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

描述(由申请人提供)：RTI为RFA-HD-08-029中描述的数据协调和分析中心(DCAC)提交了这份申请，标题为“未分娩妇女的早产：处于巨大风险中的未充分研究的人口”。DCAC由资深生物统计师Corette Parker，DrPH，Pi和Matthew Koch，MD，PhD，Co-Pi领导，他们组建了一支核心团队，拥有生物统计学、统计遗传学、围产期流行病学、母婴医学、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、流行病学和研究计算部门，并得到两位杰出顾问的称赞：剑桥大学博士戈登·CS·史密斯和德克萨斯大学加尔维斯顿医学分校博士Radek Bukowski。这一核心团队为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静产合作研究网络上共同工作。这一经历让我们共同理解了拟议研究的复杂性。Parker博士和Koch博士都有20年以上管理DCAC活动和领导多点研究的统计任务的经验。他们将适当地用RTI充足和多样化的研究人员中的其他个人来补充核心团队，为研究的每个阶段带来最合适的专业知识组合。拟议的团队将与NICHD工作人员和临床现场调查人员建立合作伙伴关系，以制定和实施共同的方案来研究未分娩的妇女，并获取和分析由此产生的数据，以确定生物标记物，并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)领导生物统计和数据管理；(2)实施通信基础设施和提供后勤支持；(3)参与制定方案，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)在标准研究程序中协助培训人员；(6)协助制定质量保证/质量控制程序；(7)为临床站点、NICHD、指导委员会和咨询与安全监测委员会编写例行和临时报告；以及(8)通过出版物和演示文稿传播研究结果。为了方便起见，项目协调员将设在位于马里兰州罗克维尔的RTI办公室，毗邻NICHD。 与公共健康相关：美国40%的孕妇是从未生过孩子的女性。作为一个群体，她们更有可能在怀孕期间出现某些并发症，但没有来自以前怀孕的信息来确定谁可能有问题，而且对这一群体作为一个整体的研究很少。这项拟议的研究将寻找能够识别这一群体中可能出现怀孕问题的孕妇的测试，以及改善她们的健康和婴儿健康的方法。

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.