Clinical Trial: MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Verinata Health, Inc.

Current Primary Outcome: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. [ Time Frame: 10 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Verinata Health, Inc.

Dates:
Date Received: May 11, 2010
Date Started: June 2010
Date Completion:
Last Updated: October 6, 2011
Last Verified: October 2011