Azoles (local routes only)

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Abdel-Salam - Clotrimazole, 2000	case control	Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families.	The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office.	Controls matched according to sex, birth week, and district of parents' residence. POR adjusted for maternal age, birth order, and maternal diseases.
Araujo - Sertaconazole (Topical), 2022	retrospective cohort (claims database)	The EFEMERIS database was used, which contained medications prescribed and dispensed to pregnant women in the Haute-Garonne region.	Not specified.	Adjusted odds ratios or hazard ratios were estimated (no other details).
Carter - Clotrimazole, 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.
Czeizel - Clotrimazole, 1999	case control	The exposure data were obtained: (i) prospectively through antenatal care logbooks and other medical records; (ii) retrospectively by questionnaires completed by mothers; and (iii) by the help of regional nurses who visited and questioned all nonrespondent case and 200 control mothers.	The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory. Autopsy was obligatory for all infant deaths during the study period (1980-1992),and pathologists sent a copy of a detailed autopsy report to the Registry.	Controls matched for sex, birth week and residence. Adjusted for maternal age, birth order, pregnancy complications, acute and chronic maternal disorders (no other details), and use of other drugs as potential confounding factors.
Daniel - Clotrimazole and/or miconazole (Vaginal), 2018	retrospective cohort (claims database)	Medication dispensions during pregnancy were retrieved from the CHS medication database which contains all drug dispensions (prescription or OTC) to all patients insured by CHS in both community and hospital pharmacies.	Data regarding admissions for spontaneous abortions was gathered from the Soroka Medical Center hospitalization database.	Adjusted for mother’s age, hypothyroidism, diabetes mellitus, hypercoagulable state, uterine disorders, the presence of a intrauterine contraceptive device, history of recurrent abortions, in-vitro fertilization (IVF) on the current pregnancy, inflammatory diseases, ethnicity and tobacco use the year before.
Jick - Azole (Topical route), 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.
Kazy b - Metronidazole (Vaginal), 2005	case control	The exposure data were obtained: (i) prospectively through antenatal care logbooks and other medical records; (ii) retrospectively by questionnaires completed by mothers; and (iii) by the help of regional nurses who visited and questioned all nonrespondent case and 200 control mothers.	Not specified.	Controls matched for sex, birth week and residence. POR adjusted for maternal age, parity and maternal diseases.
Medveczky - Clotrimazole, 2004	case control	Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families.	The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office.	Controls matched according to sex, birth week, and district of parents' residence. Multivariable unconditional logistic regression model for maternal age, birth order, and and employment status.
Molgaard-Nielsen - Clotrimazole/miconazole (Vaginal) (Controls exposed to pivmecillinam), 2016	population based cohort retrospective	Information on prescriptions for oral fluconazole (a prescription-only drug) was obtained from the National Prescription Register.	The Medical Birth Register and the National Patient Register.	No match/adjustment for this group of exposure.
Molgaard-Nielsen - Clotrimazole/miconazole (Vaginal) (Controls unexposed, NOS), 2016	population based cohort retrospective	Information on prescriptions for oral fluconazole (a prescription-only drug) was obtained from the National Prescription Register.	The Medical Birth Register and the National Patient Register.	No match/adjustment for this group of exposure.
Rosa - Clotrimazole, 1987	case control	Medicaid invoices for prescriptions.	Medicaid invoices for diagnoses.	None.
Ross - Clotrimazole, 2003	case control	Exposure information was collected from mothers using a structured telephone questionnaire. All prescription drugs recorded in the medical record were abstracted, including data for the trimester of pregnancy the drug was prescribed based upon gestational ages recorded in medical records.	Signed medical record release forms were obtained and complete copies of medical records were requested. Data were abstracted from medical records by two registered nurses using a structured protocol.	Controls matched to cases by birth date (within one year) and telephone area and exchange. Adjusted for maternal age, education, and income.
Rotem - Clotrimazole (Vaginal), 2018	retrospective cohort (claims database)	Data for drugs dispensed during pregnancy were provided by the Clalit HMO medication database.	Three databases: the deliveries database provided by the Division of Obstetrics and Gynecology, the Soroka Medical Center (SMC) paediatric hospitalisation database and SMC pregnancy termination database. All diagnoses were assigned by board-certificated neonatologists and obstetricians.	Adjusted for maternal age, ethnicity (Bedouin versus Jewish), pre-gestational diabetes, smoking, nulliparity, year of delivery/pregnancy termination.
Zarante - Clotrimazole (Vaginal), 2009	case control	Information collected in 10 Colombian hospitals (NOS).	Information collected in 10 Colombian hospitals (NOS).	No match/adjustment for this group of exposure.
Zarante - Metronidazole (Vaginal), 2009	case control	Information collected in 10 Colombian hospitals (NOS).	Information collected in 10 Colombian hospitals (NOS).	No match/adjustment for this group of exposure.
Zhu - Azoles (Local routes), 2020	retrospective cohort (claims database)	The Medicaid Analytic eXtract (MAX) including dispensing records for outpatient prescription drugs for reimbursement.	Malformations were identified with highly specific algorithms based on inpatient and outpatient diagnoses and procedure codes from ICD-9-CM (international classification of diseases, 9th revision, clinical modification), in the maternal and infant records.	No adjustment for this group of exposure.

master protocol