Development of a Prenatal Test for Fetal Aneuploidy Detection
Completed
- Conditions
- Fetal Complications
- Registration Number
- NCT01451671
- Lead Sponsor
- Cindy Cisneros
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1500
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of aneuploidy At enrollment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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
University of California San Diego🇺🇸San Diego, California, United States