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

Pregnancy Clinical Trial

— TRIGGER-2  

Official title:

Immunologic Risk of Pregnancy in Women With Lung Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689905
• Other study ID #: RC22_0581
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Nantes University Hospital
• Contact: Isabelle DANNER-BOUCHER
• Phone: +33 2 40 16 52 67
• Email: Isabelle.danner[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Rejection
• Lung Transplantation
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
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	Nantes University Hospital	Nantes	Loire Atlantique
France	Cochin Hospital (AP-HP)	Paris
France	Strasbourg University Hospital	Strasbourg
France	Foch Hospital	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Institut de Recherche en Santé Respiratoire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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