Clinical trial NCT05610670: Access to Parenthood and Gynecological Follow-up After Organ Transplantation
Official title: Access to Parenthood and Gynecological Follow-up After Organ Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenthood Status
Transplant Lung
Transplant Kidney
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Solid organ transplants affect subjects of all ages, including young women of childbearing age. The improvement in the management of young female transplant patients makes it possible to consider pregnancies, about which the literature reports reassuring data on small series. The question of gynecological follow-up, access to parenthood, as well as the information and experience of patients regarding these issues after transplantation have thus become topical issues.

Detailed description: Nowadays, solid organ transplantation is a common procedure performed all over the world on patients of all ages. It represents about 900,000 procedures per year worldwide and a little over 6,100 in France (who.int). It has become indispensable for treating certain pathologies: for example, renal transplantation is the best alternative for treating end-stage renal failure, both from the point of view of effectiveness and medical benefit for the patient and from an economic standpoint. As the indications are increasingly broad, the Foch Hospital is the leading French center for lung transplantation mainly on patients with cystic fibrosis but recently transplanted a lung on a patient with end-stage respiratory failure due to Covid-19.

Patients who have undergone a solid organ transplantation require, after the procedure and more generally throughout their life, a global management by a multidisciplinary team in order to maintain a regular and adapted surveillance, in particular because of the immunosuppressive treatments, which are subject to numerous complications (benefit-risk balance between the rejection episodes and the infectious and carcinological risks).

Pregnancy adds an increased risk of morbidity for transplant patients of childbearing age. However, progress in terms of follow-up and post-transplant treatment increasingly allows them to be authorized. In the literature, there are already some reassuring series on the course of pregnancies after renal or pulmonary transplantation, but the studies are very often limited to strict obstetrical and neonatal criteria.

Moreover, the risk of cervical dysplasia is increased in transplant patients. While the HAS recommends "joint and close follow-up between the referring physician and the gynecologist", the gynecological follow-up of young women after solid organ transplantation does not meet any specific recommendation at present.

Finally, the question of parenthood has a major place in our societies. It is in this context that it seems interesting to us to look at the gynecological follow-up of transplant patients by integrating pregnancies and their outcomes, but also the patients' experiences with regard to their desire for parenthood.

Eligibility criteria: Inclusion Criteria:

* Women treated at the Foch Hospital for kidney/pulmonary transplantation or for kidney transplantation at the Bicêtre Hospital from 2010 to 2018 (lung) and 2019 (kidney)
* Having been transplanted before the age of 40
* Over 18 years of age
* Have signed a consent form
* Affiliated to a health insurance plan

Exclusion Criteria:

* Transplantectomy within 1 year (kidney) or 2 years (lung) of transplantation
* Be deprived of liberty or under guardianship
* Not speaking or understanding French

Primary outcomes:
measure: Pregnancy rate
timeFrame: 1 month after inclusion
Secondary outcomes:
measure: Gynecological evaluation post-transplant
timeFrame: 1 month after inclusion
measure: Satisfaction with information received regarding the risks of post-transplant pregnancy
timeFrame: 1 month after inclusion
measure: Patients' experience
timeFrame: 1 month after inclusion
measure: Conception time
timeFrame: 1 month after inclusion
measure: use of MPA
timeFrame: 1 month after inclusion
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References: