Zonisamide (Epilepsy)

master protocol

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Battino, 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), 2012	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 written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist.	No adjustment for this group of comparison.
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), 2012	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 written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist.	Neither restriction to pure prospective enrollees, nor adjustment for potential confounders, nor restriction to women with epilepsy, nor use of AED information from medical records (data not shown) changed the results significantly.
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.
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 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 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.