CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation (NCT07592806) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation
2,000 participantsStarted 2026-09-01
Plain-language summary
The objective of this research is to obtain standardized and independent data on the number of pregnancies occurring in France and their follow-up up to 1 year postpartum (or post-pregnancy termination). This study will then aim to describe the clinical characteristics and maternal and perinatal outcomes of pregnancies in this specific population. These data will enable the dissemination of clear and up-to-date information to the medical community, thus contributing to better patient counseling and, more broadly, to couples. They will also serve to issue recommendations to optimize the planning and follow-up of pregnancies in women with solid organ transplants. Finally, this initiative aims to promote clinical research on pregnancies.
Who can participate
Age range
18 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patient aged 18 years or older and of childbearing age
* Has received a solid organ transplant, either isolated or combined (heart, liver, lung, pancreas, kidney)
* Has a positive blood beta-hCG test result \> 5 IU/L ("positive")
* Has signed an informed consent form
* Affiliated with a health insurance plan
Exclusion Criteria:
* Patient deprived of liberty or under legal guardianship
* Patient refuses to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome is the annual incidence of conception in the population of women with solid organ transplants (i.e., included in the study).