Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 25
- 主要终点
- Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
研究概览
简要总结
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.
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
- •Age 18 years or older at enrollment
- •Clinically confirmed pregnancy
- •Gestational age ≥8 weeks, 0 days
- •Planned or completed prenatal serum screening* (drawn during 1st and/or 2nd trimester)
- •Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam)
- •Able to provide consent for participation using language appropriate forms
排除标准
- •Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
- •Prenatal screening determination by Nuchal Translucency (NT) measurement only
结局指标
主要结局
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
时间窗: 12 months
The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.
次要结局
未报告次要终点