This is the competitive renewal application (HD 27861, 06-10) of Network 14 in the NICHD Maternal-Fetal-Trials Unit (MFMU) Network located at the University of Chicago's Department of Obstetrics and Gynecology. Its Principal and Co-Principal Investigators have extensive experience in both clinical and basic research, while the team of Investigators includes eight Maternal-Fetal Medicine specialists, a Neonatologist, an Internist who specializes in medical disorders of pregnancy, and an Obstetrician- Epidemiologist with a Ph.D in Public Health experienced in the conduct of clinical trials. There are also five Research Nurses, supervised by a proven Nurse-Educator Coordinator with an MPH. The applicant institution, the seat of a State designated Perinatal Center, experiences approximately 3,000 births yearly, approximately 50% of which are high risk-including a 21% prematurity rate. Other major problems include low birth weight (21%), hypertension (8%), diabetes (5%), and asthma (7%). Most gravidas are managed by the full-time staff. The Neonatal Intensive Care Unit (44 beds) next to the delivery suite is served by nine Neonatologists. The clinics, four of which are """"""""high risk,"""""""" abut their support services (ultrasonography, genetic counselling, and fetal diagnostic units), and contain a computerized record system which captures comprehensive information on all patients and produces a variety of reports used throughout the hospital. A second record-storing computer system will shortly link the Perinatal Center with all its participating hospitals. The pharmacy has a specialized trials section, while laboratory support includes genetic diagnosis and perinatal pathology. Special strengths include NIH funded Clinical pharmacology Training Program and Clinical Research, Nutrition, and Diabetes Research & Training Centers. The application commences with a review of the 01-04 years characterizing l) our participation in eight Network protocols, and 2) the interaction of investigators and nurses with the Steering Committee (which includes authorship on five Network abstracts and two typescripts). Also noted are our 05 year alliances with two nearby hospitals the University of Illinois Medical Center and Mercy Hospital (a University of Chicago 'Hospital affiliate) which will increase our patient recruitment base to approximately 9,10O by the 06 yr. The former alliance provides additional resources including access to Schools of Nursing and Public Health. In summary, the proposed application to continue in the Network demonstrates our continued ability to meet the requirements of the RFA solicitation, reviews our Network performance during the current award period, and describes steps taken to insure a large patient base during the period of anticipated changes in health care delivery patterns which is currently gripping our nation.
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