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ObjectivesPreterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment.MethodsThe ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and multimodal management (risk predictor/case management with pharmacological treatment) (RP-MM, active). In the active arms, only subjects stratified as higher risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects' gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher's exact test for neonatal morbidity/mortality (significance, p

The clinical management of pregnancy and spontaneous preterm birth (sPTB) relies on estimates of gestational age (GA). Our objective was to evaluate the effect of GA dating uncertainty on the observed performance of a validated proteomic biomarker risk predictor, and then to test the generalizability of that effect in a broader range of GA at blood draw. In a secondary analysis of a prospective clinical trial (PAPR; NCT01371019), we compared two GA dating categories: both ultrasound and dating by last menstrual period (LMP) (all subjects) and excluding dating by LMP (excluding LMP). The risk predictor's performance was observed at the validated risk predictor threshold both in weeks 191/7-206/7 and extended to weeks 180/7-206/7. Strict blinding and independent statistical analyses were employed. The validated biomarker risk predictor showed greater observed sensitivity of 88% at 75% specificity (increases of 17% and 1%) in more reliably dated (excluding-LMP) subjects, relative to all subjects. Excluding dating by LMP significantly improved the sensitivity in weeks 191/7-206/7. In the broader blood draw window, the previously validated risk predictor threshold significantly stratified higher and lower risk of sPTB, and the risk predictor again showed significantly greater observed sensitivity in excluding-LMP subjects. These findings have implications for testing the performance of models aimed at predicting PTB.

AbstractObjectivesPreterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment.MethodsThe ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N=847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and risk predictor/case management with pharmacological treatment (RP-MM, active). In the active arms, only subjects stratified as higher-risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects’ gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher’s exact test for neonatal morbidity/mortality (significance, p

BackgroundPreterm birth remains a common and devastating complication of pregnancy. There remains a need for effective and accurate screening methods for preterm birth. Using a proteomic approach, we previously discovered and validated (Proteomic Assessment of Preterm Risk study, NCT01371019) a preterm birth predictor comprising a ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin.ObjectiveTo determine the performance of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin to predict both spontaneous and medically indicated very preterm births, in an independent cohort distinct from the one in which it was developed.Study designThis was a prospective observational study (Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor, NCT02787213) at 18 sites in the United States. Women had blood drawn at 170/7 to 216/7 weeks' gestation. For confirmation, we planned to analyze a randomly selected subgroup of women having blood drawn between 191/7 and 206/7 weeks' gestation, with the results of the remaining study participants blinded for future validation studies. Serum from participants was analyzed by mass spectrometry. Neonatal morbidity and mortality were analyzed using a composite score by a method from the PREGNANT trial (NCT00615550, Hassan et al). Scores of 0-3 reflect increasing numbers of morbidities or length of neonatal intensive care unit stay, and 4 represents perinatal mortality.ResultsA total of 5011 women were enrolled, with 847 included in this planned substudy analysis. There were 9 preterm birth cases at

Development of effective prevention and treatment strategies for pre-eclampsia is limited by the lack of accurate methods for identification of at-risk pregnancies. We performed small RNA sequencing (RNA-seq) of maternal serum extracellular RNAs (exRNAs) to discover and verify microRNAs (miRNAs) differentially expressed in patients who later developed pre-eclampsia. Sera collected from 73 pre-eclampsia cases and 139 controls between 17 and 28 weeks gestational age (GA), divided into separate discovery and verification cohorts, are analyzed by small RNA-seq. Discovery and verification of univariate and bivariate miRNA biomarkers reveal that bivariate biomarkers verify at a markedly higher rate than univariate biomarkers. The majority of verified biomarkers contain miR-155-5p, which has been reported to mediate the pre-eclampsia-associated repression of endothelial nitric oxide synthase (eNOS) by tumor necrosis factor alpha (TNF-α). Deconvolution analysis reveals that several verified miRNA biomarkers come from the placenta and are likely carried by placenta-specific extracellular vesicles.

BackgroundThe proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Methods/designOverweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.DiscussionHispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.Trial registrationNCT01868230 May 29, 2013.

Objectives Cigarette smoking, low physical activity, and sedentary behavior are modifiable risk factors for adverse pregnancy outcomes. However, only one study has evaluated predictors of these health risk behaviors among women at high risk for gestational diabetes mellitus (GDM). Therefore, our goal was to examine predictors of smoking, low physical activity, and sedentary behavior during pregnancy in an ethnically diverse high risk cohort. Methods This cross-sectional analysis utilized baseline data from the Behaviors Affecting Baby and You (B.A.B.Y.) study conducted among prenatal care patients at high risk for GDM (personal history of GDM or family history of diabetes and body mass index [BMI] [greater than or equal to] 25 kg/m.sup.2). Smoking was assessed using questions from the Pregnancy Risk Assessment Monitoring System questionnaire and sedentary behavior (top vs. lower quartiles) and moderate/vigorous physical activity (bottom vs. upper quartile) via the Pregnancy Physical Activity Questionnaire. Results Participants (n = 400) enrolled at a mean of 12.4 (SD 3.6) weeks gestation. A total of 150 (44.1%) engaged in one, 37 (10.9%) in two, and 4 (1.2%) in three risk behaviors. Lower household income and not having children at home were each associated with a 2-6 fold increased odds of smoking, high sedentary behavior, and engaging in at least one risk behavior. Being married, Hispanic or of younger age was associated with a 2-6 fold reduced odds of smoking. BMI and personal history of GDM were not associated with risk behaviors. Conclusions for Practice Findings help characterize high risk groups and inform prenatal interventions targeting these health risk behaviors., Author(s): Carrie J. Nobles [sup.1] , Bess H. Marcus [sup.2] , Edward J. III Stanek [sup.1] , Barry Braun [sup.3] , Brian W. Whitcomb [sup.1] , JoAnn E. Manson [sup.4] [...]

Objectives To prospectively evaluate the association between gestational weight gain (GWG), prepregnancy body mass index (BMI), and hypertensive disorders of pregnancy using the revised Institute of Medicine (IOM) Guidelines. Methods We examined these associations among 1359 participants in Proyecto Buena Salud, a prospective cohort study conducted from 2006 to 2011 among women from the Caribbean Islands. Information on prepregnancy BMI, GWG, and incident diagnoses of hypertension in pregnancy were based on medical record abstraction. Results Four percent (n = 54) of women were diagnosed with hypertension in pregnancy, including 2.6 % (n = 36) with preeclampsia. As compared to women who gained within IOM GWG guidelines (22.8 %), those who gained above guidelines (52.5 %) had an odds ratio of 3.82 for hypertensive disorders (95 % CI 1.46-10.00; p.sub.trend = 0.003) and an odds ratio of 2.94 for preeclampsia (95 % CI 1.00-8.71, p.sub.trend = 0.03) after adjusting for important risk factors. Each one standard deviation (0.45 lbs/week) increase in rate of GWG was associated with a 1.74 odds of total hypertensive disorders (95 % CI 1.34-2.27) and 1.86 odds of preeclampsia (95 % CI 1.37-2.52). Conclusions for Practice Findings from this prospective study suggest that excessive GWG is associated with hypertension in pregnancy and could be a potentially modifiable risk factor in this high-risk ethnic group., Author(s): Lisa Chasan-Taber[sup.1] , Marushka Silveira[sup.1] , Molly E. Waring[sup.2] , Penelope Pekow[sup.1] , Barry Braun[sup.3] , JoAnn E. Manson[sup.4] , Caren G. Solomon[sup.4] , Glenn Markenson[sup.5] Author Affiliations: (1) [...]

Prenatal psychosocial stress has been associated with adverse pregnancy outcomes, even after controlling for known risk factors. This paper aims to evaluate correlates of high perceived stress among Hispanic women, a group with elevated rates of stress during pregnancy. We conducted this analysis among 1,426 pregnant Hispanic women using data from Proyecto Buena Salud, a prospective cohort study conducted in Western Massachusetts. Cohen's Perceived Stress Scale (PSS-14) validated in English and Spanish was administered in early (mean = 12.4 weeks gestation), mid (mean = 21.3 weeks gestation) and late (mean = 30.8 weeks gestation) pregnancy at which time bilingual interviewers collected data on socio-demographic, acculturation, behavioral, and psychosocial factors. High perceived stress was defined as a PSS score > 30. Young maternal age (odds ratio (OR) = 0.6; 95% confidence interval (CI) 0.4-0.9 for < 19 vs. 19-23 years), pre-pregnancy consumption of alcohol (OR = 2.2; 95% CI 1.4-3.5 for >12 drinks/month vs. none) and smoking (OR = 2.2; 95% CI 1.3-3.7 for > 10 cigarettes/day vs. none) were associated with high perceived stress during early pregnancy. Furthermore, higher annual household income (OR = 0.4; 95% CI 0.1-0.9 for > $30,000 vs. < $15,000), greater number of adults in the household (OR = 1.8; 95% CI 1.1-3.0 for [greater than or equal to] 3 vs. 1) and language preference (OR = 0.6; 95% CI 0.4-0.9 for Spanish vs. English) were associated with high stress during mid-pregnancy. Likewise, annual household income was inversely associated with high stress during late pregnancy. Our results have important implications for incorporation of routine screening for psychosocial stress during prenatal visits and implementation of psychosocial counseling services for women at high risk. Keywords Perceived stress * Correlates * Pregnancy * Hispanic, Introduction Considerable evidence supports a modest adverse effect of prenatal psychosocial stress on fetal and infant birth outcomes including preterm birth, low birth weight, intrauterine growth restriction, behavioral and mental [...]

Exercise during pregnancy has been associated with reduced risk of gestational diabetes mellitus, however, twice as many women are sedentary during pregnancy as compared to when they are not pregnant. We conducted 3 focus groups among 20 pregnant Latina and non-Latina white women to identify barriers and facilitators to exercise in pregnancy to inform a gestational diabetes mellitus intervention study. Quantitative analyses of demographic data, and qualitative analyses of focus groups were conducted. Women identified physical limitations and restrictions, lack of resources, energy, and time as powerful exercise barriers. Social support, access to resources, information, proper diet, scheduling, and the weather were identified as powerful facilitators. Intervention programs designed for pregnant women should facilitate social support, provide information and resources, as well as promote short-term and long-term benefits. KEYWORDS pregnancy, exercise, Latino/Hispanic DOI: 10.1080/03630240903427114

Abstract Background The purpose of this article was to describe effective strategies for recruitment of Hispanic women into a prospective cohort study of modifiable risk factors for gestational diabetes mellitus (GDM). Although Hispanic women have two to four times the risk of developing GDM compared with non-Hispanic white women, few GDM prevention studies have included Hispanic women. Methods The study was conducted in the ambulatory obstetrical practices of Baystate Medical Center located in a socioeconomically and ethnically diverse city in Massachusetts. The study employed a range of strategies to recruit Hispanic women based on a review of the literature as well as prior experience with the study population. Results Over a period of 32 months, a total of 851 Hispanic prenatal care patients were recruited. Among eligible women, 52.4% agreed to participate. Participants were young (70% Conclusions Findings suggest that investigators can successfully recruit pregnant women from ethnic minority groups of low socioeconomic status into observational studies. The study provides culturally appropriate recruitment strategies useful for practice-based settings recruiting Hispanic research participation.