Miconazole (local route only) - Medication and Pregnancy KB

Miconazole (local route only)

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Daniel 2018	Israel 2003 - 2009 retrospective cohort (claims database)	Soroka Medical Center, Clalit Health Services, Israel.	Dispensation of vaginal miconazole from the first day of the last menstrual period until the date of admission to the hospital for pregnancies that resulted in spontaneous abortion or until 20 weeks of pregnancy for pregnancies that ended with birth.	unexposed (general population or NOS) No dispensation of anti-mycotic medication (vaginal or oral).	1st trimester	633 / 62137	Vaginal exposure.
Daniel 2018	Israel 2003 - 2009 retrospective cohort (claims database)	Soroka Medical Center, Clalit Health Services, Israel.	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.		1st trimester	633 / 62137	Vaginal exposure.
Rotem 2018	Israel 1999 - 2009 retrospective cohort (claims database)	Four computerised databases in the Soroka Medical Center, Beer-Sheva, Israel.	Women who were dispensed with miconazole vaginal tablets during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnancies that were not exposed to either drug from the azoles family (e.g. vaginal, systemic or topical formulation).	1st trimester	313 / 95781	Vaginal exposure
Rotem 2018	Israel 1999 - 2009 retrospective cohort (claims database)		Data for drugs dispensed during pregnancy were provided by the Clalit HMO medication database.		1st trimester	313 / 95781	Vaginal exposure

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Kazy 2005	Hungary 1980 - 1996 case control	The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA).	Infants (liveborn infants, stillborn infants, and electively aborted fetuses) with congenital abnormalities (CAs) were selected from the Hungarian Congenital Abnormality Registry.	Infants without congenital abnormalities, matched according to sex, birth week, and district of parents' residence selected from the national birth registry of the Central Statistical Office.	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.	1st trimester, during pregnancy (anytime or not specified)	22843 / 38151	Three mild CAs (such as congenital dislocation of the hip based on the Ortolani click, congenital inguinal hernia and hemangiomas), minor variants (e.g., umbilical hernia) and CA-syndromes of Mendelian and chromosomal origin were excluded.
Kazy 2005	Hungary 1980 - 1996 case control		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, and pathologists sent a copy of a detailed autopsy report to the Registry.			1st trimester, during pregnancy (anytime or not specified)	22843 / 38151

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

master protocol