Non-Invasive Preeclampsia Screening and Biobank

Recruiting

• Conditions: Preeclampsia (PE)

• Registration Number: NCT06643741
• Lead Sponsor: Sequenom, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-16
• Study Start: 2025-02-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 6550

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay	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).

Trial Locations

Locations (4)

UT Health; 🇺🇸 Houston, Texas, United States

Rutgers Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

St. David's Women's Center of Texas; 🇺🇸 Austin, Texas, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States