Evaluation of a Noninvasive Fetal RHD Genotyping Test
IRIS
1 other identifier
observational
500
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 5, 2011
September 1, 2011
1.5 years
January 20, 2010
September 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fetal RHD determination from maternal whole blood
Between 10 and 28 weeks gestation
Eligibility Criteria
Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Sequenom Center for Molecular Medicinecollaborator
Study Sites (5)
Sharp Grossmont Hospital
San Diego, California, 91944, United States
West Coast OBGYN
San Diego, California, 92123, United States
Women's Health Care, Inc
San Diego, California, 92123, United States
Scripps Hospitals (5 San Diego locations)
San Diego, California, 92130, United States
Spectrum Health Research
Grand Rapids, Michigan, 49503, United States
Biospecimen
Whole blood collected, processed to plasma and buffy coat for DNA extraction.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
May 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 5, 2011
Record last verified: 2011-09