Link between obstetrical history and anti-HLA antibody levels
Obstetrical History and Anti-HLA Antibodies Level
This study looks at whether high levels of certain antibodies in women who have given birth are linked to serious pregnancy problems like miscarriages and fetal death.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06021925 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the association between high levels of anti-HLA antibodies and obstetrical complications in female blood donors who have previously given birth. It focuses on women who have been tested for anti-HLA antibodies at the Etablissement Français du Sang (EFS) between 2010 and 2020. The study aims to determine if there is a statistically significant correlation between the presence of these antibodies and the occurrence of severe obstetrical issues, such as miscarriages and fetal death. By analyzing the obstetrical history of these donors, the research seeks to enhance understanding of the implications of anti-HLA antibodies in pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are female blood donors over 18 years old who have given birth at least once and have been tested for anti-HLA antibodies.
Not a fit: Patients who have not given birth or those who have expressed opposition to participating in research will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for pregnant women with high anti-HLA antibody levels, potentially reducing obstetrical complications.
How similar studies have performed: While the association between anti-HLA antibodies and obstetrical complications is being explored, this specific investigation into blood donors' obstetrical history appears to be novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \[Donors meet the conditions of the Order of December 17, 2019 establishing the selection criteria for blood donors and are over 18 years old, are not protected persons and understand French well\]
Where this trial is running
Bordeaux
- Etablissement Français du Sang Nouvelle Aquitaine — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Xavier LAFARGE, Doctor — Etablissement Français du Sang (Nouvelle Aquitaine)
- Study coordinator: Xavier LAFARGE, Doctor
- Email: xavier.lafarge@efs.sante.fr
- Phone: 05 56 90 83 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.