Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
---|---|---|---|---|---|---|
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 | |
Tomson (Zonisamide), 2018 |
42 countries 1999 - 2016 |
Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known. | Offspring exposed in utero to zonisamide monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers. |
9 / 2514 | This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap. |
Study | Country Study period |
Case | Control | Sample size | Rmk |
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