Development of a Non-invasive Prenatal Test

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Ariosa Diagnostics, Inc
Sponsor:
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01451684
First received: October 10, 2011
Last updated: July 14, 2016
Last verified: July 2016

October 10, 2011
July 14, 2016
June 2011
December 2017   (final data collection date for primary outcome measure)
Absence of chromosomal abnormality [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01451684 on ClinicalTrials.gov Archive Site
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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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
This study will include women who have a singleton pregnancy.
Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
December 2017
December 2017   (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   (Adult, Senior)
No
Contact: Romielle Aquino 408-209-9098 raquino@ariosadx.com
Contact: Thomas Musci, MD 408-229-7500 tmusci@ariosadx.com
United States
 
NCT01451684
TD003
No
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Ariosa Diagnostics, Inc
Ariosa Diagnostics, Inc
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Study Director: Thomas Musci, MD Ariosa Diagnostics
Ariosa Diagnostics, Inc
July 2016

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