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Recruiting Observational

Non-Invasive Preeclampsia Screening and Biobank

NCT06643741 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2025-02-02
Last updated
2026-07-20

Condition(s) studied

Preeclampsia (PE)

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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 sites (21)

FacilityCityRegionStatus
Valley Perinatal Glendale Arizona Recruiting
Delaware Center for Maternal and Fetal Medicine Newark Delaware Recruiting
D&H National Research Centers Miami Florida Terminated
Southern Clinical Research Associates Metairie Louisiana Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Not Yet Recruiting
Cooper University Health Care Camden New Jersey Not Yet Recruiting
New Jersey Perinatal Associates Livingston New Jersey Recruiting
Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey Recruiting
Capital Health Pennington New Jersey Recruiting
Columbia University Medical Center New York New York Recruiting
Lenox Hill Hospital New York New York Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina Recruiting
Geisinger Medical Center Danville Pennsylvania Not Yet Recruiting
University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania Recruiting
Lewis Katz School of Medicine at Temple University Philadelphia Pennsylvania Not Yet Recruiting
Chattanooga Medical Research Chattanooga Tennessee Recruiting
St. David's Women's Center of Texas Austin Texas Recruiting
University of Texas Medical Branch Galveston Texas Recruiting
UT Health Houston Texas Recruiting
HCA Healthcare, Texas Maternal Fetal Medicine Houston Texas Recruiting
Macon & Joan Brock Virginia Health Sciences at Old Dominion University Norfolk Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06643741 on ClinicalTrials.gov ↗ ← All trials in Israel