The purpose of this proposal is to show that the Division of Maternal- Fetal Medicine (MFM) at the University of Utah Health Sciences Center is an excellent candidate to become a member of the Maternal-Fetal Medicine Units (MFMU) Network sponsored by the National Institute of Child Health and Human Development. The MFM Division has the past record of academic productivity, previous success in participating in multicenter trials, access to a suitable and cooperative patient population, and several unique strengths which allows the MFM Division to bring to the MFMU Network the ability to successfully perform clinical trials with a strong basic science background.
The specific aims of this proposal are: (1) to describe the organizational structure of the division with regard to the MFMU network, the demographics of our patient population, and the strengths of individual division members; (2) to show our ability to design and propose a multicenter trial; and (3) to describe special strengths of the division which will be made available to the MFMU network. We have been successful in several multicenter trials over the past five years, and our participation in these studies will be detailed. We will describe the organization of our research efforts, the patient population available for study, research nurse staffing, the clinical strengths of our program, our computerized perinatal data base, and the neonatology services available for multicenter studies. Our proposed study, entitled 'The safety and efficacy of single vs. weekly administration of corticosteroids for the acceleration of fetal lung maturity', will demonstrate our ability to use our current perinatal data base to design and execute a randomized clinical multicenter trial. The on-going research efforts in our Division have led to the development of renowned basic science programs in Perinatal Genetics (including molecular genetics) and Reproductive lmmunology and the services of these laboratories will be made available for participation in MFMU Network protocols. Most importantly, the MFM Division has access to a large number of high-risk and low-risk pregnancies because we provide clinical coverage for four affiliated hospitals with a combined delivery total of greater than 12,000 deliveries per year. Adequate patient numbers for MFMU Network protocols would be expected given the total number of patients which can be approached for enrollment and the cooperative nature of the population. These features, along with our unique geographic region, distinguish the MFM Division at the University of Utah as a productive and successful academic group which will enhance the MFMU Network.
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