Development of a Non-invasive Prenatal Test

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01451684

Enrollment

15000

Registered

2011-10-14

Start date

2011-06-30

Completion date

2019-12-31

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

Pregnancy

Keywords

pregnancy, fetus, euploid

Brief summary

This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Detailed description

Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider * Subject is able to provide informed consent * Subject is ≥ 18 years of age * Subject is at least 10 weeks gestation for general enrollment * Subject has no known risk factors for chromosomal abnormalities of the fetus * Subject has no suspected or confirmed fetal abnormalities

Exclusion criteria

* Subject is pregnant with more than two fetuses * Subject is unwilling to undergo a blood draw

Design outcomes

Primary

Measure	Time frame
Absence of chromosomal abnormality	At time of enrollment

Countries

United States

Outcome results