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Development of a Non-invasive Prenatal Test

This study is currently recruiting participants.
Verified January 2013 by Ariosa Diagnostics, Inc
Sponsor:
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01451684
First received: October 10, 2011
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Non-invasive Prenatal Test

Resource links provided by NLM:

MedlinePlus related topics: Prenatal Care
U.S. FDA Resources

Further study details as provided by Ariosa Diagnostics, Inc:

Primary Outcome Measures:
  • Absence of chromosomal abnormality [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: June 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will include women who have a singleton pregnancy.

Criteria

Inclusion Criteria:

  • Subject has singleton pregnancy confirmed via evaluation by a healthcare provider
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject is unwilling to undergo a blood draw
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451684

Contacts
Contact: Desiree Hollemon, MSN, MPH 503-686-8972 dhollemon@ariosadx.com
Contact: Thomas Musci, MD 408-229-7500 tmusci@ariosadx.com

Locations
United States, California
Ariosa Diagnostics Recruiting
San Jose, California, United States, 95138
Contact: Desiree Hollemon, MSN, MPH     408-686-8972        
Principal Investigator: Thomas Musci, MD            
Sponsors and Collaborators
Ariosa Diagnostics, Inc
Investigators
Study Director: Ken Song, MD Tandem Diagnostics
  More Information

No publications provided

Responsible Party: Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01451684     History of Changes
Other Study ID Numbers: TD003
Study First Received: October 10, 2011
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ariosa Diagnostics, Inc:
pregnancy
fetus
euploid

ClinicalTrials.gov processed this record on May 16, 2013