Actively Recruiting
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes
Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2025-09-25
1000
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment.
CONDITIONS
Official Title
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age diagnosed with IBD
- Confirmed pregnancy
- Treatment with non-anti-TNF biologics or other advanced therapies such as JAK inhibitors and S1P receptor modulators
You will not qualify if you...
- Patients who do not accept to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario de La Princesa
Madrid, Madrid, Spain, 28006
Actively Recruiting
Research Team
J
Javier P Gisbert, PhD, MD
CONTACT
M
María G Donday, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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