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

March 10, 2026 updated by: Centre Hospitalier Universitaire Dijon

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

: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8726

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All pregnant women with a diagnosis of IBD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant IBD women treated
pregnant IBD women treated by antiTNFα
Other: treated by antiTNFα
pregnant IBD women treated by antiTNFα
pregnant IBD women not treated
pregnant IBD women not treated by antiTNFα
Other: not treated by antiTNFα
pregnant IBD women not treated by antiTNFα

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complications
Time Frame: 9 months

composite criteria composed by:

  • Disease related complications
  • Treatment related complications
  • Pregnancy related complications
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious Complications in the children born from IBD mothers
Time Frame: The first year of life
Occurrence of infectious complications during the first year of life
The first year of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUU AOI 2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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