Access to Parenthood and Gynecological Follow-up After Organ Transplantation

Parenthood Status Clinical Trial

— FerGyTransplan  

Official title:

Access to Parenthood and Gynecological Follow-up After Organ Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610670
• Other study ID #: 2020_0181
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: November 10, 2024

Study information

• Verified date: June 2024
• Source: Hopital Foch
• Contact: Marie Carbonnel, MD
• Phone: 0146254853
• Email: m.carbonnel[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 10, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parenthood Status

Intervention

Other:
• Questionnaire
The questionnaire will allow us to complete the information and to collect their experiences regarding the desire and/or achievement of a pregnancy, but also their gynecological follow-up in the broad sense, on the other hand.

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Pregnancy rate (defined as the number of confirmed pregnancies (positive urine or plasma pregnancy test) out of the number of patients with a pregnancy desire) and obstetrical outcomes in renal/pulmonary transplant patients with a pregnancy desire	1 month after inclusion
Secondary	Gynecological evaluation post-transplant	Frequency of gynecological follow-up, date of return of cycles, evaluation of contraception and occurrence of post-transplant cervical dysplasia	1 month after inclusion
Secondary	Satisfaction with information received regarding the risks of post-transplant pregnancy	Satisfaction with information received regarding the risks of post-transplant pregnancy prior to transplantation on a scale of 1 to 5 (1 : not good at all - 5 : very good)	1 month after inclusion
Secondary	Patients' experience	patients' experience of their parental project and the support of the medical team in the event of difficulties in accessing parenthood (scale from 1 to 5, 1 : not good at all - 5 : very good).	1 month after inclusion
Secondary	Conception time	Conception time	1 month after inclusion
Secondary	use of MPA	number of participants who used of MPA	1 month after inclusion