Zonisamide (Epilepsy) - Medication and Pregnancy KB

Zonisamide (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Battino, 2024	Worldwide (47 countries) 1999 - 2022	Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined.	Pregnant women with epilepsy exposed to Zonisamide monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	29 / 3584	Overlapping: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Jimenez 2020 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied here.
Hernández-Díaz (Zonisamide), 2017	United States and Canada 1997 - 2017	Singleton, nonmalformed liveborn infants whose mothers had complete follow-up data.	Infants born to women who used zonisamide in monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants born to women who used lamotrigine in monotherapy throughout pregnancy.	125 / 1799	'Most women used their AED throughout pregnancy. The exception was topiramate'. The main indications for AED were epilepsy (91%).
Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2012	North America and Canada 1997 - 2011	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women who used zonisamide for epileptic indication as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). (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 for mixed indications as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation).	90 / 1562	Less than 90% of women are taking Lamotrigine for epilepsy.
Hernández-Díaz (Zonisamide) (Controls exposed to Lamotrigine, sick), 2014	United States and Canada 1997 - 2012	Women who had singleton, nonmalformed liveborns and who had complete follow-up data.	Infants of women exposed to zonisamide for epileptic indication as monotherapy throughout pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of women exposed to lamotrigine for mixed indications as monotherapy throughout pregnancy.	98 / 1581	Less than 90% of women are taking Lamotrigine for epilepsy. A more recent publication Hernández-Díaz 2017 gives a better review of the outcome 'small for gestational age'. Most women used their antiepileptic drug throughout pregnancy.
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2012	North America and Canada 1997 - 2011	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women who used zonisamide for epileptic indication as monotherapy, during the first 4 lunar months after the last menstrual period (equal 16 weeks of gestation). (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.	90 / 442
Hernández-Díaz (Zonisamide) (Controls unexposed, disease free), 2014	United States and Canada 1997 - 2012	Women who had singleton, nonmalformed liveborns and who had complete follow-up data.	Infants of women exposed to zonisamide as monotherapy throughout pregnancy. (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 drugs and without epilepsy who had been recruited among the friends and relatives of antiepileptic drugs-exposed participants.	98 / 457	Most women used their antiepileptic drug throughout pregnancy. A more recent publication (Hernández-Díaz 2017) gives a better review for the outcome 'small for gestational age'.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2021	US 2012 - 2016	Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women were recruited from the 20 epilepsy practices and through referral from obstetricians and other physicians as well as self-referral.	Children with epileptic mothers using zonisamide monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children with epileptic mothers using lamotrigine monotherapy in the third trimester.	11 / 93	Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2020	US 2012 - 2016	Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age.	Children born to pregnant women with epilepsy exposed to zonisamide 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 Children born to pregnant women with epilepsy exposed to lamotrigine monotherapy during the first trimester.	13 / 113
Meador (Zonisamide) (Controls unexposed, disease free), 2021	US 2012 - 2016	Pregnant (gestational age of 20 weeks or less) women with epilepsy and healthy women were recruited from the 20 epilepsy practices and through referral from obstetricians and other physicians as well as self-referral.	Children with epileptic mothers using zonisamide monotherapy in the third trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children of healthy women.	11 / 106	Exclusion criteria included history of psychogenic nonepileptic spells, expected IQ of less than 70, other major medical illness, and switching of ASMs in pregnancy before enrollment.
Meador (Zonisamide) (Controls unexposed, disease free), 2020	US 2012 - 2016	Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age.	Children born to pregnant women with epilepsy exposed to zonisamide monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children born to healthy pregnant women.	13 / 106
Meador (Zonisamide) (Controls unexposed, sick), 2020	US 2012 - 2016	Pregenant women with epilepsy were recruited primarily from the clinical populations at the 20 MONEAD sites, but also via referral from physicians, as well as self-referral. They were ages 14–45 years and ≤20 weeks gestational age.	Children born to pregnant women with epilepsy exposed to zonisamide monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children born to pregnant women with epilepsy with no antiepileptic drug use.	13 / 15
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024	India 1998 - 2023	All pregnancies with known outcomes in women with epilepsy enrolled in the registry during 1998 - 2013 and the diagnosis of epilepsy was confirmed before registration.	Children of women with epilepsy using Zonisamide monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children of women with epilepsy using lamotrigine monotherapy any time during the first trimester of pregnancy.	3 / 50	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021.
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024	India 1998 - 2023	All pregnancies with known outcomes in women with epilepsy enrolled in the registry during 1998 - 2013 and the diagnosis of epilepsy was confirmed before registration.	Children of women with epilepsy using Zonisamide monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children of women with epilepsy not using any antiepileptic drugs during the first trimester.	3 / 340	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021.
The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024	UK and Ireland 1996 - 2023	Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known.	Infants of women with epilepsy exposed to Zonisamide 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.	25 / 2098	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	Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known.	Infants of women with epilepsy exposed to Zonisamide 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.	25 / 541	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol