characterisation and validation of lactation information from structured electronic health records for use in pharmacoepidemiological studies.

BACKGROUND: Breastfeeding information stored within electronic health records (EHR) has recently been used for pharmacoepidemiological research, however the data are primarily collected for clinical care. OBJECTIVES: To characterise breastfeeding information recorded in structured fields in EHR during infant and postpartum health care visits, and to assess the validity of lactation status based on EHR data versus maternal report at research study visits. METHODS: We assessed breastfeeding information recorded in structured fields in EHR from one health system for a subset of 211 patients who were also enrolled in a study on breast milk composition between 2014 and 2017 that required participants to exclusively breastfeed their infants until at least 1 month of age. We assessed the frequency of breastfeeding information in EHR during the first 12 months of age and compared lactation status based on EHR with maternal report at 1 and 6-month study visits (reference standard). RESULTS: The median number of breastfeeding records in the EHR per infant was six (interquartile range 3) with most observations clustering in the first few weeks of life and around well-infant visits. At the 6-month study visit, 93.8% of participants were breastfeeding and 80.1% were exclusively breastfeeding according to maternal report. Sensitivity of EHR data for identifying ever breastfeeding was at or near 100%, and sensitivity for identifying ever exclusive breastfeeding was 98.0% (95% CI: 95.0%, 99.2%). Sensitivities were 97.3% (95% CI: 93.9%, 98.9%) for identifying any breastfeeding and 94.4% (95% CI: 89.7%, 97.0%) for exclusive breastfeeding, and positive predictive values were 99.5% (95% CI: 97.0%, 99.9%) for any breastfeeding and 95.0% (95% CI: 90.4%, 97.4%) for exclusive breastfeeding. CONCLUSIONS: Breastfeeding information in structured EHR fields have the potential to accurately classify lactation status. The validity of these data should be assessed in populations with a lower breastfeeding prevalence.

Pregnancy health in a multi-state U.S. population of systemically underserved patients and their children: PROMISE cohort design and baseline characteristics.

BACKGROUND: Gestational weight gain (GWG) is a routinely monitored aspect of pregnancy health, yet critical gaps remain about optimal GWG in pregnant people from socially marginalized groups, or with pre-pregnancy body mass index (BMI) in the lower or upper extremes. The PROMISE study aims to determine overall and trimester-specific GWG associated with the lowest risk of adverse birth outcomes and detrimental infant and child growth in these underrepresented subgroups. This paper presents methods used to construct the PROMISE cohort using electronic health record data from a network of community-based healthcare organizations and characterize the cohort with respect to baseline characteristics, longitudinal data availability, and GWG. METHODS: We developed an algorithm to identify and date pregnancies based on outpatient clinical data for patients 15 years or older. The cohort included pregnancies delivered in 2005-2020 with gestational age between 20 weeks, 0 days and 42 weeks, 6 days; and with known height and adequate weight measures needed to examine GWG patterns. We linked offspring data from birth records and clinical records. We defined study variables with attention to timing relative to pregnancy and clinical data collection processes. Descriptive analyses characterize the sociodemographic, baseline, and longitudinal data characteristics of the cohort, overall and within BMI categories. RESULTS: The cohort includes 77,599 pregnancies: 53% had incomes below the federal poverty level, 82% had public insurance, and the largest race and ethnicity groups were Hispanic (56%), non-Hispanic White (23%) and non-Hispanic Black (12%). Pre-pregnancy BMI groups included 2% underweight, 34% normal weight, 31% overweight, and 19%, 8%, and 5% Class I, II, and III obesity. Longitudinal data enable the calculation of trimester-specific GWG; e.g., a median of 2, 4, and 6 valid weight measures were available in the first, second, and third trimesters, respectively. Weekly rate of GWG was 0.00, 0.46, and 0.51 kg per week in the first, second, and third trimesters; differences in GWG between BMI groups were greatest in the second trimester. CONCLUSIONS: The PROMISE cohort enables characterization of GWG patterns and estimation of effects on child growth in underrepresented subgroups, ultimately improving the representativeness of GWG evidence and corresponding guidelines.

Pregnancy and weaning regulate human maternal liver size and function.

During pregnancy, the rodent liver undergoes hepatocyte proliferation and increases in size, followed by weaning-induced involution via hepatocyte cell death and stromal remodeling, creating a prometastatic niche. These data suggest a mechanism for increased liver metastasis in breast cancer patients with recent childbirth. It is unknown whether the human liver changes in size and function during pregnancy and weaning. In this study, abdominal imaging was obtained in healthy women at early and late pregnancy and postwean. During pregnancy time points, glucose production and utilization and circulating bile acids were measured. Independently of weight gain, most women's livers increased in size with pregnancy, then returned to baseline postwean. Putative roles for bile acids in liver growth and regression were observed. Together, the data support the hypothesis that the human liver is regulated by reproductive state with growth during pregnancy and volume loss postwean. These findings have implications for sex-specific liver diseases and for breast cancer outcomes.

COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion.

In the Vaccine Safety Datalink (VSD), we previously reported no association between coronavirus disease 2019 (COVID-19) vaccination in early pregnancy and spontaneous abortion (SAB). The present study aims to understand how time since vaccine rollout or other methodological factors could affect results. Using a case-control design and generalized estimating equations, we estimated the odds ratios (ORs) of COVID-19 vaccination in the 28 days before a SAB or last date of the surveillance period (index date) in ongoing pregnancies and occurrence of SAB, across cumulative 4-week periods from December 2020 through June 2021. Using data from a single site, we evaluated alternative methodological approaches: increasing the exposure window to 42 days, modifying the index date from the last day to the midpoint of the surveillance period, and constructing a cohort design with a time-dependent exposure model. A protective effect (OR = 0.78, 95% confidence interval: 0.69, 0.89), observed with 3-cumulative periods ending March 8, 2021, was attenuated when surveillance extended to June 28, 2021 (OR = 1.02, 95% confidence interval: 0.96, 1.08). We observed a lower OR for a 42-day window compared with a 28-day window. The time-dependent model showed no association. Timing of the surveillance appears to be an important factor affecting the observed vaccine-SAB association.

Screening for Hypertensive Disorders of Pregnancy: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Hypertensive disorders of pregnancy are a leading cause of pregnancy-related morbidity and mortality in the US. Objective: To conduct a targeted systematic review to update the evidence on the effectiveness of screening for hypertensive disorders of pregnancy to inform the US Preventive Services Task Force. Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials for relevant studies published between January 1, 2014, and January 4, 2022; surveillance through February 21, 2023. Study Selection: English-language comparative effectiveness studies comparing screening strategies in pregnant or postpartum individuals. Data Extraction and Synthesis: Two reviewers independently appraised articles and extracted relevant data from fair-or good-quality studies; no quantitative synthesis was conducted. Main outcomes and measures: Morbidity or mortality, measures of health-related quality of life. Results: The review included 6 fair-quality studies (5 trials and 1 nonrandomized study; N = 10 165) comparing changes in prenatal screening practices with usual care, which was routine screening at in-person office visits. No studies addressed screening for new-onset hypertensive disorders of pregnancy in the postpartum period. One trial (n = 2521) evaluated home blood pressure measurement as a supplement to usual care; 3 trials (total n = 5203) evaluated reduced prenatal visit schedules. One study (n = 2441) evaluated proteinuria screening conducted only for specific clinical indications, compared with a historical control group that received routine proteinuria screening. One additional trial (n = 80) only addressed the comparative harms of home blood pressure measurement. The studies did not report statistically significant differences in maternal and infant complications with alternate strategies compared with usual care; however, estimates were imprecise for serious, rare health outcomes. Home blood pressure measurement added to prenatal care visits was not associated with earlier diagnosis of a hypertensive disorder of pregnancy (104.3 vs 106.2 days), and incidence was not different between groups in 3 trials of reduced prenatal visit schedules. No harms of the different screening strategies were identified. Conclusions and Relevance: This review did not identify evidence that any alternative screening strategies for hypertensive disorders of pregnancy were more effective than routine blood pressure measurement at in-person prenatal visits. Morbidity and mortality from hypertensive disorders of pregnancy can be prevented, yet American Indian/Alaska Native persons and Black persons experience inequitable rates of adverse outcomes. Further research is needed to identify screening approaches that may lead to improved disease detection and health outcomes.

Changes in Visceral and Ectopic Adipose Tissue Stores Across Pregnancy and Their Relationship to Gestational Weight Gain.

BACKGROUND: Excessive gestational weight gain has been associated with increased total body fat (TBF), metabolic syndrome, and abdominal obesity. However, little is known about the relationship of gestational weight gain with changes in metabolically active visceral or ectopic (hepatic and skeletal muscle) lipid stores. OBJECTIVES: In a prospective study of 50 healthy, pregnant women, we assessed whether changes in weight were associated with changes in total, visceral, and ectopic lipid stores. METHODS: Participants (ages 19-39) were primarily White (84%). The mean preconception BMI was 25.8 kg/m2 (SD, 4.5 kg/m2; min-max, 17.1-35.9 kg/m2). Measurements were completed at visits 1 and 2 at means of 16 and 34 weeks gestation, respectively, and included TBF using BOD POD; abdominal subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) using MRI; and intrahepatic lipids (IHL), intramyocellular lipids (IMCL), and extramyocellular lipids (EMCL) using magnetic resonance spectroscopy. We used paired t-tests to examine changes in adipose tissue and Pearson's correlation to examine associations of adipose tissue changes and weight changes. We also examined whether changes in adipose tissue stores differed by preconception BMI (normal, overweight, and obese), using 1-way ANOVA. RESULTS: The TBF (mean change, +3.5 kg; 95% CI: 2.4-4.6 kg), SAT (mean change, +701 cm3; 95% CI: 421-981 cm3), VAT (mean change, +275 cm3; 95% CI: 170-379 cm3), and IHL (percentage water peak; median, +0.15; IQR = -0.01 to 0.32) values increased significantly; the IMCL and EMCL values did not change. Changes varied by BMI strata, with the least increase (or, for SAT, net loss) among women with obesity. Weight change was positively correlated with changes in TBF (r = 0.83; P < 0.001), SAT (r = 0.74; P < 0.001), and VAT (r = 0.63; P < 0.001) but not significantly correlated with changes in ectopic lipids (IHL, IMCL, and EMCL; -0.14 < r < 0.26). CONCLUSIONS: Preferential deposition of adipose tissue to the viscera in pregnancy, as seen in our sample, could serve an important metabolic function; however, excessive deposition in this region could negatively affect maternal health.

Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth - Eight Integrated Health Care Organizations, United States, December 15, 2020-July 22, 2021.

COVID-19 vaccines are recommended during pregnancy to prevent severe maternal morbidity and adverse birth outcomes; however, vaccination coverage among pregnant women has been low (1). Concerns among pregnant women regarding vaccine safety are a persistent barrier to vaccine acceptance during pregnancy. Previous studies of maternal COVID-19 vaccination and birth outcomes have been limited by small sample size (2) or lack of an unvaccinated comparison group (3). In this retrospective cohort study of live births from eight Vaccine Safety Datalink (VSD) health care organizations, risks for preterm birth (<37 weeks' gestation) and small-for-gestational-age (SGA) at birth (birthweight <10th percentile for gestational age) after COVID-19 vaccination (receipt of ≥1 COVID-19 vaccine doses) during pregnancy were evaluated. Risks for preterm and SGA at birth among vaccinated and unvaccinated pregnant women were compared, accounting for time-dependent vaccine exposures and propensity to be vaccinated. Single-gestation pregnancies with estimated start or last menstrual period during May 17-October 24, 2020, were eligible for inclusion. Among 46,079 pregnant women with live births and gestational age available, 10,064 (21.8%) received ≥1 COVID-19 vaccine doses during pregnancy and during December 15, 2020-July 22, 2021; nearly all (9,892; 98.3%) were vaccinated during the second or third trimester. COVID-19 vaccination during pregnancy was not associated with preterm birth (adjusted hazard ratio [aHR] = 0.91; 95% CI = 0.82-1.01). Among 40,627 live births with birthweight available, COVID-19 vaccination in pregnancy was not associated with SGA at birth (aHR = 0.95; 95% CI = 0.87-1.03). Results consistently showed no increased risk when stratified by mRNA COVID-19 vaccine dose, or by second or third trimester vaccination, compared with risk among unvaccinated pregnant women. Because of the small number of first-trimester exposures, aHRs for first-trimester vaccination could not be calculated. These data add to the evidence supporting the safety of COVID-19 vaccination during pregnancy. To reduce the risk for severe COVID-19-associated illness, CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future (4).

Impact of earlier gestational diabetes screening for pregnant people with obesity on maternal and perinatal outcomes.

OBJECTIVES: Gestational diabetes (GDM) screening at 24-28 weeks' gestation reduces risk of adverse maternal and perinatal outcomes. While experts recommend first-trimester screening for high-risk patients, including those with obesity, data supporting this recommendation is limited. METHODS: We implemented a systematic population intervention to encourage first-trimester GDM screening by oral glucose tolerance testing in a cohort of pregnant people with obesity in two integrated health systems from 2009 to 2013, and compared outcomes to the same population pre-intervention (2006-2009). Up to five years of postpartum glucose testing results (through 2018) were assessed among GDM cases in the post-intervention group. Primary outcomes were large-for-gestational-age birthweight (LGA); macrosomia; a perinatal composite outcome; gestational hypertension/preeclampsia; cesarean delivery; and medication treatment of GDM. RESULTS: A total of 40,206 patients (9,156 with obesity) were screened for GDM; 2,672 (6.6%) were diagnosed with GDM. Overall, multivariate adjusted risk for LGA and cesarean delivery were lower following the intervention (LGA: aOR 0.89 [0.82, 0.96]; cesarean delivery: 0.89 [0.85, 0.93]). This difference was more pronounced in patients diagnosed with GDM (LGA: aOR 0.52 [0.39, 0.70]; cesarean delivery 0.78 [0.65, 0.94]); insulin/oral hypoglycemic treatment rates for GDM were also higher post-intervention than pre-intervention (22 vs. 29%; p<0.0001). There were no differences for the other primary outcomes. Only 20% of patients diagnosed with GDM early in pregnancy who had postpartum testing had results in the overt diabetes range, suggesting a spectrum of diabetes detected early in pregnancy. CONCLUSIONS: First trimester GDM screening for pregnant people with obesity may improve GDM-associated outcomes.

Use of the Electronic Health Record to Assess Prevalence of Anemia and Iron Deficiency in Pregnancy.

BACKGROUND: In the United States, the prevalence of anemia, iron deficiency (ID), and iron-deficiency anemia (IDA) during pregnancy remains largely unknown as data at the national or state level are limited or nonexistent, respectively. OBJECTIVES: In an effort to identify opportunities to improve maternal health surveillance, we assessed the feasibility of anemia, ID, and IDA surveillance among first-trimester pregnancies using electronic health records (EHRs). METHODS: We identified pregnancies among Kaiser Permanente Northwest members aged ≥18 y during 2005-2016 with first-trimester prenatal care (n = 41,991). Earliest laboratory test results for hemoglobin or hematocrit and ferritin were selected. We describe the proportion of pregnancies screened for and the prevalence of anemia, ID, and IDA; the concordance of anemia status by hemoglobin compared with hematocrit; and the proportion of pregnancies with laboratory-confirmed anemia that also had an International Classification of Diseases diagnostic code related to anemia. RESULTS: Identified pregnancies included women who were 73.1% non-Hispanic (NH) white, 11.5% Hispanic, 8.5% NH Asian/Pacific Islander, and 2.9% NH black. Hemoglobin and hematocrit results were available for 92.7% (n = 38,923) pregnancies. Anemia prevalence was 2.7% (n = 1045) based on hemoglobin <11.0 g/dL or hematocrit <33%;  45.2% of anemia cases had both low hemoglobin and low hematocrit. Among pregnancies with anemia, 18.9% (n = 197) had a ferritin result; of those, 48.2% had ID (ferritin <15 µg/L). In pregnancies without anemia, 3.4% (n = 1275) had a ferritin result; of those, 23.5% had ID. Based on 1472 pregnancies with both anemia and ID assessed, prevalence of ID and IDA was 26.8% and 6.5%, respectively; estimates likely represent selective screening. CONCLUSIONS: EHR data have potential to monitor anemia prevalence and trends in health systems where prenatal anemia screening is nearly universal. However, if iron assessment is not routine, then representative estimates of ID or IDA are unattainable.

Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial.

BACKGROUND: Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of prepregnancy weight loss on health outcomes. OBJECTIVE: This study aimed to determine whether prepregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes. STUDY DESIGN: Pragmatic randomized clinical trial was conducted between May 2015 and October 2019 at Kaiser Permanente Northwest, an integrated health system. Data collection was blind to condition assignment. Eligible participants were women aged 18 to 40 years with a body mass index of ≥27 kg/m2 who were planning pregnancy within 2 years. Recruitment contacts were sent to 27,665 health system members who met age and body mass index criteria; 329 women attended screening visits, and 326 were randomized. They were randomized to either a behavioral weight loss intervention or usual care control. The intervention consisted of health coaching phone sessions weekly for 6 months and then monthly for 18 months or until end of pregnancy. We used logistic regression to examine the a priori primary hypothesis that participants in the intervention would be less likely to exceed National Academy of Medicine guidelines for gestational weight gain during each trimester and overall. Secondary and exploratory outcomes included absolute weight gain before and during pregnancy and perinatal and newborn outcomes. RESULTS: Of the 326 participants, 169 had singleton pregnancies lasting ≥14 weeks (analytical cohort: intervention, 89; control, 80). At baseline, mean age was 31.3±3.5 years, and body mass index was 34.8±5.8 kg/m2. Participants in the intervention group lost more weight before pregnancy than those in the control group (-0.25±0.51 vs -0.03±0.21 kg/wk; P<.001). However, participants in the intervention group gained more weight than those in the control group in the second trimester (0.42±0.26 vs 0.33±0.28 kg/wk; P=.04) and third trimester (0.56±0.37 vs 0.43±0.33 kg/wk; P=.02) and overall (13.2±8.20 vs 10.3±7.41 kg; P=.03). Nevertheless, arms did not differ in rates of exceeding gestational weight gain guidelines at any time point. Spontaneous pregnancy loss was less common in the intervention arm than in the control arm (8 [4.9%] vs 19 [11.8%]; odds ratio, 0.39 [0.16-0.92]), but we found no other differences in the secondary or exploratory outcomes. CONCLUSION: Participation in the prepregnancy weight loss intervention had no effect on women's likelihood of exceeding gestational weight gain guidelines. Although the intervention group successfully lost weight before conception, the intervention group was associated with greater weight gain in late pregnancy. To effectively reduce weight throughout pregnancy and improve maternal and child outcomes, prepregnancy weight loss interventions may need to be combined with intensive weight management that continues throughout delivery.

Improving management of the genitourinary syndrome of menopause: evaluation of a health system-based, cluster-randomized intervention.

BACKGROUND: Genitourinary symptoms are common in postmenopausal women and adversely affect the quality of life. National surveys and data collected from our healthcare system indicate that postmenopausal women with the genitourinary syndrome of menopause often fail to receive appropriate diagnosis or treatment. OBJECTIVE: To promote greater detection and treatment of the genitourinary syndrome of menopause, we created and tested a clinician-focused health system intervention that included clinician education sessions and a suite of evidence-based electronic health record tools. STUDY DESIGN: Using a cluster-randomized design, we allocated primary care (16) and gynecology (6) clinics to the intervention or control group. From September to November 2014, we provided training about the diagnosis and treatment of genitourinary syndrome of menopause in face-to-face presentations at each intervention clinic and in an online video. We developed clinical decision support tools in the electronic health record that contained an evidence-based, point-of-care knowledge resource, a standardized order set, and a checklist of patient education materials for the patient's after visit summary. The tools aimed to facilitate accurate diagnostic coding and prescribing (SmartSet, SmartRx) along with relevant patient information (SmartText). Clinicians who only performed visits at control clinics received no training or notification about the tools. Our primary outcome was vulvovaginal diagnoses made at well visits for women at the age of 55 years and older from November 15, 2014 to November 15, 2015. We also assessed urinary diagnoses, vaginal estrogen prescriptions, and use of the electronic tools. There was departmental support for the intervention but no prioritization within the healthcare system to incentivize change. RESULTS: In the 1-year period, 386 clinicians performed 14,921 well visits for women at the age of 55 years and older. Among the 190 clinicians who performed well visits in the intervention clinics, 109 (57.4%) completed either in-person or online educational training. The proportion of visits that included a vulvovaginal (7.2% vs 5.8%; odds ratio, 1.27; 95% confidence interval, 0.65-2.51) or urinary diagnosis (2.5% vs 3.1%; odds ratio, 0.79; 95% confidence interval, 0.55-1.13) or vaginal estrogen prescription (4.5% vs 3.7%; odds ratio, 1.24; 95% confidence interval, 0.63-2.46) did not differ between study arms. There was a significant interaction for primary care and gynecology, which revealed more vulvovaginal diagnoses by gynecology but not primary care intervention clinics (odds ratio, 1.63; 95% confidence interval, 1.15-2.31), but there was no significant interaction for prescriptions. Clinicians in the intervention clinics were more likely to use decision support tools than those in control clinics-SmartSet (22.2% vs 1.5%; odds ratio, 18.8; 95% confidence interval, 5.5-63.8) and SmartText for patient information (38.0% vs 24.4%; odds ratio, 1.91; 95% confidence interval, 1.10-3.34). A per-protocol analysis revealed similar findings. CONCLUSION: Overall, the intervention did not lead to more diagnoses or prescription therapy for postmenopausal genitourinary symptoms but did result in greater distribution of patient information. Gynecology clinicians were more likely to address genitourinary symptoms generally and were more likely to make a vulvovaginal diagnosis after the intervention. Further efforts for improving care should consider ongoing clinician education beginning with enhanced menopause curricula in residency training. Additional interventions to consider include greater access for postmenopausal women to gynecologic care, addressing treatment barriers, and development of national performance metrics.

COVID-19 Vaccination Coverage Among Pregnant Women During Pregnancy - Eight Integrated Health Care Organizations, United States, December 14, 2020-May 8, 2021.

COVID-19 vaccines are critical for ending the COVID-19 pandemic; however, current data about vaccination coverage and safety in pregnant women are limited. Pregnant women are at increased risk for severe illness and death from COVID-19 compared with nonpregnant women of reproductive age, and are at risk for adverse pregnancy outcomes, such as preterm birth (1-4). Pregnant women are eligible for and can receive any of the three COVID-19 vaccines available in the United States via Emergency Use Authorization.* Data from Vaccine Safety Datalink (VSD), a collaboration between CDC and multiple integrated health systems, were analyzed to assess receipt of ≥1 dose (first or second dose of the Pfizer-BioNTech or Moderna vaccines or a single dose of the Janssen [Johnson & Johnson] vaccine) of any COVID-19 vaccine during pregnancy, receipt of first dose of a 2-dose COVID-19 vaccine (initiation), or completion of a 1- or 2-dose COVID-19 vaccination series. During December 14, 2020-May 8, 2021, a total of 135,968 pregnant women were identified, 22,197 (16.3%) of whom had received ≥1 dose of a vaccine during pregnancy. Among these 135,968 women, 7,154 (5.3%) had initiated and 15,043 (11.1%) had completed vaccination during pregnancy. Receipt of ≥1 dose of COVID-19 vaccine during pregnancy was highest among women aged 35-49 years (22.7%) and lowest among those aged 18-24 years (5.5%), and higher among non-Hispanic Asian (Asian) (24.7%) and non-Hispanic White (White) women (19.7%) than among Hispanic (11.9%) and non-Hispanic Black (Black) women (6.0%). Vaccination coverage increased among all racial and ethnic groups over the analytic period, likely because of increased eligibility for vaccination† and increased availability of vaccine over time. These findings indicate the need for improved outreach to and engagement with pregnant women, especially those from racial and ethnic minority groups who might be at higher risk for severe health outcomes because of COVID-19 (4). In addition, providing accurate and timely information about COVID-19 vaccination to health care providers, pregnant women, and women of reproductive age can improve vaccine confidence and coverage by ensuring optimal shared clinical decision-making.

Bias in Self-reported Prepregnancy Weight Across Maternal and Clinical Characteristics.

OBJECTIVES: Prepregnancy body mass index (BMI) and gestational weight gain (GWG) are known determinants of maternal and child health; calculating both requires an accurate measure of prepregnancy weight. We compared self-reported prepregnancy weight to measured weights to assess reporting bias by maternal and clinical characteristics. METHODS: We conducted a retrospective cohort study among pregnant women using electronic health records (EHR) data from Kaiser Permanente Northwest, a non-profit integrated health care system in Oregon and southwest Washington State. We identified women age ≥ 18 years who were pregnant between 2000 and 2010 with self-reported prepregnancy weight, ≥ 2 measured weights between ≤ 365-days-prior-to and ≤ 42-days-after conception, and measured height in their EHR. We compared absolute and relative difference between self-reported weight and two "gold-standards": (1) weight measured closest to conception, and (2) usual weight (mean of weights measured 6-months-prior-to and ≤ 42-days-after conception). Generalized-estimating equations were used to assess predictors of misreport controlling for covariates, which were obtained from the EHR or linkage to birth certificate. RESULTS: Among the 16,227 included pregnancies, close agreement (± 1 kg or ≤ 2%) between self-reported and closest-measured weight was 44% and 59%, respectively. Overall, self-reported weight averaged 1.3 kg (SD 3.8) less than measured weight. Underreporting was higher among women with elevated BMI category, late prenatal care entry, and pregnancy outcome other than live/stillbirth (p < .05). Using self-reported weight, BMI was correctly classified for 91% of pregnancies, but ranged from 70 to 98% among those with underweight or obesity, respectively. Results were similar using usual weight as gold standard. CONCLUSIONS FOR PRACTICE: Accurate measure of prepregnancy weight is essential for clinical guidance and surveillance efforts that monitor maternal health and evaluate public-health programs. Identification of characteristics associated with misreport of self-reported weight can inform understanding of bias when assessing the influence of prepregnancy BMI or GWG on health outcomes.

Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Preeclampsia is a hypertensive disorder of pregnancy that poses serious maternal and infant health risks. Previous systematic reviews have established benefits of low-dose aspirin taken during pregnancy to prevent preeclampsia and its sequelae. Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of aspirin use in preventing preeclampsia in individuals at increased risk based on clinical risk factors or measurements associated with higher disease incidence than in the general population. Data Sources: Studies from previous USPSTF review (2014), literature published January 2013 through May 15, 2020, in MEDLINE, PubMed (for publisher-supplied records only), EMBASE, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through January 22, 2021. Study Selection: Good- and fair-quality randomized clinical trials (RCTs) of low-dose aspirin use during pregnancy to prevent preeclampsia among individuals at increased risk; studies conducted in general populations to evaluate potential harms. Data Extraction and Synthesis: Dual article screening and risk-of-bias assessment. Study data abstracted into prespecified forms, checked for accuracy. Random-effects meta-analysis. Main Outcomes and Measures: Diagnosis of preeclampsia; adverse pregnancy health outcomes and complications including eclampsia, perinatal mortality, preterm birth, small for gestational age, and potential bleeding harms or infant/child harms from aspirin exposure. Results: A total of 23 randomized clinical trials (RCTs) (N = 26 952) were included; 18 were conducted among participants at increased preeclampsia risk. Aspirin dosages ranged from 50 mg/d to 150 mg/d. Most trials enrolled majority White populations selected based on a range of risk factors. The incidence of preeclampsia among the trials of participants at increased risk ranged from 4% to 30%. Aspirin use was significantly associated with lower risk of preeclampsia (pooled relative risk [RR], 0.85 [95% CI, 0.75-0.95]; 16 RCTs [n = 14 093]; I2 = 0%), perinatal mortality (pooled RR, 0.79 [95% CI, 0.66-0.96]; 11 RCTs [n = 13 860]; I2 = 0%), preterm birth (pooled RR, 0.80 [95% CI, 0.67-0.95]; 13 RCTs [n = 13 619]; I2 = 49%), and intrauterine growth restriction (pooled RR, 0.82 [95% CI, 0.68-0.99]; 16 RCTs [n = 14 385]; I2 = 41%). There were no significant associations of aspirin use with risk of postpartum hemorrhage (pooled RR, 1.03 [95% CI, 0.94-1.12]; 9 RCTs [n = 23 133]; I2 = 0%) and other bleeding-related harms, or with rare perinatal or longer-term harms. Absolute risk reductions for preeclampsia associated with aspirin use ranged from -1% to -6% across larger trials (n >300) and were greater in smaller trials. For perinatal mortality, absolute risk reductions ranged from 0.5% to 1.1% in the 3 largest trials. Conclusions and Relevance: Daily low-dose aspirin during pregnancy was associated with lower risks of serious perinatal outcomes for individuals at increased risk for preeclampsia, without evident harms.

Costs of Severe Maternal Morbidity During Pregnancy in US Commercially Insured and Medicaid Populations: An Observational Study.

OBJECTIVE: To estimate the maternity-related cost of health care services in women with and without severe maternal morbidity (SMM). METHODS: Women with a live inpatient birth in the calendar year 2013 were identified in the MarketScan® Commercial and Medicaid health insurance claims databases. Costs were defined as the amounts paid by insurers plus out-of-pocket and third-party payments. Costs were calculated as total maternity-related costs and categorized as prenatal, delivery, and postpartum costs. SMM was identified using the CDC algorithm of 25 ICD-9 diagnostic and procedural codes. Variables associated with higher delivery costs were determined by multivariable linear regression analysis. RESULTS: A total of 750 women met the criteria for SMM in the Commercial population. The total, per-patient mean costs of care for women without and with SMM were $14,840 and $20,380, respectively. Delivery hospitalization costs were 76-77% of total mean costs for women without and with SMM. A total of 99 women met the criteria for SMM in the Medicaid population. The total, per-patient mean costs of care for women without and with SMM were $6894 and $10,134, respectively. Delivery costs were 71-72% of total costs. Variables independently predictive of increased delivery costs in both Commercial and Medicaid populations were delivery by cesarean section, multifetal gestation, gestational hypertension/preeclampsia, and obstetric infection. CONCLUSIONS: The occurrence of SMM was associated with an increase in maternity-related costs of 37% in the Commercial and 47% in the Medicaid population. Some of the factors associated with increased delivery hospitalization costs may be prevented.