Comparison of Aneuploidy Risk Evaluations

NCT ID: NCT01663350

Last Updated: 2013-07-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Down Syndrome Edwards Syndrome Patau Syndrome Turners Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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 Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Verinata Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

AD Williams Laboratory

Atlanta, Georgia, United States

Site Status

Prentice Women's Hospital

Chicago, Illinois, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Desert Perinatal Associates

Las Vegas, Nevada, United States

Site Status

St. Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status

Virtua Perinatology Associates of Voorhees

Voorhees Township, New Jersey, United States

Site Status

Northshore University Hospital

Manhasset, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

Site Status

Lyndhurst Clinical Research

Raleigh, North Carolina, United States

Site Status

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Maternal Fetal Medicine

Cleveland, Ohio, United States

Site Status

MacDonald Clinical Research Unit

Mayfield Heights, Ohio, United States

Site Status

Network Office of Research and Innovation Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

South Carolina Clinical Research

Columbia, South Carolina, United States

Site Status

Greenville Hospital Systems

Greenville, South Carolina, United States

Site Status

Jackson Clinic

Jackson, Tennessee, United States

Site Status

Practice Research Organization

Dallas, Texas, United States

Site Status

Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

The Group for Women

Norfolk, Virginia, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 24571752 (View on PubMed)

Other Identifiers

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VER-0007

Identifier Type: -

Identifier Source: org_study_id

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