Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
---|---|---|---|---|---|---|
Arkilo (Gabapentin), 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 gabapentin 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. |
1 / 24 | |
Bromley (Gabapentin), 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 gabapentin 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. |
14 / 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. |
Dean (Gabapentin), 2002 |
Scotland 1976 - 2000 |
Children of mothers taking antiepileptic drugs in pregnancy during the study period were ascertained from hospital obstetric records. | Children whose mothers took gabapentin monotherapy in pregnancy and continued beyond the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Sibs of exposed cases not exposed to antiepileptic drugs in utero. Either the mothers had epilepsy or the child was born before epilepsy developed. |
1 / 38 | The data for major congenital malformations include all pregnancies surviving into the second trimester, whereas frequencies for other features were based on livebirths only. The vast majority of the mothers were treated for epilepsy. |
Dreier (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 Gabapentin 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. |
138 / 5288 | |
Dreier (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 gabapentin 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. |
138 / 22203 | |
Mawer (Gabapentin) (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 gabapentin 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. |
2 / 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 (Gabapentin) (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 gabapentin 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. |
2 / 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 (Gabapentin) (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 gabapentin 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. |
2 / 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. |
Miškov (Gabapentin) (Controls exposed to Lamotrigine, sick), 2016 |
Croatia 2003 - 2013 |
Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center. | Pregnancies in women with epilepsy on gabapentin monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
exposed to other treatment, sick
Pregnancies in women with epilepsy on lamotrigine monotherapy. |
2 / 37 | Includes all Miskov's 2010 outcomes. |
Miškov (Gabapentin) (Controls unexposed, disease free), 2016 |
Croatia 2003 - 2013 |
Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center. | Pregnancies in women with epilepsy on gabapentin monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, disease free
Pregnancies in healthy controls. |
2 / 147 | Includes all Miskov's 2010 outcomes. |
Miškov (Gabapentin) (Controls unexposed, sick), 2016 |
Croatia 2003 - 2013 |
Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center. | Pregnancies in women with epilepsy on gabapentin monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed, sick
Pregnancies in women with epilepsy without antiepileptic drugs. |
2 / 4 | Includes all Miskov's 2010 outcomes. |
Morrow (Gabapentin) (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 gabapentin 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. |
31 / 647 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
Morrow (Gabapentin) (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 gabapentin 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. |
31 / 227 | Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study. |
Tomson (Gabapentin), 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 gabapentin 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. |
36 / 2514 | This study is an update of Tomson's 2011 publication. EURAP registry: potential overlap. |
Vajda (Gabapentin) (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 gabapentin 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. |
14 / 382 | |
Vajda (Gabapentin) (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 gabapentin 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. |
14 / 315 | Women taking AED for epilepsy are in majority (more than 90%). Vajda 2007; 2010 (x2) and 2014 malformations results are already included in Vajda 2013. |
Vajda (Gabapentin) (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 gabapentin 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. |
14 / 170 | |
Vajda (Gabapentin) (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 gabapentin 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. |
14 / 147 | Women taking AED for epilepsy are in majority (more than 90%). Vajda 2007; 2010 (x2) and 2014 overlap. |
Wood (Gabapentin), 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 gabapentin 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 |
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