MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Completed

Conditions studied: Pregnant Women, Prenatal Care

In brief

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.

Key facts

Study ID

NCT01122524

Run by

Verinata Health, Inc.

People needed

10000

Starts

2010-06-01

Expected to finish

2011-10-01

Last updated by the study team

2011-10-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

Where it is running

• Center for Fetal Medicine — Los Angeles, California, United States
• San Francisco Perinatal Associates — San Francisco, California, United States
• Women's Clinic of Northern Colorado — Fort Collins, Colorado, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• OB/Gyn Specialists of the Palm Beaches — West Palm Beach, Florida, United States
• New Mexico Consortium for Perinatal Research — Albuquerque, New Mexico, United States
• Winthrop University Hospital — Mineola, New York, 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
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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