Fluconazole (all routes except local only) - Cumulative dose ≤ 150 mg - Medication and Pregnancy KB

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

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
Inman (single 150mg dose) 1994	United Kingdom 1988 - 1989 retrospective cohort	A prescription-event monitoring (PEM) carried out at the Drug Safety Research Unit (DSRU).	Pregnancies in which Fluconazole (single 150mg dose) was prescribed after the last monthly period (LMP).	unexposed, sick Pregnancies in which Fluconazole was prescribed before the last monthly period (LMP).	during pregnancy (anytime or not specified)	58 / 192
Inman (single 150mg dose) 1994	United Kingdom 1988 - 1989 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.		during pregnancy (anytime or not specified)	58 / 192
Jick (92% received the single 150-mg dose preparation) 1999	United Kingdom Not specified retrospective cohort (claims database)	The United Kingdom General Practice Research Database (GPRD).	Pregnant women who received a prescription for oral Fluconazole in the first trimester of pregnancy.	unexposed (general population or NOS) Pregnant women not exposed to fluconazole or other azole.	1st trimester	234 / 1629	(Oral fluconazole: 92% received the single 150-mg dose preparation)
Jick (92% received the single 150-mg dose preparation) 1999			General Practice Research Database of prescription.		1st trimester	234 / 1629
Molgaard-Nielsen (150 mg) 2013	Denmark 1996 - 2011 population based cohort retrospective	Registry-based cohort of liveborn infants in Denmark	Women who fill prescriptions for oral fluconazole (150 mg) during the first trimester.	unexposed (general population or NOS) Women who did not fill prescriptions for oral azole antifungal agents during the first trimester.	1st trimester	4082 / 968236	Oral exposure. Dose response studied.
Molgaard-Nielsen (150 mg) 2013	Denmark 1996 - 2011 population based cohort retrospective	Registry-based cohort of liveborn infants in Denmark	Prescriptions for oral fluconazole that were filled by the women during pregnancy was obtained from the National Prescription Registry.		1st trimester	4082 / 968236	Oral exposure. Dose response studied.

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
Berard (150 mg) 2019	Canada 1998 - 2015 nested case control	The Quebec Pregnancy Cohort	Case of spontaneous abortion or stillbirth or major malformations.	Pregnancies not ending in spontaneous abortion or stillbirth (random sampling control) or major malformations (all live-births used as controls).	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%).	1st trimester, during pregnancy (anytime or not specified)	29458 / 291410	'Major congenital malformation were on singleton live births and excluded chromosomal abnormalities or pregnancies exposed to known teratogens'.
Berard (150 mg) 2019	Canada 1998 - 2015 nested case control	The Quebec Pregnancy Cohort	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).			1st trimester, during pregnancy (anytime or not specified)	29458 / 291410

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

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