Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study

Recruiting

• Conditions: Lung Transplantation; Graft Rejection; Pregnancy
• Interventions: Diagnostic Test: HLA typing of the children

• Registration Number: NCT05689905
• Lead Sponsor: Nantes University Hospital

Brief Summary

TRIGGER 1 is a previous study that evaluate the immunological risk of pregnancy in women with lung transplants in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection with a year after pregnancy.

TRIGGER 2 aims to evaluate the risk of humoral rejection if there are common antigens between the child and the lung donor. We will collect HLA typing from children to compare them to the HLA typing of the mother, the lung donor and the antibodies produced if there are.

Thus, it will help us to suggest recommendations to limit the immunological risk of pregnancy for lung transplant women.

Lung transplantation is the treatment of choice of terminal chronic respiratory failure, such as cystic fibrosis and pulmonary hypertension. Young female patient of childbearing age are concerned.

For many years, given the risk of maternal and fetal complications, pregnancies were not recommended. Studies on large cohorts of transplanted patients, particularly kidney transplanted patients, have made it possible to study the risks of maternal, obstetrical and neonatal complications.

A few studies have been published in lung transplantation on small numbers of patients. However, these publications reporting on the fate of pregnancies in cohorts of lung transplant patients do not mentioned the immunological risk, with in particular the absence of studies on the risk of humoral rejection, appearance of anti-HLA (Human Leukocyte Antigens) antibodies (Ac) and the possible appearance of anti-HLA Ac directed against the donor (donor specific antibody, DSA).

TRIGGER 1 is a previous study, whose main objective is to evaluate the immunological risk of pregnancy in women with lung transplants (mono-, bi-, or cardiopulmonary) in France, whose pregnancy has ended between January 1, 2012 and December 31, 2021. The primary endpoint is the occurrence of humoral rejection within 1 year after pregnancy.

For this study TRIGGER2, we will collect the HLA typing of the children for pregnancies that resulted in the birth of a child. Thus, we will be able to compare the HLA typing of the children with the HLA typings of the mother and the lung donor, and the antibodies produced by the mother. The primary endpoint is to evaluate the risk of humoral rejection if there are common HLA antigens between the child and the lung donor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-19
• Study Start: 2024-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children born between 01/01/2012 and 31/12/2021 of female patients over 18 years old with lung transplantation (mono, uni or cardio pulmonary) in France,
• Alive at the time of our study.
• Legal guardians' consent for oral swabbing of their child and HLA typing on this swab
• Affiliated or beneficiaries of a social security system or similar

Exclusion Criteria

• Refusal of consent by the patient and/or one of the two parents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Common HLA antigens with the lung donor	HLA typing of the children	Children who have common HLA antigens with the lung donor of their mother
No common HLA antigens with the lung donor	HLA typing of the children	Children without common HLA antigens with the lung donor of their mother.

Primary Outcome Measures

Name	Time	Method
Risk of humoral rejection if common HLA antigen between child and graft.	Baseline	Identification of common HLA antigen between child and graft by HLA typing

Trial Locations

Locations (9)

Nantes University Hospital; 🇫🇷 Nantes, Loire Atlantique, France

Cochin Hospital (AP-HP); 🇫🇷 Paris, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

Marie Lannelongue Hospital (GHSJ); 🇫🇷 Le Plessis-Robinson, France

Civils Hospitals Lyon; 🇫🇷 Lyon, France

AP-HM; 🇫🇷 Marseille, France

Strasbourg University Hospital; 🇫🇷 Strasbourg, France

Foch Hospital; 🇫🇷 Suresnes, France