Safety of IBD medications during pregnancy and breastfeeding
Official title: Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)
Run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · NCT06337565 · Data updated 2026-11-12
This study looks at how safe certain IBD medications are for pregnant women and new mothers who are breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Drugs / interventions | vedolizumab, tofacitinib |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | May 20, 2024 |
| Main results expected | May 20, 2030 |
| Study ends | May 20, 2030 |
| Registry record updated | September 25, 2025 |
| Trial ID | NCT06337565 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women over 18 years old diagnosed with IBD who are being treated with non-anti-TNF biologics or advanced therapies.
✕Probably not a fit
Patients who do not accept to participate in the study will not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on pregnant women who are being treated with non-anti-TNF agents or targeted small molecules for inflammatory bowel disease (IBD). It aims to gather data on the safety of these medications during pregnancy and breastfeeding, as this population is often excluded from clinical trials. The study will include patients from over 60 centers across Spain, although the expected number of participants is relatively low. All eligible patients who consent will be enrolled without a predetermined sample size.
Why it matters
Potential benefit: If successful, this study could provide crucial safety data that informs treatment decisions for pregnant women with IBD.
How similar studies have gone: While this study addresses a critical gap in knowledge, similar observational studies have shown success in gathering safety data for medications in special populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Universitario de La Princesa
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Javier P Gisbert, PhD, MD
- Email: javier.p.gisbert@gmail.com
- Phone: 913093911
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.