Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study (TRIGGER-2)

Immunologic Risk of Pregnancy in Women With Lung Transplant

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Graft Rejection; Lung Transplantation
• Intervention / Treatment: Diagnostic test: HLA typing of the children

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Bordeaux University Hospital
  • Grenoble, France, 38700
    • Grenoble University Hospital
  • Le Plessis-Robinson, France, 92350
    • Marie Lannelongue Hospital (GHSJ)
  • Lyon, France, 69002
    • Civils Hospitals Lyon
  • Marseille, France, 13005
    • AP-HM
  • Paris, France, 75014
    • Cochin Hospital (AP-HP)
  • Strasbourg, France, 67200
    • Strasbourg University Hospital
  • Suresnes, France, 92150
    • Foch Hospital
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.
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; The HLA typing is made on a mouth swab of the children, that is a painless non-invasive procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Institut de Recherche en Santé Respiratoire

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Transplantation Immunology; Transplant Rejection; Lung Transplantations
• Other Study ID Numbers: RC22_0581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No