Non-Invasive Preeclampsia Screening and Biobank
Recruiting now
Conditions studied: Preeclampsia (PE)
In brief
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Key facts
- Study ID
- NCT06643741
- Run by
- Sequenom, Inc.
- People needed
- 6550
- Starts
- 2025-02-02
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Macon & Joan Brock Virginia Health Sciences at Old Dominion University — Norfolk, Virginia, United States (enrolling)
- Delaware Center for Maternal and Fetal Medicine — Newark, Delaware, United States (enrolling)
- St. David's Women's Center of Texas — Austin, Texas, United States (enrolling)
- University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
- UT Health — Houston, Texas, United States (enrolling)
- HCA Healthcare, Texas Maternal Fetal Medicine — Houston, Texas, United States (enrolling)
- Valley Perinatal — Glendale, Arizona, United States (enrolling)
- Southern Clinical Research Associates — Metairie, Louisiana, United States (enrolling)
- New Jersey Perinatal Associates — Livingston, New Jersey, United States (enrolling)
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
- Capital Health — Pennington, New Jersey, United States (enrolling)
- Columbia University Medical Center — New York, New York, United States (enrolling)
- Lenox Hill Hospital — New York, New York, United States (enrolling)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
- University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
- Chattanooga Medical Research — Chattanooga, Tennessee, United States (enrolling)
- D&H National Research Centers — Miami, Florida, United States
- Lewis Katz School of Medicine at Temple University — Philadelphia, Pennsylvania, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Cooper University Health Care — Camden, New Jersey, United States
- Geisinger Medical Center — Danville, Pennsylvania, United States
Full record on ClinicalTrials.gov
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