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OBJECTIVE: The objective of this study was to estimate the effects of trimester-specific gestational weight gain (GWG) on small and large (compared with appropriate) for gestational age (i.e., SGA, LGA, and AGA) by prepregnancy BMI classifications. METHODS: We conducted a cohort study of pregnancies in a national network of community health care organizations, stratifying by prepregnancy BMI (n = 20,676 with normal weight; 19,156 with overweight; 11,647 with obesity class I; 5124 with obesity class II; and 3197 with obesity class III). SGA and LGA (vs. AGA) were modeled as a function of trimester 1, 2, or 3 GWG rate, previous trimester(s) GWG rate, and maternal characteristics using modified Poisson regression. RESULTS: GWG rates ranged from weight loss to substantial gains. GWG-LGA associations were strongest in trimester 1 (risk ratio [RR] range for 10th vs. 50th percentile GWG, across BMI categories: 0.60-0.73). GWG-SGA associations were strongest in lower BMI categories and in trimester 2; RRs were 1.62, 1.40, and 1.17 for prepregnancy normal weight, obesity class I, and obesity class III, respectively, with curvilinear associations for class II and III. CONCLUSIONS: Among people with prepregnancy obesity class II or III, GWG rate is associated with higher LGA risk in a dose-dependent manner, including understudied ranges of weight loss, but with weak associations with SGA.
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Peso al Nacer , Índice de Masa Corporal , Ganancia de Peso Gestacional , Obesidad , Pérdida de Peso , Humanos , Femenino , Embarazo , Adulto , Obesidad/epidemiología , Obesidad/fisiopatología , Obesidad/complicaciones , Recién Nacido , Estudios de Cohortes , Trimestres del Embarazo , Recién Nacido Pequeño para la Edad Gestacional , Complicaciones del Embarazo/epidemiología , Complicaciones del Embarazo/fisiopatología , Sobrepeso/epidemiología , Adulto Joven , Edad GestacionalRESUMEN
Importance: COVID-19 vaccination is recommended throughout pregnancy to prevent pregnancy complications and adverse birth outcomes associated with COVID-19 disease. To date, data on birth defects after first-trimester vaccination are limited. Objective: To evaluate the associated risks for selected major structural birth defects among live-born infants after first-trimester receipt of a messenger RNA (mRNA) COVID-19 vaccine. Design, Setting, and Participants: This was a retrospective cohort study of singleton pregnancies with estimated last menstrual period (LMP) between September 13, 2020, and April 3, 2021, and ending in live birth from March 5, 2021, to January 25, 2022. Included were data from 8 health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin in the Vaccine Safety Datalink. Exposures: Receipt of 1 or 2 mRNA COVID-19 vaccine doses in the first trimester, as part of the primary series. Main Outcomes and Measures: Selected major structural birth defects among live-born infants, identified from electronic health data using validated algorithms, with neural tube defects confirmed via medical record review. Results: Among 42â¯156 eligible pregnancies (mean [SD] maternal age, 30.9 [5.0] years) 7632 (18.1%) received an mRNA COVID-19 vaccine in the first trimester. Of 34â¯524 pregnancies without a first-trimester COVID-19 vaccination, 2045 (5.9%) were vaccinated before pregnancy, 13â¯494 (39.1%) during the second or third trimester, and 18â¯985 (55.0%) were unvaccinated before or during pregnancy. Compared with pregnant people unvaccinated in the first trimester, those vaccinated in the first trimester were older (mean [SD] age, 32.3 [4.5] years vs 30.6 [5.1] years) and differed by LMP date. After applying stabilized inverse probability weighting, differences in baseline characteristics between vaccinated and unvaccinated pregnant persons in the first trimester were negligible (standardized mean difference <0.20). Selected major structural birth defects occurred in 113 infants (1.48%) after first-trimester mRNA COVID-19 vaccination and in 488 infants (1.41%) without first-trimester vaccine exposure; the adjusted prevalence ratio was 1.02 (95% CI, 0.78-1.33). In secondary analyses, with major structural birth defect outcomes grouped by organ system, no significant differences between infants vaccinated or unvaccinated in the first trimester were identified. Conclusions and Relevance: In this multisite cohort study, among live-born infants, first-trimester mRNA COVID-19 vaccine exposure was not associated with an increased risk for selected major structural birth defects.
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Vacunas contra la COVID-19 , COVID-19 , Primer Trimestre del Embarazo , Humanos , Femenino , Embarazo , Estudios Retrospectivos , Adulto , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , COVID-19/epidemiología , Recién Nacido , Anomalías Congénitas/epidemiología , Anomalías Congénitas/prevención & control , Nacimiento Vivo/epidemiología , Vacunación/efectos adversos , Vacunación/estadística & datos numéricos , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: Coronavirus disease 2019 (COVID-19) vaccination is recommended in pregnancy to reduce the risk of severe morbidity from COVID-19. However, vaccine hesitancy persists among pregnant people, with risk of stillbirth being a primary concern. Our objective was to examine the association between COVID-19 vaccination and stillbirth. METHODS: We performed a matched case-control study in the Vaccine Safety Datalink (VSD). Stillbirths and live births were selected from singleton pregnancies among persons aged 16-49 years with at least one prenatal, delivery, or postpartum visit at eight participating VSD sites. Stillbirths identified through diagnostic codes were adjudicated to confirm the outcome, date, and gestational age at fetal death. Confirmed antepartum stillbirths that occurred between February 14, 2021, and February 27, 2022, then were matched 1:3 to live births by pregnancy start date, VSD site, and maternal age at delivery. Associations among antepartum stillbirth and COVID-19 vaccination in pregnancy, vaccine manufacturer, number of vaccine doses received, and vaccination within 6 weeks before stillbirth (or index date in live births) were evaluated using conditional logistic regression. RESULTS: In the matched analysis of 276 confirmed antepartum stillbirths and 822 live births, we found no association between COVID-19 vaccination during pregnancy and stillbirth (38.4% stillbirths vs 39.3% live births in vaccinated individuals, adjusted odds ratio [aOR] 1.02, 95% CI, 0.76-1.37). Furthermore, no association between COVID-19 vaccination and stillbirth was detected by vaccine manufacturer (Moderna: aOR 1.00, 95% CI, 0.62-1.62; Pfizer-BioNTech: aOR 1.00, 95% CI, 0.69-1.43), number of vaccine doses received during pregnancy (1 vs 0: aOR 1.17, 95% CI, 0.75-1.83; 2 vs 0: aOR 0.98, 95% CI, 0.81-1.17), or COVID-19 vaccination within the 6 weeks before stillbirth or index date compared with no vaccination (aOR 1.16, 95% CI, 0.74-1.83). CONCLUSION: No association was found between COVID-19 vaccination and stillbirth. These findings further support recommendations for COVID-19 vaccination in pregnancy.
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Vacunas contra la COVID-19 , COVID-19 , Mortinato , Humanos , Mortinato/epidemiología , Femenino , Embarazo , Adulto , Estudios de Casos y Controles , COVID-19/prevención & control , COVID-19/epidemiología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Adolescente , Adulto Joven , Persona de Mediana Edad , Complicaciones Infecciosas del Embarazo/prevención & control , SARS-CoV-2 , Vacunación/efectos adversos , Vacunación/estadística & datos numéricos , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: To evaluate the association between antenatal messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccination and risk of adverse pregnancy outcomes. METHODS: This was a retrospective cohort study of individuals with singleton pregnancies with live deliveries between June 1, 2021, and January 31, 2022, with data available from eight integrated health care systems in the Vaccine Safety Datalink. Vaccine exposure was defined as receipt of one or two mRNA COVID-19 vaccine doses (primary series) during pregnancy. Outcomes were preterm birth (PTB) before 37 weeks of gestation, small-for-gestational age (SGA) neonates, gestational diabetes mellitus (GDM), gestational hypertension, and preeclampsia-eclampsia-HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Outcomes in individuals vaccinated were compared with those in propensity-matched individuals with unexposed pregnancies. Adjusted hazard ratios (aHRs) and 95% CIs were estimated for PTB and SGA using a time-dependent covariate Cox model, and adjusted relative risks (aRRs) were estimated for GDM, gestational hypertension, and preeclampsia-eclampsia-HELLP syndrome using Poisson regression with robust variance. RESULTS: Among 55,591 individuals eligible for inclusion, 23,517 (42.3%) received one or two mRNA COVID-19 vaccine doses during pregnancy. Receipt of mRNA COVID-19 vaccination varied by maternal age, race, Hispanic ethnicity, and history of COVID-19. Compared with no vaccination, mRNA COVID-19 vaccination was associated with a decreased risk of PTB (rate: 6.4 [vaccinated] vs 7.7 [unvaccinated] per 100, aHR 0.89; 95% CI, 0.83-0.94). Messenger RNA COVID-19 vaccination was not associated with SGA (8.3 vs 7.4 per 100; aHR 1.06, 95% CI, 0.99-1.13), GDM (11.9 vs 10.6 per 100; aRR 1.00, 95% CI, 0.90-1.10), gestational hypertension (10.8 vs 9.9 per 100; aRR 1.08, 95% CI, 0.96-1.22), or preeclampsia-eclampsia-HELLP syndrome (8.9 vs 8.4 per 100; aRR 1.10, 95% CI, 0.97-1.24). CONCLUSION: Receipt of an mRNA COVID-19 vaccine during pregnancy was not associated with an increased risk of adverse pregnancy outcomes; this information will be helpful for patients and clinicians when considering COVID-19 vaccination in pregnancy.
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Vacunas contra la COVID-19 , COVID-19 , Resultado del Embarazo , Humanos , Femenino , Embarazo , Adulto , Estudios Retrospectivos , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , COVID-19/epidemiología , Recién Nacido , Nacimiento Prematuro/epidemiología , SARS-CoV-2 , Complicaciones Infecciosas del Embarazo/prevención & control , Recién Nacido Pequeño para la Edad Gestacional , Adulto Joven , Vacunación/estadística & datos numéricosRESUMEN
BACKGROUND: Lifestyle choices, metformin, and dietary supplements may prevent GDM, but the effect of intervention characteristics has not been identified. This review evaluated intervention characteristics to inform the implementation of GDM prevention interventions. METHODS: Ovid, MEDLINE/PubMed, and EMBASE databases were searched. The Template for Intervention Description and Replication (TIDieR) framework was used to examine intervention characteristics (who, what, when, where, and how). Subgroup analysis was performed by intervention characteristics. RESULTS: 116 studies involving 40,940 participants are included. Group-based physical activity interventions (RR 0.66; 95% CI 0.46, 0.95) reduce the incidence of GDM compared with individual or mixed (individual and group) delivery format (subgroup p-value = 0.04). Physical activity interventions delivered at healthcare facilities reduce the risk of GDM (RR 0.59; 95% CI 0.49, 0.72) compared with home-based interventions (subgroup p-value = 0.03). No other intervention characteristics impact the effectiveness of all other interventions. CONCLUSIONS: Dietary, physical activity, diet plus physical activity, metformin, and myoinositol interventions reduce the incidence of GDM compared with control interventions. Group and healthcare facility-based physical activity interventions show better effectiveness in preventing GDM than individual and community-based interventions. Other intervention characteristics (e.g. utilization of e-health) don't impact the effectiveness of lifestyle interventions, and thus, interventions may require consideration of the local context.
The effect of any given intervention to prevent gestational diabetes (high blood sugar levels that arise during pregnancy) may depend on the way it is delivered (how, when, what, etc). This study reviewed published literature to investigate if the effects of interventions (diet, exercise, metformin, probiotics, myoinositol) to prevent gestational diabetes differ according to the way it is being delivered (e.g., online vs in-person, by health professionals or others, etc.). Exercise delivered to group settings, or those delivered at a healthcare facility worked better to prevent gestational diabetes. Although we did not observe any differences with other delivery characteristics (e.g., online vs in-person), it does not mean they are always equally effective, it is important to consider individual situations when prescribing or developing interventions.
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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.
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Lactancia Materna , Registros Electrónicos de Salud , Lactancia , Farmacoepidemiología , Humanos , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Lactancia Materna/estadística & datos numéricos , Lactancia/fisiología , Adulto , Farmacoepidemiología/métodos , Recién Nacido , Lactante , Leche Humana/química , Reproducibilidad de los ResultadosRESUMEN
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.
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Ganancia de Peso Gestacional , Complicaciones del Embarazo , Embarazo , Niño , Femenino , Humanos , Recién Nacido , Poblaciones Vulnerables , Obesidad/epidemiología , Sobrepeso/epidemiología , Tercer Trimestre del Embarazo , Índice de Masa Corporal , Complicaciones del Embarazo/epidemiología , Resultado del Embarazo/epidemiologíaRESUMEN
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.
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Vacunas contra la COVID-19 , COVID-19 , Hemorragia Uterina , Humanos , Femenino , Vacunas contra la COVID-19/efectos adversos , Adulto , Hemorragia Uterina/etiología , Adulto Joven , COVID-19/prevención & control , COVID-19/complicaciones , Adolescente , Incidencia , SARS-CoV-2 , Vacunación/efectos adversos , Vacunación/estadística & datos numéricosRESUMEN
OBJECTIVE: Surveys of residents in obstetrics and gynecology, internal medicine, and family medicine have demonstrated low levels of knowledge and comfort in treating patients with menopausal symptoms, suggesting a need for improved training during residency. To address this problem, we used a flipped classroom design to deliver a novel menopause curriculum for medical residents. The curriculum included six podcast episodes followed by an interactive case-based classroom session. We then assessed effects of the curriculum on the residents' knowledge and preparedness to manage menopause symptoms. METHODS: We targeted 200 residents (43 obstetrics and gynecology, 86 internal medicine, and 71 family medicine) from six residency programs from 2019 to 2020. Of these, 115 (58%) completed both pre- and postcurriculum assessments, including a 15-item knowledge test and self-ratings of their knowledge, comfort, and preparedness to manage menopause. RESULTS: Following the curriculum, the proportion of correctly answered knowledge questions rose from 60.8% to 79.1% (+18.3%; 95% confidence interval, 15.4-21.2; Cohen's d = 1.2). Improvement did not significantly differ by specialty or year of residency. There were higher gains for residents who listened to the entirety of all six podcast episodes ( b = 11.4, P < 0.001) and who attended the classroom session ( b = 11.6, P = 0.003). Residents' self-ratings of knowledge, comfort, and preparedness also improved following the curriculum across all medical specialties (Cohen's d = 0.47-1.2). Residents rated the podcast format as convenient (73%) and effective (65%) compared with an equivalent amount of reading. CONCLUSIONS: Pairing a podcast with a classroom discussion was found to be an effective combination for improving menopause knowledge.
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Ginecología , Internado y Residencia , Obstetricia , Femenino , Embarazo , Humanos , Competencia Clínica , Ginecología/educación , Curriculum , Obstetricia/educación , MenopausiaRESUMEN
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.
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Vacunas contra la COVID-19 , COVID-19 , Humanos , Femenino , Vacunas contra la COVID-19/efectos adversos , Posmenopausia , COVID-19/epidemiología , COVID-19/prevención & control , COVID-19/complicaciones , Hemorragia Uterina/epidemiología , Hemorragia Uterina/etiología , Vacunación/efectos adversosRESUMEN
OBJECTIVE: To describe insurance patterns and discontinuity during pregnancy, which may affect the experiences of the pregnant person: their timely access to care, continuity of care, and health outcomes. DATA SOURCES AND STUDY SETTING: Data are from the PROMISE study, which utilizes data from community-based health care organizations (CHCOs) (e.g., federally qualified health centers that serve patients regardless of insurance status or ability to pay) in the United States from 2005 to 2021. STUDY DESIGN: This descriptive study was a cohort utilizing longitudinal electronic health record data. DATA COLLECTION/EXTRACTION METHODS: Insurance type at each encounter was recorded in the clinical database and coded as Private, Public, and Uninsured. Pregnant people were categorized into one of several insurance patterns. We analyzed the frequency and timing of insurance changes and care utilization within each group. PRINCIPAL FINDINGS: Continuous public insurance was the most common insurance pattern (69.2%), followed by uninsured/public discontinuity (11.8%), with 6.4% experiencing uninsurance throughout the entirety of pregnancy. Insurance discontinuity was experienced by 16.6% of pregnant people; a majority of these reflect people transitioning to public insurance. Those with continuous public insurance had the highest frequency of inadequate prenatal care (19.5%), while those with all three types of insurance during pregnancy had the highest percentage of intensive prenatal care (16.5%). The majority (71.7%-81.2%) of those with a discontinuous pattern experienced a single insurance change. CONCLUSIONS: Insurance discontinuity and uninsurance are common within our population of pregnant people seeking care at CHCOs. Our findings suggest that insurance status should be regarded as a dynamic rather than a static characteristic during pregnancy and should be measured accordingly. Future research is needed to assess the drivers of perinatal insurance discontinuity and if and how these discontinuities may affect health care access, utilization, and birth outcomes.
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Seguro de Salud , Pacientes no Asegurados , Femenino , Humanos , Embarazo , Estados Unidos , Cobertura del Seguro , Accesibilidad a los Servicios de Salud , Servicios de Salud ComunitariaRESUMEN
BACKGROUND: Precision prevention involves using the unique characteristics of a particular group to determine their responses to preventive interventions. This study aimed to systematically evaluate the participant characteristics associated with responses to interventions in gestational diabetes mellitus (GDM) prevention. METHODS: We searched MEDLINE, EMBASE, and Pubmed to identify lifestyle (diet, physical activity, or both), metformin, myoinositol/inositol and probiotics interventions of GDM prevention published up to May 24, 2022. RESULTS: From 10347 studies, 116 studies (n = 40940 women) are included. Physical activity results in greater GDM reduction in participants with a normal body mass index (BMI) at baseline compared to obese BMI (risk ratio, 95% confidence interval: 0.06 [0.03, 0.14] vs 0.68 [0.26, 1.60]). Combined diet and physical activity interventions result in greater GDM reduction in participants without polycystic ovary syndrome (PCOS) than those with PCOS (0.62 [0.47, 0.82] vs 1.12 [0.78-1.61]) and in those without a history of GDM than those with unspecified GDM history (0.62 [0.47, 0.81] vs 0.85 [0.76, 0.95]). Metformin interventions are more effective in participants with PCOS than those with unspecified status (0.38 [0.19, 0.74] vs 0.59 [0.25, 1.43]), or when commenced preconception than during pregnancy (0.21 [0.11, 0.40] vs 1.15 [0.86-1.55]). Parity, history of having a large-for-gestational-age infant or family history of diabetes have no effect on intervention responses. CONCLUSIONS: GDM prevention through metformin or lifestyle differs according to some individual characteristics. Future research should include trials commencing preconception and provide results disaggregated by a priori defined participant characteristics including social and environmental factors, clinical traits, and other novel risk factors to predict GDM prevention through interventions.
An individual's characteristics, such as medical, biochemical, social, and behavioural may affect their response to interventions aimed at preventing gestational diabetes, which occurs during pregnancy. Here, we evaluated the published literature on interventions such as diet, lifestyle, drug treatment and nutritional supplement and looked at which individual participant characteristics were associated with response to these interventions. Certain participant characteristics were associated with greater prevention of gestational diabetes through particular treatments. Some interventions were more effective when started prior to conception. Future studies should consider individual characteristics when assessing the effects of preventative measures.
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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 = 10â¯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.
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Determinación de la Presión Sanguínea , Hipertensión Inducida en el Embarazo , Femenino , Humanos , Lactante , Embarazo , Comités Consultivos , Hipertensión Inducida en el Embarazo/diagnóstico , Calidad de Vida , Estados Unidos , Resultado del Embarazo , Negro o Afroamericano , Indio Americano o Nativo de AlaskaRESUMEN
Background and aims: Precision prevention involves using the unique characteristics of a particular group to determine their responses to preventive interventions. This study aimed to systematically evaluate the participant characteristics associated with interventions in gestational diabetes mellitus (GDM) prevention. Methods: We searched MEDLINE, EMBASE, and Pubmed to identify lifestyle (diet, physical activity, or both), metformin, myoinositol/inositol and probiotics interventions of GDM prevention published up to May 24, 2022. Results: From 10347 studies, 116 studies (n=40940 women) were included. Physical activity resulted in greater GDM reduction in participants with a normal body mass index (BMI) at baseline compared to obese BMI (risk ratio, 95% confidence interval: 0.06 [0.03, 0.14] vs 0.68 [0.26, 1.60]). Diet and physical activity interventions resulted in greater GDM reduction in participants without polycystic ovary syndrome (PCOS) than those with PCOS (0.62 [0.47, 0.82] vs 1.12 [0.78-1.61]) and in those without a history of GDM than those with unspecified history (0.62 [0.47, 0.81] vs 0.85 [0.76, 0.95]). Metformin interventions were more effective in participants with PCOS than those with unspecified status (0.38 [0.19, 0.74] vs 0.59 [0.25, 1.43]), or when commenced preconception than during pregnancy (0.22 [0.11, 0.45] vs 1.15 [0.86-1.55]). Parity, history of having a large-for-gestational-age infant or family history of diabetes had no effect. Conclusions: GDM prevention through metformin or lifestyle differs according to some individual characteristics. Future research should include trials commencing preconception and provide results stratified by participant characteristics including social and environmental factors, clinical traits, and other novel risk factors to predict GDM prevention through interventions. Plain language summary: Precision prevention involves using a groupâ™s unique context to determine their responses to preventive interventions. This study aimed to evaluate the participant characteristics associated with interventions in GDM prevention. We searched medical literature databases to identify lifestyle (diet, physical activity), metformin, myoinositol/inositol and probiotics interventions. A total of 116 studies (n=40903 women) were included. Diet and physical activity interventions resulted in greater GDM reduction in participants without polycystic ovary syndrome (PCOS) and those without a history of GDM. Metformin interventions resulted in greater GDM reduction in participants with PCOS or when started during the preconception period. Future research should include trials starting in the preconception period, and provide results stratified by participant characteristics to predict GDM prevention through interventions.
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Importance: Adherence to COVID-19 booster vaccine recommendations has lagged in pregnant and nonpregnant adult populations. One barrier to booster vaccination is uncertainty regarding the safety of booster doses among pregnant people. Objective: To evaluate whether there is an association between COVID-19 booster vaccination during pregnancy and spontaneous abortion. Design, Setting, and Participants: This observational, case-control, surveillance study evaluated people aged 16 to 49 years with pregnancies at 6 to 19 weeks' gestation at 8 health systems in the Vaccine Safety Datalink from November 1, 2021, to June 12, 2022. Spontaneous abortion cases and ongoing pregnancy controls were evaluated during consecutive surveillance periods, defined by calendar time. Exposure: Primary exposure was receipt of a third messenger RNA (mRNA) COVID-19 vaccine dose within 28 days before spontaneous abortion or index date (midpoint of surveillance period in ongoing pregnancy controls). Secondary exposures were third mRNA vaccine doses in a 42-day window or any COVID-19 booster in 28- and 42-day windows. Main Outcomes and Measures: Spontaneous abortion cases and ongoing pregnancy controls were identified from electronic health data using a validated algorithm. Cases were assigned to a single surveillance period based on pregnancy outcome date. Eligible ongoing pregnancy time was assigned to 1 or more surveillance periods as an ongoing pregnancy-period control. Generalized estimating equations were used to estimate adjusted odds ratios (AOR) with gestational age, maternal age, antenatal visits, race and ethnicity, site, and surveillance period as covariates and robust variance estimates to account for inclusion of multiple pregnancy periods per unique pregnancy. Results: Among 112â¯718 unique pregnancies included in the study, the mean (SD) maternal age was 30.6 (5.5) years. Pregnant individuals were Asian, non-Hispanic (15.1%); Black, non-Hispanic (7.5%); Hispanic (35.6%); White, non-Hispanic (31.2%); and of other or unknown (10.6%); and 100% were female. Across eight 28-day surveillance periods, among 270â¯853 ongoing pregnancy-period controls, 11â¯095 (4.1%) had received a third mRNA COVID-19 vaccine in a 28-day window; among 14â¯226 cases, 553 (3.9%) had received a third mRNA COVID-19 vaccine within 28 days of the spontaneous abortion. Receipt of a third mRNA COVID-19 vaccine was not associated with spontaneous abortion in a 28-day window (AOR, 0.94; 95% CI, 0.86-1.03). Results were consistent when using a 42-day window (AOR, 0.97; 95% CI, 0.90-1.05) and for any COVID-19 booster in a 28-day (AOR, 0.94; 95% CI, 0.86-1.02) or 42-day (AOR, 0.96; 95% CI, 0.89-1.04) exposure window. Conclusions and Relevance: In this case-control surveillance study, COVID-19 booster vaccination in pregnancy was not associated with spontaneous abortion. These findings support the safety of recommendations for COVID-19 booster vaccination, including in pregnant populations.
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Aborto Espontáneo , COVID-19 , Adulto , Embarazo , Femenino , Humanos , Masculino , Aborto Espontáneo/epidemiología , Aborto Espontáneo/etiología , COVID-19/epidemiología , COVID-19/prevención & control , Resultado del Embarazo , Edad Materna , Vacunación/efectos adversosRESUMEN
In this multisite, observational, matched cohort study of more than 80,000 pregnant people, receipt of an mRNA monovalent coronavirus disease 2019 (COVID-19) booster vaccination in pregnancy was not associated with increased risk for thrombocytopenia, myocarditis, venous thromboembolism, ischemic stroke, or other serious adverse events within 21 or 42 days after booster vaccination. The mRNA monovalent COVID-19 booster in pregnancy was associated with an increased risk for medically attended malaise or fatigue within 7 days of vaccination (adjusted rate ratio [aRR] 3.64, 95% CI 2.42-5.48) and lymphadenopathy or lymphadenitis within 21 days (aRR 3.25, 95% CI 1.67-6.30) or 42 days (aRR 2.18, 95% CI 1.33-3.58) of vaccination. Our findings are consistent with prior evaluations of the primary COVID-19 vaccine series and are reassuring with respect to COVID-19 booster vaccination in pregnancy.
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Vacunas contra la COVID-19 , COVID-19 , Femenino , Humanos , Embarazo , Estudios de Cohortes , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , ARN Mensajero , Vacunación/efectos adversosRESUMEN
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.
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Aborto Espontáneo , Vacunas contra la COVID-19 , Femenino , Humanos , Embarazo , Aborto Espontáneo/inducido químicamente , Aborto Espontáneo/epidemiología , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Estados Unidos/epidemiología , Vacunación/efectos adversosRESUMEN
Background: Healthier lifestyles in early pregnancy are associated with lower rates of pregnancy complications, childhood adiposity, and maternal and child cardiovascular risks. However, it is not known whether lifestyle coaching initiated prior to pregnancy can affect behavior and attitudes during pregnancy. Methods: Three hundred and twenty six women planning pregnancy within 2 years with BMI ≥27 kg/m2 were randomized to a behavioral weight loss intervention or to usual care. Analyses reported here examined the intervention's impact on mid-pregnancy diet quality and activity levels; program acceptability; and effects of pregnancy on intervention engagement. Results: One hundred and sixty eight participants experienced pregnancy during the study (intervention: 91; usual care: 77). From randomization to mid-pregnancy, participants who received the intervention had larger increases in fruit intake than usual care participants (+0.67 vs. +0.06 cups; p = 0.02) and engaged in more vigorous-intensity activity (3.9 [5.5] vs. 1.2 [3.0] Met-hr/week p = 0.002) and sports/exercise (17.0 [14.1] vs. 11.0 [9.5] Met-hr/week; p = 0.03); the groups also differed in changes in sedentary time (-4.9 [15.0] vs. +0.5 [7.6] Met-hr/week; p = 0.02). Intervention satisfaction was high (>80%), and experiencing pregnancy during the intervention was associated with higher engagement. Conclusion: A coaching-based intervention beginning in pre-pregnancy successfully helped women attain healthier diet and exercise habits in mid-pregnancy. Clinical trials registration: Registered with ClinicalTrials.gov, NCT02346162, first registered on January 26, 2015, before date of initial participant enrollment (May 2015), https://clinicaltrials.gov/ct2/show/NCT02346162.
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Vacunas contra la COVID-19 , COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Vacunación , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/uso terapéutico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Femenino , Humanos , Embarazo , Vacunación/efectos adversosRESUMEN
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.