Fetal Complications Clinical Trial
Official title:
Prenatal Test for Fetal Aneuploidy Detection
NCT number | NCT01451671 |
Other study ID # | TD002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2010 |
Est. completion date | November 2019 |
Verified date | April 2020 |
Source | Roche Sequencing Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1500 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Norton Healthcare | Louisville | Kentucky |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Cindy Cisneros |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of aneuploidy | At enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
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