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. |
Study | Country Study period |
Case | Control | Sample size | Rmk |
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1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.