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

Sultiame (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
Battino (Sulthiame) (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort	The International Registry of Antiepileptic Drugs and Pregnancy (EURAP).	Pregnant women with epilepsy exposed to Sulthiame monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	early pregnancy	1 / 3584	Overlapping/update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 and Tomson 2011 => Use of Battino 2024.
Battino (Sulthiame) (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort		Reporting physicians collected information on drug therapy after each trimester.		early pregnancy	1 / 3584
Samrén (Sultiame) 1999	Netherlands 1972 - 1994 retrospective cohort	28 hospitals in four provinces of the Netherlands and National Perinatal Data Base LVR.	Children born to mothers with epilepsy and using sultiame monotherapy at least during the first trimester of pregnancy	unexposed, disease free Children born to nonepileptic nonexposed women.	at least 1st trimester	1 / 2000
Samrén (Sultiame) 1999	Netherlands 1972 - 1994 retrospective cohort		Data were collected from medical records and include medication. The prescribed dose of thedrugs was also retrieved from obstetric files.		at least 1st trimester	1 / 2000

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 (Sultiame) 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	Malformations caused by major mutant genes or chromosomal aberrations with preconceptional origin were excluded. Exposure period completed with Czeizel 1992. Czeizel 1992 congenital abnormalities results are completely overlapped by this publication.
Bànhidy (Sultiame) 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

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

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