? Core C Core C, the Clinical Coordination Core, will provide support to the investigators in carrying out their project goals related to this Program Project, Bridging physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery. The overarching goal of this Program is to understand the influence of intra-abdominal pressure, physical activity and strength on pelvic floor support and symptoms and the cultural context in which women experience those changes. The scope of this project is relevant to NICHD's described mission and specifically addresses pelvic floor disorders, as emphasized in the portfolio of the Gynecologic Health and Disease Branch.
The aims of Core C are to: 1) Train and certify study personnel and develop manuals of operation for all research procedures 2) Recruit pregnant participants in their 3rd trimester, maximizing recruitment of Mexican-Americans 3) Identify participants meeting inclusion criteria for Projects 1-3 4) Track participants, schedule study visits and procedures, coordinate delivery and retrieval of accelerometers and intra-abdominal pressure sensors 5) Maximize retention rates 6) Ensure high quality data collection and secure data management 7) Acquire, process, and store blood samples 8) Oversee regulatory requirements, participant safety, and human subjects' research protections 9) Ensure participant level financial compliance For two decades, the University of Utah has had the necessary infrastructure, and long-term successful experience, to conduct clinical studies in pregnant and postpartum women. Core C will capitalize on these successes in this Program Project Grant and will enroll 1530 women during their third trimester (the ?Primiparous Cohort?), subsequently exclude women delivered before 37 weeks gestation or by cesarean, and follow the remaining women for one year postpartum. These participants will form the various populations needed to meet specific study aims. Core C will provide participants' data to three projects to facilitate much- needed research on physical and cultural contributors to pelvic floor support and pelvic floor symptoms.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Program Projects (P01)
Project #
5P01HD080629-05
Application #
9746527
Study Section
Special Emphasis Panel (ZHD1)
Project Start
Project End
2021-06-30
Budget Start
2019-07-01
Budget End
2020-06-30
Support Year
5
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Utah
Department
Type
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112
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