Itraconazole - Medication and Pregnancy KB

Itraconazole

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
Bar-Oz 2000	International 1989 - 1998 prospective cohort	The international pharmacovigilance department of the manufacturer of itraconazole.	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.	1st trimester	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).
Bar-Oz 2000	International 1989 - 1998 prospective cohort		Details (timing and dose) of maternal drug therapy were reported by the treating physician.		1st trimester	199 / 198
De Santis 2009	Italy 2002 - 2006 prospective cohort	Two teratology information services (TIS; Telefono Rosso-TIS in Rome and CEPIG [CEntro per l’Informazione Genetica]-TIS in Padua).	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.	1st 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.
De Santis 2009	Italy 2002 - 2006 prospective cohort		A structured questionnaire used to collect information about maternal medical features and details of itraconazole therapy (dosage and timing).		1st trimester	206 / 207
Jick 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 Itraconazole in the first trimester of pregnancy.	unexposed (general population or NOS) Pregnant women not exposed to fluconazole or other azole.	1st trimester	88 / 1629
Jick 1999			General Practice Research Database of prescription.		1st trimester	88 / 1629
Molgaard-Nielsen 2013	Denmark 1996 - 2011 population based cohort retrospective	Registry-based cohort of liveborn infants in Denmark	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.	1st trimester	687 / 968236	Oral exposure.
Molgaard-Nielsen 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	687 / 968236	Oral exposure.
Molgaard-Nielsen (Controls exposed to pivmecillinam) 2016	Denmark 1997 - 2013 population based cohort retrospective	Nationwide register-based cohort study 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)	during pregnancy (anytime or not specified)	131 / 3018	Use of Oral Itraconazole.
Molgaard-Nielsen (Controls exposed to pivmecillinam) 2016	Denmark 1997 - 2013 population based cohort retrospective	Nationwide register-based cohort study in Denmark	Information on prescriptions for oral fluconazole (a prescription-only drug) was obtained from the National Prescription Register.		during pregnancy (anytime or not specified)	131 / 3018	Use of Oral Itraconazole.
Molgaard-Nielsen (Controls unexposed, NOS) 2016	Denmark 1997 - 2013 population based cohort retrospective	Nationwide register-based cohort study 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.	during pregnancy (anytime or not specified)	131 / 524	Use of Oral Itraconazole.
Molgaard-Nielsen (Controls unexposed, NOS) 2016	Denmark 1997 - 2013 population based cohort retrospective	Nationwide register-based cohort study in Denmark	Information on prescriptions for oral fluconazole (a prescription-only drug) was obtained from the National Prescription Register.		during pregnancy (anytime or not specified)	131 / 524	Use of Oral Itraconazole.

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

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

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

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