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Oxcarbazepine (Epilepsy)
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)
Samrén (Oxcarbazepine), 1999 Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000 Kaaja (Oxcarbazepine), 2003 Artama (Oxcarbazepine), 2005 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006 Hernández-Díaz (Oxcarbazepine) (Controls unexposed, disease free), 2012 Veiby (Oxcarbazepine) (Controls unexposed, sick), 2014 Tomson (Oxcarbazepine) , 2018 Vajda (Oxcarbazepine) (Controls unexposed, sick), 2019 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS), 2023
14
1.49
[
1.19
; 1.87]
148,281
2,102
probable
Major congenital malformations
Samrén (Oxcarbazepine), 1999 Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000 Kaaja (Oxcarbazepine), 2003 Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Hernández-Díaz (Oxcarbazepine) (Controls unexposed, disease free), 2012 Veiby (Oxcarbazepine) (Controls unexposed, sick), 2014 Tomson (Oxcarbazepine) , 2018 Vajda (Oxcarbazepine) (Controls unexposed, sick), 2019 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS), 2023
12
1.51
[
1.17
; 1.96]
148,254
1,999
critical
Congenital heart defects
Artama (Oxcarbazepine), 2005 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine) , 2018 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
4
1.93
[
0.87
; 4.24]
42
510
not evaluable
Limb defects
Artama (Oxcarbazepine), 2005 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
3
2.81
[
0.46
; 17.19]
12
177
not evaluable
Spina bifida
Artama (Oxcarbazepine), 2005 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Veiby (Oxcarbazepine) (Controls unexposed, sick), 2014
3
13.65
[
1.72
; 108.21]
3
152
not evaluable
Urinary malformations
Artama (Oxcarbazepine), 2005 Tomson (Oxcarbazepine) , 2018 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
3
0.92
[
0.20
; 4.14]
16
503
not evaluable
Digestive system anomalies
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
2
5.01
[
0.55
; 45.94]
4
78
not evaluable
Cleft lip with or without cleft palate
Artama (Oxcarbazepine), 2005 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006
2
5.45
[
0.36
; 83.53]
2
101
not evaluable
Hypospadias
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine) , 2018
2
2.04
[
0.16
; 25.25]
12
340
not evaluable
Nervous system anomalies
Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
1
4.82
[
0.09
; 244.75]
-
71
not evaluable
Neural Tube Defects
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine) , 2018
2
8.87
[
0.71
; 110.59]
2
340
not evaluable
Oro-facial clefts
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine) , 2018
2
6.85
[
0.59
; 80.08]
5
340
not evaluable
Polydactyly
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Tomson (Oxcarbazepine) , 2018
2
26.41
[
2.05
; 340.38]
1
335
not evaluable
Chromosomal abnormalities
Artama (Oxcarbazepine), 2005
1
9.53
[
0.19
; 482.86]
-
99
not evaluable
Cleft palate
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006
1
34.33
[
0.49
; 2389.88]
-
2
not evaluable
Ear, face and neck anomalies
Artama (Oxcarbazepine), 2005
1
1.90
[
0.09
; 39.89]
2
99
not evaluable
Eye defects
Artama (Oxcarbazepine), 2005
1
3.17
[
0.13
; 78.41]
1
99
not evaluable
Genital anomalies
Artama (Oxcarbazepine), 2005
1
1.91
[
0.22
; 16.48]
6
99
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Cohen (Oxcarbazepine) (Controls unexposed NOS), 2019 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
4
1.16
[
0.88
; 1.53]
251,970
674
not evaluable
Small for gestational age (weight)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Cohen (Oxcarbazepine) (Controls unexposed NOS), 2019 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Dreier (Oxcarbazepine), 2021
5
1.37
[
1.12
; 1.67]
209,095
2,133
not evaluable
Low birth weight (< 2500g)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
2
1.29
[
0.90
; 1.85]
91,551
670
not evaluable
Large for gestational age (weight)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
2
0.78
[
0.26
; 2.30]
86
531
not evaluable
Macrosomia (> 4000g)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
0.79
[
0.55
; 1.13]
577,138
143
not evaluable
Very preterm (28 to 32 weeks)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
0.70
[
0.04
; 11.18]
8,584
143
not evaluable
Extremely preterm (< 28 weeks)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
5.89
[
0.82
; 42.16]
2,042
143
not evaluable
Maternal consequences
Preeclampsia
Cohen (Oxcarbazepine) (Controls unexposed NOS), 2019 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
2
1.61
[
0.75
; 3.47]
53,625
4
not evaluable
Caesarean
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013
1
0.98
[
0.76
; 1.27]
430
532
not evaluable
Abruptio placentae (retroplacental hematoma)
Cohen (Oxcarbazepine) (Controls unexposed NOS), 2019
1
1.34
[
0.26
; 6.90]
20,260
-
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
1
6.14
[
0.10
; 363.16]
-
4
not evaluable
Gestational diabetes
Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
1
1.95
[
0.07
; 58.24]
1
4
not evaluable
Neonatal disorders
Neonatal medical care
Viinikainen (Oxcarbazepine) (Controls unexposed, disease free) a, 2006 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
3
3.13
[
0.43
; 22.52]
2,025
471
not evaluable
Low Apgar score (< 7) (at 1 min)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013
1
1.33
[
0.83
; 2.13]
96
465
not evaluable
Low Apgar score (< 7) (at 5 min)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013
1
0.70
[
0.14
; 3.49]
5
230
not evaluable
Neonatal disorders (as a whole)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
0.90
[
0.54
; 1.50]
222,218
143
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
2
1.87
[
0.52
; 6.65]
4,704
670
not evaluable
Behavioral disorders
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
1.09
[
0.59
; 2.02]
130
1,460
not evaluable
Emotional disorders
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
0.88
[
0.47
; 1.65]
83
1,460
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Tomson (Oxcarbazepine), 2015 Vajda (Oxcarbazepine) (Controls unexposed, sick), 2018 Trivedi (Oxcarbazepine) (Controls unexposed, sick), 2018
3
3.13
[
0.62
; 15.80]
184
337
not evaluable
Late intrauterine deaths (> 22 weeks)
Tomson (Oxcarbazepine), 2015 AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
3
2.79
[
0.68
; 11.38]
8
269
not evaluable
Perinatal death
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Tomson (Oxcarbazepine), 2015
2
2.56
[
0.96
; 6.84]
20
772
not evaluable
Elective/induced termination of pregnancy
Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021
1
8.20
[
0.13
; 511.93]
-
3
not evaluable
Early intrauterine death (< 22 weeks)
Tomson (Oxcarbazepine), 2015
1
1.01
[
0.62
; 1.65]
164
262
not evaluable
Neuro-developmental disorders
ASD (Autism spectrum disorder): Diagnosis/Risk
Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2018 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
3
1.24
[
0.82
; 1.87]
4,662
1,607
not evaluable
Language disorders/delay
Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Meador (Oxcarbazepine) (Controls unexposed, disease free), 2021
3
2.52
[
0.94
; 6.73]
72,025
166
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
2
1.24
[
0.82
; 1.87]
4,635
1,603
not evaluable
Neuro-developmental disorders (as a whole)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022
2
0.96
[
0.68
; 1.36]
10,445
1,572
not evaluable
ASD (Autism spectrum disorder): Risk
Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2018
1
1.27
[
0.06
; 25.24]
27
4
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
1.76
[
0.11
; 28.32]
3,398
143
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
1.76
[
0.11
; 28.32]
3,398
143
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
0.99
[
0.70
; 1.40]
580
1,460
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
0.99
[
0.70
; 1.40]
580
1,460
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016
1
5.76
[
1.65
; 20.13]
-
10
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
1.15
[
0.70
; 1.88]
208
1,460
not evaluable
Psychomotor developmental disorders/delay
Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016
1
2.33
[
0.69
; 7.90]
-
10
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
1.15
[
0.70
; 1.88]
208
1,460
not evaluable
Learning disorders
Elkjaer (Oxcarbazepine), 2018
1
1.06
[
1.01
; 1.12]
-
124
not evaluable
0.0
100.0
1.0