NICHD Maternal-Fetal Medicine Units (MFMU) Network

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 DESCRIPTION (provided by applicant): The Division of Maternal-Fetal Medicine at Brown University/Women & Infants Hospital of Rhode Island (WIH) has a strong commitment to a continued high-level of participation in the Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units (MFMU) Network for the purpose of investigating problems in clinical obstetrics, particularly those related to prevention of preterm birth, low birth weight, and obstetrical and medical complications of pregnancy. We have extensive experience in performing clinical trials in these areas, and a strong, stable, and proven research infrastructure. WIH, with ~8,500 annual births, is one of the largest stand- alone obstetric units in the country. We have been a participating center for the past three 5-year cycles of the MFMU Network. We remain well positioned for competitive renewal as an NICHD MFMU Network center for the next five years. Since assuming the Brown/WIH PI position in 2009, Dr. Dwight Rouse, along with Dr. Brenna Hughes as Alternate-PI, has endeavored to make Brown/WIH a Network leader, and has been increasingly successful. In the recently completed Network trial "Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial" we were tied for 2nd among all Network centers for recruitment, and in the two actively-recruiting Network randomized trials--"ARRIVE (A Randomized Trial of Induction Versus Expectant Management)" and "A Randomized Trial to Prevent Congenital Cytomegalovirus" -- we rank 3rd. Dr. Hughes leads the latter as sub-committee PI, i.e., she is the overall Network PI of the trial. This cycle, Brown/WIH investigator Dr. Erika Werner, with the joint mentorship of Drs. Rouse and Hughes, as well as Dr. Donald Coustan, presented as a concept and took through to a fully approved protocol (by a vote of 16-0) her proposal for a Network randomized trial of myo-inositol supplementation to prevent gestational diabetes. This protocol will be considered for prioritization at the next prioritization meeting. She also is a member of the Network Meta-Analysis Working Group. That is, in the current Network cycle, we have gone from being a mediocre center to one that leads in scientific and recruitment contributions. We have an experienced, competent, and enthusiastic research team in place, and are confident that our team can help the MFMU Network reach its fullest potential.