Comparison of Aneuploidy Risk Evaluations

Completed

Conditions studied: Pregnancy, Down Syndrome, Edwards Syndrome, Patau Syndrome, Turners Syndrome

In brief

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.

Key facts

Study ID

NCT01663350

Run by

Verinata Health, Inc.

People needed

3000

Starts

2012-07-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
• Prenatal screening determination by Nuchal Translucency (NT) measurement only

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.