MedTrace Logo

MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

NCT01122524 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2011-10-10

No results posted yet for this study

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

Sponsors & Collaborators

  • Verinata Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Amy J Sehnert, MD · Verinata Health, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01122524 on ClinicalTrials.gov