Regions: Inuvialuit Settlement Region, Gwich'in Settlement Area, Sahtu Settlement Area, Dehcho Region, North Slave Region, South Slave Region
Tags: health, genetics, pregnancy, prenatal health
Principal Investigator: | Hannon, Judith L (5) |
Licence Number: | 15408 |
Organization: | Canadian Blood Services |
Licensed Year(s): |
2014
2013
2012
2011
2006
|
Issued: | Feb 05, 2014 |
Objective(s): To confirm that the RHD phenotype is appropriately assigned in a population of prenatal patients.
Project Description: The objectives of this research project are to confirm that the RhD phenotype is appropriately assigned in a population of prenatal patients that has not been studied for the presence of variant RhD gene alleles that would require them to be assigned an Rh-negative status and treated with Rh immune globulin. Samples will be selected for analysis among prenatal samples from the Northwest Territories and Nunavut submitted to the Prenatal Lab Edmonton Center for testing. Informed consent will be obtained from prenatal patients of aboriginal ancestry in selected locations from Nunavut, NWT and/or The Yukon. Once the routine clinical work is done, an anonymous number will be assigned to the sample. The research team will record the following information; -patients name, date of birth, and date of the sample; and -fetal gestational, and age collection site result of the antibody screen. The patient’s identification label will be removed and the sample labelled with the study number, e.g. RHD0001. Only the research team will have access to the code book that links the study number to the serological/demographic information. One hundred and twenty consecutive prenatal samples (representing both Rh positive and Rh negative) will be shipped to Dr. Willy Flegel, Ulm Germany for testing. The DNA sequences will be reviewed by the research team to identify novel alleles. Germany will return DNA and red cells from novel alleles to the Canadian Blood Services for archiving. Germany will confirm that all DNA and red cells have been destroyed when requested to do so (anticipated to be within 2 years of sample collection). Left over blood from the Edmonton Prenatal Lab will be used for the DNA analysis after the routine clinical serological analyses and reports have been completed. One hundred and twenty prenatal patients of aboriginal ancestry from Nunavut, NWT, and/or The Yukon. There will be a process to report to and discuss with the patient the implications of the study results. The data will be tabulated for general statistical purposes; collection site, date of sample, age (in years) of the patient, current gestation, and complete Rh phenotype (Rh D, C/c, E/e), presence of atypical red cell antibodies including anti-D. The fieldwork for this study will be conducted from February 4, 2014 to December 31, 2014.