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Gabapentin (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)
Dean, 2002 Morrow (Controls unexposed, sick), 2006 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Vajda (Controls unexposed, sick), 2013 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Tomson, 2018 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Desrochers, 2022
8
1.15
[
0.91
; 1.46]
49,613
454
not evaluable
Major congenital malformations
Dean, 2002 Morrow (Controls unexposed, sick), 2006 Mawer (Gabapentin) (Controls unexposed, sick), 2010 Vajda (Controls unexposed, sick), 2013 Källén (Controls unexposed, NOS) (Indications NOS), 2013 Tomson, 2018 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Desrochers, 2022
8
1.01
[
0.75
; 1.35]
49,608
454
not evaluable
Atrial septal defect
Blotière (Controls unexposed NOS) (Other indications), 2019
1
0.79
[
0.05
; 12.59]
3,268
365
not evaluable
Congenital heart defects
Morrow (Controls exposed to Lamotrigine, sick), 2006 Desrochers, 2022
2
1.73
[
0.56
; 5.33]
5
31
not evaluable
Oro-facial clefts
Morrow (Controls exposed to Lamotrigine, sick), 2006 Blotière (Controls unexposed NOS) (Other indications), 2019 Desrochers, 2022
3
1.49
[
0.60
; 3.72]
2,816
396
not evaluable
Hypospadias
Morrow (Controls exposed to Lamotrigine, sick), 2006 Blotière (Controls unexposed NOS) (Other indications), 2019
2
1.55
[
0.31
; 7.89]
3,378
396
not evaluable
Ano-rectal atresia and stenosis
Blotière (Controls unexposed NOS) (Other indications), 2019
1
4.72
[
0.29
; 75.77]
544
365
not evaluable
Atrioventricular septal defect
Blotière (Controls unexposed NOS) (Other indications), 2019
1
4.86
[
0.30
; 77.92]
529
365
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Controls unexposed NOS) (Other indications), 2019
1
34.08
[
2.11
; 550.91]
75
365
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Controls unexposed NOS) (Other indications), 2019
1
31.19
[
1.93
; 503.78]
82
365
not evaluable
Cleft lip with or without cleft palate
Blotière (Controls unexposed NOS) (Other indications), 2019
1
1.57
[
0.10
; 25.16]
1,637
365
not evaluable
Cleft palate
Blotière (Controls unexposed NOS) (Other indications), 2019
1
2.18
[
0.14
; 34.97]
1,178
365
not evaluable
Club foot / Talipes equinovarus
Blotière (Controls unexposed NOS) (Other indications), 2019
1
1.53
[
0.10
; 24.56]
1,677
365
not evaluable
Coarctation of aorta
Blotière (Controls unexposed NOS) (Other indications), 2019
1
3.30
[
0.21
; 52.90]
779
365
not evaluable
Craniosynostosis
Blotière (Controls unexposed NOS) (Other indications), 2019
1
3.36
[
0.21
; 53.80]
766
365
not evaluable
Diaphragmatic hernia
Blotière (Controls unexposed NOS) (Other indications), 2019
1
6.80
[
0.42
; 109.07]
378
365
not evaluable
Ebstein's anomaly
Blotière (Controls unexposed NOS) (Other indications), 2019
1
50.95
[
3.14
; 827.39]
50
365
not evaluable
Gastroschisis
Blotière (Controls unexposed NOS) (Other indications), 2019
1
10.57
[
0.66
; 169.73]
243
365
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Controls unexposed NOS) (Other indications), 2019
1
11.88
[
0.74
; 190.96]
216
365
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Controls unexposed NOS) (Other indications), 2019
1
38.69
[
2.39
; 626.25]
66
365
not evaluable
Microcephaly / Small head circumference for gestational age
Blotière (Controls unexposed NOS) (Other indications), 2019
1
5.87
[
0.37
; 94.12]
438
365
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Controls unexposed NOS) (Other indications), 2019
1
6.55
[
0.41
; 105.17]
392
365
not evaluable
Omphalocele
Blotière (Controls unexposed NOS) (Other indications), 2019
1
9.65
[
0.60
; 155.04]
266
365
not evaluable
Pulmonary valve atresia
Blotière (Controls unexposed NOS) (Other indications), 2019
1
16.87
[
1.05
; 271.48]
152
365
not evaluable
Spina bifida
Blotière (Controls unexposed NOS) (Other indications), 2019
1
8.40
[
0.55
; 128.91]
617
365
not evaluable
Tetralogy of Fallot
Blotière (Controls unexposed NOS) (Other indications), 2019
1
4.40
[
0.27
; 70.58]
584
365
not evaluable
Ventricular septal defect
Blotière (Controls unexposed NOS) (Other indications), 2019
1
1.11
[
0.16
; 7.88]
4,644
365
not evaluable
Digestive system anomalies
Morrow (Controls exposed to Lamotrigine, sick), 2006
1
3.01
[
0.15
; 59.66]
3
31
not evaluable
Eye defects
Dean, 2002
1
4.85
[
0.09
; 267.23]
6
1
not evaluable
Limb defects
Morrow (Controls exposed to Lamotrigine, sick), 2006
1
4.23
[
0.20
; 89.96]
2
31
not evaluable
Minor congenital malformations
Dean, 2002
1
5.91
[
0.11
; 330.07]
5
1
not evaluable
Neural Tube Defects
Morrow (Controls exposed to Lamotrigine, sick), 2006
1
7.05
[
0.28
; 176.78]
1
31
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Kilic (Controls unexposed, sick) (Mixed indications), 2014 Arkilo, 2015 Miškov (Controls unexposed, sick), 2016 Coste (Controls unexposed, NOS) (Mixed indications), 2020
4
2.38
[
1.79
; 3.15]
91,697
453
not evaluable
Low birth weight (< 2500g)
Kilic (Controls unexposed, sick) (Mixed indications), 2014 Coste (Controls unexposed, NOS) (Mixed indications), 2020
2
2.35
[
1.68
; 3.29]
91,756
450
not evaluable
Small for gestational age (weight)
Kilic (Controls unexposed, sick) (Mixed indications), 2014 Coste (Controls unexposed, NOS) (Mixed indications), 2020
2
1.23
[
0.92
; 1.63]
168,024
450
not evaluable
Macrosomia (> 4000g)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
0.89
[
0.72
; 1.11]
577,215
378
not evaluable
Very preterm (28 to 32 weeks)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
1.05
[
0.26
; 4.23]
8,586
378
not evaluable
Extremely preterm (< 28 weeks)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
1.11
[
0.07
; 17.76]
2,041
378
not evaluable
Neonatal disorders
Neonatal disorders (as a whole)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
1.09
[
0.82
; 1.46]
222,254
378
not evaluable
Neonatal medical care
Desrochers, 2022
1
2.18
[
1.81
; 2.62]
-
870
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
0
-
-
-
-
-
Long term consequences
Behavioral disorders
Bromley, 2016
1
1.10
[
0.38
; 3.18]
-
14
not evaluable
Child/Infant death (> 28 days of life)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
0.96
[
0.14
; 6.86]
4,696
378
not evaluable
Emotional disorders
Bromley, 2016
1
1.13
[
0.39
; 3.28]
-
14
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Arkilo, 2015 Miškov (Controls unexposed, sick), 2016 Vajda (Controls unexposed, sick), 2018
3
4.41
[
0.49
; 39.98]
3
17
not evaluable
Early intrauterine death (< 22 weeks)
Arkilo, 2015 Miškov (Controls unexposed, sick), 2016
2
4.64
[
0.23
; 93.20]
2
3
not evaluable
Elective/induced termination of pregnancy
Miškov (Controls unexposed, sick), 2016
1
2.33
[
0.03
; 182.92]
-
2
not evaluable
Therapeutic terminations of pregnancy
Miškov (Controls unexposed, sick), 2016
1
2.33
[
0.03
; 182.92]
-
2
not evaluable
Late intrauterine deaths (> 22 weeks)
Arkilo, 2015
1
47.00
[
0.38
; 5814.69]
-
1
not evaluable
Neuro-developmental disorders
ASD (Autism spectrum disorder): Diagnosis
Wood, 2015 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022
3
1.34
[
0.40
; 4.45]
4,558
1,344
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Wood, 2015 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022
3
1.34
[
0.40
; 4.45]
4,558
1,344
not evaluable
Neuro-developmental disorders (as a whole)
Dean, 2002 Arkilo, 2015 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Mixed indications), 2022
4
0.96
[
0.44
; 2.10]
10,475
1,345
not evaluable
Language disorders/delay
Bromley, 2016 Coste (Controls unexposed, NOS) (Mixed indications), 2020
2
0.62
[
0.36
; 1.05]
72,028
392
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
0.67
[
0.04
; 10.66]
3,398
378
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Controls unexposed, NOS) (Mixed indications), 2020
1
0.67
[
0.04
; 10.66]
3,398
378
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Bromley, 2016
1
0.87
[
0.30
; 2.52]
-
14
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Bromley, 2016
1
0.87
[
0.30
; 2.52]
-
14
not evaluable
ASD (Autism spectrum disorder): Risk
Wood, 2015
1
17.00
[
0.13
; 2166.90]
-
1
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Bromley, 2016
1
1.33
[
0.13
; 13.89]
4
14
not evaluable
0.0
100.0
1.0