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Safety of IBD medications during pregnancy and breastfeeding

Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · NCT03894228

This study looks at how safe IBD medications are for pregnant women and their babies by comparing outcomes for children whose mothers took these drugs during pregnancy to those who didn’t.

Quick facts

Study typeObservational
Enrollment1750 (estimated)
Ages18 Years and up
SexFemale
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (other)
Locations73 sites (Santiago de Compostela, A Coruña and 72 other locations)
Trial IDNCT03894228 on ClinicalTrials.gov

What this trial studies

This observational registry will enroll pregnant women diagnosed with inflammatory bowel diseases (IBD) in Spain over a five-year period. The study aims to follow these women throughout their pregnancies and monitor their children for four years to assess the incidence of serious adverse events, particularly focusing on serious infections. The research will compare outcomes between children exposed to IBD medications in utero and those who were not, evaluating risks such as developmental issues and malformations. The main goal is to clarify the safety of IBD treatments during pregnancy for both mothers and their offspring.

Who should consider this trial

Good fit: Ideal candidates are pregnant women over 18 years of age diagnosed with inflammatory bowel diseases.

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 critical insights into the safety of IBD medications during pregnancy, potentially guiding treatment decisions for expectant mothers.

How similar studies have performed: While there have been studies on the safety of medications during pregnancy, this specific registry approach focusing on IBD is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients over 18 years of age diagnosed with IBD.
* Confirmed pregnancy.
* Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).

Exclusion Criteria:

• Patients who do not accept to participate in the study.

Where this trial is running

Santiago de Compostela, A Coruña and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Inflammatory Bowel Diseases, Pregnancy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.