Oxcarbazepine (All indications)

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Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.51 [1.21, 1.88]0%15 studies197,7922,270probable ROB2.39 [1.72; .]
Major congenital malformations1.52 [1.22, 1.89]0%13 studies197,7652,167critical ROB2.41 [1.73; .]
Spina bifida12.20 [2.32, 64.13]0%4 studies619297not evaluable ROB23.88 [4.07; .]
Congenital heart defects1.93 [0.87, 4.24]0%4 studies42510not evaluable ROB-
Oro-facial clefts4.48 [1.11, 18.10]0%4 studies2,821536not evaluable ROB8.44 [1.46; .]
Cleft lip with or without cleft palate4.64 [0.73, 29.40]0%3 studies1,639240not evaluable ROB-
Hypospadias2.01 [0.38, 10.55]0%3 studies3,383479not evaluable ROB-
Limb defects2.81 [0.46, 17.19]22%3 studies12177not evaluable ROB-
Urinary malformations0.92 [0.20, 4.14]0%3 studies16503not evaluable ROB-
Cleft palate9.82 [0.96, 100.29]0%2 studies1,178141not evaluable ROB-
Digestive system anomalies5.01 [0.55, 45.94]0%2 studies478not evaluable ROB-
Bilateral renal agenesis including Potter syndrome89.69 [5.53, 1454.36]-1 study75139not evaluable ROB178.87 [10.54; .]
Bladder exstrophy and/or epispadia82.08 [5.07, 1329.93]-1 study82139not evaluable ROB163.65 [9.60; .]
Diaphragmatic hernia17.89 [1.11, 287.94]-1 study378139not evaluable ROB35.27 [1.46; .]
Ebstein's anomaly134.09 [8.23, 2184.22]-1 study50139not evaluable ROB267.67 [15.95; .]
Gastroschisis27.81 [1.73, 448.07]-1 study243139not evaluable ROB55.11 [2.84; .]
Hypoplastic left heart (HLH/HLHS)31.27 [1.94, 504.13]-1 study216139not evaluable ROB62.04 [3.29; .]
Hypoplastic right heart (HRH/HRHS)101.82 [6.27, 1653.25]-1 study66139not evaluable ROB203.15 [12.02; .]
Neural Tube Defects8.87 [0.71, 110.59]17%2 studies2340not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula17.25 [1.07, 277.65]-1 study392139not evaluable ROB33.99 [1.35; .]
Omphalocele25.41 [1.58, 409.29]-1 study266139not evaluable ROB50.31 [2.53; .]
Polydactyly26.41 [2.05, 340.38]0%2 studies1335not evaluable ROB52.32 [3.52; .]
Pulmonary valve atresia44.40 [2.75, 716.69]-1 study152139not evaluable ROB88.30 [4.95; .]
14 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)1.07 [0.94, 1.21]0%6 studies252,5702,097not evaluable ROB-
Small for gestational age (weight)1.28 [1.04, 1.58]40%7 studies209,7983,553not evaluable ROB1.88 [1.23; .]
Low birth weight (< 2500g)1.25 [0.93, 1.68]0%3 studies91,817977not evaluable ROB-
Large for gestational age (weight)0.78 [0.26, 2.30]10%2 studies86531not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preeclampsia1.12 [0.86, 1.45]0%2 studies53,6901,113not evaluable ROB-
4 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care2.02 [0.48, 8.47]46%4 studies2,031475not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.34 [0.84, 2.13]0%2 studies98469not evaluable ROB-
Low Apgar score (< 7) (at 5 min)1.35 [0.14, 12.85]30%2 studies5234not evaluable ROB-
1 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.87 [0.52, 6.65]0%2 studies4,704670not evaluable ROB-
2 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)3.13 [0.62, 15.80]72%3 studies184337not evaluable ROB-
Late intrauterine deaths (> 22 weeks)2.79 [0.68, 11.38]0%3 studies8269not evaluable ROB-
Perinatal death2.56 [0.96, 6.84]0%2 studies20772not 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
ASD (Autism spectrum disorder): Diagnosis/Risk1.34 [0.85, 2.12]0%3 studies4,5661,576not evaluable ROB-
Language disorders/delay2.52 [0.94, 6.73]70%3 studies72,025166not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.35 [0.85, 2.13]0%2 studies4,5391,572not evaluable ROB-
Neuro-developmental disorders (as a whole)0.96 [0.68, 1.36]0%2 studies10,4451,572not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)5.76 [1.65, 20.13]-1 study10not evaluable ROB11.00 [2.68; .]
Learning disorders 1.06 [1.01, 1.12]-1 study124not evaluable ROB1.31 [1.08; .]
9 non statistically significant endpoints reported in only one study

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