Development of a Prenatal Test for Fetal Aneuploidy Detection

Cindy Cisneros1,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Fetal Complications

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

University of California San Diego

San Diego, California, United States

Norton Healthcare

Louisville, Kentucky, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Identification of aneuploidy

Time frame: At enrollment

Data from ClinicalTrials.gov

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