Carbamazepine (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)1.62 [1.34, 1.95]7%29 studies7818,918low ROB2.62 [2.02; .]
Major congenital malformations1.65 [1.38, 1.98]0%23 studies6547,897low ROB2.69 [2.10; .]
Congenital heart defects1.29 [0.81, 2.05]16%11 studies1136,510low ROB-
Minor congenital malformations2.28 [0.84, 6.14]31%6 studies75211not evaluable ROB-
Neural Tube Defects2.40 [1.00, 5.77]0%7 studies245,199not evaluable ROB-
Spina bifida2.04 [1.05, 3.97]0%6 studies61,812serious ROB3.49 [1.27; .]
Hypospadias0.97 [0.58, 1.64]0%7 studies364,672not evaluable ROB-
Limb defects1.41 [0.70, 2.83]0%5 studies323,379not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.02 [0.43, 2.44]27%5 studies40373not evaluable ROB-
Polydactyly2.73 [0.53, 14.09]0%4 studies62,042not evaluable ROB-
Cleft lip with or without cleft palate0.59 [0.09, 4.07]0%3 studies31,238not evaluable ROB-
Hip dislocation and/or dysplasia2.46 [0.14, 43.93]0%2 studies14not evaluable ROB-
Urinary malformations1.19 [0.42, 3.39]44%3 studies333,252not evaluable ROB-
Club foot / Talipes equinovarus2.72 [0.21, 34.91]0%2 studies223not evaluable ROB-
Digestive system anomalies0.69 [0.24, 1.99]0%2 studies142,147not evaluable ROB-
Oro-facial clefts1.27 [0.55, 2.93]0%3 studies234,647not evaluable ROB-
Eye defects0.49 [0.16, 1.52]0%2 studies13874not evaluable ROB-
10 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)1.05 [0.85, 1.29]0%14 studies160,9821,677low ROB-
Small for gestational age (weight)1.17 [0.79, 1.73]43%10 studies41,7823,995low ROB-
Low birth weight (< 2500g)1.16 [0.71, 1.92]50%4 studies2931,414not evaluable ROB-
Large for gestational age (weight)0.88 [0.59, 1.32]0%2 studies1101,092not evaluable ROB-
Macrosomia (> 4000g)1.04 [0.77, 1.42]0%3 studies727278not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.03 [0.88, 1.21]0%3 studies9441,480not evaluable ROB-
Preeclampsia1.07 [0.59, 1.94]0%4 studies53,648135not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)0.82 [0.11, 5.98]27%2 studies194396not evaluable ROB-
Gestational diabetes0.42 [0.11, 1.61]0%4 studies11152not evaluable ROB-
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)1.77 [0.15, 20.65]0%2 studies244not evaluable ROB-
6 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)1.56 [0.84, 2.89]0%4 studies56794not evaluable ROB-
Neonatal medical care1.19 [0.91, 1.54]0%5 studies2,0821,021not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.16 [0.79, 1.71]0%4 studies1211,014not evaluable ROB-
Feeding difficulty1.49 [0.22, 9.94]0%3 studies341not evaluable ROB-
Neonatal disorders (as a whole)1.04 [0.37, 2.96]0%2 studies2330not evaluable ROB-
Neonatal intracranial hemorrhage3.82 [0.73, 20.07]0%2 studies622not evaluable ROB-
8 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Behavioral disorders1.12 [0.67, 1.87]35%4 studies1612,785not evaluable ROB-
Child/Infant death (> 28 days of life)2.22 [0.65, 7.53]0%2 studies121,089not evaluable ROB-
Emotional disorders0.89 [0.61, 1.30]0%3 studies1282,754not evaluable ROB-
4 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)1.29 [0.91, 1.83]40%10 studies5845,135critical ROB-
Late intrauterine deaths (> 22 weeks)1.53 [0.71, 3.30]18%8 studies494,177not evaluable ROB-
Elective/induced termination of pregnancy1.82 [1.01, 3.28]0%6 studies432,472serious ROB3.03 [1.09; .]
Early intrauterine death (< 22 weeks)0.90 [0.74, 1.10]0%5 studies4313,569not evaluable ROB-
Perinatal death1.42 [0.62, 3.25]0%3 studies262,767not 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/delay1.52 [0.94, 2.45]70%15 studies257729low ROB-
Cognitive developmental disorders/delay (> 6 years old)1.19 [0.86, 1.65]24%11 studies2403,096low ROB-
Neuro-developmental disorders (as a whole)1.09 [0.71, 1.65]20%9 studies6033,003not evaluable ROB-
Psychomotor developmental disorders/delay1.01 [0.69, 1.47]0%9 studies65425not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.11 [0.93, 1.33]0%7 studies6412,827not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.16 [0.91, 1.49]0%7 studies4123,003not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.71 [0.73, 4.01]69%7 studies85303not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.14 [0.88, 1.47]0%6 studies3792,962not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.08 [0.73, 1.59]0%6 studies2352,881not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.11 [0.93, 1.33]0%5 studies6332,784not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)2.74 [1.17, 6.42]34%5 studies42392not evaluable ROB4.92 [1.61; .]
ADHD (Attention deficit hyperactivity disorder): Risk1.23 [0.49, 3.05]12%4 studies30131not evaluable ROB-
Learning disorders 1.18 [0.96, 1.45]0%3 studies51391not evaluable ROB-
ASD (Autism spectrum disorder): Risk1.27 [0.53, 3.03]0%3 studies38111not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)1.83 [0.38, 8.89]0%3 studies15279not evaluable ROB-
4 non statistically significant endpoints reported in only one study

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