Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,550
- 试验地点
- 31
- 主要终点
- Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
研究概览
简要总结
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
详细描述
To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 is female and 18 years of age and older;
- •Subject provides a signed and dated informed consent;
- •Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation;
- •Subject agrees to provide the Sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data;
- •Subject agrees to have UtAPI calculated during their SOC first trimester ultrasound and MAP collected at the first trimester SOC visit;
- •Subject agrees to provide up to 25mL of whole blood at each trimester visit;
- •Subject agrees to provide relevant medical and pregnancy/postnatal information including outcome.
排除标准
- •Subject is unlikely to return for second and third trimester testing;
- •Subject is unlikely to have pregnancy outcome data available;
- •Previous sample donation under this protocol with the same pregnancy;
- •Subject is participating in a blinded aspirin study or taking unknown doses of aspirin.
研究组 & 干预措施
Pregnant subjects between 11 and 14 weeks gestation.
This is an observational study and no study-specific intervention is defined. PE screen test results will not be reported back to the physician or subject but will be compared to birth outcome data.
结局指标
主要结局
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
时间窗: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
The results of the Preeclampsia Screen assay will be compared to pregnancy outcome data to evaluate how well the assay predicted early onset PE (\<34 weeks gestational age) and preterm PE (\<37 weeks gestational age).
次要结局
未报告次要终点