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
1,750 participants
May 21, 2019
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria1
- Patients who do not accept to participate in the study.
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Locations(73)
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NCT03894228