NCT01122524

MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Verinata Health, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnant Women
• Prenatal Care

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-05-13
• Last updated: 2011-10-10

Locations

11 sites across 1 country: United States