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Observational Study for Preeclampsia Screening

This study is looking for pregnant women to help evaluate a new non-invasive screening test for preeclampsia (a serious pregnancy complication involving high blood pressure). You can join if you are at least 18 years old, pregnant with one baby, and between 11 and 14 weeks gestation. The study will collect blood samples and medical information to see how well the Labcorp Preeclampsia Screen assay works. The goal is to improve early detection of preeclampsia. This is an observational study, meaning you won't receive any specific intervention, but your information will help develop better testing methods. The study aims to enroll 6550 participants, and its current recruitment status is unclear.

Study design
This is an observational study planning to enroll 6550 pregnant women. It is not a randomized or blinded study.
What's involved
You would provide blood samples and allow access to your prenatal and postnatal screening and diagnostic test results. You also agree to have UtAPI (Uterine Artery Pulsatility Index) calculated.
Compensation
Not stated in the trial record.
Follow-up
Your participation will involve providing information from enrollment at 10-14 weeks gestation until your pregnancy outcome is available, up to 36 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06643741

Non-Invasive Preeclampsia Screening and Biobank

Recruiting
Not specifiedAges 18+Observational
Sequenom, Inc.
~6,550 participants
Updated 2026-07-20 on ClinicalTrials.gov

At a glance

Recruiting sites
16 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
Measured over From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks

Conditions

Preeclampsia (PE)

Explore related trials

Preeclampsia

Where it's being run

21 sites across 12 states
New Jersey4
Texas4
Pennsylvania3
New York2
Arizona1
Delaware1
Florida1
Louisiana1

Study leadership

  • Emily Rosenfeld, DO · PRINCIPAL_INVESTIGATOR · Rutgers Robert Wood Johnson Medical School

Who to contact

Graham McLennan, MS
[email protected]
(858) 202-9162
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assayFrom 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).