Levetiracetam (Epilepsy) updated on 04-22-2025

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)0.93 [0.75, 1.15]0%16 studies148,3414,151low ROB-
Major congenital malformations0.91 [0.73, 1.13]0%15 studies148,3264,141low ROB-
Congenital heart defects1.21 [0.63, 2.34]0%5 studies401,362not evaluable ROB-
Minor congenital malformations2.57 [0.62, 10.76]0%3 studies1673not evaluable ROB-
Digestive system anomalies1.90 [0.47, 7.61]0%3 studies4313not evaluable ROB-
Limb defects2.43 [0.92, 6.40]0%3 studies6313not evaluable ROB-
Hypospadias1.28 [0.27, 6.13]0%3 studies131,071not evaluable ROB-
Nervous system anomalies1.95 [0.32, 11.86]0%2 studies291not evaluable ROB-
Neural Tube Defects2.59 [0.50, 13.52]0%3 studies51,071not evaluable ROB-
Oro-facial clefts1.34 [0.20, 9.12]32%3 studies121,071not evaluable ROB-
Spina bifida3.67 [0.34, 39.26]0%2 studies3177not evaluable ROB-
Urinary malformations0.53 [0.12, 2.33]0%2 studies16705not evaluable ROB-
3 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)1.50 [1.19, 1.89]0%8 studies91,4811,145not evaluable ROB2.36 [1.66; .]
Small for gestational age (weight)1.18 [0.84, 1.67]56%5 studies170,0271,853not evaluable ROB-
Large for gestational age (weight)1.28 [0.13, 12.96]0%2 studies7123not evaluable ROB-
Low birth weight (< 2500g)1.44 [0.83, 2.49]86%2 studies92,5711,684not 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-
Maternal consequences (as a whole)1.27 [0.93, 1.73]0%2 studies7101,033not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care1.50 [0.63, 3.59]0%3 studies17092not evaluable ROB-
Neonatal disorders (as a whole)1.06 [0.85, 1.33]0%2 studies222,315691not evaluable ROB-
2 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)2.96 [0.53, 16.41]35%2 studies4,703634not 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 studies201710not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths1.80 [0.52, 6.28]0%6 studies11592not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.11 [0.77, 1.60]0%5 studies220606not evaluable ROB-
Elective/induced termination of pregnancy0.88 [0.25, 3.08]0%3 studies13305not evaluable ROB-
Perinatal death2.47 [0.31, 19.60]0%2 studies13309not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Language disorders/delay0.90 [0.69, 1.15]0%9 studies72,094877not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.36 [0.78, 2.37]35%6 studies5,0842,454not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.10 [0.70, 1.71]0%5 studies5,0532,442not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)0.97 [0.41, 2.30]52%5 studies23189not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.17 [0.82, 1.68]8%5 studies1,6661,863not evaluable ROB-
Psychomotor developmental disorders/delay0.76 [0.29, 2.00]79%4 studies9171not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.27 [0.82, 1.97]14%4 studies1,6661,821not 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 (3-6 years old)0.85 [0.33, 2.16]0%3 studies3,4121,351not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.85 [0.33, 2.16]0%3 studies3,4121,351not evaluable ROB-
ASD (Autism spectrum disorder): Risk2.39 [0.45, 12.72]46%2 studies3640not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk0.91 [0.47, 1.79]0%2 studies770not evaluable ROB-
1 non statistically significant endpoints reported in only one study

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