Fluconazole (all routes except local only) - Cumulative dose ≤ 150 mg

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Berard (150 mg), 2019	nested case control	The Quebec Prescription Drug Insurance database. The filled prescription data were validated comparing them with maternal reports (the positive predictive value of prescription drug data to be ≥ 87% and the negative predictive value to be ≥ 92%).	Identification from the medical claims databases: Régie de l’assurance maladie du Québec (RAMQ) (outpatient diagnoses, procedures, women’s and physicians’ socioeconomic status), hospitalization archive database (MED-ÉCHO: diagnoses and procedures) and the Institut de la statistique du Québec (ISQ).	For intrauterine deaths: matched on gestational age at diagnosis of spontaneous abortion or stillbirth (index date) and the year of the last menstrual period. Adjusted OR obtained from multivariate conditional logistic regression model for maternal age, alcohol dependence, tobacco dependence, maternal comorbidities (hypertension, diabetes, epilepsy...), use of health services in 6 months before...
Inman (single 150mg dose), 1994	retrospective cohort	The patients were identified by means of copies of prescriptions supplied to the Drug Safety Research Unit (DSRU) in confidence by the Prescription Pricing Authority.	Simple questionnaires (green forms) were posted to the doctors requesting notably diagnosis and any events that had occurred after the drug bad been prescribed. When the outcome of pregnancy was not recorded on the green form, a further questionnaire was sent to the prescribing doctor.	None.
Jick (92% received the single 150-mg dose preparation), 1999	retrospective cohort (claims database)	General Practice Research Database of prescription.	Computer record was reviewed to identify indications of a congenital anomaly. For those with a suspected anomaly, we requested relevant clinical records from the general practitioner.	Age- and practice-matched women.
Molgaard-Nielsen (150 mg), 2013	population based cohort retrospective	Prescriptions for oral fluconazole that were filled by the women during pregnancy was obtained from the National Prescription Registry.	Cases of major birth defects were identified through the National Patient Register.	The covariates included calendar year; demographic characteristics; socioeconomic variables; and status with respect to smoking, previous births with malformation, selected coexisting conditions, and treatment with oral antibiotic agents, immunosuppressive agents, oral corticosteroids, antiepileptic agents, oral contraceptives, or drugs for in vitro fertilization

master protocol