COMPARISON OF CHORION VILLUS SAMPLING AND AMNIOCENTESIS

西北大学支持随机临床试验的概念 目的：确定绒毛取样的风险和准确性。鞋底 芝加哥地区的一个单位，那里的调查人员既是遗传学家，也是 产科医生和该地区最大的产前诊断中心，我们 有一个定义明确的推荐基础，有助于识别 怀孕早期愿意被随机分配的妇女。自3月以来 1984年，我们一直在监测持续怀孕的情况，到1985年1月 将有100多人被研究过。为了帮助实现NICHD的目标，我们 建议每月确定至少20名8-11周的受试者 怀孕，在超声波检查下有存活的怀孕，并且没有任何因素 易导致胎儿衰弱(表格A)。在随机化后分为两个 组(绒毛取样与羊膜穿刺术)，我们将详细介绍医疗 病史、前次怀孕、遗传史和社会经济因素 (表格B、C、D)。随机进入绒毛膜组的受试者将 在8-11周进行手术。超声波检查将持续一周 此后，在16周时再次出现。妊娠并发症将会是 在整个妊娠期间每隔4周记录一次。母亲的压力将会是 在入院时、24周时和终止时(分娩或胎儿 损失)。羊膜穿刺组将在16周时接受该手术， 一周后进行超声波检查，并进一步进行监测，如所述 上面。所有的胎儿损失都将接受染色体研究和 解剖，适当时进行DNA分析或代谢分析。 胎盘和脐带将在两周内进行彻底检查(表格J) 遗传学家确定的重大和次要异常(表格K)。新生儿 发育将在9个月时进行评估，长期产妇 一年和两年的并发症。诊断准确性和实验室 质量将建立在记录技术细节的基础上(表L和 m)。最后，坚持使用简历的女性将被跟踪，以便进行比较 而那些同意随机化的人。有关招聘管制的条文 如果随机化的尝试不成功，就会发生这种情况。所有数据都将 以标准表格记录，其中16个表格在本文件中详细提供 求婚。

Northwestern University supports the concept of a randomized clinical trial to determine risks and accuracy of chorionic villus sampling. The sole unit in the Chicago area in which investigators are both geneticists and obstetricians, and the largest prenatal diagnostic center in the region, we have a well-defined referral base that will facilitate identification of women early in pregnancy who are willing to be randomized. Since March 1984 we have been monitoring continuing pregnancies, and by January 1985 over 100 will have been studied. To help achieve the NICHD goal, we propose identifying at least 20 subjects per month who are 8-11 weeks pregnant, have viable pregnancies on ultrasound, and have no factors predisposing to fetal wastage (Form A). After randomization into two groups (chorionic villus sampling vs amniocentesis), we will detail medical history, prior pregnancies, genetic history and socioeconomic factors (Forms B,C,D). Subjects randomized in the chorionic villus group will undergo the procedure at 8-11 weeks. Ultrasound will be performed one week thereafter, and again at 16 weeks. Pregnancy complications will be recorded at 4-week intervals throughout gestation. Maternal stress will be assessed upon entry, at 24 weeks and upon termination (delivery or fetal loss). The amniocentesis group will undergo that procedure at 16 weeks, having an ultrasound one week later and surveillance further, as described above. All fetal losses will be subjected to chromosomal studies and anatomic dissection, with DNA analysis or metabolic assays if appropriate. Placenta and cord will be thoroughly examined (Form J) and within two weeks major and minor anomalies determined by geneticists (Form K). Neonatal development will be assessed at nine months, and long-term maternal complications at one and two years. Diagnostic accuracy and laboratory quality will be on the basis of recording technical details (Forms L and M). Finally, women insistent upon CVS will be followed to allow comparison with those agreeing to randomization. Provisions for recruiting controls are made, should attempts at randomization be unsuccessful. All data will be recorded on standard forms, 16 of which are provided in detail in this proposal.