Lamotrigine (Epilepsy) updated on 04-22-2025

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.13 [0.93, 1.37]0%17 studies4496,093low ROB-
Major congenital malformations1.14 [0.94, 1.38]0%16 studies4746,158low ROB-
Congenital heart defects1.01 [0.71, 1.45]0%5 studies261,928not evaluable ROB-
Limb defects1.04 [0.72, 1.50]0%4 studies41,814not evaluable ROB-
Neural Tube Defects0.72 [0.04, 11.59]0%2 studies352not evaluable ROB-
Digestive system anomalies0.56 [0.27, 1.18]0%2 studies11,462not evaluable ROB-
Nervous system anomalies1.13 [0.27, 4.77]0%2 studies1,462not evaluable ROB-
Oro-facial clefts4.39 [0.75, 25.72]83%2 studies1502,096not evaluable ROB-
Spina bifida1.28 [0.15, 10.73]0%2 studies5691not evaluable ROB-
Urinary malformations1.16 [0.51, 2.65]0%2 studies71,462not evaluable ROB-
Cleft lip with or without cleft palate5.93 [1.46, 24.07]-1 study104684not evaluable ROB11.33 [2.28; .]
Cleft palate21.00 [6.79, 64.98]-1 study46684not evaluable ROB41.49 [13.05; .]
6 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)0.97 [0.75, 1.26]0%9 studies175565not evaluable ROB-
Small for gestational age (weight)0.93 [0.84, 1.03]0%6 studies3,0255,621not evaluable ROB-
Large for gestational age (weight)1.47 [0.05, 41.93]71%2 studies74180not evaluable ROB-
Low birth weight (< 2500g)0.98 [0.84, 1.14]0%2 studies1,2585,402not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.00 [0.77, 1.31]0%2 studies744406not evaluable ROB-
Preeclampsia1.62 [0.98, 2.68]0%3 studies1737not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)1.63 [1.07, 2.47]-1 study185233not evaluable ROB2.64 [1.35; .]
Postpartum hemorrhage1.49 [1.06, 2.10]-1 study324233not evaluable ROB2.35 [1.31; .]
4 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)1.63 [0.85, 3.14]0%3 studies54468not evaluable ROB-
Neonatal medical care2.08 [1.10, 3.93]0%3 studies206267not evaluable ROB3.58 [1.43; .]
Fetal distress--0 study-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation--0 study-
2 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
1 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)4.27 [1.04, 17.51]6%4 studies26524not evaluable ROB8.01 [1.25; .]
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.14 [0.16, 8.05]0%2 studies650not evaluable ROB-
Elective/induced termination of pregnancy1.25 [0.05, 31.47]33%2 studies140not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths1.13 [0.07, 19.22]0%2 studies27not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay1.12 [0.69, 1.84]51%8 studies72368not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk0.91 [0.77, 1.08]0%7 studies1,13611,785not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.95 [0.74, 1.22]37%6 studies1,7208,575not evaluable ROB-
Neuro-developmental disorders (as a whole)0.84 [0.66, 1.06]0%5 studies5405,271not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis0.88 [0.73, 1.04]0%5 studies1,09511,626not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.99 [0.78, 1.26]0%6 studies4888,575not evaluable ROB-
Psychomotor developmental disorders/delay1.30 [0.47, 3.59]72%6 studies14262not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.89 [0.70, 1.13]40%4 studies1,7138,492not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.55 [0.68, 3.52]33%4 studies11141not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)1.80 [0.60, 5.41]76%4 studies1635,152not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk1.42 [0.72, 2.78]0%2 studies783not evaluable ROB-
ASD (Autism spectrum disorder): Risk1.64 [0.66, 4.06]6%2 studies41159not evaluable ROB-
Learning disorders 0.87 [0.69, 1.09]0%2 studies9249not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.72 [0.46, 1.14]0%2 studies1615,108not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.05 [0.77, 1.43]19%3 studies4468,462not evaluable ROB-

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