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Vigabatrin (All indications)
Overall results
Study description
Excluded studies
Table
Graphic
auto
during pregnancy (anytime or not specified)
1st trimester
2nd trimester
3rd trimester
2nd and/or 3rd trimester
throughout pregnancy
early pregnancy
days before delivery
late pregnancy
preconception-only
periconceptional
preconceptional for kinetic reason
at least 1st trimester
3 months (or more) before pregnancy or during pregnancy
1st and 2nd trimester
3 months or more before pregnancy or1st trimester
Whatever the period exposition
individual studies
Outcome
TE
95% CI
n cases
n exposed
k
Pub. bias
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)
Morrow (Vigabatrin) (Controls unexposed, sick), 2006 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Källén (Vigabatrin) (Controls unexposed, NOS) (Indications NOS), 2013 Tomson (Vigabatrin), 2018 Vajda (Vigabatrin) (Controls unexposed, sick), 2019
5
5.04
[
1.16
; 21.81]
49,587
20
serious
Major congenital malformations
Morrow (Vigabatrin) (Controls unexposed, sick), 2006 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Källén (Vigabatrin) (Controls unexposed, NOS) (Indications NOS), 2013 Tomson (Vigabatrin), 2018 Vajda (Vigabatrin) (Controls unexposed, sick), 2019
5
5.04
[
1.16
; 21.81]
49,587
20
serious
Congenital heart defects
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006
1
12.98
[
0.62
; 271.33]
4
6
not evaluable
Digestive system anomalies
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006
1
16.71
[
0.77
; 363.61]
3
6
not evaluable
Hypospadias
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006
1
8.96
[
0.45
; 179.29]
6
6
not evaluable
Limb defects
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006
1
23.44
[
1.00
; 547.07]
2
6
not evaluable
Neural Tube Defects
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006
1
39.12
[
1.43
; 1070.14]
1
6
not evaluable
Oro-facial clefts
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006
1
39.12
[
1.43
; 1070.14]
1
6
not evaluable
Growth parameters and prematurity
Low birth weight (< 2500g)
Kilic (Vigabatrin) (Controls unexposed, sick) (Mixed indications), 2014
1
1.68
[
0.22
; 12.99]
250
13
not evaluable
Preterm (< 37 weeks)
Kilic (Vigabatrin) (Controls unexposed, sick) (Mixed indications), 2014
1
0.51
[
0.03
; 8.67]
383
13
not evaluable
Small for gestational age (weight)
Kilic (Vigabatrin) (Controls unexposed, sick) (Mixed indications), 2014
1
0.66
[
0.09
; 5.06]
595
13
not evaluable
0.0
100.0
1.0