Clinical trial NCT06643741: Non-Invasive Preeclampsia Screening and Biobank
Official title: Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia (PE)
Keywords: preeclampsia
pregnant
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rutgers Robert Wood Johnson Medical School
name: Laboratory Corporation of America
First posted: 2024-10-16
Enrollment: 6550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation

Brief 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: 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.

Primary outcomes:
measure: Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
timeFrame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Livingston
country: United States
facility: New Jersey Perinatal Associates
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Austin
country: United States
facility: St. David's Women's Center of Texas
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: UT Health
state: Texas
city: Houston
country: United States
facility: HCA Healthcare, Texas Maternal Fetal Medicine
state: Texas
city: Norfolk
country: United States
facility: Macon & Joan Brock Virginia Health Sciences at Old Dominion University
state: Virginia
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Emily Rosenfeld, DO
role: PRINCIPAL_INVESTIGATOR
References: