Ketoconazole (all routes except local only)

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Carter, 2008	case control	Structured maternal interviews were conducted mainly by telephone in English or Spanish no later than 24 months after the expected date of delivery (EDD) to obtain data on maternal exposures during pregnancy.	Cases and controls were identified by the birth defects surveillance systems in 10 states of USA. Medical records were obtained for all cases and reviewed by clinical geneticists.	No adjustment for this group of exposure.
Kazy, 2005	case control	The exposure data were obtained prospectively through antenatal care logbooks and other medical records, and retrospectively through questionnaires completed by the infants’ mothers.	The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory. Controls were selected from the National Birth Registry of the Central Statistical Office.	Controls matched according to sex, week of birth and district of parents’ residence. Adjusted for potential confounders evaluated in an unconditional logistic regression model (NOS).
Molgaard-Nielsen, 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, immunosuppres- sive agents, oral corticosteroids, antiepileptic agents, oral contraceptives, or drugs for in vitro fertilization

master protocol