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

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: treated by antiTNFα; Other: not treated by antiTNFα

• Registration Number: NCT03134508
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-03
• Status Verified: 2017-04
• Study Completion: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8726

Inclusion Criteria

• pregnancy between 01/01/2011 and 31/12/2014
• Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)

Exclusion Criteria

• Non IBD indication of antiTNFα treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant IBD women treated	treated by antiTNFα	pregnant IBD women treated by antiTNFα
pregnant IBD women not treated	not treated by antiTNFα	pregnant IBD women not treated by antiTNFα

Primary Outcome Measures

Name	Time	Method
Overall complications	9 months	composite criteria composed by: * Disease related complications; * Treatment related complications; * Pregnancy related complications

Secondary Outcome Measures

Name	Time	Method
Infectious Complications in the children born from IBD mothers	The first year of life	Occurrence of infectious complications during the first year of life

Trial Locations

Locations (1)

Chu de Dijon; 🇫🇷 Dijon, France