MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Pregnant Women Clinical Trial

— MELISSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122524
• Other study ID #: ART-0006
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: October 6, 2011
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Verinata Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneuploidy
• Pregnant Women
• Prenatal Care

Locations

Country	Name	City	State
United States	New Mexico Consortium for Perinatal Research	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Visions Clinical Research	Boynton Beach	Florida
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Women's Clinic of Northern Colorado	Fort Collins	Colorado
United States	The Women's Hospital of Texas	Houston	Texas
United States	Center for Fetal Medicine	Los Angeles	California
United States	Winthrop University Hospital	Mineola	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	San Francisco Perinatal Associates	San Francisco	California
United States	OB/Gyn Specialists of the Palm Beaches	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Verinata Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.		10 months	No