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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All-risk pregnant women; All-risk pregnancies undergoing conventional forms of prenatal screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Verinata Health, Inc.
• Investigators: Study Director: Amy J Sehnert, MD, Verinata Health, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (ESTIMATE): August 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Endocrine System Diseases; Disease; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Heart Defects, Congenital; Cardiovascular Abnormalities; Abnormalities, Multiple; Chromosome Disorders; Sex Chromosome Disorders; Chromosome Aberrations; Sex Chromosome Disorders of Sex Development; Gonadal Dysgenesis; Syndrome; Down Syndrome; Aneuploidy; Turner Syndrome; Trisomy 13 Syndrome; Trisomy 18 Syndrome
• Other Study ID Numbers: VER-0007