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

Last updated: July 24, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Organ Transplant

Transplant Rejection

Treatment

HLA typing of the children

Clinical Study ID

NCT05689905
RC22_0581
  • Ages > 1
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Children born between 01/01/2012 and 31/12/2021 of female patients over 18 years oldwith 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 thisswab

  • Affiliated or beneficiaries of a social security system or similar

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: HLA typing of the children
Phase:
Study Start date:
February 27, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Nantes University Hospital

    Nantes, Loire Atlantique 44093
    France

    Active - Recruiting

  • Bordeaux University Hospital

    Bordeaux, 33000
    France

    Active - Recruiting

  • Grenoble University Hospital

    Grenoble, 38700
    France

    Active - Recruiting

  • Marie Lannelongue Hospital (GHSJ)

    Le Plessis-Robinson, 92350
    France

    Active - Recruiting

  • Civils Hospitals Lyon

    Lyon, 69002
    France

    Active - Recruiting

  • AP-HM

    Marseille, 13005
    France

    Active - Recruiting

  • Cochin Hospital (AP-HP)

    Paris, 75014
    France

    Active - Recruiting

  • Strasbourg University Hospital

    Strasbourg, 67200
    France

    Active - Recruiting

  • Foch Hospital

    Suresnes, 92150
    France

    Active - Recruiting

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