Access to Parenthood and Gynecological Follow-up After Organ Transplantation

NCT05610670 | Completed

• 1 other identifier: 2020_0181
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenthood Status; Transplant Lung; Transplant Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Gynecological evaluation post-transplant

  1 month after inclusion

• Satisfaction with information received regarding the risks of post-transplant pregnancy

  1 month after inclusion

• Patients' experience

  1 month after inclusion

• Conception time

  1 month after inclusion

• use of MPA

  1 month after inclusion

Study Arms (1)

Patients who underwent a kidney/pulmonary transplant before the age of 40

OTHER

The questionnaire will allow us to complete the information not obtained from the patients' files on the one hand, 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.

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Patients who underwent a kidney/pulmonary transplant before the age of 40

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 9, 2022
• Study Start: October 10, 2022
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)