Clinical Trial

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

Recruiting
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Record status
This record was last updated February 21, 2020 (before its estimated March 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain. In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2019-03-27.
Status change: Not Yet Recruiting → Recruiting 2020-02-19
Trial Details
NCT Number NCT03894228
Lead Sponsor Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Collaborators: Spanish Agency of Medicines and Health Products
Conditions Inflammatory Bowel Diseases, Pregnancy
Enrollment 1,750 participants
Start Date 2019-05-21
Primary Completion 2024-03-01 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2020-02-21