Barbesaclone (Epilepsy = ALL)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Canger (Barbesaclone), 1999 Italy
1977 - 1996
517 women with epilepsy reffered to the study mainly from the Milan metropolitan and suburban areas or other Italian regions. They were followed up during the preconceptional period and/or from the beginning of pregnancy. Infants of epileptic mothers exposed to barbesaclone monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Infants of epileptic mothers unexposed to antiepileptic drugs during pregnancy.
1 / 25 Most women gave birth at the San Paolo Hospital. Only the first pregnancies of each of the 517 women were included in the analysis.
Tomson (Barbesaclone), 2018 42 countries
1999 - 2016
Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known. Offspring exposed in utero to barbesaclone monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers.
22 / 2514 This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol