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

Sponsors

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
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Amy J Sehnert, MD Study Director Verinata Health, Inc.
Location
Facility:
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

2013-07-01

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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