NCT01122524CompletedNot Applicable
A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Verinata Health, Inc.
- Enrollment
- 10,000
- Locations
- 11
- Primary Endpoint
- Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
Study Overview
Brief Summary
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).
Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Clinically confirmed viable pregnancy at the time of enrollment
- •Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
- •Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
- •Able to provide consent for participation using language appropriate forms and consent process
Exclusion Criteria
- •Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment
Outcomes
Primary Outcomes
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
Time Frame: 10 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (11)
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