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Evaluation of a Noninvasive Fetal RHD Genotyping Test (IRIS)

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ClinicalTrials.gov Identifier: NCT01054716
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : September 5, 2011
Sponsor:
Collaborator:
Sequenom Center for Molecular Medicine
Information provided by (Responsible Party):
Sequenom, Inc.

Brief Summary:
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.

Condition or disease
Rhesus D Genotype

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of a Noninvasive Fetal RHD Genotyping Test
Study Start Date : May 2009
Primary Completion Date : November 2010
Study Completion Date : November 2010



Primary Outcome Measures :
  1. Fetal RHD determination from maternal whole blood [ Time Frame: Between 10 and 28 weeks gestation ]

Biospecimen Retention:   Samples With DNA
Whole blood collected, processed to plasma and buffy coat for DNA extraction.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054716


Locations
United States, California
Sharp Grossmont Hospital
San Diego, California, United States, 91944
West Coast OBGYN
San Diego, California, United States, 92123
Women's Health Care, Inc
San Diego, California, United States, 92123
Scripps Hospitals (5 San Diego locations)
San Diego, California, United States, 92130
United States, Michigan
Spectrum Health Research
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Sequenom, Inc.
Sequenom Center for Molecular Medicine

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT01054716     History of Changes
Other Study ID Numbers: SQNM-RHD-105
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011

Keywords provided by Sequenom, Inc.:
RhD negative
RhD disease
fetal nucleic acid
fetal DNA
cell free fetal DNA
Fetal RHD genotype