Comparison of Aneuploidy Risk Evaluations (CARE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Verinata Health, Inc.
ClinicalTrials.gov Identifier:
NCT01663350
First received: July 31, 2012
Last updated: July 12, 2013
Last verified: July 2013

July 31, 2012
July 12, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01663350 on ClinicalTrials.gov Archive Site
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Comparison of Aneuploidy Risk Evaluations
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Plasma

Non-Probability Sample

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.

  • Pregnancy
  • Down Syndrome
  • Edwards Syndrome
  • Patau Syndrome
  • Turners Syndrome
Not Provided
All-risk pregnant women
All-risk pregnancies undergoing conventional forms of prenatal screening
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
Not Provided
July 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01663350
VER-0007
No
Verinata Health, Inc.
Verinata Health, Inc.
Not Provided
Study Director: Amy J Sehnert, MD Verinata Health, Inc.
Verinata Health, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP