NCT02430584Unknown不适用
Whole Blood Specimen Collection From Pregnant Subjects
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Whole blood collection
研究概览
简要总结
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
详细描述
This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:
- be at an increased risk for fetal genetic abnormalities
- be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy.
- possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 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
- 是
入选标准
- •Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits
- •Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive
- •Subject is 18 years of age or older
- •Subject is at an increased risk for one or more of the following:
- •fetal gene and chromosome abnormalities
- •congenital fetal infection
- •known to possess irregular blood group antigens (subject or father of the baby)
- •known to have some other condition amenable to noninvasive prenatal testing
排除标准
- •Pregnancy is non-viable
结局指标
主要结局
Whole blood collection
时间窗: One or more monthly clinic visits (≥25 days apart) over 13 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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