COMPARISON OF CHORION VILLUS SAMPLING AND AMNIOCENTESIS

在拟议的临床调查中，一组接受 妊娠9-11周的绒毛取样(CVS)程序将 组成研究组，并将其与对照组妇女进行等量比较 年龄、流产史等在16周时接受羊膜穿刺术。 所有患者都将接受超声扫描，以寻找存活的证据。 妊娠在妊娠8-10周。在他们第一次访问遗传学时 该部门将招募女性参加临床试验。 不愿接受随机化的女性将成为 非随机研究(CVS)组或非随机对照 (羊膜穿刺组)。将进行后续的超声波检查 CVS组术后1周、16周和28周 两组均为妊娠。我们将在以下几个方面进行比较 母体结局变量包括术后并发症。 自发性胎儿丧失将在9至16周和16周以上计算 在联合合作样本上孕育数周。这些婴儿出生在 这两组妇女都将在分娩时接受检查，并将接受 在6个月和12个月龄时进行体格和发育检查。 与羊膜穿刺术相比，患者对CVS的心理反应将 在怀孕8周、16周和28周时也要进行研究。产前检查的准确性 使用CVS的诊断将从细胞遗传学和 生化测试和产科程序的改进将是 探索过了。

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.