| 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 | |
| Bank (Topiramate) (Mixed indications) , 2017 |
USA 2002 - 2006 |
Only pregnant women who were treated with antiepileptic drugs for epilepsy or bipolar disorder who chose to continue antiepileptic drugs during pregnancy and whose infants had umbilical cord antiepileptic drugs levels drawn at the time of delivery were included. | Singleton pregnancies in mothers taking topiramate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Singleton pregnancies in mothers taking lamotrigine monotherapy during pregnancy. |
2 / 36 | |
| Bech (Topiramate) (Mixed indications), 2018 |
Denmark 2005 - 2008 |
All births in Denmark were identified during the study period in the Danish Medical Birth Register and only offspring of mothers exposed to antiepileptic drugs were included. | Singleton offspring of mothers exposed to topiramate monotherapy within 90 days prior to conception to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Singleton offspring of mothers exposed to antiepileptic drugs at any time but not during pregnancy. |
27 / 434 | |
| 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 exposed to Lamotrigine, sick) (Mixed indications), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in 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 mothers filling at least one lamotrigine monotherapy prescription from her last menstrual period until birth. |
471 / 7950 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 because all indications included => use of Bjork 2022 data. Bjørk 2021 is an abstract of this publication. |
| Bjørk (Topiramate) (Controls unexposed NOS) (Mixed indications), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in 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. |
471 / 4463879 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 because all indications included => use of Bjork 2022 data. Bjørk 2021 is an abstract of this publication. |
| 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), 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. |
| Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 |
Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017 |
Singleton births born from mothers from five Nordic countries. | Pregnacies in 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. |
471 / 21634 | Overlapping for ASD (2 outcomes) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 because all indications included => use of Bjork 2022 data. Bjørk 2021 is an abstract of this publication. |
| Blotière (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 |
France 2011 - 2015 |
All pregnancies ending between the study period with at least 20 weeks of gestation | Pregnancies exposed to topiramate monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies exposed to lamotrigine monotherapy between 1 month before and 2 months after the beginning of pregnancy. |
517 / 2997 | Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0. |
| Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 |
France 2011 - 2015 |
All pregnancies ending between the study period with at least 20 weeks of gestation | Pregnancies exposed to topiramate monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Pregnancies with no reimbursement for antiepileptic drugs. |
517 / 1875733 | Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0. |
| 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. |
| Cohen (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 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. | Pregnancies in women 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
Pregnancies in women with at least one dispensed prescription for lamotrigine monotherapy (no other mood stabilizers or other anticonvulsants) in the first 20 weeks of pregnancy. |
2280 / 2682 | Authors excluded deliveries with a major congenital malformation (identified by ICD-9). |
| Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 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. | Pregnancies in women 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. |
2280 / 1440631 | Authors excluded deliveries with a major congenital malformation (identified by ICD-9). |
| Cohen (Topiramate) (Mixed indications) (Controls exposed to LTG), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2020 |
All pregnancies in the general population, including singleton and multiple births, live births and stillbirths, with a gestational age of at least 22 weeks occurring during the study period (terminations of pregnancy for fetal anomaly (TOPFAs) recorded in Norway, Finland and Denmark but not in Sweden or Iceland). | Pregnancies in which the mother had filled one or more prescriptions of topiramate ([ATC] code N03AX11) monotherapy during the first trimester. |
exposed to other treatment, sick
Pregnancies in which the mother had filled one or more prescriptions of lamotrigine monotherapy during the first trimester. |
509 / 8339 | Overlapping: For Kallen 2013 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Main topiramate indications: 47% epilepsy; 27% unknown; 23% migraine. |
| Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023 |
Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2020 |
All pregnancies in the general population, including singleton and multiple births, live births and stillbirths, with a gestational age of at least 22 weeks occurring during the study period (terminations of pregnancy for fetal anomaly (TOPFAs) recorded in Norway, Finland and Denmark but not in Sweden or Iceland). | Pregnancies in which the mother had filled one or more prescriptions of topiramate ([ATC] code N03AX11) monotherapy during the first trimester. |
unexposed (general population or NOS)
Pregnancies in which the mother had not filled a prescription for any Antiseizure medication (ATC code N03A) from 90 days before LMP to the end of the first trimester. |
509 / 4866362 | Overlapping: For Kallen 2013 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Main topiramate indications: 47% epilepsy; 27% unknown; 23% migraine. |
| Coste (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 |
France 2011 - 2014 |
All liveborn singleton children born during the study period. The mother had to be covered by the national health insurance general scheme for salaried workers and to have had at least one health expenditure reimbursement over the 2 years preceding the onset of pregnancy. | Children born from mothers exposed to topiramate monotherapy indicated for the treatment of epilepsy and migraine with at least one dispensing between the month preceding onset of pregnancy and its end. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children born from mothers exposed to lamotrigine monotherapy for mixed indications during pregnancy. |
477 / 2916 | Children with a diagnosis of brain malformation (ICD-10 codes Q00 to Q04 and Q05.0 to Q05.4) during their stay in the maternity unit are excluded. Results are extracted from Blotière et al. 2020 because they reported aOR for vs LTG. |
| Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 |
France 2011 - 2014 |
All liveborn singleton children born during the study period. The mother had to be covered by the national health insurance general scheme for salaried workers and to have had at least one health expenditure reimbursement over the 2 years preceding the onset of pregnancy. | Children born from mothers exposed to topiramate monotherapy indicated for the treatment of epilepsy and migraine with at least one dispensing between the month preceding onset of pregnancy and its end. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children born from mothers not exposed to any antiepileptic drug during pregnancy. |
477 / 1710441 | Children with a diagnosis of brain malformation (ICD-10 codes Q00 to Q04 and Q05.0 to Q05.4) during their stay in the maternity unit are excluded. |
| Dreier (Topiramate), 2021 |
Danemark, Finland, Iceland, Norway, Sweden 1996 (depends)-2017 |
Live-born singleton children from women with epilepsy in five Nordic countries. | Offspring of women with prescription for topiramate monotherapy from 90 days before pregnancy to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offspring of women with epilepsy not using antiseizure medication in pregnancy. |
217 / -9 | Unknown number in the exposed and unexposed group (abstract). |
| 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) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 because all indications included => use of Bjork 2022 data. |
| 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) and Intellectual disabilities (2 outcomes): Dreier 2023 and Bjork 2022, with more pregnancies in Bjork 2022 because all indications included => use of Bjork 2022 data. |
| 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%). |
| Hernández-Díaz (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 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 for mixed indications 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). |
359 / 1562 | Total congenital malformations results are completely overlapped by the update on the registry website. Less than 90% of women are taking Lamotrigine and Topiramate for epilepsy. |
| Hernández-Díaz (Topiramate) (Controls unexposed, disease free) (Mixed indications), 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 for mixed indications 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. |
359 / 442 | Total congenital malformations results are completely overlapped by the update on the registry website. Less than 90% of women are taking Topiramate for epilepsy. |
| Hernandez-Diaz (Topiramate) (Mixed indications), 2018 |
USA 2000 - 2010 |
All pregnancies in women 12 to 55 years old that resulted in a live birth enrolled in Medicaid from 3 months before the date of the LMP to 1 month after delivery. Infants were required to be enrolled in Medicaid for the first 3 months of life unless they died sooner. | Pregnancies exposed to topiramate in first trimester but without any dispensing for other anticonvulsant drugs during the 3 months before the start of pregnancy or during the first trimester. |
unexposed (general population or NOS)
Pregnancies unexposed to topiramate or other anticonvulsants during the 3 months prior to the start of pregnancy and during the first trimester. |
1790 / 1322955 | Less than 90% of women are taking Topiramate for epilepsy. Pregnancies exposed to a known teratogenic medication during the first trimester other than an antiepileptic drug and pregnancies with a documented chromosomal abnormality were excluded. |
| Hernández-Díaz (Topiramate) (Mixed indications) (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 topiramate for mixed indications as monotherapy during 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 during pregnancy. |
347 / 1581 | Less than 90% of women are taking Topiramate and Lamotrigine for epilepsy. A more recent publication Hernández-Díaz 2017 gives a better review of the outcome 'small for gestational age' (largest exposed population). |
| Hernández-Díaz (Topiramate) (Mixed indications) (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 topiramate for mixed indications as monotherapy during 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. |
347 / 457 | Less than 90% of women are taking topiramate for epilepsy. A more recent publication (Hernández-Díaz 2017) gives a better review for the outcome 'small for gestational age'. |
| 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. |
| Källén (Topiramate) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 |
Swedish 1996 - 2011 |
Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth Register. | Infants whose mothers used topiramate in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Infants whose mothers used lamotrigine in monotherapy in early pregnancy. |
49 / 1084 | Overlapping: Cohen 2023 and Kallen 2013 => less of 50% of overlapping => the 2 studies were kept. Razaz 2017 and Wide 2004 outcomes' already included in Källèn 2013 or not compared to an adequate control group. Follow-up period: author's email reply. |
| Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013 |
Swedish 1996 - 2011 |
Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth Register. | Infants whose mothers used topiramate in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy. |
49 / 1575847 | Overlapping: Cohen 2023 and Kallen 2013 => less of 50% of overlapping => the 2 studies were kept. Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply. |
| Kilic (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 |
Denmark 1997 - 2008 |
All singleton live-born children in Denmark during the study period. | Children whose mothers have been exposed to topiramate in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Children whose mothers have been exposed to lamotrigine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. |
59 / 880 | Less than 90% of women are epileptic. |
| Kilic (Topiramate) (Controls unexposed NOS) (Mixed indications), 2014 |
Denmark 1997 - 2008 |
All singleton live-born children in Denmark during the study period. | Children whose mothers have been exposed to topiramate in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
Children whose mothers haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth. |
59 / 676834 | Less than 90% of women are epileptic. |
| Kilic (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 |
Denmark 1997 - 2008 |
All singleton live-born children in Denmark during the study period. | Children whose mothers have been exposed to topiamate in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Children whose mothers have an epilepsy diagnosis and haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth. |
59 / 5296 | Less than 90% of women are epileptic. |
| 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. |
| Lyons (Topiramate) (Indications NOS), 2023 |
USA 2000 - 2015 |
Singleton live birth of mothers aged 12–55 years present in the linked mother-infant pairs in the Mother-Infant Linkage (MIL) table. | Singleton live birth of mothers with at least one dispensing of topiramate during the first trimester of pregnancy (and no use of other anticonvulsants). |
unexposed (general population or NOS)
Singleton live birth of mothers unexposed to anticonvulsants (with no dispensing for topiramate or other anticonvulsants in the 90 days prior to estimated last menstrual period through the first trimester). |
-9 / 1066086 | Numbers of cases and exposures in topiramate monotherapy group not provided by authors (topiramate monotheray studied as a sensitivity analysis in the publication). |
| 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 | |
| Mines (Topiramate) (Other indications), 2014 |
USA 1997 - 2010 |
Women with an identifiable infant born during the study period who had at least 90 days of post‐delivery enrollment and if mothers were continuously enrolled in the health plan for at least 6 months before the presumed conception date and throughout pregnancy. | Infant born to women exposed to topiramate monotherapy during the first trimester of pregnancy. |
unexposed, sick
Infant born to women formerly exposed to topiramate or any other antiepileptic drugs but with no exposure to these agents in the first trimester or 4 months before the earliest estimated date of conception. |
1745 / 13512 | There is 3.3% epilepsy indication in the topiramate cohorte and 2.5% epilepsy indication in the formerly exposed cohort. Potential cases of oral cleft identified with concurrent diagnoses of syndromic, genetic, or chromosomal defects were disqualified. |
| 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). |
| Richards (Topiramate) (Controls exposed to Lamotrigine, sick) (Indications NOS), 2019 |
New Zealand 2008 - 2012 |
Between 2012 and 2016, 89% of all eligible four-year-olds participated in the program. | Children exposed to topiramate monotherapy during pregnancy (the exposure window was defined as nine months before the day of birth). (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 during pregnancy (the exposure window was defined as nine months before the day of birth). |
28 / 149 | The National Minimum Dataset does not provide reliable diagnosis information. Indications not specified. |
| Richards (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2019 |
New Zealand 2008 - 2012 |
Between 2012 and 2016, 89% of all eligible four-year-olds participated in the program. | Children exposed to topiramate monotherapy during pregnancy (the exposure window was defined as nine months before the day of birth). (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All other children unexposed to antiepileptic drug in utero who had a Before School Check (B4SC) in the study period. |
28 / 286966 | The National Minimum Dataset does not provide reliable diagnosis information. Indications not specified. |
| Rihtman (Topiramate) (Mixed indications), 2012 |
Israel 2001 - 2006 |
Pregnant or pre-pregnant women who contacted the Teratogen Information Service during the study period with queries concerning topiramate. | Children exposed in utero at least during the first trimester to topiramate monotherapy from mothers with or without epilepsy. |
unexposed (general population or NOS)
Children recruited by means of a convenience sample from the general population. |
9 / 18 | The exclusion criteria for all groups stipulated that no children had genetic abnormalities nor had a full scale IQ of less than 70. Mixed indications because 'three took TX for reasons other than epilepsy' (33.3%). |
| The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 |
North America and Canada 1997 - 2020 |
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 as 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 pregnant women who used lamotrigine as monotherapy, during the first trimester. |
503 / 2333 | Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Indications not specified. |
| The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 |
North America and Canada 1997 - 2020 |
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 as monotherapy, during the first trimester. (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. |
503 / 1201 | Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Internal control group reported rather than the external (for relevance purpose). Indications not specified. |
| 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. |
| 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 | 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. |
| 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 exposed to Lamotrigine, sick), 2019 |
Australia 1999 - 2018 |
Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy. | Offsprings born from women nearly always 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 born from women nearly always with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy. |
53 / 406 | Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2007; 2010 (x2); 2012 (x2); 2013; 2014 and Jazayeri 2018. Study design partly completed with Vajda 2013. |
| Vajda (Topiramate) (Controls exposed to Lamotrigine, sick), 2018 |
Australia 1999 - 2016 |
Pregnant women whether treated with antiepileptic drugs or left untreated in at least the first half of pregnancy. | Offsprings of pregnant women with epilepsy exposed to topiramate in monotherapy throughout. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Offsprings of pregnant women with epilepsy exposed to lamotrigine in monotherapy throughout. |
51 / 382 | |
| 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 (Topiramate) (Controls unexposed, sick), 2019 |
Australia 1999 - 2018 |
Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy. | Offsprings born from women nearly always 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 born from women nearly always with epilepsy not treated with antiepileptic drugs in at least the first half of pregnancy. |
53 / 176 | Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2007; 2010 (x2); 2012 (x2); 2013; 2014; 2016 and Jazayeri 2018. Study design partly completed with Vajda 2013. |
| Vajda (Topiramate) (Controls unexposed, sick), 2018 |
Australia 1999 - 2016 |
Pregnant women whether treated with antiepileptic drugs or left untreated in at least the first half of pregnancy. | Offsprings of pregnant women with epilepsy exposed to topiramate in monotherapy throughout. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Offsprings of pregnant women with epilepsy that have been untreated in at least the first half of pregnancy. |
51 / 170 | |
| Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 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 or other indications. (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 or other indications. |
48 / 833 | Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Less than 90% of women are treated with Topiramate and Lamotrigine for epilepsy (Mixed indications). |
| Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 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 or other indications. (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. |
48 / 771412 | Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Less than 90% of women are treated with Topiramate and Lamotrigine for epilepsy (Mixed indications). |
| Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 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 or other indications. (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. |
48 / 3773 | Overlapping: Cohen 2023 and Veiby 2014 => less of 50% of overlapping => the 2 studies were kept. Less than 90% of women are treated with Topiramate and Lamotrigine for epilepsy (Mixed indications). |
| 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 |
|---|---|---|---|---|---|
| Margulis (Topiramate) (Mixed indication), 2012 |
USA 1997 - 2009 |
Infants with major congenital malformations as a group (including oral clefts) and separately on CL/P with or without other major congenital malformations. | Infants without congenital malformations randomly selected. | 33605 / 15367 | To avoid duplication of participants, the BDS does not enroll women who are in the same catchments as NBDPS subjects. In this study, epilepsy was reported by less than half of topiramate users. |
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