Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases
EVASION
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
1 other identifier
observational
8,726
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedMarch 12, 2026
March 1, 2026
Same day
April 26, 2017
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall complications
composite criteria composed by: * Disease related complications * Treatment related complications * Pregnancy related complications
9 months
Secondary Outcomes (1)
Infectious Complications in the children born from IBD mothers
The first year of life
Study Arms (2)
pregnant IBD women treated
pregnant IBD women treated by antiTNFα
pregnant IBD women not treated
pregnant IBD women not treated by antiTNFα
Interventions
pregnant IBD women not treated by antiTNFα
Eligibility Criteria
All pregnant women with a diagnosis of IBD
You may qualify if:
- pregnancy between 01/01/2011 and 31/12/2014
- Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)
You may not qualify if:
- Non IBD indication of antiTNFα treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu de Dijon
Dijon, France
Related Publications (1)
Luu M, Benzenine E, Doret M, Michiels C, Barkun A, Degand T, Quantin C, Bardou M. Continuous Anti-TNFalpha Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus. A Retrospective Cohort on the French National Health Insurance Database (EVASION). Am J Gastroenterol. 2018 Nov;113(11):1669-1677. doi: 10.1038/s41395-018-0176-7. Epub 2018 Jul 2.
PMID: 29961771RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 1, 2017
Study Start
March 1, 2016
Primary Completion
March 1, 2016
Study Completion
April 1, 2017
Last Updated
March 12, 2026
Record last verified: 2026-03