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Non-Invasive Preeclampsia Screening and Biobank

Sponsored by Sequenom, Inc.

About this study

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.

Where this study is enrolling (20)

Show all 20 locations
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.