Development of a Non-invasive Prenatal Test

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ariosa Diagnostics

San Jose, California, 95138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Absence of chromosomal abnormality

Time frame: At time of enrollment

Sponsors and collaborators

Lead sponsor

Cindy Cisneros

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2019
Study completion: 2019
First posted: Oct 14, 2011
Registry last updated: Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed