Clinical trial NCT01663350: Comparison of Aneuploidy Risk Evaluations
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Down Syndrome
Edwards Syndrome
Patau Syndrome
Turners Syndrome
Lead sponsor: Verinata Health, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: West Coast OB/GYN
state: California
city: Atlanta
country: United States
facility: AD Williams Laboratory
state: Georgia
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Desert Perinatal Associates
state: Nevada
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Perinatology Associates of Voorhees
state: New Jersey
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Manhasset
country: United States
facility: Northshore University Hospital
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Raleigh
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Maternal Fetal Medicine
state: Ohio
city: Mayfield Heights
country: United States
facility: MacDonald Clinical Research Unit
state: Ohio
city: Allentown
country: United States
facility: Network Office of Research and Innovation Lehigh Valley Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Clinical Research
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital Systems
state: South Carolina
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Dallas
country: United States
facility: Practice Research Organization
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
Study officials:
affiliation: Verinata Health, Inc.
name: Amy J Sehnert, MD
role: STUDY_DIRECTOR
References:
citation: 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.