The goal of this application is to demonstrate that the Maternal-Fetal Medicine Unit in the Department of Reproductive Biology at Case Western Reserve University (CWRU) is qualified to participate in the NICHD Maternal-Fetal Medicine Units Network (MFMU Network), and that participation will strengthen the MFMU Network and provide leadership in the development and conduct of collaborative research between the individual MFM Units as well as with neonatal researchers. The proposed investigators have backgrounds in clinical research, including multicenter studies and studies requiring neonatal and long term follow-up. The Unit possesses diverse clinical and research interests including: prediction and prevention of preterm birth, perinatal infection, labor induction, maternal carbohydrate metabolism/diabetes, energy expenditure in pregnancy, pathophysiology and prevention of preeclampsia, prenatal diagnosis and fetal assessment, placental function, and nutrition. While CWRU has not previously participated in the MFMU Network, it has demonstrated evidence of prior and ongoing participation in collaborative and NIH funded multicenter research. The Principal Investigator has a 10-year history of successful collaboration within the MFMU Network as the alternate Principal Investigator for UT-Memphis. During that time he played a role in the development and conduct of MFMU Network trials, and in the Networks? administrative structure. In this proposal, CWRU offers the participation of its two primary teaching affiliates, MetroHealth Medical Center and University Hospitals (including Rainbow Babies & Children?s Hospitals). Inclusion of both hospitals offers a large number of women for recruitment, and could allow focused cost/time efficient recruitment of selected subjects from a diverse population. CWRU?s NIH-funded General Clinical Research Center has an established record of successful perinatal research. The CWRU-GCRC?s value is enhanced by having Units located at both MetroHealth Medical Center and at University Hospitals. Both Units are available to support MFMU Network trials, can perform ancillary studies in their core laboratories, and could act as a Central Lab for multicenter studies. Rainbow Babies & Children?s Hospital has participated in the NICHD Neonatal Research Network since its inception, and offers special research expertise in long term follow-up. It offers a potential bridge for collaboration between the MFMU and NICU Networks in addition to follow-up for MFMU Network studies. The proposed CWRU MFMU Unit offers experienced clinicians and researchers, a large diverse patient population, as well as a demonstrated ability to conduct collaborative clinical research. The proposed MFM and Neonatology researchers have demonstrated the ability to collaborate across geographic, Hospital and Departmental boundaries, both outside and inside the NICHD MFMU and NICU Networks. The existing infrastructure at CWRU offers the potential for enhanced and cost-effective research as well as the ability to design and support ancillary studies. The investigators believe that they can successfully contribute to the MFMU Network and that they offer potential leadership as the Network expands its efforts in collaborative, longitudinal studies in the 21st Century.
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