Comparison of Aneuploidy Risk Evaluations

Completed

• Conditions: Down Syndrome; Patau Syndrome; Edwards Syndrome; Turners Syndrome; Pregnancy

• Registration Number: NCT01663350
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).	12 months	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.

Trial Locations

Locations (25)

St. Peter's University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Virtua Perinatology Associates of Voorhees; 🇺🇸 Voorhees, New Jersey, United States

South Carolina Clinical Research; 🇺🇸 Columbia, South Carolina, United States

Practice Research Organization; 🇺🇸 Dallas, Texas, United States

Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States

Maternal Fetal Medicine; 🇺🇸 Cleveland, Ohio, United States

West Coast OB/GYN; 🇺🇸 San Diego, California, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Desert Perinatal Associates; 🇺🇸 Las Vegas, Nevada, United States

AD Williams Laboratory; 🇺🇸 Atlanta, Georgia, United States

Greenville Hospital Systems; 🇺🇸 Greenville, South Carolina, United States

Jackson Clinic; 🇺🇸 Jackson, Tennessee, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

MacDonald Clinical Research Unit; 🇺🇸 Mayfield Heights, Ohio, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Northshore University Hospital; 🇺🇸 Manhasset, New York, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

Network Office of Research and Innovation Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

The Group for Women; 🇺🇸 Norfolk, Virginia, United States