COMPARISON OF CHORION VILLUS SAMPLING AND AMNIOCENTESIS

这项建议的总体目标是比较安全性和准确性 羊膜穿刺术采集绒毛(CVS) 多中心、合作的临床研究。 需要检验的具体假设是，基因分析是否 对绒毛的检查与对羊膜的检查一样准确 液体细胞，特别是在鉴定染色体异常方面 以及CVS是否与自然流产和 妊娠的其他并发症，如感染、低出生体重、 围产期先天畸形或其他问题，以及任何 在后来的后续行动中发现的其他问题。 临床研究将提供2500名患者的随机比较 接受产前基因诊断的妇女，将由四人组成 顺序阶段：1)制定一份协议和操作手册 和人员培训(为期六个月)；2)启动 2-4个临床中心的项目(6个月)；3)招聘2-4个 增设临床中心，完成患者登记(28人 月)，以及登记患者的随访(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，迈克尔·里斯医学中心记录了 它在产前基因诊断方面拥有丰富的经验，特别是在 CVS以及羊膜穿刺术，以及它愿意在 多中心研究；记录了每个中心最多25名患者的可用性 那些可能接受随机基因诊断的人在 妊娠第一个月(CVS)和第二个月(羊膜穿刺术)和临产 关于招募、随机化和执行 全面的多中心研究。迈克尔·里斯医疗中心将继续 提供产前服务给那些不想成为 随机化。

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.