CHORIONIC VILLUS SAMPLING VS AMNIOCENTESIS-DATA CENTER

本提案是对《合作协议请求书》的回应 标题为“合作临床数据协调中心”的申请 绒毛膜绒毛取样与羊膜穿刺术的比较。“合作社 协议将包括来自NICHD的代表，几个临床 中心和数据协调中心。 这项研究将比较 胎儿畸形产前诊断的两种程序： 绒毛膜绒毛取样和胎盘穿刺术。 研究目的 将比较这两种方法的诊断准确性 和并发症的发生率，包括出血、败血症、胎儿丢失， 对胎儿的伤害。 在妊娠第11周之前寻求遗传咨询的妇女 将被要求参加一项关于这两种手术的随机研究。 提供书面知情同意书的受试者将被随机分配至 这两个程序。 那些不愿意被随机分配的人将被要求 允许将有关其妊娠结果的信息用于 study. 统计与计算机系生物统计中心 科学，乔治华盛顿大学，建议作为数据 研究协调中心（DCC）。 DCC将参与所有 研究的各个阶段，并将特别负责 生物统计协作，包括研究表格、数据的设计 管理和计算机处理、中期报告和统计 分析。 拟议的工作人员在设计方面具有丰富的经验， 协调合作研究、数据管理和计算机化， 统计分析与妊娠结果有关的数据，以及 继续关注合作研究。

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.