Browsing by Author "Parry, Samuel"
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Item Antenatal Fetal Adrenal Measurements at 22 to 30 Weeks' Gestation, Fetal Growth Restriction, and Perinatal Morbidity(Thieme, 2021) Blue, Nathan R.; Hoffman, Matthew; Allshouse, Amanda A.; Grobman, William A.; Simhan, Hyagriv N.; Turan, Ozhan M.; Parry, Samuel; Chung, Judith H.; Reddy, Uma; Haas, David M.; Myers, Stephen; Mercer, Brian; Saade, George R.; Silver, Robert M.; Obstetrics and Gynecology, School of MedicineObjective: Our objective was to test the association of fetal adrenal size with perinatal morbidity among fetuses with fetal growth restriction (FGR; estimated fetal weight [EFW] < 10th percentile). Study design: This was a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) adrenal study, which measured fetal adrenal gland size at 22 to 30 weeks' gestation. We analyzed the transverse adrenal area (TAA) and fetal zone area (absolute measurements and corrected for fetal size) and the ratio of the fetal zone area to the total transverse area using a composite perinatal outcome of stillbirth, neonatal intensive care unit admission, respiratory distress syndrome, necrotizing enterocolitis, retinopathy of prematurity, sepsis, mechanical ventilation, seizure, or death. Among fetuses with FGR, adrenal measurements were compared between those that did and did not experience the composite perinatal outcome. Results: There were 1,709 eligible neonates. Seven percent (n = 120) were diagnosed with FGR at the time of adrenal measurement, and 14.7% (n = 251) experienced perinatal morbidity. EFW-corrected and absolute adrenal measurements were similar among fetuses with and without FGR as well as among those who did and did not experience morbidity. The area under the curve for corrected TAA was 0.52 (95% confidence interval 0.38-0.67). Conclusion: In our cohort, adrenal size was not associated with risk of morbidity among fetuses with FGR.Item Association of Adverse Pregnancy Outcomes With Hypertension 2 to 7 Years Postpartum(Wiley Open Access, 2019-10-01) Haas, David M.; Parker, Corette B.; Marsh, Derek J.; Grobman, William A.; Ehrenthal, Deborah B.; Greenland, Philip; Merz, C. Noel Bairey; Pemberton, Victoria L.; Silver, Robert M.; Barnes, Shannon; McNeil, Rebecca B.; Cleary, Kirsten; Reddy, Uma M.; Chung, Judith H.; Parry, Samuel; Theilen, Lauren H.; Blumenthal, Elizabeth A.; Levine, Lisa D.; Mercer, Brian M.; Simhan, Hyagriv; Polito, LuAnn; Wapner, Ronald J.; Catov, Janet; Chen, Ida; Saade, George R. Saade; NHLBI nuMoM2b Heart Health Study; Medicine, School of MedicineBackground Identifying pregnancy-associated risk factors before the development of major cardiovascular disease events could provide opportunities for prevention. The objective of this study was to determine the association between outcomes in first pregnancies and subsequent cardiovascular health. Methods and Results The Nulliparous Pregnancy Outcomes Study Monitoring Mothers-to-be Heart Health Study is a prospective observational cohort that followed 4484 women 2 to 7 years (mean 3.2 years) after their first pregnancy. Adverse pregnancy outcomes (defined as hypertensive disorders of pregnancy, small-for-gestational-age birth, preterm birth, and stillbirth) were identified prospectively in 1017 of the women (22.7%) during this pregnancy. The primary outcome was incident hypertension (HTN). Women without adverse pregnancy outcomes served as controls. Risk ratios (RR) and 95% CIs were adjusted for age, smoking, body mass index, insurance type, and race/ethnicity at enrollment during pregnancy. The overall incidence of HTN was 5.4% (95% CI 4.7% to 6.1%). Women with adverse pregnancy outcomes had higher adjusted risk of HTN at follow-up compared with controls (RR 2.4, 95% CI 1.8-3.1). The association held for individual adverse pregnancy outcomes: any hypertensive disorders of pregnancy (RR 2.7, 95% CI 2.0-3.6), preeclampsia (RR 2.8, 95% CI 2.0-4.0), and preterm birth (RR 2.7, 95% CI 1.9-3.8). Women who had an indicated preterm birth and hypertensive disorders of pregnancy had the highest risk of HTN (RR 4.3, 95% CI 2.7-6.7). Conclusions Several pregnancy complications in the first pregnancy are associated with development of HTN 2 to 7 years later. Preventive care for women should include a detailed pregnancy history to aid in counseling about HTN risk.Item Association of Cannabis Use With Nausea and Vomiting of Pregnancy(Wolters Kluwer, 2022) Metz, Torri D.; Allshouse, Amanda A.; McMillin, Gwendolyn A.; Silver, Robert M.; Smid, Marcela C.; Haas, David M.; Simhan, Hyagriv N.; Saade, George R.; Grobman, William A.; Parry, Samuel; Chung, Judith H.; Jarlenski, Marian P.; Obstetrics and Gynecology, School of MedicineOur objective was to evaluate whether cannabis use was associated with nausea and vomiting in early pregnancy. Participants from nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be) enrolled from October 2010 through September 2013 with a PUQE (Pregnancy-Unique Quantification of Emesis) questionnaire and an available stored urine sample from the first study visit (median gestational age 12 weeks) were included. Cannabis exposure was ascertained by urine immunoassay for 11-nor-9-carboxy-delta-9-tetrahydrocannabinol (THC-COOH); positive results were confirmed with liquid chromatography tandem mass spectrometry. The primary outcome was moderate-to-severe nausea by the PUQE score. Overall, 9,250 participants were included, and 5.8% (95% CI 5.4-6.3%) had detectable urine THC-COOH. In adjusted analyses, higher THC-COOH levels were associated with greater odds of moderate-to-severe nausea (20.7% in the group with THC-COOH detected vs 15.5% in the group with THC-COOH not detected, adjusted odds ratio 1.6, 95% CI 1.1-2.2 for a 500 ng/mg Cr THC-COOH increment).Item Association of Genetic Predisposition and Physical Activity With Risk of Gestational Diabetes in Nulliparous Women(American Medical Association, 2022-08-01) Pagel, Kymberleigh A.; Chu, Hoyin; Ramola, Rashika; Guerrero, Rafael F.; Chung, Judith H.; Parry, Samuel; Reddy, Uma M.; Silver, Robert M.; Steller, Jonathan G.; Yee, Lynn M.; Wapner, Ronald J.; Hahn, Matthew W.; Natarajan, Sriraam; Haas, David M.; Radivojac, Predrag; Obstetrics and Gynecology, School of MedicineImportance: Polygenic risk scores (PRS) for type 2 diabetes (T2D) can improve risk prediction for gestational diabetes (GD), yet the strength of the association between genetic and lifestyle risk factors has not been quantified. Objective: To assess the association of PRS and physical activity in existing GD risk models and identify patient subgroups who may receive the most benefits from a PRS or physical activity intervention. Design, settings, and participants: The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be cohort was established to study individuals without previous pregnancy lasting at least 20 weeks (nulliparous) and to elucidate factors associated with adverse pregnancy outcomes. A subcohort of 3533 participants with European ancestry was used for risk assessment and performance evaluation. Participants were enrolled from October 5, 2010, to December 3, 2013, and underwent genotyping between February 19, 2019, and February 28, 2020. Data were analyzed from September 15, 2020, to November 10, 2021. Exposures: Self-reported total physical activity in early pregnancy was quantified as metabolic equivalents of task (METs). Polygenic risk scores were calculated for T2D using contributions of 84 single nucleotide variants, weighted by their association in the Diabetes Genetics Replication and Meta-analysis Consortium data. Main outcomes and measures: Estimation of the development of GD from clinical, genetic, and environmental variables collected in early pregnancy, assessed using measures of model discrimination. Odds ratios and positive likelihood ratios were used to evaluate the association of PRS and physical activity with GD risk. Results: A total of 3533 women were included in this analysis (mean [SD] age, 28.6 [4.9] years). In high-risk population subgroups (body mass index ≥25 or aged ≥35 years), individuals with high PRS (top 25th percentile) or low activity levels (METs <450) had increased odds of a GD diagnosis of 25% to 75%. Compared with the general population, participants with both high PRS and low activity levels had higher odds of a GD diagnosis (odds ratio, 3.4 [95% CI, 2.3-5.3]), whereas participants with low PRS and high METs had significantly reduced risk of a GD diagnosis (odds ratio, 0.5 [95% CI, 0.3-0.9]; P = .01). Conclusions and relevance: In this cohort study, the addition of PRS was associated with the stratified risk of GD diagnosis among high-risk patient subgroups, suggesting the benefits of targeted PRS ascertainment to encourage early intervention.Item Association of Health Literacy Among Nulliparous Individuals and Maternal and Neonatal Outcomes(American Medical Association, 2021-09-01) Yee, Lynn M.; Silver, Robert; Haas, David M.; Parry, Samuel; Mercer, Brian M.; Wing, Deborah A.; Reddy, Uma; Saade, George R.; Simhan, Hyagriv; Grobman, William A.; Obstetrics and Gynecology, School of MedicineImportance: Health literacy is considered an important social determinant of health that may underlie many health disparities, but it is unclear whether inadequate health literacy among pregnant individuals is associated with adverse maternal and neonatal outcomes. Objective: To assess the association between maternal health literacy and maternal and neonatal outcomes among nulliparous individuals. Design, setting, and participants: This was a secondary analysis of a large, multicenter cohort study of 10 038 nulliparous individuals in the US (2010-2013). Participants underwent 3 antenatal study visits and had detailed maternal and neonatal data abstracted. Data analysis was performed from July to December 2019. Exposures: Between 16 and 21 weeks of gestation, health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine-Short Form, a validated 7-item word recognition test. In accordance with standard scoring, results were dichotomized as inadequate vs adequate health literacy. Main outcomes and measures: On the basis of theoretical causal pathways between health literacy and health outcomes, a priori maternal and neonatal outcomes (determined via medical records) were selected for this analysis. Multivariable Poisson regression models were constructed to estimate the associations between health literacy and outcomes. Sensitivity analyses in which education was removed from models and that excluded individuals who spoke English as a second language were performed. Results: Of 9341 participants who completed the Rapid Estimate of Adult Literacy in Medicine-Short Form, the mean (SD) age was 27.0 (5.6) years, and 2540 (27.4%) had publicly funded prenatal care. Overall, 1638 participants (17.5%) had scores indicative of inadequate health literacy. Participants with inadequate health literacy were more likely to be younger (mean [SD] age, 22.9 [5.0] vs 27.9 [5.3] years), have less educational attainment (some college education or greater, 1149 participants [73.9%] vs 5279 participants [94.5%]), have publicly funded insurance (1008 participants [62.2%] vs 1532 participants [20.0%]), and report they were a member of an underrepresented racial or ethnic group (non-Hispanic Black, 506 participants [30.9%] vs 780 participants [10.1%]; Hispanic, 516 participants [31.5%] vs 948 participants [12.3%]) compared with those with adequate health literacy. Participants who had inadequate health literacy had greater risk of cesarean delivery (adjusted risk ratio [aRR], 1.11; 95% CI, 1.01-1.23) and major perineal laceration (aRR, 1.44; 95% CI, 1.03-2.01). The adjusted risks of small-for-gestational-age status (aRR, 1.34; 95% CI, 1.14-1.58), low birth weight (aRR, 1.33; 95% CI, 1.07-1.65), and 5-minute Apgar score less than 4 (aRR, 2.78; 95% CI, 1.16-6.65) were greater for neonates born to participants with inadequate health literacy. Sensitivity analyses confirmed these findings. Conclusions and relevance: These findings suggest that inadequate maternal health literacy is associated with a variety of adverse maternal and neonatal outcomes.Item Associations of the Neighborhood Built Environment with Gestational Weight Gain(Thieme, 2023) Grobman, William A.; Crenshaw, Emma G.; Marsh, Derek J.; McNeil, Rebecca B.; Pemberton, Victoria L.; Haas, David M.; Debbink, Michelle; Mercer, Brian M.; Parry, Samuel; Reddy, Uma; Saade, George; Simhan, Hyagriv; Mukhtar, Farhana; Wing, Deborah A.; Kershaw, Kiarri N.; NICHD nuMoM2b NHLBI nuMoM2b Heart Health Study Networks; Obstetrics and Gynecology, School of MedicineObjective: This study aimed to determine whether specific factors of the built environment related to physical activity and diet are associated with inadequate and excessive gestational weight gain (GWG). Study design: This analysis is based on data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be, a prospective cohort of nulliparous women who were followed from the beginning of their pregnancies through delivery. At each study visit, home addresses were recorded and geocoded. Locations were linked to several built-environment characteristics such as the census tract National Walkability Score (the 2010 Walkability Index) and the number of gyms, parks, and grocery stores within a 3-km radius of residential address. The primary outcome of GWG (calculated as the difference between prepregnancy weight and weight at delivery) was categorized as inadequate, appropriate, or excessive based on weight gained per week of gestation. Multinomial regression (generalized logit) models evaluated the relationship between each factor in the built environment and excessive or inadequate GWG. Results: Of the 8,182 women in the analytic sample, 5,819 (71.1%) had excessive GWG, 1,426 (17.4%) had appropriate GWG, and 937 (11.5%) had inadequate GWG. For the majority of variables examined, built environments more conducive to physical activity and healthful food availability were associated with a lower odds of excessive or inadequate GWG category. For example, a higher number of gyms or parks within 3 km of a participant's residential address was associated with lower odds of having excessive (gyms: adjusted odds ratio [aOR] = 0.93 [0.89-0.96], parks: 0.94 [0.90-0.98]) or inadequate GWG (gyms: 0.91 [0.86-0.96]; parks: 0.91 [0.86-0.97]). Similarly, a higher number of grocery stores was associated with lower odds of having excessive GWG (0.94 [0.91-0.97]). Conclusion: Among a diverse population of nulliparous women, multiple aspects of the built environment are associated with excessive and inadequate GWG.Item Associations of the Neighborhood Built Environment With Physical Activity Across Pregnancy(Human Kinetics, 2021-04-15) Kershaw, Kiarri N.; Marsh, Derek J.; Crenshaw, Emma G.; McNeil, Rebecca B.; Pemberton, Victoria L.; Cordon, Sabrina A.; Haas, David M.; Debbink, Michelle P.; Mercer, Brian M.; Parry, Samuel; Reddy, Uma; Saade, George; Simhan, Hyagriv; Wapner, Ronald J.; Wing, Deborah A.; Grobman, William A.; NICHD nuMoM2b Heart Health Study Network; NHLBI nuMoM2b Heart Health Study Network; Obstetrics and Gynecology, School of MedicineBackground: Several features of the neighborhood built environment have been shown to promote leisure-time physical activity (PA) in the general population, but few studies have examined its impact on PA during pregnancy. Methods: Data were extracted from 8362 Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be cohort participants (2010-2013). Residential address information was linked to 3 built environment characteristics: number of gyms and recreation areas within a 3-km radius of residence and census block level walkability. Self-reported leisure-time PA was measured in each trimester and dichotomized as meeting PA guidelines or not. Relative risks for cross-sectional associations between neighborhood characteristics and meeting PA guidelines were estimated using Poisson regression. Results: More gyms and recreation areas were each associated with a greater chance of meeting PA guidelines in models adjusted for sociodemographic characteristics and preexisting conditions. Associations were strongest in the third trimester where each doubling in counts of gyms and recreation areas was associated with 10% (95% confidence interval, 1.07-1.13) and 8% (95% confidence interval, 1.03-1.12), respectively, greater likelihood of meeting PA guidelines. Associations were similar though weaker for walkability. Conclusions: Results from a large, multisite cohort suggest that these built environment characteristics have similar PA-promoting benefits in pregnant women as seen in more general populations.Item Developing a predictive model for perinatal morbidity among small for gestational age infants(Taylor & Francis, 2022) Blue, Nathan R.; Allhouse, Amanda A.; Grobman, William A.; Day, Robert C.; Haas, David M.; Simhan, Hyagriv N.; Parry, Samuel; Saade, George R.; Silver, Robert M.; Obstetrics and Gynecology, School of MedicineBackground: While neonates with birth weight <10th percentile are at increased risk of morbidity and mortality, most of these are constitutionally small and not at increased risk. There are no current strategies that reliably distinguish constitutionally small neonates from small neonates at the highest risk of morbidity, so additional tools for risk stratification are needed. Objective: Our objectives were to identify factors that are independently associated with perinatal morbidity among neonates with birth weight <10th percentile (small for gestational age, SGA) and to create predictive models of perinatal morbidity among SGA neonates based on the timing of information availability. Study design: This secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, was a nested case-control study. Participants were prospectively enrolled at eight U.S. centers, with data collection occurring at three standard time points during pregnancy and again after delivery. Our analysis included neonates with birth weights <10th percentile and excluded those with major congenital malformations or suspected or confirmed aneuploidy. The primary outcome was a composite of perinatal morbidity, defined as NICU admission >48 h, NEC, sepsis, RDS, mechanical ventilation, retinopathy of prematurity, seizures, grade 3 or 4 IVH, stillbirth, or death before discharge. Cases were SGA neonates that experienced the primary outcome, and controls were SGA neonates that did not. Maternal factors for potential inclusion in predictive modeling were drawn from a broad list of variables collected as part of the NuMoM2B study, including demographic, anthropometric, clinical, ultrasound, social/behavioral, dietary, and psychological variables. Characteristics that were different in bivariate analysis between cases and controls then underwent further evaluation and refinement. Continuous and multi-category variables were assessed using multiple approaches, including as continuous variables, using standard categories (such as for BMI) as well as empirically-derived cut-points identified by receiver-operating characteristics methodology. The approach for each variable that resulted in the best performance was selected for use in modeling. After variable optimization, multivariable analysis was used to derive prediction models using factors known at mid-pregnancy (Model 1) and delivery (Model 2). Results: Of the original cohort, 865 were eligible and analyzed, with 134 (15.5%) experiencing the primary outcome. After bivariable and multivariable analysis, these variables were included in Model 1: BMI, stress level, diastolic blood pressure, narcotic use (all in 1st trimester), and uterine artery pulsatility index at 16-21 weeks. Model 2 added the following variables to Model 1: preterm delivery, preeclampsia, and suspected fetal growth restriction. When models 1 and 2 were empirically tested and compared to predicted performance to demonstrate calibration, observed morbidity rates approximately followed expected rates within deciles. Models 1 and 2 had respective areas under the receiver-operating characteristic curve of 0.72 (95% CI 0.67-0.76) and 0.84 (0.80-0.88), to predict the composite morbidity. Conclusion: Using a deeply phenotyped cohort of nulliparous women, we created two models with the moderate-good prediction of perinatal morbidity among SGA neonates.Item Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk(Wiley, 2022) Job, Kathleen M.; Dallmann, André; Parry, Samuel; Saade, George; Haas, David M.; Hughes, Brenna; Berens, Pamela; Chen, Jia-Yu; Fu, Christina; Humphrey, Kelsey; Hornik, Christoph; Balevic, Stephen; Zimmerman, Kanecia; Watt, Kevin; Obstetrics and Gynecology, School of MedicineOndansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to nursing infants and no adequate study looking at ondansetron pharmacokinetics during lactation. We developed a generic physiologically based pharmacokinetic lactation model for small molecule drugs and applied this model to predict ondansetron transfer into breast milk and characterize infant exposure. Drug-specific model inputs were parameterized using data from the literature. Population-specific inputs were derived from a previously conducted systematic literature review of anatomic and physiologic changes in postpartum women. Model predictions were evaluated using ondansetron plasma and breast milk concentration data collected prospectively from 78 women in the Commonly Used Drugs During Lactation and infant Exposure (CUDDLE) study. The final model predicted breast milk and plasma exposures following a single 4 mg dose of intravenous ondansetron in 1000 simulated women who were two days postpartum. Model predictions showed good agreement with observed data. Breast milk median prediction error (MPE) was 18.4% and median absolute prediction error (MAPE) was 53.0%. Plasma MPE was 32.5% and MAPE was 43.2%. The model-predicted daily and relative infant doses were 0.005 mg/kg/day and 3.0%, respectively. This model adequately predicted ondansetron passage into breast milk. The calculated low relative infant dose indicates that mothers receiving ondansetron can safely breastfeed. The model building blocks and population database are open-source and can be adapted to other drugs.Item Dietary Fat and Fatty Acid Intake in Nulliparous Women: Associations with Preterm Birth and Distinctions by Maternal BMI(Oxford University Press, 2021-05-08) Robinson, Daniel T.; Van Horn, Linda; Balmert, Lauren; Silver, Robert M.; Parry, Samuel; Haas, David M.; Wing, Deborah A.; Grobman, William A.; Obstetrics and Gynecology, School of MedicineBackground: Evidence documenting whether diet quality, particularly dietary fatty acids, is associated with preterm birth (PTB) is limited. Objective: The aim was to measure associations between dietary fatty acid intake prior to pregnancy, specifically n-3 (ɷ-3) PUFAs and odds of PTB in US women and determine if associations differed by prepregnancy BMI. Methods: We designed a secondary analysis of dietary intake in nulliparous women enrolled in a longitudinal cohort (NCT01322529). Participants completed an FFQ, modified to assess detailed PUFA intake, during the 3 mo preceding pregnancy. Inclusion in this analytic cohort required total energy intake within 2 SDs of the group mean. Prepregnancy BMI was categorized as underweight, normal, overweight, or obese. The primary exposure was estimated intake of EPA and DHA (combined EPA+DHA), in the context of a recommended intake of 250 mg. The primary outcome was PTB (<37 wk). Adjusted regression models controlled for maternal factors relevant to PTB and evaluated associations with PUFAs. Interaction terms estimated effect modification of BMI. A false discovery rate (FDR) correction accounted for multiple comparisons. Results: Median daily intake of combined EPA+DHA in 7365 women was 70 mg (IQR: 32, 145 mg). A significant interaction term indicated the effects of EPA+DHA on odds of PTB were different for different BMI categories (P < 0.01). Specifically, higher intake of combined EPA+DHA was nominally associated with reduced odds of PTB in women with underweight (OR: 0.67; 95% CI: 0.46-0.98) and normal BMI (OR: 0.87; 95% CI: 0.78-0.96), yet was associated with increased odds of overweight BMI (OR: 1.21; 95% CI: 1.02-1.44). Associations remained significant after FDR correction. Conclusions: Based on a cohort of US women designed to identify predictors of adverse pregnancy outcomes, dietary intake of combined EPA+DHA was considerably lower than recommended. Associations between intake of these recommended n-3 fatty acids and risk of PTB differ by maternal BMI.