Non-Invasive Preeclampsia Screening and Biobank

January 21, 2026 updated by: Sequenom, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Valley Perinatal
        • Principal Investigator:
          • Ravindu Gunatilake, MD
        • Contact:
    • Delaware
      • Newark, Delaware, United States, 19718
        • Not yet recruiting
        • Delaware Center for Maternal and Fetal Medicine
        • Contact:
        • Principal Investigator:
          • Suneet Chauhan, MD, DSc
    • Florida
      • Miami, Florida, United States, 33155
        • Terminated
        • D&H National Research Centers
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Not yet recruiting
        • Southern Clinical Research Associates
        • Principal Investigator:
          • Samuel Alexander, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Cassandra Duffy, MD, MPH
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Not yet recruiting
        • Cooper University Health Care
        • Contact:
        • Principal Investigator:
          • Robin Perry, MD, MSEd
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • New Jersey Perinatal Associates
        • Principal Investigator:
          • Kathy Mathews, MD
        • Contact:
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Contact:
        • Principal Investigator:
          • Emily Rosenfeld, DO
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Capital Health
        • Principal Investigator:
          • Thomas Westover, MD
        • Contact:
    • New York
      • New York, New York, United States, 10075
        • Not yet recruiting
        • Lenox Hill Hospital
        • Contact:
        • Principal Investigator:
          • Eran Bornstein, MD
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Eve Overton, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 271057
        • Not yet recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • David Stamilio, MD, MS
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Not yet recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Paglia, MD, PhD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Perelman School of Medicine
        • Principal Investigator:
          • Lorraine Dugoff, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19140
        • Not yet recruiting
        • Lewis Katz School of Medicine at Temple University
        • Principal Investigator:
          • Laura Hart, MD
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37412
        • Recruiting
        • Chattanooga Medical Research
        • Contact:
        • Principal Investigator:
          • Scott Harsberger, MD
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • St. David's Women's Center of Texas
        • Principal Investigator:
          • Mollie McDonnold, MD
        • Contact:
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
        • Principal Investigator:
          • Hassan Harirah, MD, FRCSC
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health
        • Principal Investigator:
          • Baha M Sibai, MD
        • Contact:
      • Houston, Texas, United States, 77054
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Macon & Joan Brock Virginia Health Sciences at Old Dominion University
        • Principal Investigator:
          • George Saade, MD
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
Time Frame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sequenom, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laboratory Corporation of America
Rutgers Robert Wood Johnson Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily Rosenfeld, DO, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SQNM-PRE-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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