NCT00971334已完成不适用
Noninvasive 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
- 2,502
- 试验地点
- 35
研究概览
简要总结
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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 female
- •Subject is pregnant
- •Subject is 18 years of age or older
- •Subject provides a signed and dated informed consent
- •Subject agrees to provide a 30-50mL blood sample
- •Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy).
- •Subject plans to undergo an amniocentesis and/or CVS procedure
- •Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided
排除标准
- 未提供
研究者
研究点 (35)
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