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临床试验/NCT07377188
NCT07377188招募中不适用

Pregnancy and Inflammatory Bowel Disease

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 945 人开始时间: 2020年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
945
试验地点
1
主要终点
number of IBD flare during pregnancy

研究概览

简要总结

Inflammatory Bowel disease, including Crohn's disease and Ulcerative Colitis, are chronic diseases.

Diagnosis is most often done in women of childbearing age. IBD can have and increase the risk of intrauterine growth retardation, preterm birth… Conversely, pregnancy can have an impact on IBD activity during pregnancy. Moreover, IBD course can be influence in post-partum. The investigators will explore IBD course on 945 patients from the EPIMAD register. The investigators will cross the data on the IBD with data on pregnancy, postpartum but also breastfeeding. The principal aim of this study is to assess the number of flares during pregnancy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women between 18 and 50 years old
  • MICI diagnosed between 1988 and 2018
  • included in EPIMAD registry
  • living in Somme
  • having had at least one pregnancy

排除标准

  • women who has not had pregnancy
  • not included in EPIMAD register

研究组 & 干预措施

IBD and pregnancy

Population-based cohort of patients suffering from IBD and with at least one pregnancy.

结局指标

主要结局

number of IBD flare during pregnancy

时间窗: 2 years

次要结局

  • Number of flare during post-partum period(2 years)
  • Number of pregnancy(2 years)
  • number of children(2 years)
  • Number of Intestinal resection(2 years)
  • Number of hospitalization(2 years)
  • Number of miscarriage(2 years)
  • Number of ectopic pregnancy(2 years)
  • Time before conception(2 years)
  • Number of women with exposition to corticosteroid(2 years)
  • Exposition to biotherapy(2 years)
  • Number and indication of cesarean section(2 years)
  • Number of anoperineal lesions after the birth(2 years)
  • Wexner score for continence(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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