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

Inflammatory Bowel Diseases Clinical Trial

— EVASION  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134508
• Other study ID #: LUU AOI 2016
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: April 28, 2017
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8726
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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 antiTNFa treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• treated by antiTNFa
pregnant IBD women treated by antiTNFa
• not treated by antiTNFa
pregnant IBD women not treated by antiTNFa

Locations

Country	Name	City	State
France	Chu de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall complications	composite criteria composed by: Disease related complications; Treatment related complications; Pregnancy related complications	9 months
Secondary	Infectious Complications in the children born from IBD mothers	Occurrence of infectious complications during the first year of life	The first year of life