Observing the Safety of Inflammatory Bowel Disease Treatments During Pregnancy and Their Effects on Mothers and Children up to 4 Years

What this Trial Is About

This research aims to understand the safety of drugs used to treat inflammatory bowel diseases IBD during pregnancy and breastfeeding, focusing on outcomes for both mothers and their children. The study is observational and will follow pregnant women diagnosed with IBD Crohns disease, ulcerative colitis, or unclassified IBD over five years in Spain. It will also track the health and development of their children for up to four years, particularly looking at serious infections and other serious adverse events. Participants are grouped based on their exposure to IBD medications during pregnancy or shortly before conception those treated with biologic drugs, those treated with immunomodulators, and those not exposed to these drugs. Data will be collected at multiple points during pregnancy and after birth, including disease activity and serious adverse events for the mother, and development, infections, and other health events for the children. The study uses questionnaires and regular follow-ups every three months for children until age four. During the study, mothers will provide information through in-person visits and remote contacts, including completing developmental questionnaires for their children yearly. Researchers will gather detailed clinical data at baseline and during each trimester, delivery, and postpartum. The main outcomes measured include rates of serious infections and adverse events during pregnancy and in children up to four years old. The study also assesses developmental status and the risk of malformations or neoplasms in children related to exposure to IBD drugs.

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