Obstetrical History and Anti-HLA Antibodies Level

Blood Donors Clinical Trial

— OBS-HLA  

Official title:

Obstetrical History and Anti-HLA Antibodies Level

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021925
• Other study ID #: APHP221333
• Secondary ID: 2021-A01199-32
• Status: Recruiting
• Start date: December 13, 2023
• Est. completion date: June 13, 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Xavier LAFARGE, Doctor
• Phone: 05 56 90 83 93
• Email: xavier.lafarge[@]efs.sante.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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?

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 histiocytes, associated with fibrin deposition on the villous surface.

CHI is associated with severe obstetrical complications and a very high recurrence rate, estimated at between 70% and 100%. These complications include early and late miscarriage, fetal death, severe growth retardation in surviving fetuses, and premature delivery. The survival rate reported in the literature varies between 30% and 50%.

Anti-HLA antibodies are present in 54% of pregnant women at the end of pregnancy, and their rate increases towards the end of pregnancy. The presence of HLA antibodies also increases with the number of pregnancies, and is found in up to 74% of cases after more than 2 deliveries.

The research question concerns the existence of a statistically significant association between the presence of high levels of anti-HLA antibodies and the occurrence of one or more obstetric complications.

Recruitment information / eligibility

• 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]

Related Conditions & MeSH terms

• Blood Donors

Intervention

Other:
• Obstetrical history
Selection of donors by EFS retrospectively on the basis of inclusion criteria. Information note sent by e-mail, non-opposition as well as a questionnaire to be completed online to obtain data on obstetrical history.
• Anti-HLA Antibody tests
Analyze responses in relation to the results of the anti-HLA Antibody tests performed at the time of donation.

Locations

Country	Name	City	State
France	Etablissement Français du Sang Nouvelle Aquitaine	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Etablissement Français du Sang (Nouvelle Aquitaine)

Country where clinical trial is conducted

France, 

Outcome

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