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NCT06337565
Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes
trial in Drusgs for IBD in 1,000 participants. Currently enrolling.
20 May 2030
Quick facts
| Lead sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 20 May 2024 |
| Primary completion | 20 May 2030 |
| Estimated completion | 20 May 2030 |
| Sites | 1 location across Spain |
Conditions studied
- Drusgs for IBD — all drugs for Drusgs for IBD →
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Who can join
Adults 18 to 70, female only, with Drusgs for IBD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06337565
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06337565 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Last refreshed: 25 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06337565.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing