MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Completed

• Conditions: Pregnant Women; Prenatal Care

• Registration Number: NCT01122524
• Lead Sponsor: Verinata Health, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-13
• Study Start: 2010-06
• Primary Completion: 2011-09
• Status Verified: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.	10 months

Trial Locations

Locations (11)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Center for Fetal Medicine; 🇺🇸 Los Angeles, California, United States

San Francisco Perinatal Associates; 🇺🇸 San Francisco, California, United States

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

The Women's Hospital of Texas; 🇺🇸 Houston, Texas, United States

OB/Gyn Specialists of the Palm Beaches; 🇺🇸 West Palm Beach, Florida, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

Women's Clinic of Northern Colorado; 🇺🇸 Fort Collins, Colorado, United States

New Mexico Consortium for Perinatal Research; 🇺🇸 Albuquerque, New Mexico, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States