San Fernando De Henares

Researchers are evaluating the safety of medications used to treat inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, in pregnant women and their children. This observational registry study in Spain will follow pregnant women with IBD over five years and track their children for four years to assess the risk of serious infections, developmental issues, and other serious adverse events. The study aims to clarify the impact of these medications on pregnancy outcomes and child health, especially focusing on serious infections in children, a topic with previously conflicting results. Pregnant women with IBD will be enrolled before the 28th week of gestation and grouped based on their exposure to biologic drugs, immunomodulators, or neither during pregnancy and the three months before conception. Researchers will collect detailed information at multiple points during pregnancy and up to four years after birth. Mothers will be contacted regularly to update data on disease activity, treatment, and any serious adverse events. Children will undergo developmental assessments using questionnaires completed by their mothers at specified intervals throughout the follow-up period. Participants will have scheduled visits at baseline, each trimester, one month after delivery, and quarterly during the child's first four years. Data collected include clinical status of the mother, pregnancy complications, birth details, child development, vaccinations, infections, hospitalizations, and serious adverse events. The study will monitor outcomes such as serious infections and adverse events in both mothers and children, with data securely managed using a web-based electronic system. This long-term follow-up aims to provide comprehensive safety information on IBD treatments during pregnancy and breastfeeding.