Recruiting

Pregnancy Outcome Data and Blood Samples for Preeclampsia Screening

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Urogenital Diseases+2

+ Female Urogenital Diseases and Pregnancy Complications

+ Pre-Eclampsia

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: February 2025
See protocol details

Summary

Principal SponsorSequenom, Inc.
Study ContactGraham McLennan, MSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 2, 2025

Actual date on which the first participant was enrolled.

This study aims to gather important data from pregnant women who are expecting one baby and are being screened for pre-eclampsia, a pregnancy complication. This screening takes place between the 11th and 14th weeks of pregnancy. By collecting blood samples and medical history, this research seeks to validate a new test called the Labcorp Preeclampsia ScreenTM assay. The goal is to improve the ability to predict early, preterm, and term pre-eclampsia, potentially leading to better care and monitoring for pregnant women. Participants in the study will provide blood samples and share their pregnancy outcomes and medical history. These blood samples will be analyzed to see how well the Labcorp test can predict the risk of developing pre-eclampsia before 34 weeks or before 37 weeks of pregnancy. The performance of this test is then compared to actual pregnancy outcomes to assess its accuracy. This research could lead to the development of more effective and timely screenings for pre-eclampsia, ultimately improving health outcomes for mothers and their babies.

Official TitleCollection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
NCT06643741
Principal SponsorSequenom, Inc.
Study ContactGraham McLennan, MSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

6550 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPre-EclampsiaPregnancy ComplicationsHypertension, Pregnancy-Induced

Criteria

3 inclusion criteria required to participate
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 up to 25mL of whole blood at each trimester visit;

1 exclusion criteria prevent from participating
Previous sample donation under this protocol with the same pregnancy;

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Recruiting

Valley Perinatal

Glendale, United StatesOpen Valley Perinatal in Google Maps
Recruiting

New Jersey Perinatal Associates

Livingston, United States
Recruiting

Rutgers Robert Wood Johnson Medical School

New Brunswick, United States
Recruiting

Capital Health

Pennington, United States
Recruiting
21 Study Centers