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 (Barbexaclone) (Epilepsy) 2024 |
Worldwide (47 countries) 1999 - 2022 prospective cohort |
The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). | Pregnant women with epilepsy exposed to Barbexaclone 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 | 23 / 3584 | Overlapping/Update: Malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Tomson 2011 and Jimenez 2020 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) monotherapies studied. | |
Reporting physicians collected information on drug therapy after each trimester. | ||||||||
Canger (Barbesaclone) 1999 |
Italy 1977 - 1996 prospective cohort |
The Epilepsy Center of the San Paolo Hospital in Milan or other in the Lombardy region. | 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. |
1st trimester | 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. | |
The patients received monthly obstetric and neurologic examinations, and antiepileptic drug blood levels were tested monthly. |
Study | Country Study period Study design |
Data source | Case | Control | Exposition | Exposition period | Sample size (exposed/unexposed) Or (case / control) |
Remarks | Risk of bias |
---|
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;