NCT06337565|Recruiting
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Sponsor study identifier
observational
1,000
1 country
1
Study Start
May 20, 2024
Actual (reported)Primary Completion
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2024
Actual (reported)March 29, 2024
Actual (reported)May 20, 2024
Actual (reported)May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
4 years
To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life.
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.
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.
4 years
To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD.
4 years
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.
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
First Submitted
March 15, 2024
First Posted
March 29, 2024
Study Start
May 20, 2024
Actual (reported)Primary Completion
May 20, 2030
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 25, 2025
Record last verified: 2025-09
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