COMPARISON OF CHORION VILLUS SAMPLING AND AMNIOCENTESIS

西北大学支持随机临床试验的概念 以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，调查人员既是遗传学家， 产科医生和该地区最大的产前诊断中心，我们 有一个明确的转介基础，这将有助于识别 愿意接受随机化的妊娠早期女性。 三月以来 1984年，我们一直在监测继续怀孕，到1985年1月， 将研究100多个。 为了帮助实现NICHD的目标，我们 建议每月至少确定20名8-11周的受试者 怀孕，在超声上有可行的怀孕，并且没有任何因素 易导致胎儿消瘦（A型）。 随机分为两组后 组（绒毛膜绒毛取样与绒毛膜穿刺术），我们将详细说明医疗 病史、既往妊娠史、遗传史和社会经济因素 （表格B、C、D）。 随机分配至绒毛组的受试者将 在8-11周时进行手术。 将在一周内进行超声检查 之后，在16周时再次。 妊娠并发症将是 在整个妊娠期间每隔4周记录一次。 母亲的压力将是 在进入时、24周时和终止时（分娩或胎儿）评估 损失）。 子宫穿刺术组将在16周时进行该手术， 一周后进行超声检查，并进一步监测，如所述 以上 所有胎儿丢失将进行染色体研究， 解剖解剖，DNA分析或代谢测定（如适用）。 胎盘和脐带将被彻底检查（表格J），并在两周内 遗传学家确定的主要和次要异常（表格K）。 新生儿 将在9个月时评估发育情况， 1年和2年的并发症。 诊断准确性和实验室 质量将在记录技术细节的基础上（表格L和 M）。 最后，将对坚持CVS的女性进行随访，以进行比较 同意随机分组的人 征聘管制规定 如果随机化尝试不成功，则进行。 所有数据将 记录在标准表格上，其中16个表格在本文件中详细列出。 提议

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.