RECRUITING

Non-Invasive Preeclampsia Screening and Biobank

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Conditions

Preeclampsia (PE)preeclampsiapregnant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-02
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06643741

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is female and 18 years of age and older;
  2. * Subject provides a signed and dated informed consent;
  3. * Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation;
  4. * Subject agrees to provide the Sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data;
  5. * Subject agrees to have UtAPI calculated during their SOC first trimester ultrasound and MAP collected at the first trimester SOC visit;
  6. * Subject agrees to provide up to 25mL of whole blood at each trimester visit;
  7. * Subject agrees to provide relevant medical and pregnancy/postnatal information including outcome.
  1. * Subject is unlikely to return for second and third trimester testing;
  2. * Subject is unlikely to have pregnancy outcome data available;
  3. * Previous sample donation under this protocol with the same pregnancy;
  4. * Subject is participating in a blinded aspirin study or taking unknown doses of aspirin.

Contacts and Locations

Study Contact

Graham McLennan, MS
CONTACT
(858) 202-9162
mclenng@labcorp.com
Sarah Danowski, MS
CONTACT
(858) 349-9162
danowss@labcorp.com

Principal Investigator

Emily Rosenfeld, DO
PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School

Study Locations (Sites)

Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
St. David's Women's Center of Texas
Austin, Texas, 78758
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: Sequenom, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-02
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2025-02-02
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • preeclampsia
  • pregnant

Additional Relevant MeSH Terms

  • Preeclampsia (PE)