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

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Inman (single 150mg dose), 1994	United Kingdom 1988 - 1989	Pregnancies identified by means of copies of prescriptions supplied to the Drug Safety Research Unit (DSRU) in confidence by the Prescription Pricing Authority.	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).	58 / 192
Jick (92% received the single 150-mg dose preparation), 1999	United Kingdom Not specified	Not specified	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.	234 / 1629	(Oral fluconazole: 92% received the single 150-mg dose preparation)
Molgaard-Nielsen (150 mg), 2013	Denmark 1996 - 2011	All liveborn infants who were born in Denmark during the study period.	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.	4082 / 968236	Oral exposure. Dose response studied.

Study	Country Study period	Case	Control	Sample size	Rmk
Berard (150 mg), 2019	Canada 1998 - 2015	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).	29458 / 291410	'Major congenital malformation were on singleton live births and excluded chromosomal abnormalities or pregnancies exposed to known teratogens'.