QuestionIs mesalamine safe for treating inflammatory bowel disease (IBD) in pregnant women?
DesignCohort analytic study.
SettingA teratogen information service at a children's hospital in Toronto, Canada.
Participants165 pregnant women (median age 31 y) who contacted a teratogen information service for information about exposure to mesalamine. 165 women (median age 31 y) who received counselling for exposure during pregnancy to drugs that were not teratogenic were selected as controls from the information service's database. Control participants were matched for history of smoking and alcohol consumption.
Assessment of risk factorsTelephone and clinic interviews were used to record maternal demographics, clinical histories, details of mesalamine exposure, and concurrent drug exposures.
Main outcome measuresOutcome data were collected using telephone interviews; physicians were asked, with the mothers' consent, to confirm the medical details. The primary outcome was the incidence of major malformations (structural abnormalities that have serious consequences). Secondary outcomes were pregnancy outcome, maternal weight gain, gestational age at delivery, birth weight, method of delivery, induction of labour, use of forceps, neonatal health problems, and minor malformations.