Development of a Non-invasive Prenatal Test
1 other identifier
observational
15,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 30, 2020
April 1, 2020
8.5 years
October 10, 2011
April 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of chromosomal abnormality
At time of enrollment
Eligibility Criteria
This study will include women who have a healthy pregnancy.
You may qualify if:
- 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
You may not qualify if:
- Subject is pregnant with more than two fetuses
- Subject is unwilling to undergo a blood draw
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cindy Cisneroslead
Study Sites (1)
Ariosa Diagnostics
San Jose, California, 95138, United States
Study Officials
- STUDY DIRECTOR
Tracy Roberts
Ariosa Diagnostics
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- CRA
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 14, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 30, 2020
Record last verified: 2020-04