An observational study in Pregnancy, Down Syndrome and Edwards Syndrome, sponsored by Verinata Health, Inc.. Completed at 26 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-16.
Sponsored by Verinata Health, Inc. · Observational
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 150 across 141 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →Verinata Health, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
All-risk pregnancies undergoing conventional forms of prenatal screening
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.
Time frame: 12 months
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Verinata Health, Inc.