Status:
COMPLETED
Routine Fetal RhD Genotyping for RhD- Pregnant Women
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Rhesus Negative Pregnant Women
Eligibility:
FEMALE
18+ years
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 compri...
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). ...
Eligibility Criteria
Inclusion
- Adult Rh negative pregnant patients ( ≥ 18 years)
- Valid and confirmed result of Rh D negative status.(one copy saved into the obstetrical records)
- Absence of actively produced anti-D antibody as shown on laboratory examination of a blood sample taken within the first trimester of pregnancy.
- Evolving pregnancy at the time of inclusion in the study ( between 8 and 26 gestation weeks as confirmed by early sonography).
- Absence of a previous invasive fetal RHD genotyping ( chorionic villous sampling, amniocentesis).
- Patient having signed an informed consent for the study.
- Inclusion and delivery expected in the same maternity ward
- Patient affiliated to a social security regimen.
Exclusion
- Evolving pregnancy seen for the first time after 26 gestation weeks.
- Poor understanding of the objectives of the study ( language barrier, ...)
- Delivery expected in a maternity ward not participating at the study.
- Fetal RHD invasive genotyping performed during early pregnancy on amniotic fluid or chorionic villus.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
2532 Patients enrolled
Trial Details
Trial ID
NCT00832962
Start Date
January 1 2009
End Date
October 1 2013
Last Update
March 26 2015
Active Locations (1)
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1
Hopital Saint Antoine
Paris, France, 75012