Comparison of Aneuploidy Risk Evaluations
CARE
Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population
1 other identifier
observational
3,000
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedJuly 16, 2013
July 1, 2013
1 year
July 31, 2012
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.
12 months
Study Arms (1)
All-risk pregnant women
All-risk pregnancies undergoing conventional forms of prenatal screening
Eligibility Criteria
The study population is comprised of pregnant women at least 18 years of age, who meet the study eligibility criteria. Women who plan or have already completed prenatal screening for fetal aneuploidy during first and/or second trimester, will be recruited from approved participating clinical centers.
You may qualify if:
- 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
You may not qualify if:
- Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
- Prenatal screening determination by Nuchal Translucency (NT) measurement only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
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 Township, New Jersey, 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
Jacobi Medical Center
The Bronx, 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
Related Publications (1)
Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.
PMID: 24571752DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amy J Sehnert, MD
Verinata Health, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 13, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Last Updated
July 16, 2013
Record last verified: 2013-07