| Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
|---|---|---|---|---|---|---|
| Alsfouk (Topiramate) (Controls exposed to Lamotrigine, sick), 2021 |
Riyadh and Jeddah, Saudi Arabia. 1993 - 2020 |
Pregnant women with epilepsy followed up prospectively between the study period. | Epileptic mothers with topiramate monotherapy administered during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Epileptic mothers with lamotrigine monotherapy administered during pregnancy. |
2 / 15 | |
| Alsfouk (Topiramate) (Controls unexposed, sick), 2021 |
Riyadh and Jeddah, Saudi Arabia. 1993 - 2020 |
Pregnant women with epilepsy followed up prospectively between the study period. | Epileptic mothers with topiramate monotherapy administered during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Epileptic mothers who did not take antiseizure medications during pregnancies. |
2 / 30 | |
| AlSheikh (Topiramate) (Controls exposed to Lamotrigine, sick), 2020 |
Saudi Arabia 2018 - 2019 |
Pregnant patients with active epilepsy admitted to the Obstetrics and Gynecology outpatient clinic and those seeking follow-up from our outpatient clinic. Patients on treatment and who had at least one seizure in the past one year. | Fetuses/neonates of patients with active epilepsy who received topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Fetuses/neonates of patients with active epilepsy who received lamotrigine monotherapy during pregnancy. |
1 / 20 | |
| AlSheikh (Topiramate) (Controls unexposed, sick), 2020 |
Saudi Arabia 2018 - 2019 |
Pregnant patients with active epilepsy admitted to the Obstetrics and Gynecology outpatient clinic and those seeking follow-up from our outpatient clinic. Patients on treatment and who had at least one seizure in the past one year. | Fetuses/neonates of patients with active epilepsy who received topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Fetuses/neonates of patients with active epilepsy who did not take antiepileptic drugs during pregnancy. |
1 / 8 | |
| Arkilo (Topiramate), 2015 |
USA 2006 - 2011 |
Women with epilepsy who were pregnant between the study period and exposed to monotherapy antiepileptic medication at any point during the pregnancy. | Singleton whose epileptic mothers were exposed to topiramate monotherapy at any point during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Singleton whose epileptic mothers were exposed to lamotrigine monotherapy at any point during the pregnancy. |
2 / 24 | |
| Babic (Topiramate), 2014 |
Serbia 1998 - 2008 |
During the study period 21 women (25 pregnancies) with juvenile myoclonic epilepsy were enrolled. | Children whose epileptic mothers were exposed to topiramate in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children whose epileptic mothers were exposed to lamotrigine in monotherapy during pregnancy. |
2 / 8 | |
| 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 Topiramate monotherapy at the time of conception. |
exposed to other treatment, sick
Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception. |
204 / 3584 | Overlapping/Update: (Major) malfo as a whole: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Tomson 2011=> Use of Battino 2024 for these outcomes. |
| Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in epileptic mothers filling at least one topiramate monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnacies in epileptic mothers filling at least one lamotrigine monotherapy prescription from her last menstrual period until birth. |
246 / 5073 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. |
| Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick), 2018 |
Norway 1999 - 2008 |
Pregnancies registered in the MoBa cohort when information concerning use of folic acid supplements and/or plasma folate concentration during pregnancy was available. | Children of women with reported epilepsy and topiramate monotherapy use during 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 reported epilepsy and lamotrigine monotherapy use during pregnancy. |
10 / 104 | |
| Bjørk (Topiramate) (Controls unexposed NOS), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in epileptic mothers filling at least one topiramate monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnacies in mothers without antiseizure medication prescription from her last menstrual period until birth. |
246 / 4463879 | Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up. |
| Bjørk (Topiramate) (Controls unexposed, disease free), 2018 |
Norway 1999 - 2008 |
Pregnancies registered in the MoBa cohort when information concerning use of folic acid supplements and/or plasma folate concentration during pregnancy was available. | Children of women with reported epilepsy and topiramate monotherapy use during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
All children of mothers without reported epilepsy unexposed to antiepileptic drugs during pregnancy. |
10 / 104222 | |
| Bjørk (Topiramate) (Controls unexposed, sick), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in epileptic mothers filling at least one topiramate monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnacies in epileptic mothers without antiseizure medication prescription from her last menstrual period until birth. |
246 / 21634 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. Not the same category of age for Intellectual disabilities. |
| Bjørk (Topiramate) (Controls unexposed, sick), 2018 |
Norway 1999 - 2008 |
Pregnancies registered in the MoBa cohort when information concerning use of folic acid supplements and/or plasma folate concentration during pregnancy was available. | Children of women with reported epilepsy and topiramate monotherapy use during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of women with reported epilepsy but no antiepileptic drug intake during pregnancy. |
10 / 389 | In this control group 127 (70.9%) reported inactive epilepsy defined as not using AEDs during the 2 years before conception or no seizures during the previous 5 years. |
| Bromley (Topiramate), 2016 |
UK 2004 - 2007 |
Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug in monotherapy and whose infant had been a live birth between the study period. | Children whose epileptic mothers were exposed to topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children whose epileptic mothers were untreated by antiepileptic drugs during their pregnancy. |
27 / 55 | Design parts of this study were completed thanks to Morrow 2006. Families were not invited to participate if their child had a genetic condition associated with neurodevelopmental impairment. |
| Christensen (Topiramate) (Epilepsy) (Controls exposed to LTG), 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 |
All live-born singletons born of women with epilepsy in the included countries during the study periods. | Children of mothers with epilepsy who had redeemed at least one prescription of Topiramate monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
exposed to other treatment, sick
Children of mothers who had redeemed at least one prescription of Lamotrigine monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
290 / 5299 | Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017). |
| Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 |
All live-born singletons born of women with epilepsy in the included countries during the study periods. | Children of mothers with epilepsy who had redeemed at least one prescription of Topiramate monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period). |
unexposed, sick
Children of mothers with epilepsy who had not redeemed prescription of anti-seizure medication. |
290 / 22227 | Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017). |
| Cohen (Topiramate) (Controls exposed to Lamotrigine, sick), 2019 |
USA 2000 - 2010 |
Deliveries during the study period in mothers 12-55 years of age with continuous enrollment from 3 months before pregnancy until 1 month after delivery. They are linked to live born infants in the database. | Restricted to pregnancies in women with epilepsy with at least one dispensed prescription for topiramate monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Restricted to pregnancies in women with epilepsy with at least one dispensed prescription for lamotrigine monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. |
-9 / -9 | Authors excluded deliveries with a major congenital malformation (identified by ICD-9). No crude data are available for the epilepsy subgroup with monotherapy exposure. |
| Cohen (Topiramate) (Controls unexposed NOS), 2019 |
USA 2000 - 2010 |
Deliveries during the study period in mothers 12-55 years of age with continuous enrollment from 3 months before pregnancy until 1 month after delivery. They are linked to live born infants in the database. | Restricted to pregnancies in women with epilepsy with at least one dispensed prescription for topiramate monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnancies in patients with no dispensing of lithium or any anticonvulsant (including those not used as mood stabilizers) from 3 months before pregnancy until 20 weeks of gestation. |
-9 / 1440631 | Authors excluded deliveries with a major congenital malformation (identified by ICD-9). No crude data are available for the epilepsy subgroup with monotherapy exposure. |
| Dreier (Topiramate) (Epilepsy) (Controls exposed to LTG), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017 |
Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017). | Children prenatally exposed to Topiramate monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth. |
exposed to other treatment, sick
Children prenatally exposed to Lamotrigine monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth. |
290 / 5288 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. Not the same category of age for Intellectual disabilities. |
| Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017 |
Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017). | Children prenatally exposed to topiramate monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth. |
unexposed, sick
Children not prenatally exposed to antiseizure medication. |
290 / 22203 | Overlapping for ASD (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Dreier 2023 => use of Dreier 2023 data. Not the same category of age for Intellectual disabilities. |
| Hao (Controls exposed to LTG), 2025 |
China Not specified. |
Women with confirmed epilepsy of childbearing age attending the neurology or gynecology clinics in one of four large hospital. | Pregnant women with confirmed epilepsy that used topiramate monotherapy during the first trimester of pregnancy. |
exposed to other treatment, sick
Pregnant women with confirmed epilepsy that used lamotrigine monotherapy during the first trimester of pregnancy. |
21 / 84 | Use of monotherapy data (table 2). |
| Hao (Controls unexposed, sick), 2025 |
China Not specified. |
Women with confirmed epilepsy of childbearing age attending the neurology or gynecology clinics in one of four large hospital. | Pregnant women with confirmed epilepsy that used topiramate monotherapy during the first trimester of pregnancy. |
unexposed, sick
Pregnant women with confirmed epilepsy and no anti-seizure medication use during the first trimester. |
21 / 261 | Use of monotherapy data (table 2). |
| Hernandez-Diaz, 2024 |
USA 2000 - 2020 |
Women with epilepsy 12 through 55 years of age linked with their liveborn children, and who had insurance coverage from at least 3 months before the date of the estimated last menstrual period to 1 month after delivery. | Women with epilepsy with at least one dispensing for topiramate monotherapy during the second half of pregnancy (defined as week 19 of gestation to delivery), which is a period of substantial synaptogenesis. |
unexposed, sick
Women with epilepsy without any dispensing of antiseizure medication between 90 days before the last menstrual period and delivery. |
623 / 8815 | In antiseizure medication meta-analysis : use of monotherapy data only => for this study, use of the secondary analyses, where exposure is defined as monotherapy (only provided for the Epilepsy-Restricted Cohort). => No use of the full-cohort data. |
| Hernández-Díaz (Topiramate), 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 topiramate only for epilepsy 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). |
-9 / 1562 | Less than 90% of women are taking Lamotrigine for epilepsy. After restriction to women with epilepsy for the exposed group. |
| Hernández-Díaz (Topiramate), 2017 |
United States and Canada 1997 - 2017 |
Singleton, nonmalformed liveborn infants whose mothers had complete follow-up data. | Infants born to women who used topiramate in monotherapy during 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 during pregnancy. |
394 / 1799 | 'Most women used their AED throughout pregnancy. The exception was topiramate due to a larger proportion of women with intermittent use for migraine'. The main indications for AED were epilepsy (91%). |
| Husebye (Topiramate) (Controls exposed to Lamotrigine, sick), 2020 |
Norway 1999 - 2008 |
Children of mothers with and without epilepsy included in the MoBa cohort. | Children of mothers with epilepsy exposed to topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children of mothers with epilepsy exposed to lamotrigine monotherapy during pregnancy. |
11 / 112 | |
| Husebye (Topiramate) (Controls unexposed, disease free), 2020 |
Norway 1999 - 2008 |
Children of mothers with and without epilepsy included in the MoBa cohort. | Children of mothers with epilepsy exposed to topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children of mothers without epilepsy. |
11 / 113674 | |
| Husebye (Topiramate) (Controls unexposed, sick), 2020 |
Norway 1999 - 2008 |
Children of mothers with and without epilepsy included in the MoBa cohort. | Children of mothers with epilepsy exposed to topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children of mothers with epilepsy unexposed to antiepileptic durgs during pregnancy. |
11 / 388 | For this comparison group, results are only available according to folic acid intake. |
| Li (Topiramate) (Controls exposed to LTG), 2023 |
China 2009 - 2022 |
All pregnant participants occurring between 2009 and 2022 in the cohort of women with epilepsy (WWE) of childbearing age (20–45 years old) enrolled from 31 medical institutions. | Women with epilepsy (WWE) using Topiramate monotherapy during pregnancy. |
exposed to other treatment, sick
Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy. |
7 / 38 | Overlapping: He 2017 totally included in Li 2023. Authors did not provide analysis after monotherapy exposure but raw data of major congenital malformation provided in the e-Supp allowed to extract data for monotherapy => only this outcome reported here. |
| Li (Topiramate) (Controls unexposed, sick), 2023 |
China 2009 - 2022 |
All pregnant participants occurring between 2009 and 2022 in the cohort of women with epilepsy (WWE) of childbearing age (20–45 years old) enrolled from 31 medical institutions. | Women with epilepsy (WWE) using Topiramate monotherapy during pregnancy. |
unexposed, sick
Women with epilepsy (WWE) not using antiseizure medications during pregnancy. |
7 / 253 | Overlapping: He 2017 totally included in Li 2023. Authors did not provide analysis after monotherapy exposure but raw data of major congenital malformation provided in the e-Supp allowed to extract data for monotherapy => only this outcome reported here. |
| Madley-Dowd_SE (Topiramate) (Controls exposed to LTG), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Fetal exposure to Topiramate monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy. |
exposed to other treatment, sick
Fetal exposure to Lamotrigine monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy. |
71 / 2383 | Data extracted from the e-Supp pdf (Table S10). |
| Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 |
Sweden 1995 - 2020 |
All liveborn children born between July 1, 1995, and December 31, 2020. | Fetal exposure to Topiramate monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy. |
unexposed, sick
No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication. |
71 / 10769 | Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10). |
| Madley-Dowd_UK (Topiramate) (Controls exposed to LTG) (Epilepsy), 2024 |
United Kingdom 1995 - 2018 |
All liveborn children of women aged 11–49 years in the Clinical Practice Research Datalink (CPRD) Pregnancy Register born between January 1, 1995, and December 31, 2018. | Fetal exposure to Topiramate monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
exposed to other treatment, sick
Fetal exposure to Lamotrigine monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
43 / 791 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S10). |
| Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 |
United Kingdom 1995 - 2018 |
All liveborn children of women aged 11–49 years in the Clinical Practice Research Datalink (CPRD) Pregnancy Register born between January 1, 1995, and December 31, 2018. | Fetal exposure to Topiramate monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period. |
unexposed, sick
No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication. |
43 / 4075 | Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10). |
| Mawer (Topiramate) (Controls exposed to Lamotrigine, sick), 2010 |
UK 2000 - 2006 |
Midwives in the antenatal clinics approached each woman, who gave a history of epilepsy (n=231), whatever her stage of gestation. | Children born to mothers with epilepsy exposed to topiramate monotherapy in utero. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children born to mothers with epilepsy exposed to lamotrigine monotherapy in utero. |
3 / 40 | Kini's 2007 malformation results are completely overlapped by this study (largest exposed population, longer study period). Period of exposure confirm by author's email. |
| Mawer (Topiramate) (Controls unexposed, disease free), 2010 |
UK 2000 - 2006 |
Women with epilepsy (WWE) and the healthy woman controls attending the same clinic. | Children born to mothers with epilepsy exposed to topiramate monotherapy in utero. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Children born to mothers without epilepsy who attended the same clinic on the same day or a few days later. |
3 / 315 | Kini's 2007 malformation results are completely overlapped by this study (largest exposed population, longer study period). Period of exposure confirm by author's email. |
| Mawer (Topiramate) (Controls unexposed, sick), 2010 |
UK 2000 - 2006 |
Midwives in the antenatal clinics approached each woman, who gave a history of epilepsy (n=231), whatever her stage of gestation. | Children born to mothers with epilepsy exposed to topiramate monotherapy in utero. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to women with untreated epilepsy, who took no antiepileptic drugs before or during pregnancy. |
3 / 46 | Kini's 2007 malformation results are completely overlapped by this study (largest exposed population, longer study period). Period of exposure confirm by author's email. |
| Meador (Topiramate) (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 topiramate 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. |
5 / 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 (Topiramate) (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 topiramate 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. |
6 / 113 | |
| Meador (Topiramate) (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 topiramate 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. |
5 / 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 (Topiramate) (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 topiramate 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. |
6 / 106 | |
| Meador (Topiramate) (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 topiramate 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. |
6 / 15 | |
| Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 |
UK and Ireland 1996 - 2005 |
Pregnant women with epilepsy, whether or not they were taking an AED, 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 topiramate 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. |
28 / 647 | There is a larger sample of women exposed to topiramate in this study than in Campbell's 2013 so its malformations results are preferred. Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
| Morrow (Topiramate) (Controls unexposed, sick), 2006 |
UK and Ireland 1996 - 2005 |
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 topiramate 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 and who didn't take any antiepileptic drugs during pregnancy. |
28 / 227 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
| Nadebaum (Topiramate), 2011 |
Australia 2007 - 2009 |
160 women with epilepsy and their 173 children aged 6 to 8 years recruited through the register. | Children exposed to topiramate monotherapy in utero from epileptic mother. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed to lamotrigine monotherapy in utero from epileptic mother. |
1 / 9 | Children with major birth defects or a diagnosis of epilepsy were ineligible for the study to avoid possible confounding effects of these known risk factors for intellectual impairment. |
| Ornoy (Topiramate), 2008 |
Israel 1996 - 2006 |
Pregnancies of women who contacted the Israeli Teratogen Information Service (TIS) during the study period in regard to exposure to topiramate. | Pregnancies exposed to topiramate monotherapy at least during the first trimester of pregnancy. |
unexposed (general population or NOS)
Pregnancies of women who contacted the TIS at the same period of time and were exposed to non-teratogenic agents. |
29 / 212 | The design of the study isn't made explicit in the materials and methods so an other publication from the Israeli Teratogen Information Service is used to complete those informations (Diav-Citrin 2008). |
| Razaz (Topiramate), 2024 |
Denmark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
All singleton births at 22 or more completed gestational weeks in the 5 Nordic countries during the different study periods. | Mothers with epilepsy who filled a prescription for Topiramate monotherapy between the date of the last menstrual period (LMP) and the day of birth. |
unexposed, sick
Mothers with epilepsy who did not fill an antiseizure medication (ASM) prescription in the period between 90 days before the last menstrual period (LMP) and the day of birth. |
249 / 19043 | |
| Razaz (Topiramate) (Controls exposed to Lamotrigine, sick), 2017 |
Sweden 1997- 2011 |
All singleton births at 22 or more completed gestational weeks. | Infants of mothers with epilepsy who had reimbursement for topiramate monotherapy between 30 days before the estimated day of conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants of mothers with epilepsy who had reimbursement for lamotrigine monotherapy between 30 days before the estimated day of conception to the day of birth. |
24 / 503 | |
| Razaz (Topiramate) (Controls unexposed, disease free), 2017 |
Sweden 1997- 2011 |
All singleton births at 22 or more completed gestational weeks. | Infants of mothers with epilepsy who had reimbursement for topiramate monotherapy between 30 days before the estimated day of conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Infants of mothers without epilepsy. |
24 / 1424279 | |
| Razaz (Topiramate) (Controls unexposed, sick), 2017 |
Sweden 1997- 2011 |
All singleton births at 22 or more completed gestational weeks. | Infants of mothers with epilepsy who had reimbursement for topiramate monotherapy between 30 days before the estimated day of conception to the day of birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Infants of mothers with epilepsy not receiving antiepileptic drug between 30 days before the estimated day of conception to the day of birth. |
24 / 1868 | |
| Thomas (Topiramate) (Controls exposed to Lamotrigine, sick), 2021 |
India 1998 - 2019 |
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 topiramate 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. |
9 / 50 | Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication. |
| Thomas (Topiramate) (Controls unexposed, disease free), 2021 |
India 1998 - 2015 |
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 topiramate 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, disease free
Children of women without epilepsy in the first trimester of pregnancy and not using antiepileptic drugs from the antenatal clinic of government hospital. |
6 / 319 | This external control group is only available in the 2017 publication. |
| Thomas (Topiramate) (Controls unexposed, sick), 2021 |
India 1998 - 2019 |
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 topiramate 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. |
9 / 340 | Study design completed with Thomas et al., 2017. |
| Thomas b (Controls exposed to LTG), 2022 |
India 1998 - 2019 |
All babies of women with epilepsy (WWE) enrolled in the pre-pregnancy stage or in the first trimester of pregnancy, who were over 12 months of age on 31st December, 2020 (and less than 24 months). | Infants of women with epilepsy who were exposed to Topiramate monotherapy at anytime during the antenatal period. |
exposed to other treatment, sick
Infants of women with epilepsy who were exposed to Lamotrigine monotherapy at anytime during the antenatal period. |
6 / 26 | No use of delayed mental development, because discrepancy in LTG data '1/26 (11.5%)'. |
| Thomas b (Controls unexposed, sick), 2022 |
India 1998 - 2019 |
All babies of women with epilepsy (WWE) enrolled in the pre-pregnancy stage or in the first trimester of pregnancy, who were over 12 months of age on 31st December, 2020 (and less than 24 months). | Infants of women with epilepsy who were exposed to Topiramate monotherapy at anytime during the antenatal period. |
unexposed, sick
Infants of women with epilepsy who were not exposed to any antiseizure medications (ASMs) during pregnancy. |
6 / 110 | |
| Tomson (Topiramate), 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 topiramate 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. |
152 / 2514 | Overlapping/Update: (Major) malfo as a whole: Battino 2024 (1999-2022) updates Tomson 2018 (1999-2016), Tomson 2011, Martinez 2009 => These outcomes are not reported here (use of Battino 2024). |
| Trivedi (Topiramate) (Controls exposed to Lamotrigine, sick), 2018 |
India 1998 - 2015 |
All women with epilepsy who had completed their pregnancies and enrolled in the registry between the study period. The diagnosis of epilepsy was confirmed before registration. | Pregnant women with epilepsy who used topiramate 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
Pregnant women with epilepsy who used lamotrigine monotherapy any time during the first trimester of pregnancy. |
11 / 48 | Study design partly completed with cites source Thomas et al., 2017. |
| Trivedi (Topiramate) (Controls unexposed, sick), 2018 |
India 1998 - 2015 |
All women with epilepsy who had completed their pregnancies and enrolled in the registry between the study period. The diagnosis of epilepsy was confirmed before registration. | Pregnant women with epilepsy who used topiramate 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
Pregnant women with epilepsy who were not on antiepileptic drug during their first trimester. |
11 / 178 | Study design partly completed with cites source Thomas et al., 2017. |
| Vajda (Topiramate) (Controls exposed to Lamotrigine, sick), 2013 |
Australia 1999 - 2013 |
Pregnant women with epilepsy whether treated with antiepileptic drugs or left untreated or pregnant women taking antiepileptic drugs for other purposes. | Offsprings from women with epilepsy exposed to topiramate in monotherapy in at least 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
Offsprings from women with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy. |
44 / 315 | Women taking AED for epilepsy are in majority (more than 90%). Vajda 2019 provides the most recent update for major malformations results for this register. Specific malformations' results are extracted from the review by Weston et al. 2016. |
| Vajda (Topiramate) (Controls unexposed, sick), 2013 |
Australia 1999 - 2013 |
Pregnant women with epilepsy whether treated with antiepileptic drugs or left untreated or pregnant women taking antiepileptic drugs for other purposes. | Offsprings from women with epilepsy exposed to topiramate in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offsprings from women with epilepsy not exposed to antiepileptic drugs in at least the first trimester of pregnancy. |
44 / 147 | Women taking AED for epilepsy are in majority (more than 90%). Vajda 2019 provides the most recent update for major malformations results for this register. Specific malformations' results are extracted from the review by Weston et al. 2016. |
| Vajda a (Topiramate) (Controls exposed to LTG), 2024 |
Australia 1999 - 2023 |
Women with epilepsy (WWE), with voluntary inclusion, with known outcomes but in which that outcome was unknown at the time of the pregnancy’s enrolment. | Women with epilepsy exposed to Topiramate monotherapy during pregnancy. |
exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine monotherapy during pregnancy. |
58 / 442 | Overlapping between Vajda 2024a (1999 - 2023) and Vajda 2018 (1999 - 2016) based on the same register and for the almost same outcome (with or without elective termination) => Use of Vajda 2024a because accounting for more relevant confounders. |
| Vajda a (Topiramate) (Controls unexposed sick), 2024 |
Australia 1999 - 2023 |
Women with epilepsy (WWE), with voluntary inclusion, with known outcomes but in which that outcome was unknown at the time of the pregnancy’s enrolment. | Women with epilepsy exposed to Topiramate monotherapy during pregnancy. |
unexposed, sick
Women with epilepsy unexposed to antiseizure medication during pregnancy. |
58 / 184 | Overlapping between Vajda 2024a (1999 - 2023) and Vajda 2018 (1999 - 2016) based on the same register and for the almost same outcome (with or without elective termination) => Use of Vajda 2024a because accounting for more relevant confounders. |
| Vajda b (Topiramate) (Epilepsy) (Controls exposed to Lamotrigine, sick), 2024 |
Australia 1999 - 2022 |
Pregnant women with epilepsy collected in the Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs between 1999 and mid- 2022. | Women with epilepsy exposed to topiramate in monotherapy in early pregnancy. |
exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine in monotherapy in early pregnancy. |
65 / 473 | Overlapping: Vajda 2024 totally included other APR data (Vajda 2019; Vajda 2007; 2010 (x2); 2012 (x2); 2013; 2014). Study design partly completed with Vajda 2013. |
| Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick), 2024 |
Australia 1999 - 2022 |
Pregnant women with epilepsy collected in the Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs between 1999 and mid- 2022. | Women with epilepsy exposed to topiramate in monotherapy in early pregnancy. |
unexposed, sick
Women with epilepsy not treated with antiepileptic drugs in early pregnancy. |
65 / 201 | Overlapping: Vajda 2024 totally included other APR data (Vajda 2019; Vajda 2007; 2010 (x2); 2012 (x2); 2013; 2014). Study design partly completed with Vajda 2013. |
| Veiby (Topiramate) (Controls exposed to Lamotrigine, sick), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to topiramate as monotherapy indicated for their mothers' epilepsy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children exposed prenatally to lamotrigine as monotherapy indicated for their mothers' epilepsy. |
43 / 593 | We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy. |
| Veiby (Topiramate) (Controls unexposed, disease free), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to topiramate as monotherapy indicated for their mothers' epilepsy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
All unexposed children born to women without epilepsy. |
43 / 771412 | We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy. |
| Veiby (Topiramate) (Controls unexposed, sick), 2014 |
Norway 1999 - 2011 |
777,785 deliveries recorded in the database during the study period. | Children exposed prenatally to topiramate as monotherapy indicated for their mothers' epilepsy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children born to women with a history of epilepsy but no antiepileptic drug treatment during pregnancy. |
43 / 3773 | We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy. |
| Wood (Topiramate), 2015 |
Australia 2007 - 2010 |
Women with epilepsy and their children (aged 6–8 years) exposed in utero with antiepileptic drugs were identified through the Australian Pregnancy Register for Women on Antiepileptic Medication (APR). | Children of women with epilepsy exposed to topiramate in monotherapy during 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 exposed to lamotrigine in monotherapy during pregnancy. |
1 / 9 | Children with major birth defects or a diagnosis of epilepsy were excluded, as these conditions are known risk factors for autism spectrum disorders. Child IQ isn't specified for this monotherapy alone. |
| Study | Country Study period |
Case | Control | Sample size | Rmk |
|---|
4 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.
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