COMPARISON OF CHORION VILLUS SAMPLING AND AMNIOCENTESIS

本提案的总体目标是比较安全性和准确性 绒毛膜绒毛取样（CVS）与绒毛膜穿刺术的方法， 多中心合作临床研究。 有待检验的具体假设是， 在绒毛膜绒毛上进行的检查与在羊膜上进行的检查一样准确 液体细胞，特别是在染色体异常的鉴定中 受孕;以及，CVS是否与自然流产有关， 其他妊娠并发症，如感染、低出生体重， 先天性畸形或围产期的其他问题，以及任何 在后续行动中发现的其他问题。 临床研究将提供2500例随机比较 接受产前基因诊断的妇女，将包括四个 分阶段进行：1）制定协议和业务手册 （2）开始执行《联合国海洋法公约》， 项目由2-4个临床中心（6个月）; 3）招募2-4名 增加临床中心，完成患者入组（28 月），以及入选患者的随访（8个月）;以及，4） 数据分析和报告（12个月）。 作为参与的临床中心，Michael Reese医疗中心记录了 其在产前基因诊断方面的丰富经验，特别是 CVS以及与脊髓穿刺术，并愿意合作， 多中心研究;记录了每项研究最多25名患者的可用性 月谁可能接受随机化的遗传诊断， 妊娠的第一个（CVS）和第二个（胎盘穿刺术）三个月和目前 招募、随机化和开展 综合多中心研究。 迈克尔·里斯医疗中心将继续 提供产前服务的妇女谁不希望 随机的

The overall aim of this proposal is to compare the safety and the accuracy of Chorionic Villi Sampling (CVS) with amniocentesis by means of a multicenter, cooperative clinical study. The specific hypotheses to be tested are whether the genetic analyses performed on chorionic villi are as accurate as those performed on amniotic fluid cells, particularly in the identification of chromosomally abnormal conceptions; and, whether CVS is associated with spontaneous abortion and other complications of pregnancy such as infection, low birth weight, congenital malformations or other problems in the perinatal period, and any other problems identified at later follow-up. The clinical study will provide for the randomized comparision of 2500 women undergoing prenatal genetic diagnosis and will consist of four sequential phases: 1) the development of a protocol and operations manual and training of personnel (six months duration); 2) initiation of the project by 2-4 clinical centers (six months); 3) the recruitment of 2-4 additional clinical centers, completion of the enrollment of patients (28 months), and follow-up of enrolled patients (8 months); and, 4) the analysis and reporting of data (12 months). As a participating clinical center, Michael Reese Medical Center documents its extensive experiences in prenatal genetic diagnoses, specifically with CVS as well as with amniocentesis, and its willingness to cooperate in a multicenter study; documents the availability of up to 25 patients per month who are likely to accept randomization for genetic diagnoses in the first (CVS) and second (amniocentesis) trimesters of pregnancy and presents a detailed plan for recruitment, randomization and conduct of a comprehensive multicenter study. Michael Reese Medical Center will remain available to provide prenatal sevices for women who do not wish to be randomized.