Safety of IBD medications during pregnancy and breastfeeding
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · NCT06337565
This study looks at how safe certain IBD medications are for pregnant women and new mothers who are breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (other) |
| Drugs / interventions | vedolizumab, tofacitinib |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06337565 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not accept to participate in the study will not benefit from the findings.
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 performed: While this study addresses a critical gap in knowledge, similar observational studies have shown success in gathering safety data for medications in special populations.
Eligibility criteria
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 this trial is running
Madrid, Madrid
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Drusgs for IBD