Bupropion (Smoking cessation indication)

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Bérard (Controls exposed to nicotine patch), 2016	retrospective cohort (claims database)	The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration). To collect data on nicotine patch replacement therapy purchased over the counter, a random sample of 8505 women taken within the QPC were asked to fill annually a standardized questionnaire.	The medical service database (Régie de l’Assurance Maladie du Québec: diagnoses, medical procedures, socioeconomic status of women, and prescribers), the hospitalization archive database (MedEcho: diagnoses and procedures), and the Quebec Statistics database (patient sociodemographic, birthweight).	Adjusted for maternal age, work status, place of living, education level, annual family income, welfare status, maternal hypertension, diabetes, asthma, depression, and health services utilization before pregnancy.
Bérard (Controls unexposed, sick), 2016	retrospective cohort (claims database)	The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration). To collect data on nicotine patch replacement therapy purchased over the counter, a random sample of 8505 women taken within the QPC were asked to fill annually a standardized questionnaire.	The medical service database (Régie de l’Assurance Maladie du Québec: diagnoses, medical procedures, socioeconomic status of women, and prescribers), the hospitalization archive database (MedEcho: diagnoses and procedures), and the Quebec Statistics database (patient sociodemographic, birthweight).	Adjusted for maternal age, work status, place of living, education level, annual family income, welfare status, maternal hypertension, diabetes, asthma, depression, and health services utilization before pregnancy.
Kranzler, 2021	randomized controlled trial	Participants randomly assigned them to receive 10 weeks of treatment with bupropion or placebo, under double-blind conditions. To promote medication adherence, a personalized text-messaging system was used and designed to be highly relevant to pregnant women.	Birth outcomes were obtained from medical records.	No adjustment. Randomisation.
Nanovskaya, 2017	randomized controlled trial	Participants received bupropion or placebo. To confirm use of medication, participants keep a daily diary of the number of pills taken. Subjects then returned the study drug bottles to the research nurse who performed pill counts. Compliance to study medication was also biochemically confirmed.	At every visit, a research nurse monitored the adverse events (AEs) Subjects, primary investigators, and research nurses were blinded to pharmacotherapy group assignment.	No adjustment. Randomisation.
Tran, 2025	retrospective cohort (claims database)	Bupropion are prescription-only medicines and were captured by dispensing data (Pharmaceutical Collection and Pharmaceutical Benefits Scheme databases).	Major malformations were identified from diagnoses in hospital admissions or cause of death records (within 18 months from birth) identified in administrative databases.	Singletons only. Exclusion of women with teratogenic exposure (viral infection or medicines). Adjusted for year of conception, infant’s sex, maternal age, education level, and remoteness and social deprivation of residential areas, ..., parity, body mass index, a previous child having an MCM, and comorbidities (preexisting diabetes, hypertension, alcohol disorders, ...).
Tran (Controls exposed to Nicotine replacement therapy), 2020	retrospective cohort (claims database)	Dispensing data for pharmaceuticals subsidised through the Pharmaceutical Benefits Scheme (PBS, 2003–2013).	The outcomes were derived from the perinatal record, hospital record relating to the mother’s delivery, hospital record relating to the baby’s birth and mortality data obtained via 3 data sources including perinatal data, hospital admissions and deaths.	No adjustment/propensity scores for this group of comparison.
Tran (Controls unexposed, sick), 2020	retrospective cohort (claims database)	Dispensing data for pharmaceuticals subsidised through the Pharmaceutical Benefits Scheme (PBS, 2003–2013).	The outcomes were derived from the perinatal record, hospital record relating to the mother’s delivery, hospital record relating to the baby’s birth and mortality data obtained via 3 data sources including perinatal data, hospital admissions and deaths.	Propensity scores included state of birth, year, maternal age at conception, Aboriginal and/or Torres Strait Islander status, country of birth, marital status, quintiles of socio- economic disadvantage scores, parity, number of hospital admissions in the year prior, pre-existing maternal morbidities (mental health, diabetes, hypertension, ...), previous child with a major congenital anomaly...

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