Hospital Universitario de La Princesa
Madrid, 28006, Spain
Location status: Recruiting
Location contact
Javier P. Gisbert, PhD, MD
CONTACT
María G Donday, PhD
CONTACT
Recruiting
NCT Number: NCT06337565
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients over 18 years of age diagnosed with IBD.
- Confirmed pregnancy.
- - Treatment with non-anti-TNF biologics or other advanced therapies (i.e JAK inhibitors, S1P receptor modulators and molecules approved in the forthcoming years).
Exclusion criteria
- Patients who do not accept to participate in the study
Treatment and study plan
Primary outcomes
-
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).
Time frame: 4 years
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.
Secondary outcomes
-
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.
Time frame: 4 years
The clinicians will complete the ASQ-3 escale. To assess children developmental status.
-
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.
Time frame: 4 years
To calculate the proportion of children with congenital malformations (based on the definition of the Wordld Health Organization) based on the mothers´treatment.
-
To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD.
Time frame: 4 years
To calculate the proportion of children with neoplasm based on the mothers´ treatment
Study contacts
Contact information is provided by the study sponsor or research team.
Javier P Gisbert, PhD, MD
CONTACT
María G Donday, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Other
Registry information
Official study title
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)
Important dates
- Study start
- 2024
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Mar 29, 2024
- Registry last updated
- Sep 25, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.