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. (part of Labcorp) · 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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 6,550 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
First submitted after Sequenom, Inc. became part of Labcorp.
Counted across the registry records on this site, refreshed daily.
Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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Plan to share: No
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