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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03134508
Acronym
EVASION
Enrollment
8726
Registered
2017-05-01
Start date
2016-03-01
Completion date
2017-04-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

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.

Interventions

OTHERtreated by antiTNFα

pregnant IBD women treated by antiTNFα

OTHERnot treated by antiTNFα

pregnant IBD women not treated by antiTNFα

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall complications9 monthscomposite criteria composed by: * Disease related complications * Treatment related complications * Pregnancy related complications

Secondary

MeasureTime frameDescription
Infectious Complications in the children born from IBD mothersThe first year of lifeOccurrence of infectious complications during the first year of life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026