Over the past nine years as a member of the MFMU network, the UNC MFMU site has completed six randomized clinical trials and has one observational study and two network trials ongoing. We are number four in recruiting among the 14 sites, and are ranked number three in adherence and quality overall. UNC excels at Hispanic recruitment;overall 31% of our participants are Hispanic. 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, 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, an NIH Clinical Nutrition Research Center, and one of the top General Clinical Research Centers in the nation. UNC serves as the lead organization with two other UNC Healthcare locations (Wake AhecA/WakeMed and Rex Hospital) serving as recruitment sites. With the addition of a third recruitment site, MAHEC/Mission Hospital in this application, we have more than 19,000 births each year across sites, 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 this region, and MAHEC/Mission Hospital provides the same for 17 counties in the western part of the state. Overall, the majority of prenatal patients at WakeMed and UNC are indigent;the Rex patient population is predominately lower risk patients and the majority has some form of private coverage;MAHEC/Mission Hospital patients are roughly half and half. Racial and ethnic diversity in our recruitment has been strong with 64% white participants and 27% African Americans;additionally 31% are Hispanic. UNC, Wake AHEC/WakeMed, and MAHEC/Mission have state of the art Level III neonatal intensive care units, and Rex has a Level II nursery. Together, these four components of the UNC Healthcare System bring more than twenty 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.

Public Health Relevance

The University of North Carolina Maternal Fetal Medicine Unit (MFMU) network site has been a significant contributor to the network for the past nine years, completing eight randomized clinical trials, having two observational studies and two randomized trials in progress, and starting two more trials in June. Network studies investigate problems in clinical obstetrics, particularly those related to low birth weight, prematurity, and medical problems of pregnancy, and contribute to the development of evidence-based practices in the field of maternal-fetal medicine. This is particularly important in North Carolina as the state ranks in the bottom third of the nation with regard to perinatal/maternal health and infant mortality.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD040560-14
Application #
8451571
Study Section
Special Emphasis Panel (ZHD1-DRG-D (50))
Program Officer
Ilekis, John V
Project Start
2001-04-18
Project End
2016-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
14
Fiscal Year
2013
Total Cost
$276,690
Indirect Cost
$89,737
Name
University of North Carolina Chapel Hill
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Caritis, Steve N; Feghali, Maisa N; Grobman, William A et al. (2016) What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth. Semin Perinatol 40:273-80
Yee, Lynn M; Sandoval, Grecio; Bailit, Jennifer et al. (2016) Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol 128:1039-1047
Landon, Mark B; Grobman, William A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network (2016) What We Have Learned About Trial of Labor After Cesarean Delivery from the Maternal-Fetal Medicine Units Cesarean Registry. Semin Perinatol 40:281-6
Froehlich, Rosemary J; Sandoval, Grecio; Bailit, Jennifer L et al. (2016) Association of Recorded Estimated Fetal Weight and Cesarean Delivery in Attempted Vaginal Delivery at Term. Obstet Gynecol 128:487-94
Manuck, Tracy A; Rice, Madeline Murguia; Bailit, Jennifer L et al. (2016) Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort. Am J Obstet Gynecol 215:103.e1-103.e14
Bloom, Steven L; Belfort, Michael; Saade, George et al. (2016) What we have learned about intrapartum fetal monitoring trials in the MFMU Network. Semin Perinatol 40:307-17
Salazar, Ashley; Tolivaisa, Susan; Allard, Donna et al. (2016) What we have learned about best practices for recruitment and retention in multicenter pregnancy studies. Semin Perinatol 40:321-7
Rice, Madeline Murguia; Landon, Mark B; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units (MFMU) Network (2016) What we have learned about treating mild gestational diabetes mellitus. Semin Perinatol 40:298-302
Blackwell, Sean C; Landon, Mark B; Mele, Lisa et al. (2016) Relationship Between Excessive Gestational Weight Gain and Neonatal Adiposity in Women With Mild Gestational Diabetes Mellitus. Obstet Gynecol 128:1325-1332
Basraon, Sanmaan K; Mele, Lisa; Myatt, Leslie et al. (2016) Relationship of Early Pregnancy Waist-to-Hip Ratio versus Body Mass Index with Gestational Diabetes Mellitus and Insulin Resistance. Am J Perinatol 33:114-21

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