The objective of this application is for Wayne State University (WSU) to continue as a Maternal-Fetal Medicine Unit (MFMU) Network site. We are committed to cooperative research and offer a large patient base (9,800 deliveries/year), including a high percentage of minorities, from which to enroll into network protocols. We propose to achieve this objective with WSU MFMU highly qualified research team, which has strong leadership, with knowledge and experience in research design and collaboration in multicenter randomized clinical trials, as well as adequate time commitment and resources for performance of Network studies. 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. WSU is tied for 4th in ranking for enrollment during the current cycle. WSU contributed 23.8% of pregnant women of African American descent into MFMU studies. It is our expectation that we will continue to be an integral and contributing member of the MFMU in research, identified by other members as innovators of new projects. Sixteen subspecialists in maternal-fetal medicine (three also subspecialized in clinical genetics), and two neonatologists will collaborate in the MFMU Network Center. Our computerized perinatal database now contains over 145,736 deliveries. Our long-range research goal is to develop strategies for the prevention of preterm birth. The central hypothesis of the concept proposal is that treatment with 17 Hydroxyprogesterone Caproate (17-OHP) reduces the risk of preterm birth in women who have previously experienced a midtrimester spontaneous pregnancy loss, or experience mid-trimester vaginal bleeding in the current pregnancy.
The specific aims are to identify women with a spontaneous pregnancy loss at 13-20 weeks in prior pregnancy or with presence of vaginal bleeding at 13-20 weeks in the current pregnancy, and to test the effectiveness of treatment with 17-OHP to reduce the rate of PTB. The concept proposal is a randomized, double-blind, placebo controlled, multicenter trial. The proposed research is innovative for its study design, patient selection, and utility of survival analysis. The outcomes will be significant because the will provide stronger foundation for treatment with 17-OHP. Our application and research proposal will reduce preterm delivery, and improve the health of pregnant women, their fetuses, and neonates.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD027917-20
Application #
7806393
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (23))
Program Officer
Spong, Catherine
Project Start
1991-04-01
Project End
2011-03-31
Budget Start
2009-12-01
Budget End
2010-11-30
Support Year
20
Fiscal Year
2010
Total Cost
$275,749
Indirect Cost
Name
Wayne State University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
Tita, Alan T N; Jablonski, Kathleen A; Bailit, Jennifer L et al. (2018) Neonatal outcomes of elective early-term births after demonstrated fetal lung maturity. Am J Obstet Gynecol 219:296.e1-296.e8
Grobman, William A; Bailit, Jennifer; Sandoval, Grecio et al. (2018) The Association of Decision-to-Incision Time for Cesarean Delivery with Maternal and Neonatal Outcomes. Am J Perinatol 35:247-253
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Chauhan, Suneet P; Weiner, Steven J; Saade, George R et al. (2018) Intrapartum Fetal Heart Rate Tracing Among Small-for-Gestational Age Compared With Appropriate-for-Gestational-Age Neonates. Obstet Gynecol 132:1019-1025
Kominiarek, Michelle A; Saade, George; Mele, Lisa et al. (2018) Association Between Gestational Weight Gain and Perinatal Outcomes. Obstet Gynecol 132:875-881
Kominiarek, Michelle A; Smid, Marcela C; Mele, Lisa et al. (2018) Child Neurodevelopmental Outcomes by Prepregnancy Body Mass Index and Gestational Weight Gain. Obstet Gynecol 132:1386-1393
Varner, Michael W; Mele, Lisa; Casey, Brian M et al. (2018) Thyroid function in neonates of women with subclinical hypothyroidism or hypothyroxinemia. J Perinatol 38:1490-1495
Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Pasko, Daniel N; McGee, Paula; Grobman, William A et al. (2018) Variation in the Nulliparous, Term, Singleton, Vertex Cesarean Delivery Rate. Obstet Gynecol 131:1039-1048

Showing the most recent 10 out of 251 publications