Non-Invasive Preeclampsia Screening and Biobank

Sequenom

Status: Enrolling

Conditions: Preeclampsia (PE)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06643741

SQNM-PRE-401

Details and patient eligibility

About

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

Full description

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.

Enrollment: 6,550 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

6,550 participants in 1 patient group

Pregnant subjects between 11 and 14 weeks gestation.

Description:

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.