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.
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).
None
Pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.
Other
Prospective
Not listed
To calculate the incide rate of serious infections during pregnancy (evaluated and the end of pregnancy) based on the medications used to treat IBD.
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.
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.
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.
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.
2. To calculate the Odds ratio of serious adverse events (including abortions) during pregnancy and delivery based on the drugs used for the treatment of IBD.
To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with drugs used for the treatment of IBD.
3. To measure the developmental status of children born from IBD mothers with the ASQ-3 questionnaire during the first 4 years.
To asses the developmental status of children born from IBD mothers during the first 4 years.
4. To calculate the Hazard ratio of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different drugs to treat IBD with the risk in children who were not exposed.
5. To calculate the proportion of children with malformations and to compare the proportions between exposure groups (children exposed to biologics with those non exposed to these drugs).
To compare the prevalence of malformations in children exposed to biologics to treat IBD in utero with the prevalence in children who were not exposed
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Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Lead sponsor
Spanish Agency of Medicines and Health Products
Collaborator
