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

NCT03894228 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1750

Last updated 2020-02-21

No results posted yet for this study

Summary

This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.

In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.

Conditions

  • Inflammatory Bowel Diseases
  • Pregnancy

Sponsors & Collaborators

  • Spanish Agency of Medicines and Health Products

    collaborator OTHER_GOV

  • Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2024-03-01
Completion
2028-03-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894228 on ClinicalTrials.gov