Sultiame (Epilepsy = All indications)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Battino (Sulthiame) (Epilepsy), 2024	Worldwide (47 countries) 1999 - 2022	Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined.	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.	1 / 3584	Overlapping/update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 and Tomson 2011 => Use of Battino 2024.
Samrén (Sultiame), 1999	Netherlands 1972 - 1994	Offspring of women with epilepsy, with or without antiepileptic drug use during pregnancy, born during the study period.	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.	1 / 2000

Study	Country Study period	Case	Control	Sample size	Rmk
Bànhidy (Sultiame), 2011	Hungary 1980 - 1996	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.	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.