Non-Invasive Preeclampsia Screening and Biobank

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

Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.