Non-Invasive Preeclampsia Screening and Biobank
Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
1 other identifier
observational
6,550
1 country
21
Brief Summary
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedStudy Start
First participant enrolled
February 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
January 23, 2026
December 1, 2025
1.3 years
October 14, 2024
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
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).
From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
Study Arms (1)
Pregnant subjects between 11 and 14 weeks gestation.
This is an observational study and no study-specific intervention is defined. PE screen test results will not be reported back to the physician or subject but will be compared to birth outcome data.
Eligibility Criteria
Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Rutgers Robert Wood Johnson Medical Schoolcollaborator
- Laboratory Corporation of Americacollaborator
Study Sites (21)
Valley Perinatal
Glendale, Arizona, 85304, United States
Delaware Center for Maternal and Fetal Medicine
Newark, Delaware, 19718, United States
D&H National Research Centers
Miami, Florida, 33155, United States
Southern Clinical Research Associates
Metairie, Louisiana, 70001, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Cooper University Health Care
Camden, New Jersey, 08103, United States
New Jersey Perinatal Associates
Livingston, New Jersey, 07039, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Capital Health
Pennington, New Jersey, 08534, United States
Columbia University Medical Center
New York, New York, 10032, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 271057, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140, United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37412, 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
UT Health
Houston, Texas, 77030, United States
HCA Healthcare, Texas Maternal Fetal Medicine
Houston, Texas, 77054, United States
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, 23507, United States
Biospecimen
Whole blood processed to plasma and serum will be obtained from all subjects. A subset of subjects will be asked to provide remnant placental tissue following delivery
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Rosenfeld, DO
Rutgers Robert Wood Johnson Medical School
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2024
First Posted
October 16, 2024
Study Start
February 2, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
January 23, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share