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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Other: treated by antiTNFα; Other: not treated by antiTNFα

Study type: Observational

Funder types: Other

Identifiers

NCT03134508

LUU AOI 2016

Details and patient eligibility

About

: 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.

Enrollment: 8,726 patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

8,726 participants in 2 patient groups

pregnant IBD women treated

Description:

pregnant IBD women treated by antiTNFα

Treatment:

Other: treated by antiTNFα

pregnant IBD women not treated

Description:

pregnant IBD women not treated by antiTNFα

Treatment:

Other: not treated by antiTNFα