Vigabatrin (All indications) - Medication and Pregnancy KB

Vigabatrin (All indications)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Battino (Vigabatrin) (Epilepsy), 2024	Worldwide (47 countries) 1999 - 2022	Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined.	Pregnant women with epilepsy exposed to Vigabatrin monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	5 / 3584	Overlapping/Update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Tomson 2011 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied.
Christensen (Vigabatrin) (Epilepsy) (Controls exposed to LTG), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women with epilepsy in the included countries during the study periods.	Children of mothers with epilepsy who had redeemed at least one prescription of Vigabatrin 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).	9 / 5299	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Christensen (Vigabatrin) (Epilepsy) (Controls unexposed, general population), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women with epilepsy in the included countries during the study periods.	Children of mothers with epilepsy who had redeemed at least one prescription of Vigabatrin 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.	9 / 22227	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Källén (Vigabatrin) (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 vigabatrin 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.	8 / 1084	Indications for antiepileptic drugs are not specified. Wide 2004 outcomes' are already included in Källèn et al 2013 or are not compared to an adequate control group. Follow-up period known thanks to author's email reply.
Källén (Vigabatrin) (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 vigabatrin 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.	8 / 1575847	Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply.
Kilic (Vigabatrin) (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 vigabatrin 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.	13 / 880	Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
Kilic (Vigabatrin) (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 vigabatrin 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.	13 / 676834	Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
Kilic (Vigabatrin) (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 vigabatrin 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.	13 / 5296	Less than 90% of women are epileptic. Overlapping: For LBW and SGA: Kilic 2014 included in a larger study published by Christensen 2024 ((longer study period, 5 countries and more pregnancies) => use of Christensen 2024 for these outcomes.
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.
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

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

1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol