protocolSection identificationModule nctId: NCT06337565, orgStudyIdInfo id: GIS-DUMBO 2-2024, briefTitle: Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2030-05-20, completionDateStruct date: 2030-05-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Drusgs for IBD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: To assess the safety of new drugs (non-anti-TNF biologics and targeted small molecules) used for IBD treatment both for pregnancy and in offspring, mainly focused on the risk of serious infections (from birth and in the first 4 years of life)., secondaryOutcomes measure: To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD., secondaryOutcomes measure: To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life., secondaryOutcomes measure: To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different new drugs to treat IBD with that of children who were not exposed to these agents., secondaryOutcomes measure: To compare the prevalence of malformations in children exposed to new drugs to treat IBD in utero with that of children who were not exposed to these agents., secondaryOutcomes measure: To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de La Princesa, city: Madrid, zip: 28006, country: Spain, contacts name: Javier P. Gisbert, PhD, MD, role: CONTACT, phone: 913093911, email: javier.p.gisbert@gmail.com, contacts name: María G Donday, PhD, role: CONTACT, phone: 913093911, email: mariagdonday@gmail.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False