Development of a Prenatal Test for Fetal Aneuploidy Detection

Prenatal Test for Fetal Aneuploidy Detection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01451671

Enrollment

1500

Registered

2011-10-14

Start date

2010-11-30

Completion date

2019-11-30

Last updated

2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Complications

Keywords

fetal, aneuploidy, non-invasive, prenatal, cell free DNA

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Identification of aneuploidy	At enrollment

Countries

United States

Outcome results