The Specific Aim of this application is a successful competitive renewal for the University of Utah clinical center in the 2011-2016 NICHD MFMU Network. The University of Utah MFMU Network site has been a Network leader in recruitment and retention, data quality markers, and academic productivity during its 15- year Network membership. The Utah site has submitted 16 proposals (including 8 in the current Network cycle) to the Network Steering Committee and Utah faculty are Principal Investigators on two active Network protocols. The Utah site PI (Michael Varner MD) has numerous Network administrative responsibilities and has worked tirelessly to develop successful collaborations with obstetric care providers in the community and between the MFMU Network and other NICHD-funded clinical research networks. Fifteen Board- Certified/Board Eligible MFM Division faculty plus 5 MFM Fellows provide 24/7/365 coverage for the 5 participating Utah hospitals. These 5 participating hospitals represent 20,000 deliveries per year (40% of the deliveries in the State of Utah). The population recruited into MFMU Network studies over the previous 15 years is representative of the population of the northern Utah urban corridor. NICU, Neonatal Follow-Up Programs, Perinatal Data systems and a team of almost 30 research personnel are available for the design and execution of clinical trials. The University of Utah is experienced with, and accepting of, the MFMU Network budgetary mechanisms and is enthusiastically committed to continued participation in the NICHD MFMU Network. This support is documented from the Senior Vice-President for Health Sciences (Dr. Betz), the Department Chair (Dr. Peterson) and the Medical Directors of NICUs and MFM Services as well as the Hospital Administrators of all 5 participating hospitals and the Medical Director for Intermountain Healthcare. The University of Utah is one of the most productive MFU Network sites, contributing numerous concepts and protocols, large numbers of well-characterized study participants, and high-quality research data. Dr. Varner's ability to enlist wide-spread community participation and to attract-retain an excellent research staff are major factors in this success and will continue if Utah is selected for continued Network participation.

Public Health Relevance

Obstetrical management protocols require validation prior to implementation. Because large numbers of participants of varied racial-ethnic-sociodemographic backgrounds are required for protocol validation, multicenter clinical trials are generally required to ensure that study outcomes are generalizable. The NICHD MFMU Network is the premiere obstetric clinical trials network in the world and has made numerous important contributions to clinical obstetrics. The University of Utah is a leading member of this Network.

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 #
5U10HD034208-20
Application #
8638041
Study Section
Special Emphasis Panel (ZHD1-DRG-D (50))
Program Officer
Ilekis, John V
Project Start
1996-05-01
Project End
2016-03-31
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
20
Fiscal Year
2014
Total Cost
$355,497
Indirect Cost
$116,908
Name
University of Utah
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
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Caritis, Steve N; Feghali, Maisa N; Grobman, William A et al. (2016) What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth. Semin Perinatol 40:273-80
Yee, Lynn M; Sandoval, Grecio; Bailit, Jennifer et al. (2016) Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol 128:1039-1047
Landon, Mark B; Grobman, William A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network (2016) What We Have Learned About Trial of Labor After Cesarean Delivery from the Maternal-Fetal Medicine Units Cesarean Registry. Semin Perinatol 40:281-6

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