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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-14
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

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

Trial Locations

Locations (3)

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States