Phenobarbital (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)2.20 [1.61, 3.02]0%15 studies3561,169low ROB3.83 [2.59; .]
Major congenital malformations2.23 [1.57, 3.17]0%11 studies3051,018low ROB3.89 [2.51; .]
Congenital heart defects3.84 [1.95, 7.54]13%6 studies53646not evaluable ROB7.13 [3.31; .]
Hypospadias3.00 [0.73, 12.35]0%5 studies11509not evaluable ROB-
Microcephaly / Small head circumference for gestational age2.50 [1.04, 5.99]0%5 studies38214serious ROB4.43 [1.24; .]
Minor congenital malformations1.92 [0.88, 4.18]11%4 studies59173not evaluable ROB-
Hip dislocation and/or dysplasia4.08 [0.31, 53.22]0%2 studies116not evaluable ROB-
Neural Tube Defects4.12 [0.63, 26.77]21%4 studies6576not evaluable ROB-
Polydactyly12.12 [1.45, 101.31]0%3 studies4298not evaluable ROB23.72 [2.26; .]
Spina bifida4.53 [0.09, 216.52]67%2 studies430not evaluable ROB-
Urinary malformations0.59 [0.11, 3.19]0%2 studies15431not evaluable ROB-
Oro-facial clefts4.09 [1.38, 12.13]0%2 studies15493not evaluable ROB7.65 [2.11; .]
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)1.13 [0.50, 2.55]0%4 studies91,265110not evaluable ROB-
Small for gestational age (weight)2.36 [1.62, 3.45]11%4 studies167,394273not evaluable ROB4.15 [2.61; .]
Macrosomia (> 4000g)0.49 [0.29, 0.82]0%2 studies577,11494not evaluable ROB3.54 [.; 1.72]
Low birth weight (< 2500g)2.95 [1.60, 5.44]-1 study91,46784not evaluable ROB5.35 [2.58; .]
3 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
3 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Feeding difficulty5.62 [0.72, 44.00]0%3 studies315not evaluable ROB-
Neonatal disorders (as a whole)0.77 [0.39, 1.52]0%2 studies222,21288not evaluable ROB-
Low Apgar score (< 7) (at 1 min)0.55 [0.02, 15.67]36%2 studies222not evaluable ROB-
Neonatal intracranial hemorrhage5.02 [0.27, 92.72]0%2 studies25not evaluable ROB-
7 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)1.27 [0.15, 10.56]0%2 studies4,69697not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)1.67 [0.62, 4.44]32%3 studies183401not evaluable ROB-
Early intrauterine death (< 22 weeks)1.06 [0.63, 1.79]1%2 studies165263not evaluable ROB-
Perinatal death0.67 [0.06, 7.16]0%2 studies3321not 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/delay2.51 [1.33, 4.74]23%4 studies72,019133not evaluable ROB4.46 [2.00; .]
Neuro-developmental disorders (as a whole)1.63 [0.65, 4.08]0%4 studies10,030151not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)7.18 [1.16, 44.46]34%2 studies3,39987not evaluable ROB13.84 [1.59; .]
Cognitive developmental disorders/delay (> 6 years old)2.93 [1.39, 6.17]0%3 studies149not evaluable ROB5.30 [2.12; .]
Learning disorders 3.12 [0.30, 32.23]78%2 studies761not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)0.70 [0.27, 1.84]0%2 studies2454not evaluable ROB-
Psychomotor developmental disorders/delay0.56 [0.20, 1.61]0%2 studies2045not evaluable ROB-
4 non statistically significant endpoints reported in only one study

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