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Non-Invasive Preeclampsia Screening and Biobank
NCT06643741 · Sequenom, Inc.
In plain English
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Official title
Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
About this study
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
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 target: 6550 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-02-02
Estimated completion: 2026-07-01
Last updated: 2026-01-23
Primary outcomes
- • Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay (From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks)
Sponsor
Sequenom, Inc. · industry
With: Rutgers Robert Wood Johnson Medical School, Laboratory Corporation of America
Contacts & investigators
ContactGraham McLennan, MS · contact · mclenng@labcorp.com · (858) 202-9162
ContactSarah Danowski, MS · contact · danowss@labcorp.com · (858) 349-9162
InvestigatorEmily Rosenfeld, DO · principal_investigator, Rutgers Robert Wood Johnson Medical School
All locations (21)
Valley PerinatalRecruiting
Glendale, Arizona, United States
Delaware Center for Maternal and Fetal MedicineNot Yet Recruiting
Newark, Delaware, United States
D&H National Research CentersTerminated
Miami, Florida, United States
Southern Clinical Research AssociatesNot Yet Recruiting
Metairie, Louisiana, United States
Beth Israel Deaconess Medical CenterNot Yet Recruiting
Boston, Massachusetts, United States
Cooper University Health CareNot Yet Recruiting
Camden, New Jersey, United States
New Jersey Perinatal AssociatesRecruiting
Livingston, New Jersey, United States
Rutgers Robert Wood Johnson Medical SchoolRecruiting
New Brunswick, New Jersey, United States
Capital HealthRecruiting
Pennington, New Jersey, United States
Columbia University Medical CenterNot Yet Recruiting
New York, New York, United States
Lenox Hill HospitalNot Yet Recruiting
New York, New York, United States
Wake Forest University Health SciencesNot Yet Recruiting
Winston-Salem, North Carolina, United States
Geisinger Medical CenterNot Yet Recruiting
Danville, Pennsylvania, United States
University of Pennsylvania Perelman School of MedicineRecruiting
Philadelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple UniversityNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Chattanooga Medical ResearchRecruiting
Chattanooga, Tennessee, United States
St. David's Women's Center of TexasRecruiting
Austin, Texas, United States
University of Texas Medical BranchRecruiting
Galveston, Texas, United States
UT HealthRecruiting
Houston, Texas, United States
HCA Healthcare, Texas Maternal Fetal MedicineRecruiting
Houston, Texas, United States
Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityRecruiting
Norfolk, Virginia, United States