Status:
COMPLETED
A Noninvasive Test for Fetal RHD Genotype
Lead Sponsor:
Sequenom, Inc.
Collaborating Sponsors:
NAFTNet
Conditions:
Rhesus D Genotype
Eligibility:
FEMALE
18+ years
Brief Summary
The objective of this study is to evaluate the performance of Sequenom's noninvasive test for fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The study is specifically des...
Detailed Description
In the United States and Canada, routine obstetrical care includes a blood test to determine the blood type of the mother (ABO and RhD). An antibody screen for anti-red cell antibodies in the mother's...
Eligibility Criteria
Inclusion
- Female at least 18 years of age
- RhD negative by serology
- Pregnant at no more than 11-13 weeks gestation confirmed by ultrasound
- Willing to provide signed and dated informed consent
- Able and willing to comply with the protocol
Exclusion
- RhD negative women known to be alloimmunized to the RhD antigen
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00871195
Start Date
April 1 2009
End Date
April 1 2012
Last Update
May 10 2012
Active Locations (13)
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1
Obstetrix Medical Group of Phoenix
Phoenix, Arizona, United States, 85006
2
Wayne State University
Detroit, Michigan, United States, 48201
3
Mt. Sinai School of Medicine
New York, New York, United States, 10029
4
Columbia University
New York, New York, United States, 10032