Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,726
- 试验地点
- 1
- 主要终点
- Overall complications
研究概览
简要总结
: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnancy between 01/01/2011 and 31/12/2014
- •Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)
排除标准
- •Non IBD indication of antiTNFα treatment
研究组 & 干预措施
pregnant IBD women treated
pregnant IBD women treated by antiTNFα
干预措施: treated by antiTNFα (Other)
pregnant IBD women not treated
pregnant IBD women not treated by antiTNFα
干预措施: not treated by antiTNFα (Other)
结局指标
主要结局
Overall complications
时间窗: 9 months
composite criteria composed by: * Disease related complications * Treatment related complications * Pregnancy related complications
次要结局
- Infectious Complications in the children born from IBD mothers(The first year of life)