Clinical trialNCT01122524CompletedObservational

MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

SponsorVerinata Health, Inc.Enrollment10,000Pregnant WomenPrenatal Care

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Amy J Sehnert, MD
Verinata Health, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2010
Primary completion: 30 Sept 2011
Completion: 31 Oct 2011
Last update posted: 10 Oct 2011
Registered enrollment: 10,000
Registry id: NCT01122524

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.