MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

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Key information

Conditions

Pregnant Women Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Prenatal Care

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Center for Fetal Medicine, Los Angeles, 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
Clinically confirmed viable pregnancy at the time of enrollment
Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
Able to provide consent for participation using language appropriate forms and consent process

Exclusion criteria

Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

Treatment and study plan

Primary outcomes

Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.

Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Verinata Health, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test

Acronym: MELISSA

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 13, 2010
Registry last updated: Oct 10, 2011

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