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NCT06643741RecruitingAccepts Healthy Volunteers

Non-Invasive Preeclampsia Screening and Biobank

Sequenom, Inc.

Start Date

2/2/2025

Completion Date

7/1/2026

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Preeclampsia (PE)

Locations

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