Prospective Collection of Whole Blood Specimens in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 16
- 主要终点
- Collect Whole Blood Specimens in Pregnant Women
研究概览
简要总结
To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.
详细描述
This is a prospective multicenter study in which whole blood specimens will be collected from pregnant women scheduled for an invasive procedure.
After the standard-of-care invasive procedure is performed in accordance with the site's clinical procedures, invasive prenatal diagnostic procedure results will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Be 18 years of age or older at enrollment,
- •Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
- •Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling [CVS], amniocentesis, or percutaneous umbilical cord blood sampling [cordocentesis]) for cytogenetic analysis of the fetus
排除标准
- •Has a known maternal chromosomal anomaly,
- •Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
- •Has a history of transplant or malignancy, or
- •Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
- •Already participated in this study (enrolled previously).
结局指标
主要结局
Collect Whole Blood Specimens in Pregnant Women
时间窗: 3 years
To collect maternal whole blood specimens from approximately 5,150 women with corresponding cytogenetic results from invasive prenatal diagnostic procedures (performed per the standard of care) to achieve sample size goals
次要结局
未报告次要终点