Non-Invasive Preeclampsia Screening and Biobank
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preeclampsia (PE). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
Overview
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Detailed description
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.
Primary outcome measures
- Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay [Time frame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 21 centers
- Valley Perinatal — Glendale
- Delaware Center for Maternal and Fetal Medicine — Newark
- D&H National Research Centers — Miami
- Southern Clinical Research Associates — Metairie
- Beth Israel Deaconess Medical Center — Boston
- Cooper University Health Care — Camden
- New Jersey Perinatal Associates — Livingston
- Rutgers Robert Wood Johnson Medical School — New Brunswick
- … and 13 more centers
Identifiers
NCT: NCT06643741 · SQNM-PRE-401