Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases
- Conditions
- Inflammatory Bowel Diseases
- Registration Number
- NCT03134508
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8726
- pregnancy between 01/01/2011 and 31/12/2014
- Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)
- Non IBD indication of antiTNFα treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall complications 9 months composite criteria composed by:
* Disease related complications
* Treatment related complications
* Pregnancy related complications
- Secondary Outcome Measures
Name Time Method Infectious Complications in the children born from IBD mothers The first year of life Occurrence of infectious complications during the first year of life
Trial Locations
- Locations (1)
Chu de Dijon
🇫🇷Dijon, France
Chu de Dijon🇫🇷Dijon, France