START UP, PREPARATION, AND TEST ENROLLMENT FOR THE TIMING OF DELIVERY (TIME) AIM OF THE STUDY OF PREGNANCY AND NEONATAL HEALTH (SPAN)

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The Division of Intramural Population Health Research (DIPHR) at the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) designs and conducts original epidemiological, behavioral, and biostatistical research encompassing several research domains such as human reproduction and development, pregnancy and related complications, pediatric and adolescent health and behaviors, and methodologic research relevant for our mission. The Division comprises three intramural research branches, Epidemiology, Biostatistics & Bioinformatics, and Social and Behavioral Sciences, and its mission is to design and implement original research with the potential for high impact findings that impact public health. Under the developmental origins of health and disease (DOHaD) hypothesis, early life exposures can “program” an individual for health and chronic disease risk through cellular adaptations to biological processes. Prenatal exposures and genetic factors impact fetal growth and development and neonatal health, important determinants of life-long health and disease. We propose an approach to examine a) the father’s role, b) placental determinants, and c) timing of delivery in relation to fetal and neonatal health and development. A cohort study will be performed to collect common data elements from approximately 10,728 pregnant women and their neonates and approximately 3825 male partners with a randomized trial conducted in women with gestational diabetes (approximately 3450 women, an addition of 2730). African American women will be oversampled (~4250). It is anticipated that multiple study sites will be established.