Zonisamide (All indications)

master protocol

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Battino (Zonisamide) (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.
Hernández-Díaz (Zonisamide), 2017	prospective cohort	Women were questioned with a computer-assisted telephone interview 3 times.	Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained.	Confunders included calendar year, maternal age, race, diabetes, cigarette smoking, alcohol use, periconceptional folic acid supplementation, illicit drug use, and education.
Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2014	prospective cohort	Women were questioned with a computer-assisted telephone interview 3 times.	Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The neonates’ doctors were asked to return copies of their examination findings.	No adjustment for those outcomes.
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2014	prospective cohort	Women were questioned with a computer-assisted telephone interview 3 times.	Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The neonates’ doctors were asked to return copies of their examination findings.	No adjustment for those outcomes.
Källén (Zonisamide) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	population based cohort retrospective	At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).	The Swedish Medical Birth Registry contain information based on standardized medical records from the first and further antenatal visit, the delivery and the paediatric examination. Supplemented with data from the Register of Birth Defects and Hospital Discharge Register.	No adjustment for this group of comparison.
Källén (Zonisamide) (Controls unexposed, NOS) (Indications NOS), 2013	population based cohort retrospective	At the midwife interview at the first antenatal care visit, the woman was asked if she had used any drugs since she became pregnant. Or determined by the use of the Swedish Register of Prescribed Drugs (since 2006).	The Swedish Medical Birth Registry contain information based on standardized medical records from the first and further antenatal visit, the delivery and the paediatric examination. Supplemented with data from the Register of Birth Defects and Hospital Discharge Register.	Adjustment was made for year of birth, maternal age (5-year class), parity, smoking in early pregnancy and BMI.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2021	prospective cohort	Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.	Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.	Adjusted for mother's IQ, education level, and post-birth average Beck Anxiety Inventory (BAI) score, and child's sex, ethnicity, and birthweight.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020	prospective cohort	Data were obtained from participants and their medical records.	Data were obtained from participants and their medical records.	No adjustment for this group of exposure.
Meador (Zonisamide) (Controls unexposed, disease free), 2021	prospective cohort	Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.	Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.	Adjusted for mother's IQ, education level, and post-birth average Beck Anxiety Inventory (BAI) score, and child's sex, ethnicity, and birthweight.
Meador (Zonisamide) (Controls unexposed, disease free), 2020	prospective cohort	Data were obtained from participants and their medical records.	Data were obtained from participants and their medical records.	No adjustment for this group of exposure.
Meador (Zonisamide) (Controls unexposed, sick), 2020	prospective cohort	Data were obtained from participants and their medical records.	Data were obtained from participants and their medical records.	No adjustment for this group of exposure.
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 (Zonisamide) (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 (Zonisamide) (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.