Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

描述（由申请人提供）：RTI向RFA-HD-08- 029中描述的数据协调和分析中心（DCAC）提交了本申请，标题为“未生育妇女的早产：一个未充分研究的高风险人群。“DCAC由Corette帕克，DrPH，PI和Matthew Koch，MD，PhD，Co-PI，高级生物统计学家领导，他们组建了一个核心团队，拥有生物统计学，统计遗传学，围产期流行病学，母胎医学，妊娠结局和测量，数据管理和项目协调方面的专业知识。该团队来自RTI的统计学、流行病学和研究计算部门，并得到了两位杰出顾问的称赞，他们是剑桥大学的Gordon CS Smith医学博士和德克萨斯大学加尔维斯顿医学分支的Radek Bukowski医学博士。这个核心团队为DCAC和整个网络的挑战和成功运营带来了独特的力量。大多数团队成员在NICHD死胎合作研究网络上共同工作。这种经验提供了一个共同的理解的复杂性，拟议的研究。帕克博士和科赫博士都有20多年管理DCAC活动和领导多中心研究统计任务的经验。他们将补充核心团队与其他个人，适当的，从RTI的充足和多样化的研究人员，使最适当的专业知识组合的每个阶段的研究。拟议的团队将与NICHD工作人员和临床研究人员建立伙伴关系，以制定和实施共同的协议，研究未经产的妇女，并获取和分析所产生的数据，以确定生物标志物，了解早产和其他不良妊娠结局的机制和预测。DCAC的职责将包括：（1）在生物统计和数据管理方面提供领导;（2）实施通信基础设施并提供后勤支持;（3）参与方案开发，包括数据收集工具、操作手册和其他研究材料;（4）实施数据收集和管理系统;（5）协助培训标准研究程序的人员;（6）协助制定QA/QC程序，（7）为临床研究中心、NICHD、指导委员会和咨询与安全监测委员会编制常规和特别报告;（8）通过出版物和演示文稿传播研究结果。为方便起见，项目协调员将设在马里兰州罗克维尔的RTI办公室，毗邻NICHD。 公共卫生相关性：美国40%的孕妇从未生过孩子。作为一个群体，她们更有可能在怀孕期间出现某些并发症，但没有以前怀孕的信息来确定谁可能有问题，而且对整个群体的研究很少。这项拟议中的研究将寻找测试，以确定这组孕妇谁可能发展与他们的怀孕问题和方法，以改善他们的健康和他们的婴儿的健康。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.