Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Drusgs for IBD

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Javier P Gisbert, PhD, MD; Phone Number: 913093911; Email: javier.p.gisbert@gmail.com
• Study Contact Backup: Name: María G Donday, PhD; Phone Number: 913093911; Email: mariagdonday@gmail.com

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28006
      • Recruiting
      • Hospital Universitario de la Princesa
      • Contact: María G Donday, PhD; Phone Number: 913093911; Email: mariagdonday@gmail.com
      • Contact: Javier P. Gisbert, PhD, MD; Phone Number: 913093911; Email: javier.p.gisbert@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD.		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.	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.		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.	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	4 years

Collaborators and Investigators

• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): May 20, 2030
• Study Completion (Estimated): May 20, 2030

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GIS-DUMBO 2-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No