Lamotrigine (Epilepsy)

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)1.25 [0.98, 1.59]0%14 studies4304,501low ROB-
Major congenital malformations1.27 [1.00, 1.61]0%13 studies4564,566low ROB1.86 [1.07; .]
Congenital heart defects1.64 [0.62, 4.32]0%4 studies26516not evaluable ROB-
Limb defects0.90 [0.15, 5.60]0%3 studies4402not evaluable ROB-
Neural Tube Defects0.72 [0.04, 11.59]0%2 studies352not evaluable ROB-
Spina bifida1.28 [0.15, 10.73]0%2 studies5691not 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; .]
Minor congenital malformations--0 study-
Oro-facial clefts10.40 [4.32, 25.03]-1 study150684not evaluable ROB20.29 [8.11; .]
3 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)0.96 [0.74, 1.24]0%8 studies160,770560not evaluable ROB-
Small for gestational age (weight)0.95 [0.86, 1.06]0%7 studies41,7515,174not evaluable ROB-
Low birth weight (< 2500g)1.15 [0.60, 2.23]0%2 studies93276not evaluable ROB-
Large for gestational age (weight)1.47 [0.05, 41.93]71%2 studies74180not 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 studies53,64237not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)1.63 [1.07, 2.47]-1 study185233not evaluable ROB2.64 [1.35; .]
Gestational diabetes1.14 [0.09, 14.45]0%2 studies147not evaluable ROB-
Postpartum hemorrhage1.49 [1.06, 2.10]-1 study324233not evaluable ROB2.35 [1.31; .]
2 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
Behavioral disorders1.00 [0.35, 2.85]51%2 studies1325,332not evaluable ROB-
Emotional disorders1.08 [0.57, 2.07]8%2 studies5575,371not evaluable ROB-
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)4.26 [1.24, 14.63]0%4 studies31580not evaluable ROB7.98 [1.78; .]
Elective/induced termination of pregnancy1.25 [0.05, 31.47]33%2 studies140not evaluable ROB-
Late intrauterine deaths (> 22 weeks)1.13 [0.07, 19.22]0%2 studies27not evaluable ROB-
3 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-
Neuro-developmental disorders (as a whole)0.84 [0.66, 1.06]0%5 studies5405,271not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.89 [0.73, 1.09]0%5 studies6305,401not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk0.99 [0.65, 1.50]25%5 studies4295,477not evaluable ROB-
Psychomotor developmental disorders/delay2.21 [1.14, 4.32]14%5 studies14236not evaluable ROB3.85 [1.53; .]
ASD (Autism spectrum disorder): Diagnosis0.84 [0.64, 1.10]0%4 studies3895,401not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.82 [0.59, 1.13]0%4 studies2605,401not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.85 [0.69, 1.05]0%3 studies6235,318not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)2.24 [0.77, 6.57]21%3 studies11115not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk1.42 [0.72, 2.78]0%2 studies783not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)3.39 [0.56, 20.57]68%3 studies379not evaluable ROB-
Learning disorders 0.87 [0.69, 1.09]0%2 studies9249not evaluable ROB-
4 non statistically significant endpoints reported in only one study

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