Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- accuracy of NIPT for prenatal diagnosing chromosomal anomalies
研究概览
简要总结
This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.
详细描述
Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.
Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.
Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.
Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.
- •only singleton were included
排除标准
- •women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.
- •Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.
结局指标
主要结局
accuracy of NIPT for prenatal diagnosing chromosomal anomalies
时间窗: July,2016-July, 2017
sensitive, false negative rate, and false positive rate of NIPT compared with CMA
次要结局
未报告次要终点
研究者
YiYang Zhu
Director,Clinical dean of Prenatal Diagnosis Center
Taizhou Hospital