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 studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Inman (> 150mg), 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 (two or more doses of 150 mg) was prescribed after the last monthly period (LMP).	unexposed, sick Pregnancies in which Fluconazole was prescribed before the last monthly period (LMP).	2 / 192
Molgaard-Nielsen (300 - 6000mg), 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, i.e: 300 -6000 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.	3270 / 968236	Oral exposure. Dose response studied. The 2 high doses (300 mg and 350-6000 mg) were pooled.
Molgaard-Nielsen (> 350-5600), 2016	Denmark 1997 - 2013	All pregnancies ending with a singleton live birth, stillbirth, spontaneous abortion, and other abortive outcomes (including ectopic pregnancy, hydatidiform mole, other abnormal products of gestation, or induced abortion) in Denmark.	Exposure to oral fluconazole (350-5600 mg) during the specific time windows: gestational week 7 to 22 and week 7 to birth for spontaneous abortion and stillbirth, respectively.	unexposed (general population or NOS) Non exposure to fluconazole during the specific time windows: gestational week 7 to 22 and week 7 to birth for spontaneous abortion and stillbirth, respectively.	472 / 1400113	Use of Oral Fluconazole. Analysis of dose response: low dose (150-300 mg) vs high dose (350-5600 mg).
Pasternak (>300 mg), 2018	Sweden and Norway 2005 - 2015	All pregnancies with singleton live births and stillbirths.	Oral fluconazole exposure (>300 mg) at any time during pregnancy, as defined by filled prescriptions.	unexposed (general population or NOS) No fluconazole exposure at any time during pregnancy, as defined by filled prescriptions.	4543 / 106690	Oral exposure. Dose effect analysis.

Case-control studies (cohort)

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

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