Ketoconazole (all routes except local only) - Medication and Pregnancy KB

Ketoconazole (all routes except local only)

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
Molgaard-Nielsen 2013	Denmark 1996 - 2011 population based cohort retrospective	Registry-based cohort of liveborn infants in Denmark	Women who fill prescriptions for oral ketoconazole 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	72 / 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	72 / 968236	Oral exposure.

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
Carter 2008	USA 1997 - 2003 case control	National Birth Defects Prevention Study (NBDPS), USA	Cases with selected birth defects (included live births, stillbirths 20 weeks or longer or greater than 500 g, or elective terminations).	Live births without birth defects that were randomly selected from birth certificates or birth hospitals in the geographic regions monitored by the state surveillance systems.	Structured maternal interviews were conducted mainly by telephone in English or Spanish no later than 24 months after the expected date of delivery (EDD) to obtain data on maternal exposures during pregnancy.	1st trimester	12274 / 4774
Carter 2008	USA 1997 - 2003 case control	National Birth Defects Prevention Study (NBDPS), USA	Cases and controls were identified by the birth defects surveillance systems in 10 states of USA. Medical records were obtained for all cases and reviewed by clinical geneticists.			1st trimester	12274 / 4774
Kazy 2005	Hungary 1980 - 1996 case control	Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA)	Cases with isolated and multiple congenital anomalies selected from the Hungarian Congenital Abnormality Registry.	Newborn infants without congenital abnormality.	The exposure data were obtained prospectively through antenatal care logbooks and other medical records, and retrospectively through questionnaires completed by the infants’ mothers.	1st trimester	22843 / 38151	Oral ketoconazole exposure.
Kazy 2005	Hungary 1980 - 1996 case control		The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory. Controls were selected from the National Birth Registry of the Central Statistical Office.			1st trimester	22843 / 38151	Oral ketoconazole exposure.

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

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