Ignite Creation Date:
2024-05-05 @ 9:10 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00832962
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-01-13
Brief Title:
Routine Fetal RhD Genotyping for RhD- Pregnant Women
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effectiveness of Routine Fetal RhD Genotyping for RhD- Pregnant Women
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENIFERH
Brief Summary:
The study is divided in two sub-studies The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy GENIFERH 1 RhD typing group and the second will be a conventional management ie without RHD fetal typing GENIFERH 1 control group The two groups will consist of 13 maternity wards spread over French territory The second study GENIFERH 2 is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies
Detailed Description:
Alloimmunisation against the RhD RH red cell surface antigen is the commonest cause of haemolytic disease of the fetus and newborn It can be avoided by anti D immunoglobulin administration RhIg At the end of year 2005 new recommendations about anti-D prophylaxis in France proposed that all RhD negative pregnant women should be given anti-D immunoglobulin at 28 weeks gestation However about one third of these women would be carrying an RhD negative fetus and would receive the treatment unnecessarily A non-invasive fetal RHD typing kit CE labelled since June 2007 is available and could be proposed to all RhD negative pregnant women Applicable from the end of the first trimester of pregnancy on fetal DNA isolated from maternal plasma this assay allows RhIg to be specifically injected to unsensitized pregnancies with RhD positive fetus only and to promote the use of antenatal RhIg prophylaxis in a rational approach with economical and ethical impactThe study is divided in two sub-studies The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy GENIFERH 1 RhD typing group and the second will be a conventional management ie without RHD fetal typing GENIFERH 1 control group The two groups will consist of 13 maternity wards spread over French territory The second study GENIFERH 2 is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IC 0606 | None | None | None |