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Non-Invasive Preeclampsia Screening and Biobank

Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects blood samples to check for preeclampsia, a pregnancy problem that involves high blood pressure. It is for women age 18 or older who are 11 to 14 weeks pregnant with one baby.

Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are female and age 18 or older.
  • Sign and date a form agreeing to join the study.
  • Are 11 to 14 weeks pregnant with one baby.
  • Allow the study sponsor to see test results and related records from before and after birth.
  • Agree to a blood flow measurement during your routine early pregnancy ultrasound and an average blood pressure measurement at that visit.
  • Agree to give up to 25 mL of blood, about 5 teaspoons, at each trimester visit.
  • Agree to share health and pregnancy information, including what happens during and after birth.

Who can't join

  • Are unlikely to return for testing in the second and third trimesters.
  • Are unlikely to have records available about how the pregnancy ends.
  • Have already donated a sample for this study during this pregnancy.
  • Are in an aspirin study where treatment assignments are kept hidden, or take aspirin in an unknown dose.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (21)

AZ

DE

FL

LA

MA

NC

NJ

NY

PA

TN

TX

VA