CHORION VILLUS SAMPLING VS. AMNIOCENTESIS--DATA CENTER

该提案回应了《合作协议》的要求 题为“协作临床数据协调中心”的申请 绒毛取样与羊膜穿刺术的比较 协议将包括来自NICHD的代表，几个临床 中心，以及数据协调中心。拟议中的研究将比较 胎儿异常的两种产前诊断程序： 绒毛取样和羊膜穿刺术。研究的目标 将就诊断的准确性比较这两种程序 以及并发症的发生率，包括出血、败血症、胎儿丢失和 对胎儿的伤害。 怀孕11周前寻求遗传咨询的妇女 将被要求参加这两种手术的随机研究。 那些给予书面知情同意的人将被随机分配到以下其中之一 这两个程序。那些不愿意被随机分组的人将被要求 允许将有关其妊娠结局的信息用于 学习。 统计与计算机系生物统计中心 乔治华盛顿大学理工学院建议将数据作为 研究的协调中心(DCC)。DCC将参与所有 研究的各个阶段，并将特别负责 生物统计学合作，包括设计研究表格、数据 管理和计算机处理、中期报告和统计 分析。拟议的工作人员具有丰富的设计经验和 协调合作研究、数据管理和计算机化， 与妊娠结局有关的数据的统计分析，以及 对合作研究的持续兴趣。

This proposal responds to the Request for Cooperative Agreement Applications entitled "Data Coordinating Center for Cooperative Clinical Comparison of Chorion Villus Sampling and Amniocentesis." The cooperative agreement will include representatives from NICHD, several clinical centers, and a data coordinating center. The proposed study will compare two procedures for prenatal diagnosis of abnormalities in the fetus: chorion villus sampling and amniocentesis. The objectives of the study will be to compare the two procedures with respect to accuracy of diagnosis and rates of complications, including bleeding, sepsis, fetal loss, and injury to the fetus. Women seeking genetic counseling prior to the eleventh week of gestation will be asked to participate in a randomized study of the two procedures. Those giving written informed consent will be randomly assigned to one of the two procedures. Those not willing to be randomized will be asked for permission for information about their pregnancy outcomes to be used in the study. The Biostatistics Center of the Department of Statistics and Computer Science, The George Washington University, proposes to serve as the Data Coordinating Center (DCC) for the study. The DCC will participate in all phases of the study, and will be particularly responsible for biostatistical collaboration including design of study forms, data management and computer processing, interim reporting, and statistical analyses. The proposed staff have extensive experience in the design and coordination of cooperative studies, data management and computerization, statistical analysis of data relating to outcomes of pregnancy, and a continuing interest in cooperative research.