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Primidone (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)
Lowe (Primidone) (Controls unexposed, sick), 1973 Canger (Primidone), 1999 Kaneko (Primidone), 1999 Samrén (Primidone), 1999 Dean (Primidone), 2002 Kaaja (Primidone), 2003 Bànhidy (Primidone), 2011 Källén (Primidone) (Controls unexposed, NOS) (Indications NOS), 2013 Tomson (Primidone), 2018 Vajda (Primidone) (Controls unexposed, sick), 2019
10
2.74
[
1.43
; 5.24]
49,650
161
low
Major congenital malformations
Canger (Primidone), 1999 Samrén (Primidone), 1999 Dean (Primidone), 2002 Kaaja (Primidone), 2003 Bànhidy (Primidone), 2011 Källén (Primidone) (Controls unexposed, NOS) (Indications NOS), 2013 Tomson (Primidone), 2018 Vajda (Primidone) (Controls unexposed, sick), 2019
8
2.45
[
1.08
; 5.52]
49,633
122
not evaluable
Cleft lip with or without cleft palate
Lowe (Primidone) (Controls unexposed, sick), 1973
1
31.57
[
0.54
; 1833.75]
-
4
not evaluable
Minor congenital malformations
Battino (Primidone), 1992 Dean (Primidone), 2002
2
3.46
[
0.38
; 31.70]
12
33
not evaluable
Neural Tube Defects
Canger (Primidone), 1999 Bànhidy (Primidone), 2011
2
0.63
[
0.05
; 8.17]
1
41
not evaluable
Club foot / Talipes equinovarus
Bànhidy (Primidone), 2011
1
5.18
[
0.18
; 150.46]
1
7
not evaluable
Congenital heart defects
Bànhidy (Primidone), 2011
1
0.16
[
0.01
; 3.42]
5
6
not evaluable
Eye defects
Dean (Primidone), 2002
1
1.62
[
0.06
; 44.25]
6
2
not evaluable
Hypospadias
Bànhidy (Primidone), 2011
1
0.25
[
0.01
; 5.72]
3
6
not evaluable
Microcephaly / Small head circumference for gestational age
Battino (Primidone), 1999
1
2.33
[
0.55
; 9.99]
10
34
not evaluable
Polydactyly
Bànhidy (Primidone), 2011
1
0.35
[
0.01
; 8.58]
2
6
not evaluable
Spina bifida
Czeizel (Primidone), 1992
1
0.33
[
0.01
; 12.82]
1
3
not evaluable
Growth parameters and prematurity
Small for gestational age (weight)
Burja (Primidone) (Controls unexposed, sick), 2006 Kilic (Primidone) (Controls unexposed, sick) (Mixed indications), 2014
2
4.47
[
0.14
; 140.06]
599
21
not evaluable
Preterm (< 37 weeks)
Koch (Primidone), 1996 Kilic (Primidone) (Controls unexposed, sick) (Mixed indications), 2014
2
6.23
[
0.60
; 64.99]
391
34
not evaluable
Low birth weight (< 2500g)
Kilic (Primidone) (Controls unexposed, sick) (Mixed indications), 2014
1
1.06
[
0.14
; 7.97]
250
20
not evaluable
Neonatal disorders
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
Burja (Primidone) (Controls unexposed, sick), 2006
1
63.00
[
0.51
; 7760.63]
-
1
not evaluable
Feeding difficulty
Burja (Primidone) (Controls unexposed, sick), 2006
1
20.33
[
0.29
; 1423.95]
1
1
not evaluable
Neonatal intracranial hemorrhage
Burja (Primidone) (Controls unexposed, sick), 2006
1
11.80
[
0.19
; 731.60]
2
1
not evaluable
Intrauterine deaths
Perinatal death
Canger (Primidone), 1999
1
0.71
[
0.01
; 37.03]
-
35
not evaluable
Neuro-developmental disorders
Cognitive developmental disorders/delay (> 6 years old)
Titze (Primidone) (Controls unexposed, sick), 2008
1
0.45
[
0.02
; 12.49]
1
9
not evaluable
Neuro-developmental disorders (as a whole)
Katz (Primidone), 2001 Dean (Primidone), 2002
2
2.15
[
0.15
; 30.90]
4
4
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Titze (Primidone) (Controls unexposed, sick), 2008
1
0.45
[
0.02
; 12.49]
1
9
not evaluable
Psychomotor developmental disorders/delay
Koch (Primidone), 1996
1
1.67
[
0.26
; 10.64]
6
11
not evaluable
0.0
100.0
1.0