DESCRIPTION (provided by applicant): Committed to improving the health and well-being of mothers and their families, Duke Maternal-Fetal Medicine (MFM) is dedicated to continued participation in the NICHD Maternal-Fetal Medicine Units Network (MFMU). Duke MFM is well-suited to continue as an MFMU site given our research infrastructure, successful track record in basic and translational research, and patient volume. With 4 primary research faculty and 15 research staff, Duke MFM has a highly functional research team with over 20 years of experience in single and multi-center studies. Content expertise includes prematurity, premature rupture of membranes, fetal growth restriction, dysfunctional labor, maternal immunization, and maternal medical conditions. Technical expertise includes study design, recruitment and retention, molecular biology, data safety monitoring, coordinating and analysis, and decision/cost-effectiveness modeling. With 14 faculty, 6 fellows, 7 midwives, and 3 nurse practitioners, Duke MFM provides full service high-risk prenatal care and delivery, prenatal diagnosis, and consultative services for the Duke University Health System (DUHS). As a MFMU site since 2011, Duke MFM has served on administrative working groups and committees, protocol subcommittees, and submitted ancillary and secondary analyses. We have further strengthened our existing relationships with obstetricians in the community to successfully prioritize and enroll participants into MFMU trials and will continue to recruit participants from ~5,800 annual births across two DUHS institutions in Durham, North Carolina - Duke University Medical Center (~3,375) and Duke Regional Hospital (DRH) (~2,425). High risk conditions like hypertension, diabetes, asthma, multi-fetal gestation, prematurity, and low birthweight occur among half of all births across DUHS. Duke MFM has a highly productive and collegial relationship with Neonatology, providing continued expertise and support for their participation in the NICHD Neonatal Research Network and vice versa. Further, we have active partnerships across the Duke University campus including neonatology, pediatrics, infectious diseases, immunology, nursing, pathology, genetics, pharmacology, epidemiology, research pharmacies and the Duke Translational Medicine Institute (NIH CTSA), which can aid our success in the MFMU. Duke MFM is committed to working cooperatively with NICHD and the MFMU and has the expertise, resources, and institutional support to be a productive and successful site involved in multicenter collaborative research involving perinatal health.

PUBLIC HEALTH RELEVANCE (provided by applicant): Intervention strategies for maternal-fetal conditions such as prematurity, low birth weight, and preeclampsia remain controversial. Observational and randomized trials conducted in a premier academic multi-center network, like the MFMU, allows for adequately-sized populations of socio-demographically diverse women in a timely manner and the potential for rapid dissemination of efficacious interventions to practicing obstetricians.