Ethosuximide (Epilepsy) - Medication and Pregnancy KB

Ethosuximide (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Dean (Ethosuximide), 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 ethosuximide 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.	4 / 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.
Kaaja (Ethosuximide), 2003	Finland 1980 - 1998	All women with epilepsy regardless of whether they used antiepileptic drugs during the index pregnancy.	Infants whose epileptic mothers took ethosuximide as monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Infants whose epileptic mothers didn't take any antiepileptic drugs during the first trimester.	2 / 239
Kini (Ethosuximide) (Controls exposed to Lamotrigine, sick), 2006	UK 1989 - 1999	375 children aged between 6 months and 16 years from 219 mothers with epilepsy exposed and not exposed to antiepileptic drugs during pregnancy attending epilepsy clinics or antenatal care between the study period.	Children exposed to ethosuximide monotherapy during pregnancy and with epileptic mothers. (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 and with epileptic mothers.	1 / 9	Because we don't know the exact number of children exposed to lamotrigine and analyzed for malformations, this outcome cannot be reported here.
Kini (Ethosuximide) (Controls unexposed, sick), 2006	UK 1989 - 1999	375 children aged between 6 months and 16 years from 219 mothers with epilepsy exposed and not exposed to antiepileptic drugs during pregnancy attending epilepsy clinics or antenatal care between the study period.	Children exposed to ethosuximide monotherapy during pregnancy and with epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children not exposed to antiepileptic drugs during pregnancy and with epileptic mothers.	1 / 101	Because we don't know the exact number of children exposed to ethosuximide and analyzed for malformations, this outcome cannot be reported here.
Morrow (Ethosuximide) (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 ethosuximide 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.	12 / 647	Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Morrow (Ethosuximide) (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 ethosuximide 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.	12 / 227	Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Samrén (Ethosuximide), 1999	Netherlands 1972 - 1994	Offspring of women with epilepsy, with or without antiepileptic drug use during pregnancy, born during the study period.	Children born to mothers with epilepsy and using ethosuximide monotherapy at least during the first trimester of pregnancy	unexposed, disease free Children born to nonepileptic nonexposed women.	9 / 2000
Tomson (Ethosuximide), 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 ethosuximide 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.	12 / 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 (Ethosuximide) (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 ethosuximide 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.	5 / 406	Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013.
Vajda (Ethosuximide) (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 ethosuximide 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.	5 / 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
Bànhidy (Ethosuximide), 2011	Hungary 1980 - 1996	Children affected with congenital abnormalities and who had mothers with medically recorded epilepsy.	Newborn infants without congenital abnormality and who had mothers with medically recorded epilepsy.	95 / 90	Malformations caused by major mutant genes or chromosomal aberrations with preconceptional origin were excluded. Exposure period completed with Czeizel 1992.

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