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Recruiting
NCT06643741
Non-Invasive Preeclampsia Screening and Biobank
Conditions: Preeclampsia (PE)
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 6550
Sponsor: Sequenom, Inc.
Location: Valley Perinatal Glendale Arizona
Summary
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
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.
Source: ClinicalTrials.gov (NCT06643741). StuddyBuddy aggregates publicly available trial information.