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Phenobarbital (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 (Phenobarbital) (Controls unexposed, sick), 1973 Robert (Phenobarbital), 1986 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Kaneko (Phenobarbital), 1999 Samrén (Phenobarbital), 1999 Canger (Phenobarbital), 1999 Dean (Phenobarbital), 2002 Kaaja (Phenobarbital), 2003 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Bànhidy (Phenobarbital), 2011 Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 Källén (Phenobarbital) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Phenobarbital), 2018 Vajda (Phenobarbital) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022
17
2.48
[
1.83
; 3.35]
49,892
1,200
low
Major congenital malformations
Robert (Phenobarbital), 1986 Canger (Phenobarbital), 1999 Samrén (Phenobarbital), 1999 Dean (Phenobarbital), 2002 Kaaja (Phenobarbital), 2003 Bànhidy (Phenobarbital), 2011 Källén (Phenobarbital) (Controls unexposed, NOS) (Indications NOS), 2013 Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Phenobarbital), 2018 Vajda (Phenobarbital) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022
13
2.56
[
1.85
; 3.54]
49,841
1,049
low
Congenital heart defects
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021
5
3.93
[
1.79
; 8.63]
48
646
not evaluable
Hypospadias
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
5
3.03
[
0.81
; 11.39]
3,379
589
not evaluable
Microcephaly / Small head circumference for gestational age
Kelly (Phenobarbital), 1984 Dravet (Phenobarbital), 1992 Battino (Phenobarbital), 1999 Díaz-Romero (Phenobarbital), 1999 Holmes (Phenobarbital) (Controls unexposed, sick), 2001 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
6
3.09
[
1.34
; 7.13]
476
294
not evaluable
Minor congenital malformations
Robert (Phenobarbital), 1986 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Battino (Phenobarbital), 1992 Dean (Phenobarbital), 2002
4
1.92
[
0.88
; 4.18]
59
173
not evaluable
Spina bifida
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
3
6.95
[
0.78
; 61.60]
620
119
not evaluable
Oro-facial clefts
Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Tomson (Phenobarbital), 2018 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
4
4.46
[
1.70
; 11.72]
2,831
600
not evaluable
Ano-rectal atresia and stenosis
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
2
4.00
[
0.12
; 134.90]
545
92
not evaluable
Cleft lip with or without cleft palate
Lowe (Phenobarbital) (Controls unexposed, sick), 1973 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
2
6.86
[
0.84
; 56.26]
1,638
133
not evaluable
Club foot / Talipes equinovarus
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
2
4.55
[
0.47
; 44.55]
1,677
92
not evaluable
Craniosynostosis
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
2
8.30
[
0.83
; 83.23]
766
84
not evaluable
Hip dislocation and/or dysplasia
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991
2
4.08
[
0.31
; 53.22]
1
16
not evaluable
Neural Tube Defects
Canger (Phenobarbital), 1999 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018
3
2.92
[
0.29
; 29.59]
5
576
not evaluable
Polydactyly
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Tomson (Phenobarbital), 2018
2
13.45
[
0.76
; 236.46]
2
298
not evaluable
Urinary malformations
Tomson (Phenobarbital), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021
2
0.59
[
0.11
; 3.19]
15
431
not evaluable
Atrial septal defect
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
3.60
[
0.22
; 58.12]
3,268
80
not evaluable
Atrioventricular septal defect
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
22.27
[
1.38
; 359.70]
529
80
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
Out of scale
156.25
[
9.60
; 2543.08]
75
80
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
Out of scale
142.99
[
8.79
; 2325.49]
82
80
not evaluable
Cleft palate
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
10.00
[
0.62
; 161.44]
1,178
80
not evaluable
Coarctation of aorta
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
15.13
[
0.94
; 244.20]
779
80
not evaluable
Congenital cataract
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991
1
0.59
[
0.02
; 15.81]
1
12
not evaluable
Diaphragmatic hernia
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
31.16
[
1.93
; 503.50]
378
80
not evaluable
Digestive system anomalies
Thomas (Phenobarbital) (Controls unexposed, sick), 2021
1
0.83
[
0.03
; 20.42]
1
137
not evaluable
Down syndrom / Trisomy 21
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991
1
2.14
[
0.03
; 131.94]
-
4
not evaluable
Ebstein's anomaly
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
Out of scale
233.60
[
14.29
; 3819.26]
50
80
not evaluable
Gastroschisis
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
48.44
[
3.00
; 783.49]
243
80
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
54.48
[
3.37
; 881.52]
216
80
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
Out of scale
177.39
[
10.89
; 2890.83]
66
80
not evaluable
Limb defects
Thomas (Phenobarbital) (Controls unexposed, sick), 2021
1
2.50
[
0.35
; 17.96]
4
137
not evaluable
Nervous system anomalies
Thomas (Phenobarbital) (Controls unexposed, sick), 2021
1
7.52
[
0.30
; 185.67]
1
137
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
30.05
[
1.86
; 485.50]
392
80
not evaluable
Omphalocele
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
44.26
[
2.74
; 715.69]
266
80
not evaluable
Pulmonary valve atresia
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
77.35
[
4.77
; 1253.19]
152
80
not evaluable
Tetralogy of Fallot
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
20.18
[
1.25
; 325.80]
584
80
not evaluable
Ventricular septal defect
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019
1
10.50
[
1.91
; 57.73]
4,645
80
not evaluable
Eye defects
Dean (Phenobarbital), 2002
1
0.92
[
0.30
; 2.84]
15
61
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Koch (Phenobarbital), 1996 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
5
1.34
[
0.80
; 2.23]
91,658
206
not evaluable
Small for gestational age (weight)
Endo (Phenobarbital) (Controls unexposed, sick), 2004 Burja (Phenobarbital) (Controls unexposed, sick), 2006 Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
5
2.20
[
1.66
; 2.91]
168,006
369
not evaluable
Low birth weight (< 2500g)
Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
2
2.54
[
1.60
; 4.02]
91,725
180
not evaluable
Macrosomia (> 4000g)
Endo (Phenobarbital) (Controls unexposed, sick), 2004 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
2
0.49
[
0.29
; 0.82]
577,114
94
not evaluable
Extremely preterm (< 28 weeks)
Coste (Phenobarbital) (Controls unexposed, NOS), 2020
1
5.01
[
0.31
; 80.81]
2,041
84
not evaluable
Very preterm (28 to 32 weeks)
Coste (Phenobarbital) (Controls unexposed, NOS), 2020
1
2.39
[
0.33
; 17.16]
8,585
84
not evaluable
Large head circumference for gestational age
Díaz-Romero (Phenobarbital), 1999
1
5.00
[
0.07
; 366.35]
-
2
not evaluable
Maternal consequences
Assisted deliveries (forceps, vacuum, ...)
Endo (Phenobarbital) (Controls unexposed, sick), 2004
1
0.05
[
0.00
; 6.68]
-
10
not evaluable
Caesarean
Endo (Phenobarbital) (Controls unexposed, sick), 2004
1
0.18
[
0.00
; 12.84]
1
10
not evaluable
Polyhydramnios
Endo (Phenobarbital) (Controls unexposed, sick), 2004
1
0.05
[
0.00
; 6.68]
-
10
not evaluable
Neonatal disorders
Feeding difficulty
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Yerby (Phenobarbital), 1992 Burja (Phenobarbital) (Controls unexposed, sick), 2006
3
5.62
[
0.72
; 44.00]
3
15
not evaluable
Neonatal disorders (as a whole)
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
2
0.77
[
0.39
; 1.52]
222,212
88
not evaluable
Neonatal intracranial hemorrhage
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Shankaran (Phenobarbital) (Other indications), 2002 Burja (Phenobarbital) (Controls unexposed, sick), 2006
3
1.04
[
0.66
; 1.62]
100
230
not evaluable
Low Apgar score (< 7) (at 1 min)
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Endo (Phenobarbital) (Controls unexposed, sick), 2004
2
0.55
[
0.02
; 15.67]
2
22
not evaluable
Cerebral palsy
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991
1
1.87
[
0.03
; 100.54]
-
12
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
Burja (Phenobarbital) (Controls unexposed, sick), 2006
1
63.00
[
0.51
; 7760.63]
-
1
not evaluable
Jaundice
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991
1
0.62
[
0.02
; 19.59]
1
4
not evaluable
Neonatal hypotonia
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991
1
2.14
[
0.03
; 131.94]
-
4
not evaluable
Neonatal infections
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991
1
2.14
[
0.03
; 131.94]
-
4
not evaluable
Neonatal medical care
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991
1
2.14
[
0.03
; 131.94]
-
4
not evaluable
Neonatal tachypnea
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991
1
2.14
[
0.03
; 131.94]
-
4
not evaluable
Eye deficiency / Visual abnormality
Shankaran (Phenobarbital) (Other indications), 2002
1
2.66
[
0.27
; 25.79]
4
224
not evaluable
Hearing loss / Auditory deficit
Shankaran (Phenobarbital) (Other indications), 2002
1
0.88
[
0.30
; 2.54]
14
224
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Shankaran (Phenobarbital) (Other indications), 2002 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
3
1.87
[
0.51
; 6.88]
4,703
395
not evaluable
Child/Infant head circumference abnormalities (> 1 year)
0
-
-
-
-
-
Child/Infant lenght abnormalities (> 1 year)
0
-
-
-
-
-
Child/Infant weight abnormalities (> 1 year)
0
-
-
-
-
-
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Tomson (Phenobarbital), 2015 Miškov (Phenobarbital) (Controls unexposed, sick), 2016 Trivedi (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2018
3
0.92
[
0.41
; 2.07]
182
401
not evaluable
Early intrauterine death (< 22 weeks)
Tomson (Phenobarbital), 2015 Miškov (Phenobarbital) (Controls unexposed, sick), 2016
2
1.06
[
0.63
; 1.79]
165
263
not evaluable
Elective/induced termination of pregnancy
Miškov (Phenobarbital) (Controls unexposed, sick), 2016
1
1.40
[
0.02
; 97.44]
-
3
not evaluable
Therapeutic terminations of pregnancy
Miškov (Phenobarbital) (Controls unexposed, sick), 2016
1
1.40
[
0.02
; 97.44]
-
3
not evaluable
Perinatal death
Canger (Phenobarbital), 1999 Tomson (Phenobarbital), 2015
2
0.67
[
0.06
; 7.16]
3
321
not evaluable
Late intrauterine deaths (> 22 weeks)
Tomson (Phenobarbital), 2015
1
2.46
[
0.49
; 12.25]
8
260
not evaluable
Neuro-developmental disorders
Neuro-developmental disorders (as a whole)
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Katz (Phenobarbital), 2001 Dean (Phenobarbital) (Controls unexposed, sick), 2007 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Bjørk (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2022
5
2.01
[
1.15
; 3.54]
10,481
326
not evaluable
Language disorders/delay
Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Adams (Phenobarbital), 2022 Thomas (Phenobarbitone), 2022
4
2.51
[
1.33
; 4.74]
72,019
133
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Bjørk (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2022
2
2.36
[
1.00
; 5.54]
4,552
259
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Bjørk (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2022
2
2.36
[
1.00
; 5.54]
4,552
259
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020
2
7.18
[
1.16
; 44.46]
3,399
87
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Titze (Phenobarbital) (Controls unexposed, sick), 2008 Adams (Phenobarbital), 2022 Thomas (Phenobarbitone), 2022
3
2.93
[
1.39
; 6.17]
1
49
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Kelly (Phenobarbital), 1984 Thomas b (Phenobarbital), 2008
2
0.70
[
0.27
; 1.84]
24
54
not evaluable
Learning disorders
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Elkjaer (Phenobarbital), 2018
2
3.12
[
0.30
; 32.23]
7
61
not evaluable
Psychomotor developmental disorders/delay
Koch (Phenobarbital), 1996 Thomas b (Phenobarbital), 2008
2
0.56
[
0.20
; 1.61]
20
45
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Phenobarbital) (Controls unexposed, NOS), 2020
1
3.00
[
0.41
; 21.94]
3,399
84
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Titze (Phenobarbital) (Controls unexposed, sick), 2008
1
1.53
[
0.05
; 49.80]
1
3
not evaluable
Severe cognitive developmental delay (Mental retardation) (< 3 years old)
0
-
-
-
-
-
0.0
100.0
1.0