RTI submits this application for the Data Coordinating and Analysis Center (DCAC) described in RFA-HD-08- 029 and entitled "Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk." The DCAC is led by Corette Parker, DrPH, PI, and Matthew Koch, MD, PhD, Co-PI, senior biostatisticians, who have assembled a core team with expertise in biostatistics, statistical genetics, perinatal epidemiology, maternal-fetal medicine, pregnancy outcomes and measurements, data management and project coordination. The team is drawn from the statistics and epidemiology and research computing division units at RTI and complimented by two distinguished consultants, Gordon CS Smith, MD, PhD of Cambridge University, and Radek Bukowski, MD, PhD of the University of Texas Medical Branch at Galveston. This core team brings unique strength to the challenges and successful operation of the DCAC and the Network as a whole. Most of the team members work together on the NICHD Stillbirth Collaborative Research Network. This experience provides a joint understanding ofthe complexities ofthe proposed study. Drs. Parker and Koch each have 20+ years of experience managing DCAC activities and leading statistical tasks for multisite studies. They will supplement the core team with other individuals, as appropriate, from RTI's ample and diverse research staff to bring the most appropriate mix of expertise to each phase of the research. The proposed team will establish a partnership with the NICHD staff and Clinical Site Investigators to develop and implement common protocols to study nulliparous women and to acquire and analyze the resulting data to identify biomarkers and understand the mechanism and prediction of preterm birth and other adverse pregnancy outcomes. The DCAC responsibilities will include (1) providing leadership in biostatistics and data management;(2) implementing a communications infrastructure and providing logistics support;(3) participating in protocol development, including data collection instruments, manuals of operation, and other study materials;(4) implementing data collection and management systems;(5) assisting in training personnel in standard study procedures;(6) assisting in development of QA/QC procedures, (7) producing routine and ad hoc reports for clinical sites, NICHD, the Steering Committee, and the Advisory and Safety Monitoring Committee;and (8) disseminating study results through publications and presentations. The project coordinator will be located at RTI's office in Rockville, MD adjacent to NICHD for convenience.
Forty percent of pregnant women in the U.S. are women who have never born a baby. As a group, they are more likely to have certain complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem and there has been very little research done on this group as a whole. The proposed research will look for tests that identify pregnant women in this group who might develop a problem with their pregnancy and ways to improve their health and the health of their baby.