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
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
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.
Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
Exclusion Criteria:
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.
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
Plan to share: No
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Sequenom, Inc.