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

Recruitingn/aAges 18 Years - anyFemaleGrupo Espanol de Trabajo en Enfermedad de Crohn y…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

73 sites
Complejo Hospitalario Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Clínico Universitario San Cecilio
Granada, Spain
Hospital Infanta Elena
Huelva, Spain
Hospital Universitario Juan Ramón Jimenez
Huelva, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital San Juan de Dios del Aljarafe
Seville, Spain

…and 65 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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