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Completed

NCT Number: NCT03134508

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

: 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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chu de Dijon

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treated by antiTNFα

Other

pregnant IBD women treated by antiTNFα

not treated by antiTNFα

Other

pregnant IBD women not treated by antiTNFα

Primary outcomes

  1. Overall complications

    Time frame: 9 months

    composite criteria composed by:

    • Disease related complications
    • Treatment related complications
    • Pregnancy related complications

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: EVASION

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 1, 2017
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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