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

Condition(s) studied

Study 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

Primary outcome measure(s)

• To calculate the incide rate of serious infections during pregnancy (evaluated and the end of pregnancy) based on the medications used to treat IBD. — 9 months
  To assess the prevalence of complications related to drugs used for IBD treatment for pregnancy.
• To calculate the incide rate of serious infections for the offspring (at eh age of 4 years) based on the medications used to treat IBD. — 4 years
  To assess the prevalence of complications related to drugs used for IBD treatment for the offspring.
• To calculate the incide rate of serious adverse events during pregnancy (evaluated at the end of pregnancy) based on the medications used to treat IBD. — 9 months
  To asses the prevalence of complications related to drugs used for IBD treatment for pregnancy.
• To calculate the incide rate of serious adverse events during offspring (at the age of 4 years) based on the medications used to treat IBD. — 4 years
  To asses the prevalence of complications related to drugs used for IBD treatment for offspring mainly focused on the risck of serious infections at the age of 4 years.

Trial sites (73)

+ 33 more sites — see the full list on the official registry below.

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