Comparison of Aneuploidy Risk Evaluations

Pregnancy Clinical Trial

— CARE  

Official title:

Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All‐Risk' Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663350
• Other study ID #: VER-0007
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: July 12, 2013
• Start date: July 2012

Study information

• Verified date: July 2013
• Source: Verinata Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneuploidy
• Down Syndrome
• Edwards Syndrome
• Gonadal Dysgenesis
• Patau Syndrome
• Pregnancy
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome
• Turners Syndrome

Locations

Country	Name	City	State
United States	Network Office of Research and Innovation Lehigh Valley Health Network	Allentown	Pennsylvania
United States	AD Williams Laboratory	Atlanta	Georgia
United States	Jacobi Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Prentice Women's Hospital	Chicago	Illinois
United States	Maternal Fetal Medicine	Cleveland	Ohio
United States	South Carolina Clinical Research	Columbia	South Carolina
United States	Practice Research Organization	Dallas	Texas
United States	Greenville Hospital Systems	Greenville	South Carolina
United States	Jackson Clinic	Jackson	Tennessee
United States	Desert Perinatal Associates	Las Vegas	Nevada
United States	Northshore University Hospital	Manhasset	New York
United States	MacDonald Clinical Research Unit	Mayfield Heights	Ohio
United States	Winthrop University Hospital	Mineola	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	St. Peter's University Hospital	New Brunswick	New Jersey
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	The Group for Women	Norfolk	Virginia
United States	Lyndhurst Clinical Research	Raleigh	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	West Coast OB/GYN	San Diego	California
United States	Washington University	St. Louis	Missouri
United States	Virtua Perinatology Associates of Voorhees	Voorhees	New Jersey
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Verinata Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No