Clinical trial NCT05689905: Immunologic Risk of Pregnancy in Women With Lung Transplantion : a National Multicentric Study
Official title: Immunologic Risk of Pregnancy in Women With Lung Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplantation
Graft Rejection
Pregnancy
Keywords: Lung Transplantations
Pregnancy
Transplant Rejection
Transplantation Immunology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé Respiratoire
First posted: 2023-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of female lung transplant patients, a rare pathology, and their children.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Risk of humoral rejection if common HLA antigen between child and graft.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire Atlantique
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue Hospital (GHSJ)
city: Lyon
country: France
facility: Civils Hospitals Lyon
city: Marseille
country: France
facility: AP-HM
city: Paris
country: France
facility: Cochin Hospital (AP-HP)
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
References: