Comparison of Aneuploidy Risk Evaluations (CARE)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||July 2012|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
All-risk pregnant women
All-risk pregnancies undergoing conventional forms of prenatal screening
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663350
Show 26 Study Locations
|Study Director:||Amy J Sehnert, MD||Verinata Health, Inc.|