NCT03894228 Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)
| NCT ID | NCT03894228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,750 participants |
| Start Date | 2019-05-21 |
| Primary Completion | 2024-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,750 participants in total. It began in 2019-05-21 with a primary completion date of 2024-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03894228 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03894228 currently recruiting?
Yes, NCT03894228 is actively recruiting participants. Contact the research team at mariachs2005@gmail.com for enrollment information.
Where is the NCT03894228 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Córdoba, Spain, Granada, Spain, Huelva, Spain and 11 additional locations.
Who is sponsoring the NCT03894228 clinical trial?
NCT03894228 is sponsored by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa. The trial plans to enroll 1,750 participants.