Informations générales (source: ClinicalTrials.gov)
Immunologic Risk of Pregnancy in Women With Lung Transplant (TRIGGER-2)
Observational
Nantes University Hospital (Voir sur ClinicalTrials)
février 2024
mars 2025
26 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Pierre-régis BURGEL, PU-PH | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Olivier BRUGIERE, PU-PH | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - 13005 - Marseille - France | Martine-Louise REYNAUD, PU-PH | Contact (sur clinicalTrials) | |||
| Bordeaux University Hospital - 33000 - Bordeaux - France | Julie MACEY, PH | Contact (sur clinicalTrials) | |||
| Civils Hospitals Lyon - 69002 - Lyon - France | Claire MERVEILLEUX DU VIGNAUX, PH | Contact (sur clinicalTrials) | |||
| Grenoble University Hospital - 38700 - Grenoble - France | Christel SAINT-RAYMOND, PH | Contact (sur clinicalTrials) | |||
| Marie Lannelongue Hospital (GHSJ) - 92350 - Le Plessis-Robinson - France | Jérôme LE PAVEC, PH | Contact (sur clinicalTrials) | |||
| Nantes University Hospital - 44093 - Nantes - Loire Atlantique - France | Isabelle DANNER-BOUCHER | Contact (sur clinicalTrials) | |||
| Strasbourg University Hospital - 67200 - Strasbourg - France | Romain KESSLER, PU-PH | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- Refusal of consent by the patient and/or one of the two parents