RECRUITING

Non-Invasive Preeclampsia Screening and Biobank

Description

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

Study Overview

Study Details

Study overview

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

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

Non-Invasive Preeclampsia Screening and Biobank

Condition
Preeclampsia (PE)
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States, 08901

Austin

St. David's Women's Center of Texas, Austin, Texas, United States, 78758

Galveston

University of Texas Medical Branch, Galveston, Texas, United States, 77555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Sequenom, Inc.,

Emily Rosenfeld, DO, PRINCIPAL_INVESTIGATOR, Rutgers Robert Wood Johnson Medical School

Study Record Dates

2026-07-01