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Non-invasive screening for preeclampsia in pregnant women

Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia

Observational Sequenom, Inc. · NCT06643741

This study is testing a new blood test to see if it can help detect preeclampsia early in pregnant women.

Quick facts

Study typeObservational
Enrollment6550 (estimated)
Ages18 Years and up
SexFemale
SponsorSequenom, Inc. Industry-sponsored
Locations21 sites (Glendale, Arizona and 20 other locations)
Trial IDNCT06643741 on ClinicalTrials.gov

What this trial studies

This study involves enrolling pregnant women between 11 and 14 weeks of gestation to collect blood samples and relevant medical history for evaluating preeclampsia. The goal is to validate the Labcorp Preeclampsia ScreenTM assay and gather data on pregnancy outcomes. Participants will provide blood samples at each trimester visit and agree to share prenatal and postnatal screening results. The collected data will help in assessing the performance of the assay and developing new testing methods.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 and older, carrying a singleton fetus between 11 and 14 weeks of gestation.

Not a fit: Patients who are unlikely to return for follow-up testing or those participating in other conflicting studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of preeclampsia, improving maternal and fetal health outcomes.

How similar studies have performed: Other studies have shown promise in non-invasive screening methods for preeclampsia, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Glendale, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Preeclampsiapreeclampsiapregnant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.