A """"""""concept"""""""" protocol for evaluating the efficacy of antenatal steroids following preterm premature rupture of membranes (PT-PROM) is submitted to demonstrate the capabilities of the investigators in protocol development. This protocol is a randomized double blind controlled study in which patients presenting with PROM will be stratified into two groups one at 24-28 weeks and the other at 29-32 or 34 weeks. Data are provided from 60 PT-PROM patients recently cared for at Thomas Jefferson University Hospital (TJUH) to provide insight into potential study problems. The key issues to successfully participate in the collaborative research network, aside from the """"""""concept"""""""" protocol, are the resources, personnel, and experience of the physician research team. The Jefferson Medical College Clinical Center (JMC-CC) has recently been formed by a merger of the two largest perinatal centers in the Philadelphia area: Thomas Jefferson University Hospital and Pennsylvania Hospital. This center formed under the aegis of Jefferson Medical College provides a large single entity for clinical care, research and education. The JMC-CC is applying to perform collaborative research as a participant in the cooperative Multicenter Maternal-Fetal Medicine (MFM) Network. This academic center will provide access to a population of over 6500 deliveries per year of which over 3000 are patients of the hospital faculty or clinic. There is a total available faculty of 13.5 Maternal- Fetal Medicine subspecialists. The participating physicians are academically productive and have participated in multiple previous multicenter studies. Five MFM subspecialists will take primary responsibility for network protocols. These physicians will have a minimum of 20% protected time for participation in the study and the principal investigator will have 40%. The JMC-CC has an existing structure to perform clinical research. This includes three full-time research nurses, a departmental obstetrical data system, a full-time physician data manager, and a data entry clerk. All patients of the JMC-CC are available to participate in research projects and a system of active chart surveillance is in place to maximize enrollment. Thirty to 50% of the patient population is high-risk and approximately 95% of the patients receive their prenatal care within the center. The JMC-CC has extensive experience and expertise in antenatal testing and intrapartum diagnoses and has one of the country's largest antenatal testing and ultrasound units. Additional assets include perinatal pathology, genetics, a fetal cardiology and physiology unit, and a reproductive immunology laboratory. The JMC-CC is supported by one of the largest neonatal divisions in the country which cares for over 2300 neonates per year and is an active participant in national multicenter trials. The center has an active community outreach network with over 40,000 deliveries under its direction.
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