COMPARISON OF CHORION VILLUS SAMPLING AND AMNIOCENTESIS

对于拟议的临床研究，一组接受 在妊娠9-11周时进行绒毛膜绒毛取样（CVS）程序， 包括研究组，并将与对照组妇女进行比较 在年龄、流产史等方面，在16周时接受子宫穿刺术。 所有患者都将接受超声扫描， 怀孕8-10周。 在他们第一次访问遗传学时， 将招募妇女参加临床试验。 不愿意接受随机化的女性将成为 非随机研究（CVS）组或非随机对照组 穿刺组。 将进行随访超声检查 CVS组术后1周以及16周和28周时 两组的妊娠。 将对一些 产妇结局变量，包括术后并发症。 将计算9 - 16周和16+周之间的自发性胎儿丢失 联合协作样本的妊娠周数。 出生的婴儿 两组妇女将在分娩时接受检查，并将给予 在6个月和12个月大时进行体格和发育检查。 与穿刺术相比，患者对CVS的心理反应将 也可以在妊娠8周、16周和28周时进行研究。 产前诊断的准确性 使用CVS的诊断将在细胞遗传学和 生化测试和产科程序的改进将是 探讨了

For the proposed clinical investigation, a cohort of women undergoing the chorionic villus sampling (CVS) procedure at 9-11 weeks gestation will comprise the study group and will be compared with control women equivalent in age, history of abortion, etc. undergoing amniocentesis at 16 weeks. All patients will be scanned ultrasonically for evidence of a viable pregnancy at 8-10 weeks gestation. At their initial visit to the genetics division, women will be recruited for participation in the clinical trial. Women unwilling to accept randomization will become part of the nonrandomized study (CVS) group or the nonrandomized control (amniocentesis) group. Follow-up ultrasound examinations will be conducted at 1 - week post procedure for the CVS group and at 16 and 28 weeks gestation for both groups. Comparisons will be made on a number of maternal outcome variables including post procedure complications. Spontaneous fetal loss will be calculated between 9 and 16 weeks and at 16+ weeks gestation on the combined collaborative sample. The infants born to both groups of women will be examined upon delivery, and will be given physical and developmental examinations at 6 and 12 months of age. Patients' psychological responses to CVS compared to amniocentesis will also be studied at 8, 16, and 28 weeks gestation. The accuracy of prenatal diagnosis using CVS will be evaluated with respect to cytogenetic and biochemical tests, and improvements in the obstetrical procedure will be explored.