CompletedNot Applicable

Comparison of Aneuploidy Risk Evaluations

United States3,000 participantsStarted 2012-07

Plain-language summary

This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older at enrollment * Clinically confirmed pregnancy * Gestational age ≥8 weeks, 0 days * Planned or completed prenatal serum screening\* (drawn during 1st and/or 2nd trimester) * Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam) * Able to provide consent for participation using language appropriate forms Exclusion Criteria: * Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment * Prenatal screening determination by Nuchal Translucency (NT) measurement only

What they're measuring

Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).

Timeframe: 12 months

Trial details

NCT IDNCT01663350

SponsorVerinata Health, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Pregnancy trials