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Development of a Prenatal Test for Fetal Aneuploidy Detection

CompletedN/A

Sponsor: Cindy Cisneros

Conditions: Fetal Complications

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

San Diego, California, United States
Louisville, Kentucky, United States
Milwaukee, Wisconsin, United States