Clomethiazol (Epilepsy = All indications) - Medication and Pregnancy KB

Clomethiazol (Epilepsy = All indications)

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

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

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
Bànhidy (Clomethiazol) 2011	Hungary 1980 - 1996 case control	Hungarian Congenital Abnormality Registry (HCAR), the National Birth Registry of the Central Statistical Office and the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA).	Children affected with congenital abnormalities and who had mothers with medically recorded epilepsy.	Newborn infants without congenital abnormality and who had mothers with medically recorded epilepsy.	Mothers were mailed a questionnaire (after the selection of cases and controls) requested information on medicinal products taken during pregnancy and to send their prenatal maternity logbook and other medical records. Regional nurses were asked to visit and question the non-respondent.	throughout pregnancy	95 / 90	Congenital abnormalities syndromes caused by major mutant genes or chromosomal aberrations with preconceptional origin were excluded. Exposure period completed with Czeizel 1992.
Bànhidy (Clomethiazol) 2011	Hungary 1980 - 1996 case control		Notification of cases with congenital abnormality is mandatory for physicians to the HCAR. Pathologists sent a copy of autopsy report for stillbirths and infant deaths cases and defect diagnosed in prenatal diagnostic centers with or without termination of pregnancy were also included.			throughout pregnancy	95 / 90
Czeizel (Clomethiazol) 1992	Hungary 1980 - 1987 case control	The Hungarian Case-Control Surveillance of Congenital Anomalies.	Children affected with congenital abnormalities born from treated or untreated mothers.	Children without congenital abnormalities born from treated or untreated mothers.	Mothers were mailed a questionnaire requested information on medicinal products taken during pregnancy and to send their prenatal maternity logbook which related drug prescriptions. Regional nurses were asked to visit and question the non-respondent.	throughout pregnancy	100 / 54	The study design was partly completed thanks to the reference [6] cited in the publication. All congenital abnormalities except spina bifida are overlapped by the publication of Bànhidy 2011. Clomethiazol is a synonym of Chlormethiazol.
Czeizel (Clomethiazol) 1992	Hungary 1980 - 1987 case control		Notification of cases with congenital abnormality is mandatory for physicians to the HCAR. Pathologists sent autopsy report for stillbirths and infant deaths cases. Prenatally diagnosed and electively terminated malformed fetuses have also been registered.			throughout pregnancy	100 / 54

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

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