Primidone AND Phenobarbital (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)2.13 [1.55, 2.92]4%15 studies3721,321low ROB3.67 [2.47; .]
Major congenital malformations2.11 [1.51, 2.94]0%11 studies3151,131low ROB3.63 [2.39; .]
Congenital heart defects3.07 [1.18, 8.01]48%6 studies53652not evaluable ROB5.60 [1.64; .]
Hypospadias1.92 [0.49, 7.48]0%5 studies11515not evaluable ROB-
Microcephaly / Small head circumference for gestational age2.55 [1.08, 6.05]0%5 studies45248serious ROB4.54 [1.36; .]
Minor congenital malformations1.93 [0.91, 4.11]8%4 studies66206not evaluable ROB-
Spina bifida2.86 [0.19, 42.89]46%3 studies533not evaluable ROB-
Hip dislocation and/or dysplasia4.08 [0.31, 53.22]0%2 studies116not evaluable ROB-
Neural Tube Defects2.60 [0.40, 17.05]26%4 studies6617not evaluable ROB-
Polydactyly4.00 [0.24, 66.68]49%3 studies4304not evaluable ROB-
Club foot / Talipes equinovarus1.89 [0.11, 32.38]0%2 studies119not evaluable ROB-
Urinary malformations0.59 [0.11, 3.19]0%2 studies15431not evaluable ROB-
Ano-rectal atresia and stenosis0.59 [0.02, 15.81]-1 study112not evaluable ROB-
Cleft lip with or without cleft palate5.97 [0.24, 149.03]-1 study157not evaluable ROB-
Congenital cataract0.59 [0.02, 15.81]-1 study112not evaluable ROB-
Craniosynostosis2.14 [0.03, 131.94]-1 study4not evaluable ROB-
Digestive system anomalies0.83 [0.03, 20.42]-1 study1137not evaluable ROB-
Down syndrom / Trisomy 212.14 [0.03, 131.94]-1 study4not evaluable ROB-
Limb defects2.50 [0.35, 17.96]-1 study4137not evaluable ROB-
Nervous system anomalies7.52 [0.30, 185.67]-1 study1137not evaluable ROB-
Oro-facial clefts4.09 [1.38, 12.13]0%2 studies15493not evaluable ROB7.65 [2.11; .]
Eye defects0.89 [0.29, 2.73]-1 study1563not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Small for gestational age (weight)2.19 [1.44, 3.35]29%5 studies169,818321not evaluable ROB3.81 [2.23; .]
Preterm (< 37 weeks)1.20 [0.42, 3.41]51%5 studies91,269194not evaluable ROB-
Low birth weight (< 2500g)1.47 [0.50, 4.31]62%3 studies92,473181not evaluable ROB-
Macrosomia (> 4000g)0.49 [0.29, 0.82]0%2 studies577,11494not evaluable ROB3.54 [.; 1.72]
Extremely preterm (< 28 weeks)5.01 [0.31, 80.81]-1 study2,04184not evaluable ROB-
Very preterm (28 to 32 weeks)2.39 [0.33, 17.16]-1 study8,58584not evaluable ROB-
Large head circumference for gestational age5.00 [0.07, 366.35]-1 study2not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Assisted deliveries (forceps, vacuum, ...)0.05 [0.00, 6.68]-1 study10not evaluable ROB-
Caesarean0.18 [0.00, 12.84]-1 study110not evaluable ROB-
Polyhydramnios0.05 [0.00, 6.68]-1 study10not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Feeding difficulty4.51 [0.63, 32.30]0%3 studies316not 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 hemorrhage3.06 [0.22, 43.15]0%2 studies26not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation21.00 [0.30, 1469.95]-1 study2not evaluable ROB-
Cerebral palsy1.87 [0.03, 100.54]-1 study12not evaluable ROB-
Jaundice / Icterus0.62 [0.02, 19.59]-1 study14not evaluable ROB-
Neonatal hypotonia2.14 [0.03, 131.94]-1 study4not evaluable ROB-
Neonatal infections2.14 [0.03, 131.94]-1 study4not evaluable ROB-
Neonatal medical care2.14 [0.03, 131.94]-1 study4not evaluable ROB-
Neonatal tachypnea2.14 [0.03, 131.94]-1 study4not evaluable ROB-

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 deaths (< 22 weeks) / Spontaneous abortions1.06 [0.63, 1.79]1%2 studies165263not evaluable ROB-
Elective/induced termination of pregnancy1.40 [0.02, 97.44]-1 study3not evaluable ROB-
Therapeutic terminations of pregnancy1.40 [0.02, 97.44]-1 study3not evaluable ROB-
Perinatal death0.59 [0.05, 6.30]0%2 studies3356not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths2.46 [0.49, 12.25]-1 study8260not evaluable ROB-

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)1.60 [0.64, 4.00]0%4 studies10,030153not 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)2.70 [1.28, 5.68]0%3 studies158not evaluable ROB4.84 [1.88; .]
ASD (Autism spectrum disorder): Diagnosis2.39 [0.15, 38.48]-1 study4,28084not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk2.39 [0.15, 38.48]-1 study4,28084not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.06 [0.14, 8.09]53%2 studies396not evaluable ROB-
Psychomotor developmental disorders/delay1.34 [0.82, 2.21]0%2 studies698not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)3.00 [0.41, 21.94]-1 study3,39984not evaluable ROB-
Learning disorders 13.75 [1.48, 127.48]-1 study77not evaluable ROB26.99 [2.33; .]
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.33 [0.01, 9.07]-1 study112not evaluable ROB-

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