Browsing by Author "Saade, George"
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Item Association between aspirin use during pregnancy and cardiovascular risk factors 2-7 years after delivery: The nuMoM2b Heart Health Study(Elsevier, 2022) Theilen, Lauren H.; Greenland, Philip; Varagic, Jasmina; Catov, Janet; Shanks, Anthony L.; Thorsten, Vanessa; Parker, Corette B.; McNeil, Rebecca; Mercer, Brian; Hoffman, Matthew; Wapner, Ronald; Haas, David; Simhan, Hyagriv; Grobman, William; Chung, Judith H.; Levine, Lisa D.; Barnes, Shannon; Merz, Noel Bairey; Saade, George; Silver, Robert M.; Obstetrics and Gynecology, School of MedicineObjectives: To evaluate the association between aspirin use during first pregnancy and later maternal cardiovascular risk. Study design: In this secondary analysis of a prospective cohort, we included participants who carried their first pregnancy to 20 + weeks, had data regarding aspirin use, and attended a study visit 2-7 years following delivery. The exposure was aspirin use during the first pregnancy. We calculated aspirin use propensity scores from logistic regression models including baseline variables associated with aspirin use in pregnancy and cardiovascular risk. Outcomes of interest were incident cardiovascular-related diagnoses 2-7 years following delivery. Robust Poisson regression calculated the risk of outcomes by aspirin exposure, adjusting for the aspirin use propensity score. Main outcome measures: The primary outcome was a composite of incident cardiovascular diagnoses at the time of the study visit: cardiovascular events, chronic hypertension, metabolic syndrome, prediabetes or type 2 diabetes, dyslipidemia, and chronic kidney disease. Results: Of 4,480 women included, 84 (1.9%) reported taking aspirin during their first pregnancy. 52.6% of participants in the aspirin-exposed group and 43.0% in the unexposed group had the primary outcome. After adjusting for the aspirin use propensity scores, aspirin use during the first pregnancy was not associated with any of the outcomes. Conclusion: We did not detect an association between aspirin use during the first pregnancy and cardiovascular-related diagnoses 2-7 years later. Our study was only powered to detect a large difference in relative risk, so we cannot rule out a smaller difference that may be clinically meaningful.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 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 Gestational Weight Gain and Pregnancy Outcomes among Nulliparous Women(Thieme, 2021) Dude, Annie M.; Grobman, William; Haas, David; Mercer, Brian M.; Parry, Samuel; Silver, Robert M.; Wapner, Ronald; Wing, Deborah; Saade, George; Reddy, Uma; Iams, Jay; Kominiarek, Michelle A.; Obstetrics and Gynecology, School of MedicineObjective: To determine the association between total gestational weight gain and perinatal outcomes. Study design: Data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be (NuMoM2b) study were used. Total gestational weight gain was categorized as inadequate, adequate, or excessive based on the 2009 Institute of Medicine guidelines. Outcomes examined included hypertensive disorders of pregnancy, mode of delivery, shoulder dystocia, large for gestational age or small for-gestational age birth weight, and neonatal intensive care unit admission. Results: Among 8,628 women, 1,666 (19.3%) had inadequate, 2,945 (34.1%) had adequate, and 4,017 (46.6%) had excessive gestational weight gain. Excessive gestational weight gain was associated with higher odds of hypertensive disorders (adjusted odds ratio [aOR] = 2.05, 95% confidence interval [CI]: 1.78-2.36) Cesarean delivery (aOR = 1.24, 95% CI: 1.09-1.41), and large for gestational age birth weight (aOR = 1.49, 95% CI: 1.23-1.80), but lower odds of small for gestational age birth weight (aOR = 0.59, 95% CI: 0.50-0.71). Conversely, inadequate gestational weight gain was associated with lower odds of hypertensive disorders (aOR = 0.75, 95% CI: 0.62-0.92), Cesarean delivery (aOR = 0.77, 95% CI: 0.65-0.92), and a large for gestational age birth weight (aOR = 0.72, 95% CI: 0.55-0.94), but higher odds of having a small for gestational age birth weight (aOR = 1.64, 95% CI: 1.37-1.96). Conclusion: Both excessive and inadequate gestational weight gain are associated with adverse maternal and neonatal outcomes.Item Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial(Elsevier, 2023) Martin, Samantha L.; Allman, Phillip H.; Dugoff, Lorraine; Sibai, Baha; Lynch, Stephanie; Ferrara, Jennifer; Aagaard, Kjersti; Zornes, Christina; Wilson, Jennifer L.; Gibson, Marie; Adams, Molly; Longo, Sherri A.; Staples, Amy; Saade, George; Beche, Imene; Carter, Ebony B.; Owens, Michelle Y.; Simhan, Hyagriv; Frey, Heather A.; Khan, Shama; Palatnik, Anna; August, Phyllis; Irby, Les'Shon; Lee, Tiffany; Lee, Christine; Schum, Paula; Chan-Akeley, Rosalyn; Duhon, Catera; Rincon, Monica; Gibson, Kelly; Wiegand, Samantha; Eastham, Donna; Oparil, Suzanne; Szychowski, Jeff M.; Tita, Alan; Chronic Hypertension and Pregnancy Consortium; Obstetrics and Gynecology, School of MedicineBackground: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. Objective: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. Study design: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. Results: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. Conclusion: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.Item Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia(Wolters Kluwer, 2022) Costantine, Maged M.; Sibai, Baha; Bombard, Allan T.; Sarno, Mark; West, Holly; Haas, David M.; Tita, Alan T.; Paidas, Michael J.; Clark, Erin A. S.; Boggess, Kim; Grotegut, Chad; Grobman, William; Su, Emily J.; Burd, Irina; Saade, George; Chavez, Martin R.; Paglia, Michael J.; Merriam, Audrey; Torres, Carlos; Habli, Mounira; Macones, Georges; Wen, Tony; Bofill, James; Palatnik, Anna; Edwards, Rodney K.; Haeri, Sina; Oberoi, Pankaj; Mazloom, Amin; Cooper, Matthew; Lockton, Steven; Hankins, Gary D.; Obstetrics and Gynecology, School of MedicineBackground: The ability to diagnose preeclampsia clinically is suboptimal. Our objective was to validate a novel multianalyte assay and characterize its performance, when intended for use as an aid to rule-out preeclampsia. Methods: Prospective, multicenter cohort study of pregnant individuals presenting between 280/7 and 366/7 weeks' with preeclampsia-associated signs and symptoms. Individuals not diagnosed with preeclampsia after baseline evaluation were enrolled in the study cohort, with those who later developed preeclampsia, classified as cases and compared with a negative control group who did not develop preeclampsia. Individuals with assay values at time of enrollment ≥0.0325, determined using a previously developed algorithm, considered at risk. The primary analysis was the time to develop preeclampsia assessed using a multivariate Cox regression model. Results: One thousand thirty-six pregnant individuals were enrolled in the study cohort with an incidence of preeclampsia of 30.3% (27.6%-33.2%). The time to develop preeclampsia was shorter for those with an at-risk compared with negative assay result (log-rank P<0.0001; adjusted hazard ratio of 4.81 [3.69-6.27, P<0.0001]). The performance metrics for the assay to rule-out preeclampsia within 7 days of enrollment showed a sensitivity 76.4% (67.5%-83.5%), negative predictive value 95.0% (92.8%-96.6%), and negative likelihood ratio 0.46 (0.32-0.65). Assay performance improved if delivery occurred <37 weeks and for individuals enrolled between 28 and 35 weeks. Conclusions: We confirmed that a novel multianalyte assay was associated with the time to develop preeclampsia and has a moderate sensitivity and negative likelihood ratio but high negative predictive value when assessed as an aid to rule out preeclampsia within 7 days of enrollment.Item The association between personal weight gain goals, provider recommendations, and appropriate gestational weight gain(Elsevier, 2020) Dude, Annie M.; Plunkett, Beth; Grobman, William; Scifres, Christina M.; Mercer, Brian M.; Parry, Samuel; Silver, Robert M.; Wapner, Ronald; Wing, Deborah A.; Saade, George; Reddy, Uma; Iams, Jay; Simhan, Hyagriv; Kominiarek, Michelle A.; Obstetrics and Gynecology, School of MedicineBackground: Nearly half of all women exceed the 2009 Institute of Medicine guidelines for gestational weight gain. Excess gestational weight gain is associated with adverse pregnancy outcomes. Objective: Our objective was to determine whether having a personal gestational weight gain goal consistent with the Institute of Medicine's recommendations for appropriate gestational weight gain and whether having a discussion with one's obstetrical provider regarding that goal were associated with appropriate gestational weight gain. Study design: This is a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be study, a prospective cohort study of nulliparous women. We asked women at their first study visit (between 6 and 13 weeks' gestation) whether they had a gestational weight gain goal and what that goal was. Furthermore, we asked whether their provider discussed a gestational weight gain goal and what that goal was. We classified personal and provider-recommended gestational weight gain goals as consistent or inconsistent with the Institute of Medicine guidelines, taking into account a woman's initial body mass index category (underweight, normal weight, overweight, and obese). We included women with live singleton term deliveries (between 37 and 43 weeks' gestation) in this analysis. We classified the primary outcome, which was gestational weight gain (defined as the difference between first visit weight and final weight before delivery), as inadequate, appropriate, or excessive, based on the Institute of Medicine guidelines and initial body mass index category. We used Student t, Wilcoxon rank-sum, and chi-square tests for bivariable analyses, and multinomial logistic regression was performed to control for confounding variables. Results: Of 6727 eligible women, 3799 (56.5% of all eligible women) stated they had a gestational weight gain goal. Of the 3799 women with a stated goal, 2589 (38.5% of all women) had a goal consistent with the Institute of Medicine's recommendations. In addition, of the 6727 eligible women, 2188 (32.5%) reported that they discussed gestational weight gain with their provider, and 1548 of these (23.0% of all women) recalled that their provider gave a gestational weight gain goal in accordance with the Institute of Medicine guidelines. Although having any gestational weight gain goal was not associated with appropriate gestational weight gain, having a gestational weight gain goal that was consistent with the Institute of Medicine's recommendations was associated with a reduced risk of excessive (adjusted relative risk ratio, 0.77; 95% confidence interval, 0.64-0.92) and inadequate weight gain (adjusted relative risk ratio, 0.66; 95% confidence interval, 0.53-0.82). Conversely, discussing gestational weight gain goals with a provider was not associated with either inadequate or excessive gestational weight gain even if the provider's recommendations for gestational weight gain were consistent with the guidelines. Conclusion: Nulliparas who delivered singleton pregnancies at term who had a personal gestational weight gain goal consistent with the Institute of Medicine's recommendations were less likely to have excessive or inadequate gestational weight gain. Further study is required to evaluate the most effective way to communicate this information to patients.Item Weight gain in early, mid, and late pregnancy and hypertensive disorders of pregnancy(Elsevier, 2020-04) Dude, Annie M.; Kominiarek, Michelle A.; Haas, David M.; Iams, Jay; Mercer, Brian M.; Parry, Samuel; Reddy, Uma M.; Saade, George; Silver, Robert M.; Simhan, Hyagriv; Wapner, Ronald; Wing, Deborah; Grobman, William; Obstetrics and Gynecology, School of MedicineObjective: To examine the relationship of weight change during early, mid, and late pregnancy with the development of a hypertensive disorder of pregnancy (HDP). Study design: These data are from a prospective cohort study of nulliparous women with live singleton pregnancies. "Early" weight change was defined as the difference between self-reported pre-pregnancy weight and weight at the first visit (between 6 and 13 weeks' gestation); "mid" weight change was defined as the weight change between the first and second visits (between 16 and 21 weeks' gestation); "late" weight change was defined as the weight change between the second and third visits (between 22 and 29 weeks' gestation). Weight change in each time period was further characterized as inadequate, adequate, or excessive based on the Institute of Medicine's (IOM's) trimester-specific weekly weight gain goals based on pre-pregnancy body mass index. Multivariable Poisson regression was performed to adjust for potential confounders. Main outcome measure: Development of any hypertensive disorder of pregnancy. Results: Of 8296 women, 1564 (18.9%) developed a HDP. Weight gain in excess of the IOM recommendations during the latter two time periods was significantly associated with HDP. Specifically, trimester-specific excessive weight gain in the mid period (aIRR 1.16, 95% CI 1.01-1.35) as well as in the late period (aIRR = 1.19, 95% CI = 1.02-1.40) was associated with increased risk of developing HDP. The weight gain preceded the onset of clinically apparent disease. Conclusions: Excessive weight gain as early as the early second trimester was associated with increased risks of development of HDP.