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RecruitingNCT06643741Updated Jul 20, 2026

Non-Invasive Preeclampsia Screening and Biobank

An observational study in Preeclampsia (PE), sponsored by Sequenom, Inc.. Recruiting at 21 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Sequenom, Inc. · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
6,550
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Preeclampsia (PE)

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Keywords

  • preeclampsia
  • pregnant
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
6,550 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

05

What researchers measure

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).

    Time frame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks

06

Study locations

16 of 21 sites recruiting
  • Valley Perinatal
    Glendale, Arizona 85304, United States
    Recruiting
  • Delaware Center for Maternal and Fetal Medicine
    Newark, Delaware 19718, United States
    Recruiting
  • D&H National Research Centers
    Miami, Florida 33155, United States
    Terminated
  • Southern Clinical Research Associates
    Metairie, Louisiana 70001, United States
    • Shaune Braud, RN · Contact · sbraud@scrallc.com · 504-810-4414
    • Samuel Alexander, MD · Principal investigator
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Not yet recruiting
  • Cooper University Health Care
    Camden, New Jersey 08103, United States
    Not yet recruiting
  • New Jersey Perinatal Associates
    Livingston, New Jersey 07039, United States
    Recruiting
  • Rutgers Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08901, United States
    • Emily Rosenfeld, DO · Contact · er720@rwjms.rutgers.edu · (732) 235-6200
    • Emily Rosenfeld, DO · Principal investigator
    Recruiting
  • Capital Health
    Pennington, New Jersey 08534, United States
    Recruiting
  • Columbia University Medical Center
    New York, New York 10032, United States
    Recruiting
  • Lenox Hill Hospital
    New York, New York 10075, United States
    • Tamika Wong · Contact · twong4@northwell.edu · 212-434-4836
    • Eran Bornstein, MD · Principal investigator
    Recruiting
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 271057, United States
    • Christina Tulbert · Contact · ctulbert@wakehealth.edu · 336-716-2383
    • David Stamilio, MD, MS · Principal investigator
    Recruiting
  • Geisinger Medical Center
    Danville, Pennsylvania 17822, United States
    Not yet recruiting
  • University of Pennsylvania Perelman School of Medicine
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Lewis Katz School of Medicine at Temple University
    Philadelphia, Pennsylvania 19140, United States
    Not yet recruiting
  • Chattanooga Medical Research
    Chattanooga, Tennessee 37412, United States
    Recruiting
  • St. David's Women's Center of Texas
    Austin, Texas 78758, United States
    Recruiting
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
    • Sonia Robazetti, RN · Contact · scrobaze@utmb.edu
    • Hassan Harirah, MD, FRCSC · Principal investigator
    Recruiting
  • UT Health
    Houston, Texas 77030, United States
    Recruiting
  • HCA Healthcare, Texas Maternal Fetal Medicine
    Houston, Texas 77054, United States
    Recruiting
  • Macon & Joan Brock Virginia Health Sciences at Old Dominion University
    Norfolk, Virginia 23507, United States
    • Caitlyn Mcadams · Contact · cmcadams@odu.edu · (757) 446-5653
    • George Saade, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06643741
Lead sponsor
Sequenom, Inc.
Collaborators
Rutgers Robert Wood Johnson Medical School, Laboratory Corporation of America
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Feb 2, 2025
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jul 20, 2026

Study contacts

Graham McLennan, MS
Contact
mclenng@labcorp.com
(858) 202-9162
Sarah Danowski, MS
Contact
danowss@labcorp.com
(858) 349-9162
Emily Rosenfeld, DO
principal investigator · Rutgers Robert Wood Johnson Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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