Comparison of Aneuploidy Risk Evaluations

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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Key information

Conditions

Pregnancy Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Down Syndrome Edwards Syndrome Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Intellectual Disability Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Patau Syndrome Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Trisomy 13 Syndrome Trisomy 18 Syndrome Turner Syndrome Turners Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

West Coast OB/GYN, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).

Time frame: 12 months

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.

Sponsors and collaborators

Lead sponsor

Verinata Health, Inc.

Industry

Registry information

Official study title

Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population

Acronym: CARE

Important dates

Study start: 2012
Primary completion: 2013
First posted: Aug 13, 2012
Registry last updated: Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed