Comparison of Aneuploidy Risk Evaluations

Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population


Lead Sponsor: Verinata Health, Inc.

Source Verinata Health, Inc.
Brief Summary

This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.

Overall Status Completed
Start Date 2012-07-01
Primary Completion Date 2013-07-01
Study Type Observational
Primary Outcome
Measure Time Frame
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). 12 months
Enrollment 3000

Sampling Method:

Non-Probability Sample


Inclusion Criteria: - Age 18 years or older at enrollment - Clinically confirmed pregnancy - Gestational age ≥8 weeks, 0 days - Planned or completed prenatal serum screening* (drawn during 1st and/or 2nd trimester) - Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam) - Able to provide consent for participation using language appropriate forms Exclusion Criteria: - Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment - Prenatal screening determination by Nuchal Translucency (NT) measurement only



Minimum Age:

18 Years

Maximum Age:


Healthy Volunteers:


Overall Official
Last Name Role Affiliation
Amy J Sehnert, MD Study Director Verinata Health, Inc.
West Coast OB/GYN | San Diego, California, United States
AD Williams Laboratory | Atlanta, Georgia, United States
Prentice Women's Hospital | Chicago, Illinois, United States
William Beaumont Hospital | Royal Oak, Michigan, United States
University of Minnesota | Minneapolis, Minnesota, United States
Washington University | St. Louis, Missouri, United States
Desert Perinatal Associates | Las Vegas, Nevada, United States
St. Peter's University Hospital | New Brunswick, New Jersey, United States
Virtua Perinatology Associates of Voorhees | Voorhees, New Jersey, United States
Jacobi Medical Center | Bronx, New York, United States
Northshore University Hospital | Manhasset, New York, United States
Winthrop University Hospital | Mineola, New York, United States
Long Island Jewish Medical Center | New Hyde Park, New York, United States
Mount Sinai Medical Center | New York, New York, United States
Lyndhurst Clinical Research | Raleigh, North Carolina, United States
Lyndhurst Clinical Research | Winston-Salem, North Carolina, United States
Maternal Fetal Medicine | Cleveland, Ohio, United States
MacDonald Clinical Research Unit | Mayfield Heights, Ohio, United States
Network Office of Research and Innovation Lehigh Valley Health Network | Allentown, Pennsylvania, United States
Medical University of South Carolina | Charleston, South Carolina, United States
South Carolina Clinical Research | Columbia, South Carolina, United States
Greenville Hospital Systems | Greenville, South Carolina, United States
Jackson Clinic | Jackson, Tennessee, United States
Practice Research Organization | Dallas, Texas, United States
Eastern Virginia Medical School | Norfolk, Virginia, United States
The Group for Women | Norfolk, Virginia, United States
Location Countries

United States

Verification Date


Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: All-risk pregnant women

Description: All-risk pregnancies undergoing conventional forms of prenatal screening

Acronym CARE
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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