Comparison of Aneuploidy Risk Evaluations

Verinata Health, Inc.3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Pregnancy Down Syndrome Edwards Syndrome Patau Syndrome Turners Syndrome

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (26)

West Coast OB/GYN

Outcomes

Primary Outcomes

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

The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.

Time frame: 12 months

Data from ClinicalTrials.gov

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