A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test

Verinata Health, Inc.11 sites in 1 country10,000 target enrollmentJune 2010

ConditionsPregnant Women Prenatal Care

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pregnant Women
Sponsor: Verinata Health, Inc.
Enrollment: 10000
Locations: 11
Primary Endpoint: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

October 2011

Last Updated

14 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Verinata Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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