Development of a Prenatal Test for Fetal Aneuploidy Detection
Completed
Conditions studied: Fetal Complications
In brief
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.
Key facts
- Study ID
- NCT01451671
- Run by
- Cindy Cisneros
- People needed
- 1500
- Starts
- 2010-11-01
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2020-04-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subject is pregnant with more than one fetus
- Subject (mother) has a known aneuploidy
Where it is running
- University of California San Diego — San Diego, California, United States
- Norton Healthcare — Louisville, Kentucky, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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