Itraconazole - Medication and Pregnancy KB

Itraconazole

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Bar-Oz, 2000	International 1989 - 1998	Exposed pregnancies reported to manufacturer by the treating physician at the time of exposure and non exposed pregnancies who contacted the Motherisk Program.	Pregnant patients who were known to have first-trimester exposure to itraconazole.	unexposed (general population or NOS) Pregnant women not exposed to any known teratogens and who contacted the Motherisk Program, a Canadian teratogen information service.	199 / 198	Oral exposure. In cases in which data were available, however, the daily itraconazole doses ranged between 50 and 800 mg (median, 200 mg). Mean exposure duration 8.5±12.4j (range, 1-90 days; median, 3 days).
De Santis, 2009	Italy 2002 - 2006	Women who contacted on of the two teratology information services.	Pregnant women exposed during their first trimester to oral itraconazole therapy.	unexposed (general population or NOS) Pregnant women exposed only to non-teratogenic (e.g. paracetamol [acetaminophen], hair dying) substances during their first trimester.	206 / 207	Oral exposure. The mean daily dose of drug was 182.23±62.58 mg and the mean duration of therapy was 6.9±6.4 days.
Jick, 1999	United Kingdom Not specified	Not specified	Pregnant women who received a prescription for oral Itraconazole in the first trimester of pregnancy.	unexposed (general population or NOS) Pregnant women not exposed to fluconazole or other azole.	88 / 1629
Molgaard-Nielsen, 2013	Denmark 1996 - 2011	All liveborn infants who were born in Denmark during the study period.	Women who fill prescriptions for oral itraconazole agents during the first trimester.	unexposed (general population or NOS) Women who did not fill prescriptions for oral azole antifungal agents during the first trimester.	687 / 968236	Oral exposure.
Molgaard-Nielsen (Controls exposed to pivmecillinam), 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 itraconazole during the specific time windows: gestational week 7 to 22 and week 7 to birth for spontaneous abortion and stillbirth, respectively. (This is a subanalysis among the whole analysis performed in the study)	exposed to other treatment, sick Exposure to pivmecillinam during the specific time windows: gestational week 7 to 22 and week 7 to birth for spontaneous abortion and stillbirth, respectively. (This is a subanalysis among the whole analysis performed in the study)	131 / 3018	Use of Oral Itraconazole.
Molgaard-Nielsen (Controls unexposed, NOS), 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 itraconazole during the specific time windows: gestational week 7 to 22 and week 7 to birth for spontaneous abortion and stillbirth, respectively. (This is a subanalysis among the whole analysis performed in the study)	unexposed (general population or NOS) No exposure to itraconazole during the specific time windows: gestational week 7 to 22 and week 7 to birth for spontaneous abortion and stillbirth, respectively.	131 / 524	Use of Oral Itraconazole.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

Warning! There are no case-control studies available for this drug.

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