Lacosamide (All indications)

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Battino (Epilepsy), 2024	prospective cohort	Reporting physicians collected information on drug therapy after each trimester.	Abnormalities in the offspring were recorded descriptively by reporting physicians. A committee blinded to type of exposure assessed and categorized these abnormalities. When necessary, the committee solicited additional information from the reporting physicians.	Exclusion of pregnancies exposed to known teratogenic drugs, and those with comorbidities associated with teratogenic risks. No adjustment for this group of comparison.
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG), 2024	prospective cohort	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.	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. As far as feasible, the accuracy of medical details provided by the women has been confirmed by their treating medical practitioners.	None.
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024	prospective cohort	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.	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. As far as feasible, the accuracy of medical details provided by the women has been confirmed by their treating medical practitioners.	None.
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024	prospective cohort	Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.	Screening for major congenital malformation with antenatal screening by serum alpha fetoprotein estimation and detailed anomaly scan between 12 and 18 weeks of pregnancy; physical examination at birth, at 3 months of age (at least) and at 1 year of age if possible.	No adjustment for this group of comparison.
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024	prospective cohort	Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.	Screening for major congenital malformation with antenatal screening by serum alpha fetoprotein estimation and detailed anomaly scan between 12 and 18 weeks of pregnancy; physical examination at birth, at 3 months of age (at least) and at 1 year of age if possible.	No adjustment.
The NAAED (Controls exposed to LTG) (Indications NOS), 2024	prospective cohort	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.	Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist.	No adjustment for this group of comparison.
The NAAED (Controls unexposed, disease free) (Indications NOS), 2024	prospective cohort	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.	Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist.	Not specified.
The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024	prospective cohort	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.	Outcome data were collected by sending the patient’s general practitioner a standardised questionnaire for completion during the follow-up duration. Other health care practitioners were contacted if identified.	None.
The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024	prospective cohort	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.	Outcome data were collected by sending the patient’s general practitioner a standardised questionnaire for completion during the follow-up duration. Other health care practitioners were contacted if identified.	None.
The West China Registry (Epilepsy) (Controls exposed to LTG), 2024	prospective cohort	The use of antiseizure medications on the included patients was registered by doctors and trained researchers.	After delivery, the offspring of the Women with epilepsy (WWE) were followed up by pediatricians. Offspring health was assessed by a multidisciplinary team, composed mainly of pediatricians and pediatric neurologists.	No adjustment. The exclusion criteria were as follows: (1) intelligence quotient (IQ) <70, ... (4) a voluntary termination of pregnancy of the mother’s personal choice and unrelated to fetal health.
The West China Registry (Epilepsy) (Controls unexposed, sick), 2024	prospective cohort	The use of antiseizure medications on the included patients was registered by doctors and trained researchers.	After delivery, the offspring of the Women with epilepsy (WWE) were followed up by pediatricians. Offspring health was assessed by a multidisciplinary team, composed mainly of pediatricians and pediatric neurologists.	No adjustment. The exclusion criteria were as follows: (1) intelligence quotient (IQ) <70, ... (4) a voluntary termination of pregnancy of the mother’s personal choice and unrelated to fetal health.

master protocol