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临床试验/NCT07592806
NCT07592806尚未招募不适用

CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation

Hopital Foch0 个研究点目标入组 2,000 人开始时间: 2026年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Hopital Foch
入组人数
2,000

研究概览

简要总结

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.

详细描述

According to North American and Australian registries, pregnancy is both a joyful and high-risk event for women who have received a solid organ transplant. Typically, a transplanted woman has a probability comparable to that of the general population of giving birth to a live infant, but she is likely to deliver prematurely (median gestational age: 32 weeks), to have a growth-restricted baby (median birth weight around 2.3 kg), and often in a context of preeclampsia (in at least 30% of cases)(1).

Today, these are the data shared with patients planning a pregnancy, despite uncertainty as to their accuracy and applicability in France or even Europe.

Among the unknowns that remain despite these registry data, the following should be noted:

Uncertainty about the level of pregnancy planning in this specific context: What proportion of women of childbearing age have been informed of the possibility of becoming pregnant, of the associated risks, and of necessary precautions (e.g., stopping mycophenolate mofetil at least 6 weeks before conception);

Variability in the information provided from one center to another, due to the absence of a national, consensus-based document addressing fertility and contraception in the post-transplantation setting;

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Patient deprived of liberty or under legal guardianship
  • Patient refuses to participate in the study

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

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