Brivaracetam (All indications) - Medication and Pregnancy KB

Brivaracetam (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 Brivaracetam 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	2 / 3584
Battino (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort		Reporting physicians collected information on drug therapy after each trimester.		early pregnancy	2 / 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 Brivaracetam 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	15 / 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	15 / 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 Brivaracetam 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	15 / 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	15 / 1311

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