Non-Invasive Preeclampsia Screening and Biobank
ConditionPreeclampsia (PE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSequenom, Inc.
About this trial
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial population
Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6,550 Participants
are grouped into 1 trial groupGroup A: Pregnant subjects between 11 and 14 weeks gestation.
Trial outcomes
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sequenom, Inc.
Lead sponsor
Rutgers Robert Wood Johnson Medical School
Collaborator
Laboratory Corporation of America
Collaborator
Source ClinicalTrials.gov