Status:

RECRUITING

Obstetrical History and Anti-HLA Antibodies Level

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

Etablissement Français du Sang (Nouvelle Aquitaine)

Conditions:

Blood Donors

Anti-HLA Antibody

Eligibility:

FEMALE

18+ years

Brief Summary

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 Etabl...

Detailed Description

Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of around 5 in 10,000 pregnancies. It is defined by major infiltration of the intervillous cavity by CD68+ maternal hist...

Eligibility Criteria

Inclusion

  • 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

  • None \[Donors meet the conditions of the Order of December 17, 2019 establishing the selection criteria for blood donors and are over 18 years old, are not protected persons and understand French well\]

Key Trial Info

Start Date :

December 13 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 13 2024

Estimated Enrollment :

6000 Patients enrolled

Trial Details

Trial ID

NCT06021925

Start Date

December 13 2023

End Date

June 13 2024

Last Update

January 24 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Etablissement Français du Sang Nouvelle Aquitaine

Bordeaux, France, 33075

Obstetrical History and Anti-HLA Antibodies Level | DecenTrialz