NCT06337565

Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes

Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

• Drusgs for IBD

Timeline

• Start date: 2024-05-20
• Primary completion: 2030-05-20
• Completion: 2030-05-20
• First posted: 2024-03-29
• Last updated: 2025-09-25

Locations

1 site across 1 country: Spain