NCT04488393已完成不适用
Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.
研究概览
简要总结
This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;
- •subject was 18 or older at the time of NIPT
排除标准
- 未提供
结局指标
主要结局
Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.
时间窗: time from maternal blood draw to delivery
Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.
时间窗: time from maternal blood draw to delivery
次要结局
未报告次要终点
研究者
Lorraine Dugoff
Professor of Obstetrics and Gynecology
University of Pennsylvania
研究点 (1)
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