NCT02226315终止不适用
A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay
研究概览
简要总结
This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
- •Subject was 18 years of age or older at the time of NIPT;
- •Subject provides signed and dated informed consent in English;
排除标准
- •Subjects' treating physician is not located in the United States.
结局指标
主要结局
Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay
时间窗: Subjects contacted within 3 years after pregnancy is completed
Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient
次要结局
未报告次要终点
研究者
研究点 (1)
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