NCT03134508

Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,726 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

: 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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	treated by antiTNFα	pregnant IBD women treated by antiTNFα
OTHER	not treated by antiTNFα	pregnant IBD women not treated by antiTNFα

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-03-01
• Completion: 2017-04-01
• First posted: 2017-05-01
• Last updated: 2026-03-12

Locations

1 site across 1 country: France