Carbamazepine (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)1.50 [1.26, 1.78]29%33 studies205,30913,674critical ROB2.36 [1.83; .]
Major congenital malformations1.48 [1.23, 1.77]28%27 studies205,18212,653critical ROB2.32 [1.77; .]
Congenital heart defects1.06 [0.76, 1.47]34%15 studies18,34111,723low ROB-
Hypospadias1.20 [0.84, 1.71]0%11 studies9,51110,054low ROB-
Spina bifida2.11 [1.12, 3.95]0%8 studies6262,403not evaluable ROB3.63 [1.50; .]
Limb defects1.26 [0.78, 2.03]0%7 studies1,3264,407not evaluable ROB-
Minor congenital malformations2.63 [1.25, 5.54]22%7 studies118244not evaluable ROB4.70 [1.81; .]
Neural Tube Defects2.40 [1.00, 5.77]0%7 studies245,199not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.26 [0.58, 2.73]19%7 studies482919not evaluable ROB-
Oro-facial clefts1.23 [0.71, 2.12]0%7 studies5,60210,029not evaluable ROB-
Club foot / Talipes equinovarus1.15 [0.48, 2.71]24%5 studies3,8114,720not evaluable ROB-
Polydactyly1.71 [0.74, 3.99]0%5 studies3,0953,553not evaluable ROB-
Cleft lip with or without cleft palate0.73 [0.15, 3.55]0%4 studies1,6401,750not evaluable ROB-
Nervous system anomalies1.12 [0.41, 3.07]16%4 studies3754,192not evaluable ROB-
Urinary malformations1.30 [0.60, 2.80]19%4 studies383,937not evaluable ROB-
Ano-rectal atresia and stenosis1.70 [0.20, 14.15]0%2 studies545523not evaluable ROB-
Cardiac septal defects0.88 [0.54, 1.43]0%2 studies16,5712,196not evaluable ROB-
Craniosynostosis2.56 [0.25, 25.83]0%2 studies766515not evaluable ROB-
Digestive system anomalies0.76 [0.32, 1.80]0%3 studies212,832not evaluable ROB-
Genital anomalies1.37 [0.64, 2.93]0%3 studies1,0441,833not evaluable ROB-
Hip dislocation and/or dysplasia2.46 [0.14, 43.93]0%2 studies14not evaluable ROB-
Cleft palate5.03 [1.14, 22.26]0%2 studies1,181584not evaluable ROB9.53 [1.53; .]
Diaphragmatic hernia1.66 [0.31, 8.82]0%2 studies378512not evaluable ROB-
Atrial septal defect0.56 [0.03, 8.97]-1 study3,268512not evaluable ROB-
Atrioventricular septal defect3.46 [0.22, 55.50]-1 study529512not evaluable ROB-
Bilateral renal agenesis including Potter syndrome24.28 [1.50, 392.37]-1 study75512not evaluable ROB48.06 [2.37; .]
Bladder exstrophy and/or epispadia22.22 [1.38, 358.80]-1 study82512not evaluable ROB43.94 [2.10; .]
Coarctation of aorta2.35 [0.15, 37.68]-1 study779512not evaluable ROB-
Congenital cataract0.65 [0.02, 17.40]-1 study111not evaluable ROB-
Down syndrom / Trisomy 213.00 [0.05, 194.76]-1 study3not evaluable ROB-
Ebstein's anomaly36.31 [2.24, 589.29]-1 study50512not evaluable ROB72.11 [3.90; .]
Eye defects0.49 [0.16, 1.52]0%2 studies13874not evaluable ROB-
Gastroschisis7.53 [0.47, 120.88]-1 study243512not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)8.47 [0.53, 136.01]-1 study216512not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)27.57 [1.70, 446.03]-1 study66512not evaluable ROB54.64 [2.80; .]
Oesophageal atresia with or without tracheo-oesophageal fistula4.67 [0.29, 74.91]-1 study392512not evaluable ROB-
Omphalocele6.88 [0.43, 110.42]-1 study266512not evaluable ROB-
Pulmonary valve atresia12.02 [0.75, 193.35]-1 study152512not evaluable ROB-
Tetralogy of Fallot3.14 [0.20, 50.27]-1 study584512not evaluable ROB-
Ventricular septal defect0.39 [0.02, 6.31]-1 study4,643512not evaluable ROB-
Chromosomal abnormalities8.20 [0.42, 158.93]-1 study3805not evaluable ROB-
Ear, face and neck anomalies0.23 [0.01, 4.86]-1 study2805not evaluable ROB-
Eye, ear, face and neck malformations0.40 [0.02, 9.96]-1 study1685not evaluable ROB-
Respiratory system anomalies1.83 [0.30, 10.97]-1 study5685not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.06 [0.88, 1.27]12%16 studies252,4643,556critical ROB-
Small for gestational age (weight)1.12 [0.93, 1.36]30%13 studies209,5476,050low ROB-
Low birth weight (< 2500g)1.26 [0.93, 1.70]36%5 studies91,6262,053not evaluable ROB-
Large for gestational age (weight)0.88 [0.59, 1.32]0%2 studies1101,092not evaluable ROB-
Macrosomia (> 4000g)0.99 [0.82, 1.20]0%3 studies576,481570not evaluable ROB-
Very preterm (28 to 32 weeks)1.28 [0.41, 3.99]-1 study8,559468not evaluable ROB-
Extremely preterm (< 28 weeks)0.90 [0.06, 14.35]-1 study2,036468not evaluable ROB-
Large head circumference for gestational age0.29 [0.01, 16.12]-1 study26not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.03 [0.88, 1.21]0%3 studies9441,480not evaluable ROB-
Preeclampsia1.24 [0.92, 1.67]0%4 studies53,7351,367not 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-
Postpartum hemorrhage1.18 [0.88, 1.58]-1 study342388not evaluable ROB-
Abruptio placentae (retroplacental hematoma)0.92 [0.52, 1.63]-1 study20,2881,232not evaluable ROB-
Polyhydramnios0.23 [0.00, 17.06]-1 study18not evaluable ROB-
Maternal consequences (as a whole)2.53 [0.59, 10.85]-1 study1531not evaluable ROB-
Maternal death0.37 [0.01, 19.78]-1 study29not evaluable ROB-
Maternal liver disorder / failure during pregnancy1.15 [0.04, 30.40]-1 study129not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)1.79 [1.13, 2.84]0%6 studies1321,146not evaluable ROB2.98 [1.51; .]
Neonatal medical care1.20 [0.92, 1.55]0%6 studies2,0901,029serious ROB-
Low Apgar score (< 7) (at 1 min)1.18 [0.80, 1.73]0%5 studies1241,022not evaluable ROB-
Neonatal disorders (as a whole)0.97 [0.75, 1.26]0%3 studies221,852498not evaluable ROB-
Feeding difficulty1.49 [0.22, 9.94]0%3 studies341not evaluable ROB-
Neonatal intracranial hemorrhage3.82 [0.73, 20.07]0%2 studies622not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation1.70 [0.03, 89.48]-1 study19not evaluable ROB-
Cerebral palsy6.79 [0.25, 182.34]-1 study111not evaluable ROB-
Jaundice3.50 [0.14, 84.70]-1 study23not evaluable ROB-
Neonatal death (< 28 days of life)1.66 [0.19, 14.33]-1 study6573not evaluable ROB-
Neonatal hypotonia3.00 [0.05, 194.76]-1 study3not evaluable ROB-
Neonatal infections3.00 [0.05, 194.76]-1 study3not evaluable ROB-
Neonatal tachypnea3.00 [0.05, 194.76]-1 study3not evaluable ROB-
Fetal distress0.75 [0.14, 4.04]-1 study716not evaluable ROB-

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)1.65 [0.59, 4.67]0%3 studies4,7081,557not evaluable ROB-
Emotional disorders0.89 [0.61, 1.30]0%3 studies1282,754not evaluable ROB-
Child/Infant growth abnormalities (> 1 year)0.52 [0.12, 2.16]-1 study963not evaluable ROB-
Child/Infant head circumference abnormalities (> 1 year)5.81 [0.27, 123.89]-1 study252not evaluable ROB-
Child/Infant lenght abnormalities (> 1 year)1.65 [0.45, 6.05]-1 study1094not evaluable ROB-
Child/Infant weight abnormalities (> 1 year)1.25 [0.43, 3.59]-1 study1594not evaluable ROB-

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-
Therapeutic terminations of pregnancy0.28 [0.00, 16.82]-1 study13not evaluable ROB-
Ectopic pregnancy3.84 [0.16, 94.34]-1 study11,718not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay1.62 [1.13, 2.33]56%15 studies71,9921,021probable ROB2.63 [1.51; .]
Cognitive developmental disorders/delay (> 6 years old)1.34 [0.94, 1.92]36%11 studies1953,687low ROB-
Neuro-developmental disorders (as a whole)1.46 [1.05, 2.03]17%10 studies10,5944,118low ROB2.27 [1.27; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.18 [1.00, 1.40]0%8 studies12,4993,028not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.16 [0.92, 1.46]0%7 studies4,6053,886not evaluable ROB-
Psychomotor developmental disorders/delay1.01 [0.69, 1.47]0%9 studies65425not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.14 [0.90, 1.44]0%6 studies4,5723,845not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.60 [1.14, 2.27]0%6 studies1903,472not evaluable ROB2.59 [1.53; .]
Cognitive developmental disorders/delay (< 3 years old)1.71 [0.73, 4.01]69%7 studies85303not 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)2.75 [1.33, 5.68]27%5 studies3,419684not evaluable ROB4.95 [2.00; .]
ADHD (Attention deficit hyperactivity disorder): Risk1.66 [1.08, 2.54]0%5 studies11,888332not evaluable ROB2.71 [1.39; .]
Learning disorders 1.24 [0.94, 1.65]0%3 studies51455not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)2.02 [0.65, 6.23]0%3 studies3,392571not evaluable ROB-
ASD (Autism spectrum disorder): Risk1.27 [0.53, 3.03]0%3 studies38111not evaluable ROB-
Childhood autism (F84.0)1.40 [0.37, 5.33]-1 study2,067386not evaluable ROB-
Fonctions adaptatives (A CONSOLIDER)1.00 [0.53, 1.89]-1 study55not evaluable ROB-
Fonctions exécutives (A CONSOLIDER)1.41 [0.76, 2.61]-1 study61not evaluable ROB-
Fonctions mnésiques (A CONSOLIDER)1.24 [0.67, 2.29]-1 study61not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (< 3 years old)1.48 [0.45, 4.89]-1 study1248not evaluable ROB-

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