Blood Donors Clinical Trial
— OBS-HLAOfficial title:
Obstetrical History and Anti-HLA Antibodies Level
Chronic histiocytic intervillositis (CHI) is associated with severe and recurrent obstetrical complications. A link between anti-HLA Antibodies (Ab) and CHI has recently been established. At the Etablissement Français du Sang (EFS), donors who have already given birth once and have high levels of anti-HLA are excluded from donating apheresis platelets and therapeutic plasma to prevent TRALI (Transfusion Related Acute Lung Injury). No studies have examined the obstetrical history of these donors. The question is: is there an association between anti-HLA levels and obstetrical complications?
Status | Recruiting |
Enrollment | 6000 |
Est. completion date | June 13, 2024 |
Est. primary completion date | June 13, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female blood donors who have been tested for anti-HLA antibodies in the context of TRALI prevention between 2010 and 2020 at EFS Nouvelle Aquitaine [The donors meet the conditions of the Order of December 17, 2019 establishing the selection criteria for blood donors and are over 18 years old, are not protected persons and understand French well] - Women who have already given birth at least once (non-nulliparous women) - Women who have not expressed their opposition at the time of donation to participating in a research project and to be contacted Exclusion Criteria: - None [Donors meet the conditions of the Order of December 17, 2019 establishing the selection criteria for blood donors and are over 18 years old, are not protected persons and understand French well] |
Country | Name | City | State |
---|---|---|---|
France | Etablissement Français du Sang Nouvelle Aquitaine | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Etablissement Français du Sang (Nouvelle Aquitaine) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the association between the occurrence of obstetrical complications and the level of anti-HLA Ab measured during the screening test performed by the EFS. | Obstetrical complications are defined as (binomial qualitative variable) :
Preterm delivery < 37 WA Fetal death in utero whatever the term Early or late miscarriage Early or late pre-eclampsia Medical termination of pregnancy Intrauterine growth retardation <3rd percentile |
2 months | |
Secondary | Type and precocity of obstetrical complication (multinomial qualitative variable) | Preterm deliveries < 37 WA and = 34 WA
Premature deliveries < 34 WA Fetal death in utero regardless of term Late miscarriage < 22 WA and = 14 WA Early miscarriage < 14 WA Late pre-eclampsia > 37 WA and = 34 WA Early pre-eclampsia < 34 WA Medical termination of pregnancy Intrauterine growth retardation <3rd percentile |
2 months | |
Secondary | Measure the association between the type and precocity of obstetrical complications according to the type of anti-HLA Ab (class I and/or class II), when these Ab are found during the screening test performed by the EFS | Preterm deliveries < 37 WA and = 34 WA
Premature deliveries < 34 WA Fetal death in utero regardless of term Late miscarriage < 22 WA and = 14 WA Early miscarriage < 14 WA Late pre-eclampsia > 37 WA and = 34 WA Early pre-eclampsia < 34 WA Medical termination of pregnancy Intrauterine growth retardation <3rd percentile |
2 months | |
Secondary | Verify the absence of response bias by comparing the HLA Ab levels of responding versus non-responding donors. | Anti-HLA antibody rate (median) | 2 months |
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