Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia

What this Trial Is About

Researchers are studying pregnant women between 11 and 14 weeks of gestation to evaluate non-invasive screening methods for preeclampsia (PE), a pregnancy condition. The study aims to collect pregnancy outcome data, medical histories, and blood samples to validate the Labcorp Preeclampsia ScreenTM assay and to develop new testing methods. This observational study focuses on women carrying a single fetus and does not involve any experimental treatments. Participants will be observed without any study-specific interventions. Blood samples will be collected during each trimester, up to 25 mL each time, and ultrasound measurements and blood pressure readings will be recorded during standard first trimester visits. The PE screening test results will not be shared with participants or their physicians but will be compared to birth outcomes to assess the test's accuracy. During the study, participants will provide consent and agree to share prenatal and postnatal screening or diagnostic test results. Researchers will collect relevant medical and pregnancy information, including outcomes after delivery. The primary outcome measure is the performance of the Labcorp Preeclampsia Screen assay, evaluated from enrollment until pregnancy outcome is available, which may be up to 36 weeks. The total study participation spans from early pregnancy through delivery outcome collection.

Non-Invasive Preeclampsia Screening and Biobank