RecruitingNot Applicable

Non-Invasive Preeclampsia Screening and Biobank

United States6,550 participantsStarted 2025-02-02

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay

Timeframe: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks

Trial details

NCT IDNCT06643741

SponsorSequenom, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-01

Contact for this trial

Graham McLennan, MS

(858) 202-9162 mclenng@labcorp.com

View on ClinicalTrials.gov More Preeclampsia (PE) trials