Evaluation of a Noninvasive Fetal RHD Genotyping Test (IRIS)

This study has been completed.
Sponsor:
Collaborator:
Sequenom Center for Molecular Medicine
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01054716
First received: January 20, 2010
Last updated: September 1, 2011
Last verified: September 2011

January 20, 2010
September 1, 2011
May 2009
November 2010   (final data collection date for primary outcome measure)
Fetal RHD determination from maternal whole blood [ Time Frame: Between 10 and 28 weeks gestation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01054716 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of a Noninvasive Fetal RHD Genotyping Test
Evaluation of a Noninvasive Fetal RHD Genotyping Test

This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood collected, processed to plasma and buffy coat for DNA extraction.

Non-Probability Sample

Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.

Rhesus D Genotype
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.
 
Completed
500
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is 18-64 years of age
  • Subject is female
  • Subject is pregnant
  • Subject is RhD negative
  • Subject is between 10 and 28 weeks gestation
  • Subject provides informed consent
  • Subject agrees to provide neonatal RHD and sex outcome

Exclusion Criteria:

  • None
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054716
SQNM-RHD-105
No
Sequenom, Inc.
Sequenom, Inc.
Sequenom Center for Molecular Medicine
Not Provided
Sequenom, Inc.
September 2011

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