NCT00847990已完成不适用
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 25
- 主要终点
- Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis
研究概览
简要总结
The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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 is willing to provide written informed consent
- •Pregnant female with singleton gestation 18 years of age or older
- •Subject agrees to provide a 20 to 30 mL venous blood sample
- •Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
- •Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy
排除标准
- •Subject lacks the capacity to provide informed consent
- •Twins, triplets or other multiple gestation
结局指标
主要结局
Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis
时间窗: During the 1st and 2nd trimester of pregnancy
次要结局
未报告次要终点
研究者
研究点 (25)
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