Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689905
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2022-11-30
Brief Title:
Immunologic Risk of Pregnancy in Women With Lung Transplantion a National Multicentric Study
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Immunologic Risk of Pregnancy in Women With Lung Transplant
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIGGER-2
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None