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

NCT05689905 | Completed

• 1 other identifier: RC22_0581
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 9

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.

Conditions

Lung Transplantation; Graft Rejection; Pregnancy

Keywords

Lung Transplantations; Pregnancy; Transplant Rejection; Transplantation Immunology

Outcome Measures

Primary Outcomes (1)

• Risk of humoral rejection if common HLA antigen between child and graft.

  Identification of common HLA antigen between child and graft by HLA typing

  Baseline

Study Arms (2)

Common HLA antigens with the lung donor

Children who have common HLA antigens with the lung donor of their mother

Diagnostic Test: HLA typing of the children

No common HLA antigens with the lung donor

Children without common HLA antigens with the lung donor of their mother.

Diagnostic Test: HLA typing of the children

Interventions

HLA typing of the children DIAGNOSTIC_TEST

The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.

Common HLA antigens with the lung donor; No common HLA antigens with the lung donor

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of female lung transplant patients, a rare pathology, and their children.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Institut de Recherche en Santé Respiratoire: collaborator

Study Sites (9)

Nantes University Hospital

Nantes, Loire Atlantique, 44093, France

Location

Bordeaux University Hospital

Bordeaux, 33000, France

Location

Grenoble University Hospital

Grenoble, 38700, France

Location

Marie Lannelongue Hospital (GHSJ)

Le Plessis-Robinson, 92350, France

Location

Civils Hospitals Lyon

Lyon, 69002, France

Location

AP-HM

Marseille, 13005, France

Location

Cochin Hospital (AP-HP)

Paris, 75014, France

Location

Strasbourg University Hospital

Strasbourg, 67200, France

Location

Foch Hospital

Suresnes, 92150, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva swab from the mother's child with a lung transplant.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 19, 2023
• Study Start: February 27, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: March 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)