Development of a Non-invasive Prenatal Test

This study is currently recruiting participants.
Verified August 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: August 15, 2013
Last verified: August 2013

October 10, 2011
August 15, 2013
June 2011
January 2016   (final data collection date for primary outcome measure)
Absence of chromosomal abnormality [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01451684 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Development of a Non-invasive Prenatal Test
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

This study will include women who have a singleton pregnancy.

Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Desiree Hollemon, MSN, MPH 503-686-8972 dhollemon@ariosadx.com
Contact: Thomas Musci, MD 408-229-7500 tmusci@ariosadx.com
United States
 
NCT01451684
TD003
No
Ariosa Diagnostics, Inc
Ariosa Diagnostics, Inc
Not Provided
Study Director: Thomas Musci, MD Ariosa Diagnostics
Ariosa Diagnostics, Inc
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP