Levetiracetam (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)1.04 [0.81, 1.33]0%13 studies197,7453,477low ROB-
Major congenital malformations1.03 [0.81, 1.32]0%12 studies197,7453,467low ROB-
Congenital heart defects1.33 [0.64, 2.78]0%4 studies401,177not evaluable ROB-
Hypospadias1.01 [0.26, 3.95]0%4 studies3,3841,650not evaluable ROB-
Oro-facial clefts1.24 [0.37, 4.19]0%4 studies2,8281,650not evaluable ROB-
Spina bifida3.19 [0.53, 19.33]0%3 studies619756not evaluable ROB-
Cleft lip with or without cleft palate2.09 [0.28, 15.72]0%2 studies1,638642not evaluable ROB-
Digestive system anomalies2.24 [0.25, 20.02]0%2 studies4128not evaluable ROB-
Limb defects3.89 [0.74, 20.42]0%2 studies6128not evaluable ROB-
Neural Tube Defects2.59 [0.50, 13.52]0%3 studies51,071not evaluable ROB-
Urinary malformations0.53 [0.12, 2.33]0%2 studies16705not evaluable ROB-
Bilateral renal agenesis including Potter syndrome21.47 [1.33, 346.88]-1 study75579not evaluable ROB42.44 [1.99; .]
Bladder exstrophy and/or epispadia19.65 [1.22, 317.20]-1 study82579not evaluable ROB38.79 [1.73; .]
Ebstein's anomaly32.10 [1.98, 520.95]-1 study50579not evaluable ROB63.70 [3.37; .]
Hypoplastic left heart (HLH/HLHS)15.10 [1.03, 220.38]-1 study217579not evaluable ROB29.69 [1.22; .]
Hypoplastic right heart (HRH/HRHS)24.38 [1.51, 394.31]-1 study66579not evaluable ROB48.25 [2.38; .]
18 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)1.49 [1.15, 1.94]0%8 studies91,815855not evaluable ROB2.35 [1.56; .]
Small for gestational age (weight)1.22 [0.96, 1.54]21%8 studies168,1291,855not evaluable ROB-
Low birth weight (< 2500g)1.93 [1.49, 2.50]0%3 studies91,833660not evaluable ROB3.26 [2.34; .]
Large for gestational age (weight)1.28 [0.13, 12.96]0%2 studies7123not evaluable ROB-
Very preterm (28 to 32 weeks)1.10 [0.20, 5.96]51%2 studies8,593718not evaluable ROB-
Extremely preterm (< 28 weeks)1.01 [0.19, 5.41]0%2 studies2,043718not evaluable ROB-
Macrosomia (> 4000g)0.67 [0.56, 0.80]-1 study577,255621not evaluable ROB2.35 [.; 1.80]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean1.50 [0.67, 3.41]0%2 studies36541not evaluable ROB-
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)1.20 [0.07, 20.23]0%2 studies27not evaluable ROB-
Gestational diabetes0.37 [0.04, 3.82]0%2 studies227not 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 care1.40 [0.62, 3.15]0%4 studies17799not evaluable ROB-
Low Apgar score (< 7) (at 1 min)2.01 [0.39, 10.26]0%2 studies7319not evaluable ROB-
Low Apgar score (< 7) (at 5 min)7.00 [0.63, 78.08]0%2 studies319not evaluable ROB-
Neonatal disorders (as a whole)1.06 [0.85, 1.33]0%2 studies222,315691not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)2.96 [0.53, 16.41]35%2 studies4,703634not evaluable ROB-
Emotional disorders1.29 [0.67, 2.49]58%3 studies5031,131not evaluable ROB-
Behavioral disorders0.79 [0.43, 1.45]0%2 studies1970not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)1.15 [0.78, 1.69]0%6 studies202656not evaluable ROB-
Late intrauterine deaths (> 22 weeks)1.72 [0.43, 6.99]0%5 studies9371not evaluable ROB-
Perinatal death2.47 [0.31, 19.60]0%2 studies13309not evaluable ROB-
Early intrauterine death (< 22 weeks)1.10 [0.72, 1.68]0%3 studies173339not evaluable ROB-
Elective/induced termination of pregnancy0.44 [0.03, 7.32]0%2 studies84not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay0.89 [0.68, 1.16]0%7 studies72,083851not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.83 [0.88, 3.83]39%4 studies4,5941,667not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.40 [0.75, 2.61]6%3 studies4,5631,655not evaluable ROB-
Neuro-developmental disorders (as a whole)1.08 [0.65, 1.80]0%3 studies10,4701,636not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.56 [0.51, 4.80]47%3 studies23109not evaluable ROB-
Psychomotor developmental disorders/delay1.08 [0.53, 2.22]29%3 studies9109not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.18 [0.58, 2.39]46%3 studies5471,133not evaluable ROB-
ASD (Autism spectrum disorder): Risk2.39 [0.45, 12.72]46%2 studies3640not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.17 [0.24, 5.62]39%2 studies5471,091not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk0.91 [0.47, 1.79]0%2 studies770not evaluable ROB-
3 non statistically significant endpoints reported in only one study

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