Eslicarbazepine (All indications) - Medication and Pregnancy KB

Eslicarbazepine (All indications)

Exposed non-exposed, cohort studies

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 (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort	The International Registry of Antiepileptic Drugs and Pregnancy (EURAP).	Pregnant women with epilepsy exposed to Eslicarbazepine acetate 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	7 / 3584
Battino (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort		Reporting physicians collected information on drug therapy after each trimester.		early pregnancy	7 / 3584
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 Eslicarbazepine 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	10 / 2461	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries.
The NAAED (Indications NOS) (Controls exposed to LTG) 2024	North America and Canada 1997 - 2023 prospective cohort	The North American Antiepileptic Drug Pregnancy Register	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.		1st trimester	10 / 2461
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 Eslicarbazepine 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	10 / 1311	Data extracted from the publication Perucca 2024 (for exposed pregnancies) and the North American AED pregnancy registry website (for controls).
	North America and Canada 1997 - 2023 prospective cohort	The North American Antiepileptic Drug Pregnancy Register	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.		1st trimester	10 / 1311
The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine) 2024	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Infants of women with epilepsy exposed to Eslicarbazepine acetate in 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 women with epilepsy exposed to lamotrigine in monotherapy during the first trimester.	1st trimester	1 / 2098	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.
	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.		1st trimester	1 / 2098
The UKIEPR (Epilepsy) (Controls unexposed, sick) 2024	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Infants of women with epilepsy exposed to Eslicarbazepine in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Infants of women with epilepsy on no antiepileptic drugs during pregnancy.	1st trimester	1 / 541	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.
The UKIEPR (Epilepsy) (Controls unexposed, sick) 2024	UK and Ireland 1996 - 2023 prospective cohort	The United Kingdom Epilepsy and Pregnancy Register	Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.		1st trimester	1 / 541

Case-control studies

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;

Empty. There are no case-control studies available for this drug.

master protocol