Collecting Pregnancy Data and Blood Samples From Women Pregnant Between 11 and 14 Weeks to Study Preeclampsia

What this Trial Is About

Researchers are collecting pregnancy outcome data, medical histories, and blood samples from women who are pregnant with a single fetus between 11 and 14 weeks of gestation. The study aims to support the validation of the Labcorp Preeclampsia ScreenTM assay by examining its performance and developing new testing methods for early, preterm, and term preeclampsia PE. This is an observational study with no specific treatment or intervention. Women enrolled will undergo routine prenatal care including first trimester ultrasound and blood pressure measurements as part of standard care. Blood samples of up to 25 mL will be collected during each trimester visit. The PE screen test results will not be shared with participants or their doctors but will be compared to pregnancy outcomes. Participants will provide informed consent and allow access to their prenatal and postnatal test results and medical data. The study team will evaluate the assay using baseline serum samples collected from enrollment until pregnancy outcome is available, up to 36 weeks of gestation. The total involvement includes multiple sample collections and data sharing throughout pregnancy to monitor and assess preeclampsia risk.

Non-Invasive Preeclampsia Screening and Biobank