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

NCT06337565 | Recruiting

• 1 other identifier: GIS-DUMBO 2-2024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 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.

  4 years

• To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life.

  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.

  4 years

• To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD.

  4 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: \- Confirmed pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Patients who do not accept to participate in the study

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Central Study Contacts

Javier P Gisbert, PhD, MD

CONTACT

913093911; javier.p.gisbert@gmail.com

María G Donday, PhD

CONTACT

913093911; mariagdonday@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, gastroenterologist

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): May 20, 2030
• Study Completion (Estimated): May 20, 2030
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

ES (1)