Topiramate (Epilepsy)

Exposed non-exposed, cohort studies

Study Country
Study period
Study design		 Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Alsfouk (Topiramate) (Controls exposed to Lamotrigine, sick)
2021 		Riyadh and Jeddah, Saudi Arabia.
1993 - 2020
retrospective cohort 		The King Faisal Specialist Hospital and Research Centre (KFSHRC), Riyadh and Jeddah, Saudi Arabia. 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. 		during pregnancy (anytime or not specified) 2 / 15
Patients’ electronic and paper-based medical records.
Alsfouk (Topiramate) (Controls unexposed, sick)
2021 		Riyadh and Jeddah, Saudi Arabia.
1993 - 2020
retrospective cohort 		The King Faisal Specialist Hospital and Research Centre (KFSHRC), Riyadh and Jeddah, Saudi Arabia. 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. 		during pregnancy (anytime or not specified) 2 / 30
Patients’ electronic and paper-based medical records.
AlSheikh (Topiramate) (Controls exposed to Lamotrigine, sick)
2020 		Saudi Arabia
2018 - 2019
prospective cohort 		King Fahd University Hospital 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. 		during pregnancy (anytime or not specified) 1 / 20
Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'.
AlSheikh (Topiramate) (Controls unexposed, sick)
2020 		Saudi Arabia
2018 - 2019
prospective cohort 		King Fahd University Hospital 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. 		during pregnancy (anytime or not specified) 1 / 8
Information was collected through a structured questionnaire ‘Questionnaire for Investigation of Epilepsy in Tropical Countries'.
Arkilo (Topiramate)
2015 		USA
2006 - 2011
retrospective cohort 		Minnesota Epilepsy Group, P.A. of United Hospital and Children's Hospitals and Clinics of Minnesota 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. 		during pregnancy (anytime or not specified) 2 / 24
Questionnaires were sent to women.
Babic (Topiramate)
2014 		Serbia
1998 - 2008
prospective cohort 		Clinic of Neurology and Psychiatry for Children and Youth 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. 		during pregnancy (anytime or not specified) 2 / 8
Not specified.
Battino
2024 		Worldwide (47 countries)
1999 - 2022
prospective cohort 		The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). 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. 		early pregnancy 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.
Reporting physicians collected information on drug therapy after each trimester.
Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick)
2022 		Danemark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		Social register data from Danemark, Finland, Iceland, Norway, Sweden for SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy. 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. 		during pregnancy (anytime or not specified) 246 / 5073 Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up.
Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01.
Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick)
2018 		Norway
1999 - 2008
population based cohort propective 		The Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. 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. 		during pregnancy (anytime or not specified) 10 / 104
Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway.
Bjørk (Topiramate) (Controls unexposed NOS)
2022 		Danemark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		Social register data from Danemark, Finland, Iceland, Norway, Sweden for SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy. 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. 		during pregnancy (anytime or not specified) 246 / 4463879 Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up.
Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01.
Bjørk (Topiramate) (Controls unexposed, disease free)
2018 		Norway
1999 - 2008
population based cohort propective 		The Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. 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. 		during pregnancy (anytime or not specified) 10 / 104222
Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway.
Bjørk (Topiramate) (Controls unexposed, sick)
2018 		Norway
1999 - 2008
population based cohort propective 		The Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. 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. 		during pregnancy (anytime or not specified) 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.
Information on anti-epileptics use was obtained from the questionnaires completed by mothers during gestational weeks 17 to 19 (Q1) and 30 (Q2); and through the Medical Birth Registry of Norway.
Bjørk (Topiramate) (Controls unexposed, sick)
2022 		Danemark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		Social register data from Danemark, Finland, Iceland, Norway, Sweden for SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy. 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. 		during pregnancy (anytime or not specified) 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.
Prescriptions through national prescription registers according to Anatomical Therapeutic Chemical classification codes N03, N05BA09, and S01EC01.
Bromley (Topiramate)
2016 		UK
2004 - 2007
retrospective cohort (registry) 		The UK Epilepsy and Pregnancy Register. 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. 		during pregnancy (anytime or not specified) 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.
Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.
Christensen (Topiramate) (Epilepsy) (Controls exposed to LTG)
2024 		Denmark, Finland, Iceland, Norway, and Sweden
1996 - 2017
population based cohort retrospective 		Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project. 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). 		during pregnancy (anytime or not specified) 290 / 5299 Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing.
Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population)
2024 		Denmark, Finland, Iceland, Norway, and Sweden
1996 - 2017
population based cohort retrospective 		Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project. 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. 		during pregnancy (anytime or not specified) 290 / 22227 Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing.
Cohen (Topiramate) (Controls exposed to Lamotrigine, sick)
2019 		USA
2000 - 2010
retrospective cohort (claims database) 		Medicaid Analytic eXtract (MAX) 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. 		early 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.
The Medicaid Analytic Extract data include prescriptions filled on an outpatient basis.
Cohen (Topiramate) (Controls unexposed NOS)
2019 		USA
2000 - 2010
retrospective cohort (claims database) 		Medicaid Analytic eXtract (MAX) 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. 		early pregnancy -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.
The Medicaid Analytic Extract data include prescriptions filled on an outpatient basis.
Dreier (Topiramate) (Epilepsy) (Controls exposed to LTG)
2023 		Denmark, Finland, Iceland, Norway, and Sweden.
1996 - 2017
population based cohort propective 		A prospective, population-based register study within the SCAN-AED project, based on children born in Denmark, Finland, Iceland, Norway, and Sweden. 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. 		during pregnancy (anytime or not specified) 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.
Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code.
Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick)
2023 		Denmark, Finland, Iceland, Norway, and Sweden.
1996 - 2017
population based cohort propective 		A prospective, population-based register study within the SCAN-AED project, based on children born in Denmark, Finland, Iceland, Norway, and Sweden. 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. 		during pregnancy (anytime or not specified) 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.
Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code.
Hao (Controls exposed to LTG)
2025 		China
Not specified.
prospective cohort 		The West China Registry of Pregnancy in Epilepsy (WCRP_ Epi), an ongoing prospective multicenter cohort study based in Sichuan Province, Southwest China. 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. 		1st trimester 21 / 84 Use of monotherapy data (table 2).
Treatment information was collected through case report forms mainly through face-to-face visits in the neurology clinic or remotely by video/telephone calls, at each trimester of pregnancy.
Hao (Controls unexposed, sick)
2025 		China
Not specified.
prospective cohort 		The West China Registry of Pregnancy in Epilepsy (WCRP_ Epi), an ongoing prospective multicenter cohort study based in Sichuan Province, Southwest China. 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. 		1st trimester 21 / 261 Use of monotherapy data (table 2).
Treatment information was collected through case report forms mainly through face-to-face visits in the neurology clinic or remotely by video/telephone calls, at each trimester of pregnancy.
Hernandez-Diaz
2024 		USA
2000 - 2020
retrospective cohort (claims database) 		Medicaid beneficiaries nationwide, and the Merative MarketScan Commercial Claims and Encounters Database (referred as MarketScan). 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. 		2nd and/or 3rd trimester 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.
Medicaid beneficiaries nationwide, and the Merative MarketScan Commercial Claims and Encounters Database, two data sources that contain information on dispensed outpatient prescription medications.
Hernández-Díaz (Topiramate)
2017 		United States and Canada
1997 - 2017
prospective cohort 		The North American Antiepileptic Drug Pregnancy Registry 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. 		during pregnancy (anytime or not specified) 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%).
Women were questioned with a computer-assisted telephone interview 3 times.
Hernández-Díaz (Topiramate)
2012 		North America and Canada
1997 - 2011
prospective cohort 		The North American Antiepileptic Drug Pregnancy Register and the Active Malformations Surveillance Program. 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). 		1st trimester -9 / 1562 Less than 90% of women are taking Lamotrigine for epilepsy. After restriction to women with epilepsy for the exposed group.
Women were questioned with a computer-assisted telephone interview 3 times.
Husebye (Topiramate) (Controls exposed to Lamotrigine, sick)
2020 		Norway
1999 - 2008
population based cohort propective 		Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. 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. 		during pregnancy (anytime or not specified) 11 / 112
Information on the anti-epileptic (AED) use was obtained from the maternal questionnaires completed during gesta week 17–19 and week 30 and from Medical Birth Registry data. AEDs plasma concentrations were analysed in maternal and umbilical cord samples (73%) and were detected in 93% of children.
Husebye (Topiramate) (Controls unexposed, disease free)
2020 		Norway
1999 - 2008
population based cohort propective 		Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. 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. 		during pregnancy (anytime or not specified) 11 / 113674
Information on the anti-epileptic (AED) use was obtained from the maternal questionnaires completed during gesta week 17–19 and week 30 and from Medical Birth Registry data. AEDs plasma concentrations were analysed in maternal and umbilical cord samples (73%) and were detected in 93% of children.
Husebye (Topiramate) (Controls unexposed, sick)
2020 		Norway
1999 - 2008
population based cohort propective 		Norwegian Mother and Child Cohort Study (MoBa) and The Medical Birth Registry of Norway. 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. 		during pregnancy (anytime or not specified) 11 / 388 For this comparison group, results are only available according to folic acid intake.
Information on the anti-epileptic (AED) use was obtained from the maternal questionnaires completed during gesta week 17–19 and week 30 and from Medical Birth Registry data. AEDs plasma concentrations were analysed in maternal and umbilical cord samples (73%) and were detected in 93% of children.
Li (Topiramate) (Controls exposed to LTG)
2023 		China
2009 - 2022
prospective cohort 		A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center. Women with epilepsy (WWE) using Topiramate monotherapy during pregnancy. exposed to other treatment, sick
Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy. 		during pregnancy (anytime or not specified) 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.
The use of antiseizure medications on the included patients was registered by doctors and trained researchers.
Li (Topiramate) (Controls unexposed, sick)
2023 		China
2009 - 2022
prospective cohort 		A prospective cohort study entitled 'Construction and Application of the Women with Epilepsy of Child-bearing Age Ontology (WWECA)', with West China Hospital of Sichuan University as the main center. Women with epilepsy (WWE) using Topiramate monotherapy during pregnancy. unexposed, sick
Women with epilepsy (WWE) not using antiseizure medications during pregnancy. 		during pregnancy (anytime or not specified) 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.
The use of antiseizure medications on the included patients was registered by doctors and trained researchers.
Madley-Dowd_SE (Topiramate) (Controls exposed to LTG)
2024 		Sweden
1995 - 2020
population based cohort retrospective 		The Swedish Developmental Origins of Health and Disease (DOHaD) cohort, which is a registry study linking several national electronic data sources. 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. 		during pregnancy (anytime or not specified) 71 / 2383 Data extracted from the e-Supp pdf (Table S10).
Self-reported maternal consumption of antiseizure medications were prospectively recorded at antenatal care visits (from a structured interview at the first visit at 8–10 weeks of gestation, supplemented from 2005 with drug all prescription dispensations in Sweden (tetrachoric correlation 0.98).
Madley-Dowd_SE (Topiramate) (Controls unexposed, sick)
2024 		Sweden
1995 - 2020
population based cohort retrospective 		The Swedish Developmental Origins of Health and Disease (DOHaD) cohort, which is a registry study linking several national electronic data sources. 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. 		during pregnancy (anytime or not specified) 71 / 10769 Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Self-reported maternal consumption of antiseizure medications were prospectively recorded at antenatal care visits (from a structured interview at the first visit at 8–10 weeks of gestation, supplemented from 2005 with drug all prescription dispensations in Sweden (tetrachoric correlation 0.98).
Madley-Dowd_UK (Topiramate) (Controls exposed to LTG) (Epilepsy)
2024 		United Kingdom
1995 - 2018
retrospective cohort (claims database) 		The UK primary care-based Clinical Practice Research Datalink (CPRD) GOLD, with linkage to the CPRD Pregnancy Register, the CPRD Mother-Baby link, the Hospital Episode Statistics (HES) database, ... 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. 		during pregnancy (anytime or not specified) 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).
Prescriptions were identified from primary care records.
Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy)
2024 		United Kingdom
1995 - 2018
retrospective cohort (claims database) 		The UK primary care-based Clinical Practice Research Datalink (CPRD) GOLD, with linkage to the CPRD Pregnancy Register, the CPRD Mother-Baby link, the Hospital Episode Statistics (HES) database, ... 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. 		during pregnancy (anytime or not specified) 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).
Prescriptions were identified from primary care records.
Mawer (Topiramate) (Controls exposed to Lamotrigine, sick)
2010 		UK
2000 - 2006
prospective cohort 		11 National Health Service (NHS) hospitals within Merseyside and Greater Manchester. 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. 		1st trimester 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.
The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.
Mawer (Topiramate) (Controls unexposed, disease free)
2010 		UK
2000 - 2006
prospective cohort 		11 National Health Service (NHS) hospitals within Merseyside and Greater Manchester. 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. 		1st trimester 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.
The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.
Mawer (Topiramate) (Controls unexposed, sick)
2010 		UK
2000 - 2006
prospective cohort 		11 National Health Service (NHS) hospitals within Merseyside and Greater Manchester. 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. 		1st trimester 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.
The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.
Meador (Topiramate) (Controls exposed to Lamotrigine, sick)
2020 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). 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. 		1st trimester 6 / 113
Data were obtained from participants and their medical records.
Meador (Topiramate) (Controls exposed to Lamotrigine, sick)
2021 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). 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. 		3rd 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.
Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.
Meador (Topiramate) (Controls unexposed, disease free)
2020 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). 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. 		1st trimester 6 / 106
Data were obtained from participants and their medical records.
Meador (Topiramate) (Controls unexposed, disease free)
2021 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). 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. 		3rd trimester 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.
Data were collected from participants using a daily electronic diary that was verified at study visits and with medical records.
Meador (Topiramate) (Controls unexposed, sick)
2020 		US
2012 - 2016
prospective cohort 		The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study (20 US tertiary epilepsy centers). 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. 		1st trimester 6 / 15
Data were obtained from participants and their medical records.
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick)
2006 		UK and Ireland
1996 - 2005
prospective cohort 		The UK Epilepsy and Pregnancy Register 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. 		1st 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.
Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.
Morrow (Topiramate) (Controls unexposed, sick)
2006 		UK and Ireland
1996 - 2005
prospective cohort 		The UK Epilepsy and Pregnancy Register 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. 		1st trimester 28 / 227 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.
Nadebaum (Topiramate)
2011 		Australia
2007 - 2009
prospective cohort 		The Australian Pregnancy Register for Women with Epilepsy and Allied Disorders (APR). 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. 		during pregnancy (anytime or not specified) 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.
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners.
Ornoy (Topiramate)
2008 		Israel
1996 - 2006
prospective cohort 		Israeli Teratogens Information Service 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. 		at least 1st trimester 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).
Details of exposure were collected during pregnancy at the initial contact before pregnancy outcome was known, using a structured questionnaire.
Razaz (Topiramate)
2024 		Denmark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		The SCAN-AED project, using the Nordic register infrastructures. 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. 		during pregnancy (anytime or not specified) 249 / 19043
Prescription for antiseizure medication (ASM) was ascertained using nationwide prescription registers and identified ASMs based on Anatomical Therapeutic Chemical Classification.
Razaz (Topiramate) (Controls exposed to Lamotrigine, sick)
2017 		Sweden
1997- 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish National Patient Register and the Prescribed Drug Registry. 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. 		during pregnancy (anytime or not specified) 24 / 503
The Prescribed Drug Registry stores data on all drugs prescribed in ambulatory care and dispensed at a Swedish pharmacy. Prescription were coded using the Drug Identification Numbers and the ATC system.
Razaz (Topiramate) (Controls unexposed, disease free)
2017 		Sweden
1997- 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish National Patient Register and the Prescribed Drug Registry. 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. 		during pregnancy (anytime or not specified) 24 / 1424279
The Prescribed Drug Registry stores data on all drugs prescribed in ambulatory care and dispensed at a Swedish pharmacy. Prescription were coded using the Drug Identification Numbers and the ATC system.
Razaz (Topiramate) (Controls unexposed, sick)
2017 		Sweden
1997- 2011
population based cohort retrospective 		The Swedish Medical Birth Register, the Swedish National Patient Register and the Prescribed Drug Registry. 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. 		during pregnancy (anytime or not specified) 24 / 1868
The Prescribed Drug Registry stores data on all drugs prescribed in ambulatory care and dispensed at a Swedish pharmacy. Prescription were coded using the Drug Identification Numbers and the ATC system.
Thomas (Topiramate) (Controls exposed to Lamotrigine, sick)
2021 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 9 / 50 Study design completed with Thomas et al., 2017. Keni's 2018 malformations results are already reported in this publication.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Thomas (Topiramate) (Controls unexposed, disease free)
2021 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 6 / 319 This external control group is only available in the 2017 publication.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Thomas (Topiramate) (Controls unexposed, sick)
2021 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 9 / 340 Study design completed with Thomas et al., 2017.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Thomas b (Controls exposed to LTG)
2022 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP), India. 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. 		during pregnancy (anytime or not specified) 6 / 26 No use of delayed mental development, because discrepancy in LTG data '1/26 (11.5%)'.
Each pregnant woman in the Kerala Registry of Epilepsy and Pregnancy (KREP) maintained a pregnancy diary to record the daily use of antiseizure medications (ASMs). Data were then transferred to the clinical records of the registry during their clinic visits.
Thomas b (Controls unexposed, sick)
2022 		India
1998 - 2019
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP), India. 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. 		during pregnancy (anytime or not specified) 6 / 110
Each pregnant woman in the Kerala Registry of Epilepsy and Pregnancy (KREP) maintained a pregnancy diary to record the daily use of antiseizure medications (ASMs). Data were then transferred to the clinical records of the registry during their clinic visits.
Tomson (Topiramate)
2018 		42 countries
1999 - 2016
prospective cohort 		The EURAP epilepsy and pregnancy registry 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. 		at least 1st trimester 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).
Information obtained during early pregnancy and follow-up by the treating physician who transferred it online to a EURAP national coordinator. He then, reviewed the reports for completeness and accuracy before transmission to the EURAP central database.
Trivedi (Topiramate) (Controls exposed to Lamotrigine, sick)
2018 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 11 / 48 Study design partly completed with cites source Thomas et al., 2017.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Trivedi (Topiramate) (Controls unexposed, sick)
2018 		India
1998 - 2015
prospective cohort 		The Kerala Registry of Epilepsy and Pregnancy (KREP) 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. 		1st trimester 11 / 178 Study design partly completed with cites source Thomas et al., 2017.
Women were instructed to record the use of the antiepileptic drugs on a daily basis in the pregnancy diary that was given to them.
Vajda (Topiramate) (Controls exposed to Lamotrigine, sick)
2013 		Australia
1999 - 2013
prospective cohort 		The Australian Register of Antiepileptic Drugs in Pregnancy. 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. 		at least 1st trimester 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.
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners.
Vajda (Topiramate) (Controls unexposed, sick)
2013 		Australia
1999 - 2013
prospective cohort 		The Australian Register of Antiepileptic Drugs in Pregnancy. 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. 		at least 1st trimester 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.
Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners.
Vajda a (Topiramate) (Controls exposed to LTG)
2024 		Australia
1999 - 2023
prospective cohort 		The Australian Pregnancy Register of Antiepileptic Drugs (APR). Women with epilepsy exposed to Topiramate monotherapy during pregnancy. exposed to other treatment, sick
Women with epilepsy exposed to lamotrigine monotherapy during pregnancy. 		during pregnancy (anytime or not specified) 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.
Not specified. All contact between the pregnant women and the Melbourne-based register has been by telephone.
Vajda a (Topiramate) (Controls unexposed sick)
2024 		Australia
1999 - 2023
prospective cohort 		The Australian Pregnancy Register of Antiepileptic Drugs (APR). Women with epilepsy exposed to Topiramate monotherapy during pregnancy. unexposed, sick
Women with epilepsy unexposed to antiseizure medication during pregnancy. 		during pregnancy (anytime or not specified) 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.
Not specified. All contact between the pregnant women and the Melbourne-based register has been by telephone.
Vajda b (Topiramate) (Epilepsy) (Controls exposed to Lamotrigine, sick)
2024 		Australia
1999 - 2022
prospective cohort 		The Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs (referred to as ‘Australian Pregnancy Register’ from this point forward). 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. 		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.
Details are obtained by four in-depth telephone interviews with the women (at time of enrolment; at approximately 28 weeks of pregnancy; after the 1st post-partum (pp) month, and at one year pp). The accuracy of the information provided by the pregnant women is checked with their treating doctors.
Vajda b (Topiramate) (Epilepsy) (Controls unexposed, sick)
2024 		Australia
1999 - 2022
prospective cohort 		The Raoul Wallenberg Australian Pregnancy Register of Antiepileptic Drugs (referred to as ‘Australian Pregnancy Register’ from this point forward). Women with epilepsy exposed to topiramate in monotherapy in early pregnancy. unexposed, sick
Women with epilepsy not treated with antiepileptic drugs in early pregnancy. 		at least 1st trimester 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.
Details are obtained by four in-depth telephone interviews with the women (at time of enrolment; at approximately 28 weeks of pregnancy; after the 1st post-partum (pp) month, and at one year pp). The accuracy of the information provided by the pregnant women is checked with their treating doctors.
Veiby (Topiramate) (Controls exposed to Lamotrigine, sick)
2014 		Norway
1999 - 2011
population based cohort retrospective 		Medical Birth Registry of Norway 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. 		throughout pregnancy 43 / 593 We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy.
A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System).
Veiby (Topiramate) (Controls unexposed, disease free)
2014 		Norway
1999 - 2011
population based cohort retrospective 		Medical Birth Registry of Norway 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. 		throughout pregnancy 43 / 771412 We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy.
A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System).
Veiby (Topiramate) (Controls unexposed, sick)
2014 		Norway
1999 - 2011
population based cohort retrospective 		Medical Birth Registry of Norway 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. 		throughout pregnancy 43 / 3773 We will only consider the subgroup of women exposed to antiepileptic drugs for the strict indication of epilepsy.
A standardised notification form is filled in from the first prenatal visit with the general practitioner until discharge and transferred to the database by practitioners attending the delivery. (According to ATC Classification System).
Wood (Topiramate)
2015 		Australia
2007 - 2010
prospective cohort 		The Australian Pregnancy Register (APR) for Women on Antiepileptic Medication. 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. 		during pregnancy (anytime or not specified) 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.
Details are obtained by four in-depth telephone interviews with the women. And treating doctors are contacted to confirm medical details.

Case-control studies

Study Country
Study period
Study design		 Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

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

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