Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3000 participants
OBSERVATIONAL
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All-risk pregnant women
All-risk pregnancies undergoing conventional forms of prenatal screening
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Prenatal screening determination by Nuchal Translucency (NT) measurement only
18 Years
FEMALE
No
Sponsors
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Verinata Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amy J Sehnert, MD
Role: STUDY_DIRECTOR
Verinata Health, Inc.
Locations
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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
Countries
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References
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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.
Other Identifiers
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VER-0007
Identifier Type: -
Identifier Source: org_study_id
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