Our overall goal is to improve the health of pregnant women, their fetuses, and neonates. The objective of this application is to continue the Maternal-Fetal Medicine Unit (MFMU) Clinical Center at Wayne State University. We are committed to cooperative research and offer a large patient base (13,000 deliveries/year), including a high percentage of minorities, from which to enroll into network protocols. We propose to achieve this objective by documenting that Wayne State's spectrum of research expertise and resources is consistent with continuing our successful participation in the Network; our capability and intent of recruitment, rigorous patient evaluations and treatment of subjects using common protocols are documented by both current status and past performance. It is our expectation that we will continue to be an integral and contributing member of the MFMU in research identified by other members and as innovators of new projects; the concept protocol is a clinical trial aimed at prevention of preterm delivery. Twelve subspecialists in maternal-fetal medicine (one also subspecialized in clinical genetics), and two neonatologists will collaborate in the MFMU Network Center. Additional research faculty in the Department of Obstetrics and Gynecology, and other departments will provide support as needed Seven experienced research nurses are currently employed to accomplish network protocols. The Division of Neonatology is also submitting their Neonatal Network Grant renewal proposal and continues to collaborate closely with the MFMU Network. Our computerized perinatal database now contains over 110,000 deliveries. One of our long-range research goals is to develop strategies for the prevention of preterm birth. The speck objective of our concept protocol is to reduce the rate of spontaneous preterm birth (SPTB) less than 32 weeks' gestation. The central hypothesis of the proposed research is that midtrimester antibiotic treatment of women found to be at increased risk for early SPTB will reduce preterm delivery at less than 32 weeks, lengthening gestation.
The specific aims are to select pregnant women at increased risk for SPTB less than 32 weeks, and to establish the efficacy of antibiotic treatment in reduction of SPTB less than 32 weeks of gestation. The proposed research is innovative because the antibiotic treatment is given to women at risk for early SPTB selected by a discriminating multiple serum marker screening. The outcomes will be significant because they will provide a strong foundation for midtrimester antibiotic treatment of women identified to be at risk for SPTB less than 32 weeks, and thereby reduction of perinatal morbidity and mortality.
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