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Simple blood test may spot preeclampsia risk before symptoms appear

NCT ID NCT06643741

Diagnosis Sponsor: Sequenom, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study aims to improve early detection of preeclampsia, a dangerous pregnancy condition. Researchers will collect blood samples from over 6,500 pregnant women between 11-14 weeks of pregnancy and compare the results with pregnancy outcomes. The goal is to see how well a new blood test can predict early and preterm preeclampsia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 6,550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia (PE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Capital Health

    RECRUITING

    Pennington, New Jersey, 08534, United States

  • Chattanooga Medical Research

    RECRUITING

    Chattanooga, Tennessee, 37412, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Cooper University Health Care

    NOT_YET_RECRUITING

    Camden, New Jersey, 08103, United States

  • D&H National Research Centers

    TERMINATED

    Miami, Florida, 33155, United States

  • Delaware Center for Maternal and Fetal Medicine

    RECRUITING

    Newark, Delaware, 19718, United States

  • Geisinger Medical Center

    NOT_YET_RECRUITING

    Danville, Pennsylvania, 17822, United States

  • HCA Healthcare, Texas Maternal Fetal Medicine

    RECRUITING

    Houston, Texas, 77054, United States

  • Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Lewis Katz School of Medicine at Temple University

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Macon & Joan Brock Virginia Health Sciences at Old Dominion University

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • New Jersey Perinatal Associates

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Rutgers Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Southern Clinical Research Associates

    RECRUITING

    Metairie, Louisiana, 70001, United States

  • St. David's Women's Center of Texas

    RECRUITING

    Austin, Texas, 78758, United States

  • UT Health

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Pennsylvania Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77555, United States

  • Valley Perinatal

    RECRUITING

    Glendale, Arizona, 85304, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 271057, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.