Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)
Recruiting
Observational Study
Inflammatory Bowel Diseases
Pregnancy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 1,750 (estimated)
- Sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Other
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About This Trial
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, infe…
Trial Locations
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Eligibility 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.
Contacts