The objective of this application is for Wayne State University (WSU) to continue as a Maternal-Fetal Medicine Unit (MFMU) network site. With respect to academic productivity in the MFMU network WSU is ranked in the middle for patient recruitment and retention/completion, and 5.5 in adherence/data quality, with 100% 12 and 24 months infant follow-up in the TSH trial. WSU contributed a disproportionately high number (21%) of African American patients enrolled, by the 14 MFMU centers, to the 2 RCTs initiated in the current funding cycle. The WSU Principal Investigator participated in Committees and Subcommittees, and contributed to research development and design of the TSH protocol. WSU investigators submitted 10 proposals and first authored 6 MFMU publications. The WSU MFMU team achieved the objectives with highly qualified leadership that has knowledge and experience in research design, and collaboration in multicenter randomized clinical trials, experienced research staff, in the presence of extensive research infrastructure. The WSU Principal Investigator increased his protected time to 50%, dedicated to MFMU related activities, and is adding 2 sites, which will increase the patient population available at WSU for MFMU recruitment by 70% to 9418 deliveries/year. Health care providers in the 3 sites are required to provide access to all patients for screening and enrollment to research studies. Maternal-fetal staff, including 13 faculty and 7 fellows, are very productive with 265 peer-reviewed publications, and contribution to 11 non-MFMU studies of cooperative or multicenter design. WSU has been a center in the NICHD Neonatal Research Network since 1986. The large high quality perinatal data system assisted in writing this application, and has a unique notification system for MFMU research nurses of MFMU enrolled patients. Special strengths include faculty with experience in research administration, the Mott center for research, and the NICHD Perinatology Research Branch. The central hypothesis of our concept proposal is that treatment with azithromycin will reduce the risk of spontaneous preterm birth (SPTB) among women that (Uu) undergo mid-trimester genetic amniocentesis for clinical indications, and have Ureaplasma urealyticum detected in amniotic fluid, by polymerase chain reaction (PCR). The concept proposal is a randomized, double-blind, placebo controlled, multicenter trial. The proposed research is innovative. Results could change practice, by providing a strong foundation for routine PCR testing of AF obtained during amniocentesis for clinical indications, administration of antibiotics, and reduction in PTB. The research proposal is expected to reduce PTB and improve the health of pregnant women their neonates.

Public Health Relevance

): Preterm birth accounts for 70% of neonatal deaths and 50% of long-term neurological poor outcomes in children. This proposal is relevant to maternal-fetal health because it may change management of pregnant women by healthcare providers, and result in reduction of preterm births.

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 #
5U10HD027917-25
Application #
8638039
Study Section
Special Emphasis Panel (ZHD1-DRG-D (SY))
Program Officer
Ilekis, John V
Project Start
1991-04-01
Project End
2016-03-31
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
25
Fiscal Year
2014
Total Cost
$72,764
Indirect Cost
$27,385
Name
Wayne State University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
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
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

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