Development of a Prenatal Test for Fetal Aneuploidy Detection

This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

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Key information

Conditions

Fetal Complications Aneuploidy Chromosome Aberrations Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California San Diego, 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

Subject has singleton pregnancy
Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
Subject is able to provide informed consent
Subject is ≥ 18 years of age

Exclusion criteria

Subject is pregnant with more than one fetus
Subject (mother) has a known aneuploidy

Treatment and study plan

Primary outcomes

Identification of aneuploidy

Time frame: At enrollment

Sponsors and collaborators

Lead sponsor

Cindy Cisneros

Industry

Registry information

Official study title

Prenatal Test for Fetal Aneuploidy Detection

Important dates

Study start: 2010
Primary completion: 2019
Study completion: 2019
First posted: Oct 14, 2011
Registry last updated: Apr 30, 2020

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.

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