Drusgs for IBDNCT06337565
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes
An observational study of Drusgs for IBD, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Drusgs for IBD
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2024to 20 May 2030
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- Patients who do not accept to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Javier P. Gisbert, PhD, MD, 913093911, javier.p.gisbert@gmail.com
María G Donday, PhD, 913093911, mariagdonday@gmail.com
About this study
Official title: Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)
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.
- Conditions
- Drusgs for IBD
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (5)
To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start20 May 2024
- Primary completion20 May 2030 (estimated)
- Study completion20 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drusgs for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Chaparro Sánchez, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337565
- Sponsor's protocol ID
- GIS-DUMBO 2-2024
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)
- ClinicalTrials.gov ID
- NCT06337565
- Acronym / sponsor ID
- GIS-DUMBO 2-2024
- Conditions
- Drusgs for IBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 May 2030 (estimated)
- Study completion
- 20 May 2030 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who do not accept to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 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
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 evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drusgs for IBD, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier P Gisbert, PhD, MD (913093911, javier.p.gisbert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.