The Specific Aim of this application is a successful competitive renewal for the University of Utah clinical center in the 2011-2016 NICHD MFMU Network. The University of Utah MFMU Network site has been a Network leader in recruitment and retention, data quality markers, and academic productivity during its 15- year Network membership. The Utah site has submitted 16 proposals (including 8 in the current Network cycle) to the Network Steering Committee and Utah faculty are Principal Investigators on two active Network protocols. The Utah site PI (Michael Varner MD) has numerous Network administrative responsibilities and has worked tirelessly to develop successful collaborations with obstetric care providers in the community and between the MFMU Network and other NICHD-funded clinical research networks. Fifteen Board- Certified/Board Eligible MFM Division faculty plus 5 MFM Fellows provide 24/7/365 coverage for the 5 participating Utah hospitals. These 5 participating hospitals represent 20,000 deliveries per year (40% of the deliveries in the State of Utah). The population recruited into MFMU Network studies over the previous 15 years is representative of the population of the northern Utah urban corridor. NICU, Neonatal Follow-Up Programs, Perinatal Data systems and a team of almost 30 research personnel are available for the design and execution of clinical trials. The University of Utah is experienced with, and accepting of, the MFMU Network budgetary mechanisms and is enthusiastically committed to continued participation in the NICHD MFMU Network. This support is documented from the Senior Vice-President for Health Sciences (Dr. Betz), the Department Chair (Dr. Peterson) and the Medical Directors of NICUs and MFM Services as well as the Hospital Administrators of all 5 participating hospitals and the Medical Director for Intermountain Healthcare. The University of Utah is one of the most productive MFU Network sites, contributing numerous concepts and protocols, large numbers of well-characterized study participants, and high-quality research data. Dr. Varner's ability to enlist wide-spread community participation and to attract-retain an excellent research staff are major factors in this success and will continue if Utah is selected for continued Network participation.
Obstetrical management protocols require validation prior to implementation. Because large numbers of participants of varied racial-ethnic-sociodemographic backgrounds are required for protocol validation, multicenter clinical trials are generally required to ensure that study outcomes are generalizable. The NICHD MFMU Network is the premiere obstetric clinical trials network in the world and has made numerous important contributions to clinical obstetrics. The University of Utah is a leading member of this Network.
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