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Lamotrigine (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)
Holmes, 2008 Mawer (Controls unexposed, sick), 2010 Charlton, 2011 Rihtman, 2013 Cassina, 2013 Campbell, 2014 Veiby (Controls unexposed, sick), 2014 Vanya (Controls unexposed, sick), 2015 Petersen (Controls unexposed, sick), 2017 Vajda, 2019 Meador (Controls unexposed, sick), 2020 Aydin, 2020 Thomas (Controls unexposed, sick), 2021 Hosny, 2021
14
1.25
[
0.98
; 1.59]
430
4,501
low
Major congenital malformations
Holmes, 2008 Mawer (Controls unexposed, sick), 2010 Charlton, 2011 Cassina, 2013 Campbell, 2014 Veiby (Controls unexposed, sick), 2014 Vanya (Controls unexposed, sick), 2015 Diav-Citrin, 2017 Petersen (Controls unexposed, sick), 2017 Vajda, 2019 Meador (Controls unexposed, sick), 2020 Thomas (Controls unexposed, sick), 2021 Hosny, 2021
13
1.27
[
1.00
; 1.61]
456
4,566
low
Congenital heart defects
Mawer (Controls unexposed, sick), 2010 Vajda, 2013 Diav-Citrin, 2017 Thomas (Controls unexposed, sick), 2021
4
1.64
[
0.62
; 4.32]
26
516
not evaluable
Limb defects
Mawer (Controls unexposed, sick), 2010 Vajda, 2013 Thomas (Controls unexposed, sick), 2021
3
0.90
[
0.15
; 5.60]
4
402
not evaluable
Neural Tube Defects
Mawer (Controls unexposed, sick), 2010 Vajda, 2013
2
0.72
[
0.04
; 11.59]
-
352
not evaluable
Spina bifida
Charlton, 2011 Veiby (Controls unexposed, sick), 2014
2
1.28
[
0.15
; 10.73]
5
691
not evaluable
Cleft lip with or without cleft palate
Holmes, 2008
1
5.93
[
1.46
; 24.07]
104
684
not evaluable
Cleft palate
Holmes, 2008
1
21.00
[
6.79
; 64.98]
46
684
not evaluable
Digestive system anomalies
Thomas (Controls unexposed, sick), 2021
1
2.28
[
0.09
; 56.74]
1
50
not evaluable
Minor congenital malformations
0
-
-
-
-
-
Nervous system anomalies
Thomas (Controls unexposed, sick), 2021
1
6.86
[
0.13
; 349.61]
-
50
not evaluable
Oro-facial clefts
Holmes, 2008
1
10.40
[
4.32
; 25.03]
150
684
not evaluable
Urinary malformations
Thomas (Controls unexposed, sick), 2021
1
1.14
[
0.13
; 9.64]
7
50
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Cummings, 2011 Artama (Controls unexposed, sick), 2013 Veiby (Controls unexposed, sick) b, 2013 Miškov (Controls unexposed, sick), 2016 Cohen, 2019 Aydin, 2020 Van Marter (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023
8
0.96
[
0.74
; 1.24]
160,770
560
not evaluable
Small for gestational age (weight)
Artama (Controls unexposed, sick), 2013 Veiby (Controls unexposed, sick) b, 2013 Cohen, 2019 Aydin, 2020 Dreier, 2021 Van Marter (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023
7
0.95
[
0.86
; 1.06]
41,751
5,174
not evaluable
Low birth weight (< 2500g)
Artama (Controls unexposed, sick), 2013 Veiby (Controls unexposed, sick) b, 2013
2
1.15
[
0.60
; 2.23]
93
276
not evaluable
Large for gestational age (weight)
Artama (Controls unexposed, sick), 2013 Aydin, 2020
2
1.47
[
0.05
; 41.93]
74
180
not evaluable
Extremely preterm (< 28 weeks)
Van Marter (Controls unexposed, sick), 2021
1
0.13
[
0.00
; 6.93]
-
110
not evaluable
Very preterm (28 to 32 weeks)
Van Marter (Controls unexposed, sick), 2021
1
0.13
[
0.01
; 2.17]
2
110
not evaluable
Maternal consequences
Caesarean
Borthen (Controls unexposed, sick), 2010 Artama (Controls unexposed, sick), 2013
2
1.00
[
0.77
; 1.31]
744
406
not evaluable
Preeclampsia
Borthen (Controls unexposed, sick), 2011 Cohen, 2019 Aydin, 2020
3
1.62
[
0.98
; 2.68]
53,642
37
not evaluable
Assisted deliveries (forceps, vacuum, ...)
Borthen (Controls unexposed, sick), 2010
1
1.63
[
1.07
; 2.47]
185
233
not evaluable
Gestational diabetes
Rihtman, 2013 Aydin, 2020
2
1.14
[
0.09
; 14.45]
1
47
not evaluable
Postpartum hemorrhage
Borthen (Controls unexposed, sick), 2010
1
1.49
[
1.06
; 2.10]
324
233
not evaluable
Abruptio placentae (retroplacental hematoma)
Cohen, 2019
1
0.77
[
0.25
; 2.35]
20,260
-
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin, 2020
1
3.31
[
0.06
; 183.69]
-
7
not evaluable
Neonatal disorders
Low Apgar score (< 7) (at 5 min)
Borthen (Controls unexposed, sick), 2010 Artama (Controls unexposed, sick), 2013 Veiby (Controls unexposed, sick) b, 2013
3
1.63
[
0.85
; 3.14]
54
468
not evaluable
Neonatal medical care
Artama (Controls unexposed, sick), 2013 Aydin, 2020 Bromley (Lamotrigine) (Epilepsy), 2023
3
2.08
[
1.10
; 3.93]
206
267
not evaluable
Low Apgar score (< 7) (at 1 min)
Artama (Controls unexposed, sick), 2013
1
1.69
[
0.35
; 8.14]
78
154
not evaluable
Fetal distress
0
-
-
-
-
-
Neonatal disorders (as a whole)
Bromley (Lamotrigine) (Epilepsy), 2023
1
1.20
[
0.58
; 2.48]
38
106
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
0
-
-
-
-
-
Long term consequences
Behavioral disorders
Veiby (Controls unexposed, sick) b, 2013 Dreier, 2023
2
1.00
[
0.35
; 2.85]
132
5,332
not evaluable
Child/Infant death (> 28 days of life)
Artama (Controls unexposed, sick), 2013
1
2.33
[
0.19
; 28.62]
6
173
not evaluable
Emotional disorders
Cohen-Israel, 2018 Dreier, 2023
2
1.08
[
0.57
; 2.07]
557
5,371
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Miškov (Controls unexposed, sick), 2016 Trivedi, 2018 Vajda, 2018 Meador (Controls unexposed, sick), 2020
4
4.26
[
1.24
; 14.63]
31
580
not evaluable
Elective/induced termination of pregnancy
Miškov (Controls unexposed, sick), 2016 Hosny, 2021
2
1.25
[
0.05
; 31.47]
1
40
not evaluable
Early intrauterine death (< 22 weeks)
Miškov (Controls unexposed, sick), 2016
1
0.73
[
0.03
; 17.26]
3
37
not evaluable
Late intrauterine deaths (> 22 weeks)
AlSheikh, 2020 Aydin, 2020
2
1.13
[
0.07
; 19.22]
-
27
not evaluable
Perinatal death
Artama (Controls unexposed, sick), 2013
1
0.49
[
0.03
; 8.47]
10
173
not evaluable
Therapeutic terminations of pregnancy
Miškov (Controls unexposed, sick), 2016
1
0.10
[
0.00
; 5.62]
-
37
not evaluable
Neuro-developmental disorders
Language disorders/delay
Rihtman, 2013 Baker (Controls unexposed, sick), 2015 Videman, 2016 Kasradze, 2017 Cohen-Israel, 2018 Husebye (Controls unexposed, sick), 2020 Bromley (Lamotrigine) (Epilepsy), 2023 Meador, 2023
8
1.12
[
0.69
; 1.84]
72
368
not evaluable
Neuro-developmental disorders (as a whole)
Dean, 2007 Rihtman, 2013 Bromley (Controls unexposed, sick), 2013 Charlton (Controls unexposed, sick), 2017 Bjørk (Controls unexposed, sick), 2022
5
0.84
[
0.66
; 1.06]
540
5,271
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Rihtman, 2013 Veiby (Controls unexposed, sick) b, 2013 Bromley (Controls unexposed, sick), 2013 Wiggs, 2020 Dreier, 2023
5
0.89
[
0.73
; 1.09]
630
5,401
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Bromley (Controls unexposed, sick), 2013 Bjørk (Controls unexposed, sick), 2018 Cohen-Israel, 2018 Wiggs, 2020 Dreier, 2023
5
0.99
[
0.65
; 1.50]
429
5,477
not evaluable
Psychomotor developmental disorders/delay
Rihtman, 2013 Bromley (Controls unexposed, sick), 2013 Videman, 2016 Cohen-Israel, 2018 Bromley (Lamotrigine) (Epilepsy), 2023
5
2.21
[
1.14
; 4.32]
14
236
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Bromley (Controls unexposed, sick), 2013 Cohen-Israel, 2018 Wiggs, 2020 Dreier, 2023
4
0.84
[
0.64
; 1.10]
389
5,401
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Gopinath, 2015 Baker (Controls unexposed, sick), 2015 Cohen-Israel, 2018 Dreier, 2023
4
0.82
[
0.59
; 1.13]
260
5,401
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Bromley (Controls unexposed, sick), 2013 Wiggs, 2020 Dreier, 2023
3
0.85
[
0.69
; 1.05]
623
5,318
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Bromley (Controls unexposed, sick), 2010 Videman, 2016 Bromley (Lamotrigine) (Epilepsy), 2023
3
2.24
[
0.77
; 6.57]
11
115
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Rihtman, 2013 Veiby (Controls unexposed, sick) b, 2013
2
1.42
[
0.72
; 2.78]
7
83
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Cummings, 2011 Rihtman, 2013 Kasradze, 2017
3
3.39
[
0.56
; 20.57]
3
79
not evaluable
Learning disorders
Cohen-Israel, 2018 Ren (Lamotrigine) (Epilepsy), 2023
2
0.87
[
0.69
; 1.09]
9
249
not evaluable
ASD (Autism spectrum disorder): Risk
Bjørk (Controls unexposed, sick), 2018
1
1.87
[
0.91
; 3.84]
40
76
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Cummings, 2011
1
0.41
[
0.02
; 10.40]
1
35
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Dreier, 2023
1
0.85
[
0.58
; 1.24]
218
5,288
not evaluable
0.0
100.0
1.0
