Vigabatrin (Epilepsy)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Mawer (Vigabatrin) (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 vigabatrin 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.
1 / 40 Period of exposure confirm by author's email.
Mawer (Vigabatrin) (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 vigabatrin 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.
1 / 315 Period of exposure confirm by author's email.
Mawer (Vigabatrin) (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 vigabatrin 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.
1 / 46 Period of exposure confirm by author's email.
Morrow (Vigabatrin) (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 vigabatrin 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.
6 / 647 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Morrow (Vigabatrin) (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 vigabatrin 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.
6 / 227 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Tomson (Vigabatrin), 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 vigabatrin 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.
4 / 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.
Vajda (Vigabatrin) (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 vigabatrin 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.
1 / 406 Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013.
Vajda (Vigabatrin) (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 vigabatrin 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.
1 / 176 Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol