| 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 |
|---|---|---|---|---|---|---|---|---|
|
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG) 2024 |
Australia 1999 - 2023 prospective cohort |
The Australian Pregnancy Register of Antiepileptic Drugs (APR). | Women with epilepsy exposed to Perampanel monotherapy at time of conception. |
exposed to other treatment, sick
Women with epilepsy exposed to Lamotrigine monotherapy at time of conception. |
at least 1st trimester | 3 / 406 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries, and with de-depublication of pregnancies of EURAP registry. | |
| Enrolment on the pregnant women own initiative after becoming aware through various sources of the Register’s existence and purpose. Data collection concerning each woman’s medical details at enrolment, at 7 months of pregnancy, at first postnatal month, and at one year after pregnancy ended. | ||||||||
|
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick) 2024 |
Australia 1999 - 2023 prospective cohort |
The Australian Pregnancy Register of Antiepileptic Drugs (APR). | Women with epilepsy exposed to Perampanel monotherapy at time of conception. |
unexposed, sick
Women with epilepsy unexposed to antiseizure medication in at least the first few months of pregnancy. |
at least 1st trimester | 3 / 207 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries (and Vajda 2024 for the control group), and with de-depublication of pregnancies of EURAP registry. | |
| Enrolment on the pregnant women own initiative after becoming aware through various sources of the Register’s existence and purpose. Data collection concerning each woman’s medical details at enrolment, at 7 months of pregnancy, at first postnatal month, and at one year after pregnancy ended. | ||||||||
|
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine) 2024 |
India 1998 - 2023 prospective cohort |
The Kerala Registry of Epilepsy and Pregnancy (KREP) | Children of women with epilepsy using Perampanel monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children of women with epilepsy using lamotrigine monotherapy any time during the first trimester of pregnancy. |
1st trimester | 2 / 50 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021. | |
| Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | ||||||||
|
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick) 2024 |
India 1998 - 2023 prospective cohort |
The Kerala Registry of Epilepsy and Pregnancy (KREP) | Children of women with epilepsy using Perampanel monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of women with epilepsy not using any antiepileptic drugs during the first trimester. |
1st trimester | 2 / 340 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021. | |
| Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them. | ||||||||
|
The NAAED (Indications NOS) (Controls exposed to LTG) 2024 |
North America and Canada 1997 - 2023 prospective cohort |
The North American Antiepileptic Drug Pregnancy Register | Infants of pregnant women who used Perampanel as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants of pregnant women who used lamotrigine as monotherapy, during the first trimester. |
1st trimester | 5 / 2461 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. | |
| Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication. | ||||||||
|
The NAAED (Indications NOS) (Controls unexposed, disease free) 2024 |
North America and Canada 1997 - 2023 prospective cohort |
The North American Antiepileptic Drug Pregnancy Register | Infants of pregnant women who used Perampanel as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug. |
1st trimester | 5 / 1311 | Data extracted from the publication Perucca 2024 (for exposed pregnancies) and the North American AED pregnancy registry website (for controls). | |
| Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication. | ||||||||
|
The West China Registry (Epilepsy) (Controls exposed to LTG) 2024 |
China 2009 - 2023 prospective cohort |
A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center. | Women with epilepsy (WWE) using Perampanel monotherapy during pregnancy. |
exposed to other treatment, sick
Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy. |
during pregnancy (anytime or not specified) | 3 / 38 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries, and with de-depublication of pregnancies of EURAP registry. Period of exposure not specified => considered as during pregnancy. | |
| The use of antiseizure medications on the included patients was registered by doctors and trained researchers. | ||||||||
|
The West China Registry (Epilepsy) (Controls unexposed, sick) 2024 |
China 2009 - 2023 prospective cohort |
A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center. | Women with epilepsy (WWE) using Perampanel monotherapy during pregnancy. |
unexposed, sick
Women with epilepsy (WWE) not using antiseizure medications during pregnancy. |
during pregnancy (anytime or not specified) | 3 / 253 | Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries (and Li 2023 for control group), and with de-depublication of pregnancies of EURAP registry. Period of exposure not specified. | |
| The use of antiseizure medications on the included patients was registered by doctors and trained researchers. | ||||||||
| 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;
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