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Non-Invasive Preeclampsia Screening and Biobank

RecruitingObservational studyHealthy volunteers welcome

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

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

Full eligibility 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.

About the study

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

Sponsor: Sequenom, Inc. · Participants: 6,550 · Started: Feb 2, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06643741

Locations in the U.S.

ArizonaValley Perinatal, Glendale
DelawareDelaware Center for Maternal and Fetal Medicine, Newark
LouisianaSouthern Clinical Research Associates, Metairie
MassachusettsBeth Israel Deaconess Medical Center, Boston (Not yet recruiting)
New JerseyCooper University Health Care, Camden (Not yet recruiting)
New Jersey Perinatal Associates, Livingston
Rutgers Robert Wood Johnson Medical School, New Brunswick
Capital Health, Pennington
New YorkColumbia University Medical Center, New York
Lenox Hill Hospital, New York
North CarolinaWake Forest University Health Sciences, Winston-Salem
PennsylvaniaGeisinger Medical Center, Danville (Not yet recruiting)
Lewis Katz School of Medicine at Temple University, Philadelphia (Not yet recruiting)
University of Pennsylvania Perelman School of Medicine, Philadelphia
TennesseeChattanooga Medical Research, Chattanooga
TexasSt. David's Women's Center of Texas, Austin
University of Texas Medical Branch, Galveston
HCA Healthcare, Texas Maternal Fetal Medicine, Houston
UT Health, Houston
VirginiaMacon & Joan Brock Virginia Health Sciences at Old Dominion University, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.