Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site

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DESCRIPTION (provided by applicant): The Division of Maternal-Fetal Medicine at Brown University/Women and Infants Hospital of Rhode Island (WIH) has a strong commitment to a continued high-level of participation in the NICHD MFMU Network for the purpose of investigating problems in clinical obstetrics, particularly those related to low birth weight, prematurity, and medical problems of pregnancy. We have extensive experience in performing clinical trials in these areas, and a strong, stable, and proven research infrastructure. WIH, with 9,000 annual births, is one of the largest obstetric units in the country. We have been a participating center for the past two 5-year cycles of the MFMU Network. Dwight J. Rouse, MD, MSPH was recruited to be the Brown/WIH Network Principal Investigator in September, 2009. Prior to this he was the Principal Investigator for the University of Alabama at Birmingham (UAB) MFMU Network site from 2001 to 2009. In that role, he maintained UAB as a vital and leading Network center (consistently ranked in the top three). According to the most recent cumulative performance report issued by the Network's Biostatistical Coordinating Center (BCC) Brown/WIH was ranked 2nd highest in Data Quality (edits and audits) and 7th in Patient Recruitment and Retention among 14 centers. We are confident we can retain our high ranking in the former and improve our ranking in the latter. Dr. Rouse's faculty recruitment package included additional Departmental academic open-ended funding for the full time equivalent of two research nurses who are dedicated solely to the Network. With this funding we hired three research assistants (rather than two nurses) and re-configured the deployment of our personnel. Accordingly, our recruitment has increased dramatically. Indeed, since 9/09, Brown/WIH has screened the greatest number of patients, and recruited the second greatest number to the only randomized Network trial ongoing since that time-the SCAN Trial (17-a hydroxyprogesterone caproate for the prevention of preterm birth in nulliparas with a short cervix) We also dramatically increased screening for the TSH trial, to a maximum of 205 (individually-consented) patients in one month. We believe that we remain well positioned for competitive renewal as an NICHD MFMU Network center for the next five years. Our goal is not only to participate in the MFMU Network, but to turn Brown/WIH into one of its leading sites in terms of protocol development, start-up and completion, data interpretation, manuscript preparation and publication in top-tier journals, and support of Network functions across all protocols and centers. PUBLIC HEALTH RELEVANCE: The health and economic burdens of pregnancy-specific disorders such as preeclampsia, and adverse pregnancy outcomes such as preterm birth are substantial and have proved largely intractable. Moreover, pregnancy outcomes in the United States compare unfavorably with many developed-world nations. Brown/WIH, by participating in the MFMU Network, can help provide the necessary, highest quality scientific evidence and redress these burdens.