NICHD Maternal Fetal Medicine Units Network

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DESCRIPTION (provided by applicant): As a new member of the Network, the UNC MFMU site has completed four randomized clinical trials and one observational study; is conducting follow-up studies for two trials; and has five trials ongoing. We have consistently ranked in the top half of overall recruitment among all network sites and excelled at Hispanic recruitment. This track record as a strong site, coupled with our tradition of excellence in clinical trials research and perinatal epidemiology makes us ideally suited to continue as a highly productive member of the Network. We have assembled a talented and committed team of physicians, research fellows, graduate students, research nurses, clinical research assistants, laboratory staff, and other investigators in our Perinatal Research Core, an alliance of investigators dedicated to understanding and improving pregnancy outcomes through state-of-the-art research. The Core is supported by a well-established infrastructure consisting of clinical tracking systems, data management resources, and specialized research services such as computer assisted telephone interviewing facilities, an NIH Clinical Nutrition Research Center, one of the top General Clinical Research Centers in the nation, a Comprehensive Center for Inflammatory Disorders, the Center for Oral and Systemic Diseases, and the Center for Women's Health Research. With the addition of Rex Healthcare in this application, our sites have more than 13,000 births each year, 33% of which are high-risk by virtue of maternal co-morbidities, including substance abuse, fetal anomalies, pregnancy complications, or preterm birth risk profile, including multiple gestations. UNC and WakeMed provide virtually all of the high-risk prenatal clinic and hospital-based care for our prenatal population because of a system of low-risk community clinics staffed by non-OB/GYNs using uniform screening and referral protocols. Patients from these clinics give birth at UNC or WakeMed. Overall, the majority of prenatal patients at WakeMed and UNC are indigent: 55% at UNC and 64% at WakeMed have Medicaid or are self-pay; 45% at UNC and 36% at WakeMed have some form of private coverage. The Rex patient population is predominately lower risk patients and the majority have some form of private coverage. Rex has a large birthing center and facilities where patients from more than 30 private practices in Wake County give birth. We currently work with 18 of these practices in other NIH-funded research. Affiliation with Rex will further broaden our base for outpatient recruitment. Racial and ethnic diversity in our recruitment has been strong with 42% white participants, 29% Hispanics, and 27% African Americans. UNC and WakeMed have Level 3 neonatal care units, and Rex has a Level 2 nursery. UNC is simultaneously applying to join the Neonatal Research Network this year. Together, our three partner institutions bring more than fifteen years of productive multi-site research, experienced investigators, state-of-the-art care facilities, a stable population, ongoing enhancements of computerized perinatal databases, and commitment to excellence in collaborative research as part of the MFMU.