Primidone (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)2.74 [1.43, 5.24]0%10 studies49,650161low ROB4.92 [2.22; .]
Major congenital malformations2.45 [1.08, 5.52]9%8 studies49,633122not evaluable ROB4.33 [1.38; .]
Cleft lip with or without cleft palate31.57 [0.54, 1833.75]-1 study4not evaluable ROB-
Minor congenital malformations3.46 [0.38, 31.70]0%2 studies1233not evaluable ROB-
Neural Tube Defects1.01 [0.06, 17.08]0%2 studies141not evaluable ROB-
Club foot / Talipes equinovarus1.91 [0.03, 109.96]-1 study17not evaluable ROB-
Congenital heart defects0.16 [0.01, 3.56]-1 study56not evaluable ROB-
Eye defects1.62 [0.06, 44.25]-1 study62not evaluable ROB-
Hypospadias0.29 [0.01, 7.14]-1 study36not evaluable ROB-
Microcephaly / Small head circumference for gestational age2.33 [0.55, 9.99]-1 study1034not evaluable ROB-
Polydactyly0.49 [0.02, 13.92]-1 study26not evaluable ROB-
Spina bifida0.71 [0.01, 49.71]-1 study13not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Small for gestational age (weight)4.47 [0.14, 140.06]56%2 studies59921not evaluable ROB-
Preterm (< 37 weeks)6.23 [0.60, 64.99]70%2 studies39134not evaluable ROB-
Low birth weight (< 2500g)1.06 [0.14, 7.97]-1 study25020not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation63.00 [0.51, 7760.63]-1 study1not evaluable ROB-
Feeding difficulty20.33 [0.29, 1423.95]-1 study11not evaluable ROB-
Neonatal intracranial hemorrhage11.80 [0.19, 731.60]-1 study21not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Perinatal death0.71 [0.01, 37.03]-1 study35not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Cognitive developmental disorders/delay (> 6 years old)0.45 [0.02, 12.49]-1 study19not evaluable ROB-
Neuro-developmental disorders (as a whole)2.15 [0.15, 30.90]0%2 studies44not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.45 [0.02, 12.49]-1 study19not evaluable ROB-
Psychomotor developmental disorders/delay1.67 [0.26, 10.64]-1 study611not evaluable ROB-

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