Lamotrigine (All indications)

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)1.01 [0.92, 1.11]0%16 studies198,22915,836probable ROB-
Major congenital malformations1.02 [0.92, 1.12]0%15 studies198,25515,901probable ROB-
Congenital heart defects1.16 [0.78, 1.71]29%7 studies18,22910,212not evaluable ROB-
Limb defects1.24 [0.41, 3.76]0%4 studies1,269675not evaluable ROB-
Oro-facial clefts1.85 [0.77, 4.43]84%5 studies5,72913,104not evaluable ROB-
Club foot / Talipes equinovarus1.12 [0.80, 1.57]0%4 studies3,80712,420not evaluable ROB-
Hypospadias1.14 [0.82, 1.59]0%4 studies9,48013,253not evaluable ROB-
Cleft palate3.22 [0.42, 25.01]86%3 studies1,2263,681not evaluable ROB-
Nervous system anomalies1.44 [0.90, 2.29]0%3 studies3678,662not evaluable ROB-
Neural Tube Defects0.72 [0.04, 11.59]0%2 studies352not evaluable ROB-
Spina bifida1.04 [0.25, 4.41]0%3 studies6223,928not evaluable ROB-
Cardiac septal defects1.46 [0.94, 2.26]0%2 studies16,5771,917not evaluable ROB-
Cleft lip with or without cleft palate2.30 [0.32, 16.29]69%2 studies1,7433,681not evaluable ROB-
Minor congenital malformations--0 study-
22 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)1.11 [0.97, 1.26]26%12 studies252,9938,529low ROB-
Small for gestational age (weight)0.94 [0.86, 1.04]20%10 studies209,96813,126low ROB-
Low birth weight (< 2500g)1.16 [1.02, 1.32]0%5 studies91,8265,546not evaluable ROB1.59 [1.15; .]
Extremely preterm (< 28 weeks)0.51 [0.14, 1.87]0%2 studies2,0382,923not evaluable ROB-
Very preterm (28 to 32 weeks)0.53 [0.19, 1.45]15%2 studies8,5672,923not evaluable ROB-
Large for gestational age (weight)1.47 [0.05, 41.93]71%2 studies74180not evaluable ROB-
Macrosomia (> 4000g)0.89 [0.82, 0.97]-1 study577,1802,813not evaluable ROB1.49 [.; 1.22]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.00 [0.77, 1.31]0%2 studies744406not evaluable ROB-
Preeclampsia1.09 [0.90, 1.31]0%3 studies53,7802,719not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)1.63 [1.07, 2.47]-1 study185233not evaluable ROB2.64 [1.35; .]
Gestational diabetes1.19 [0.32, 4.49]0%3 studies1966not 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)1.22 [0.76, 1.94]0%4 studies1311,343not evaluable ROB-
Neonatal medical care2.08 [1.10, 3.93]0%3 studies206267not evaluable ROB3.58 [1.43; .]
Neonatal disorders (as a whole)0.95 [0.85, 1.07]0%2 studies222,1572,919not evaluable ROB-
Fetal distress--0 study-
3 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-
Child/Infant death (> 28 days of life)1.22 [0.65, 2.30]0%2 studies4,7102,986not evaluable ROB-
Emotional disorders1.08 [0.57, 2.07]8%2 studies5575,371not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)3.03 [1.12, 8.22]0%6 studies451,541not evaluable ROB5.51 [1.47; .]
Elective/induced termination of pregnancy1.39 [0.20, 9.76]0%3 studies5988not evaluable ROB-
Late intrauterine deaths (> 22 weeks)1.07 [0.13, 8.49]0%3 studies2975not 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 [0.79, 1.58]46%9 studies72,0533,181not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.02 [0.72, 1.45]28%6 studies4,65510,952not evaluable ROB-
Neuro-developmental disorders (as a whole)1.08 [0.66, 1.76]52%6 studies10,56810,961not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.21 [0.81, 1.81]56%6 studies12,4845,550not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis0.87 [0.70, 1.09]0%5 studies4,61510,876not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.59 [0.42, 0.83]0%4 studies2088,063not evaluable ROB2.79 [.; 1.71]
Psychomotor developmental disorders/delay2.21 [1.14, 4.32]14%5 studies14236not evaluable ROB3.85 [1.53; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.85 [0.69, 1.05]0%3 studies6235,318not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)2.53 [1.15, 5.56]52%4 studies3,4032,892not evaluable ROB4.50 [1.57; .]
ADHD (Attention deficit hyperactivity disorder): Risk1.81 [1.17, 2.79]0%3 studies11,861232not evaluable ROB3.01 [1.61; .]
Cognitive developmental disorders/delay (< 3 years old)2.24 [0.77, 6.57]21%3 studies11115not evaluable ROB-
Learning disorders 0.92 [0.74, 1.13]0%2 studies9275not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)2.10 [0.84, 5.24]10%2 studies3,4012,848not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.53 [0.35, 0.80]-1 study1667,950not evaluable ROB3.20 [.; 1.82]
3 non statistically significant endpoints reported in only one study

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