NICHD Maternal-Fetal Medicine Units (MFMU) Network

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PROJECT SUMMARY/ABSTRACT Over the past 20 years, University of North Carolina at Chapel Hill (UNC) (Center 27) has proven its commitment as a member of the Maternal Fetal Medicine Unit Network (MFMU) by conducting clinical trials with efficiency, excellent subject recruitment and retention, and high data quality. The UNC MFMU has completed 17 studies, with 10 currently active, including a COVID-19 study and two others that were approved this year. We average 7th overall in recruiting among all sites, and #7 in retention/completion. UNC Health Care serves as the lead organization in our consortium for research, with three other health systems as satellites--Wake Health and Hospitals in Raleigh, NC; Duke Health and Hospitals in Durham; and the Prisma Health System in Greenville, SC. Collectively, we operate eight labor and delivery units, one free standing birth center, and five neonatal intensive care units with each system having an NICU follow up clinic for graduates. Our region-wide sampling frame affords us access to virtually every birth and mother to be and her baby in the “Triangle”, a region in the Piedmont of North Carolina with a population of >2 million. With Prisma Health in Greenville, SC as a satellite site, we average >25,000 births across sites, of which >30% are considered high- risk because of maternal co-morbidities, including substance abuse, fetal anomalies, pregnancy complications, or preterm birth risk profile. The population served by these four full service health systems is ethnically diverse, with ~11% of our participants being Hispanic, and includes families at a full range of socioeconomic status. We are the only Network center to have a population-based context in which to recruit. Together, these health care systems bring more than 30 years of productive multi-site research, experienced investigators, state-of-the-art care facilities, a stable population, and a commitment to excellence as an active participant in the MFMU network. All Health Systems in our coalition rely on Epic as their electronic health record of choice, and over the past five years our team has developed manuals and protocols to facilitate patient recruitment, data abstracting, and data sharing. With COVID causing a shutdown in research at each site (~March 13-June 1), recruitment has slowed down. However, we have continued working and have modified our protocols to ensure continued productivity. In this proposal we will describe our plans to maintain our record of success by completing ongoing studies of the MFMU Network. Our proven record of performance, coupled with our large, diverse base of potential study participants and our knowledge of clinical trials and observational studies will enable us to continue our substantive contribution to the quality and quantity of research in the MFMU Network.