Recruiting

Preeclampsia Screening

Sponsor:

Sequenom, Inc.

Code:

NCT06643741

Conditions

Preeclampsia (PE)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Preeclampsia (PE)

Study ID

NCT06643741

Start date

Feb 2, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

6550 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Graham McLennan, MS

(858) 202-9162mclenng@labcorp.com

Sarah Danowski, MS

(858) 349-9162danowss@labcorp.com

Locations

Valley Perinatal

Recruiting

Glendale, Arizona, United States, 85304

Contacts

Tina Rommes

480-660--4040amin@valleyperinatal.com

Principal Investigator:

Ravindu Gunatilake, MD

Delaware Center for Maternal and Fetal Medicine

Recruiting

Newark, Delaware, United States, 19718

Contacts

Carrie Kitto

302-319-5680ckitto@christianacare.org

Principal Investigator:

Suneet Chauhan, MD, DSc

Southern Clinical Research Associates

Recruiting

Metairie, Louisiana, United States, 70001

Contacts

Shaune Braud, RN

504-810-4414sbraud@scrallc.com

Principal Investigator:

Samuel Alexander, MD

New Jersey Perinatal Associates

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Megha Soni

msoni@njperinatal.com

Principal Investigator:

Kathy Mathews, MD

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Emily Rosenfeld, DO

(732) 235-6200er720@rwjms.rutgers.edu

Principal Investigator:

Emily Rosenfeld, DO

Capital Health

Recruiting

Pennington, New Jersey, United States, 08534

Contacts

Saadia Kazmi

609-3944-130skazmi@capitalhealth.org

Principal Investigator:

Thomas Westover, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Casandra Almonte

646-284-5360ca2344@cumc.columbia.edu

Principal Investigator:

Eve Overton, MD

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Tamika Wong

212-434-4836twong4@northwell.edu

Principal Investigator:

Eran Bornstein, MD

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 271057

Contacts

Christina Tulbert

336-716-2383ctulbert@wakehealth.edu

Principal Investigator:

David Stamilio, MD, MS

University of Pennsylvania Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Elaina Symes

267-438-2709Elaina.symes@pennmedicine.UPenn.edu

Principal Investigator:

Lorraine Dugoff, MD

Chattanooga Medical Research

Recruiting

Chattanooga, Tennessee, United States, 37412

Contacts

Yvonne Chester

423-648-7794ychester@chattmedresearch.com

Principal Investigator:

Scott Harsberger, MD

St. David's Women's Center of Texas

Recruiting

Austin, Texas, United States, 78758

Contacts

Adrianna Knight, BSN, RN

512-493-6925adrianna.knight@stdavids.com

Principal Investigator:

Mollie McDonnold, MD

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Sonia Robazetti, RN

scrobaze@utmb.edu

Principal Investigator:

Hassan Harirah, MD, FRCSC

UT Health

Recruiting

Houston, Texas, United States, 77030

Contacts

Sunbola S Ashimi

(713) 500-6484sunbola.s.ashimi@uth.tmc.edu

Principal Investigator:

Baha M Sibai, MD

HCA Healthcare, Texas Maternal Fetal Medicine

Recruiting

Houston, Texas, United States, 77054

Contacts

Valencia Moore, BSN, RN

346-581-4802valencia.moore@hcahealthcare.com

David Kennedy

832-237-6301david.kennedy@hcahealthcare.com

Principal Investigator:

Kjersti Aagaard, MD, PhD, FACOG

Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Caitlyn Mcadams

(757) 446-5653cmcadams@odu.edu

Principal Investigator:

George Saade, MD

More Information

Sponsor

Sequenom, Inc.

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • preeclampsia
  • pregnant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sequenom, Inc. on 2026-07-20.