An observational study in Drusgs for IBD, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Observational
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.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
The measure is, number of participants with serious adverse events (all patients included should be treated with the IBD drug). And compare number of mothers with serious adverse event with differents treatments groups.
Time frame: 4 years
To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD.
Time frame: 4 years
To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life.
The clinicians will complete the ASQ-3 escale. To assess children developmental status.
Time frame: 4 years
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.
Time frame: 4 years
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.
To calculate the proportion of children with congenital malformations (based on the definition of the Wordld Health Organization) based on the mothers´treatment.
Time frame: 4 years
To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD.
To calculate the proportion of children with neoplasm based on the mothers´ treatment
Time frame: 4 years
Plan to share: Undecided
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa