Gabapentin (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)1.15 [0.91, 1.46]0%8 studies49,613454not evaluable ROB-
Major congenital malformations1.01 [0.75, 1.35]0%8 studies49,608454not evaluable ROB-
Congenital heart defects1.73 [0.56, 5.33]32%2 studies531not evaluable ROB-
Oro-facial clefts1.49 [0.60, 3.72]0%3 studies2,816396not evaluable ROB-
Hypospadias1.55 [0.31, 7.89]0%2 studies3,378396not evaluable ROB-
Bilateral renal agenesis including Potter syndrome34.08 [2.11, 550.91]-1 study75365not evaluable ROB67.65 [3.64; .]
Bladder exstrophy and/or epispadia31.19 [1.93, 503.78]-1 study82365not evaluable ROB61.87 [3.27; .]
Ebstein's anomaly50.95 [3.14, 827.39]-1 study50365not evaluable ROB101.40 [5.73; .]
Hypoplastic right heart (HRH/HRHS)38.69 [2.39, 626.25]-1 study66365not evaluable ROB76.88 [4.21; .]
Pulmonary valve atresia16.87 [1.05, 271.48]-1 study152365not evaluable ROB33.23 [1.27; .]
22 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)2.38 [1.79, 3.15]0%4 studies91,697453not evaluable ROB4.19 [2.99; .]
Low birth weight (< 2500g)2.35 [1.68, 3.29]7%2 studies91,756450not evaluable ROB4.14 [2.75; .]
Small for gestational age (weight)1.23 [0.92, 1.63]0%2 studies168,024450not 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 care2.18 [1.81, 2.62]-1 study870not evaluable ROB3.78 [3.02; .]
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation--0 study-
1 non statistically significant endpoints reported in only one study

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

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)4.41 [0.49, 39.98]0%3 studies317not evaluable ROB-
Early intrauterine death (< 22 weeks)4.64 [0.23, 93.20]0%2 studies23not 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
ASD (Autism spectrum disorder): Diagnosis1.34 [0.40, 4.45]58%3 studies4,5581,344not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.34 [0.40, 4.45]58%3 studies4,5581,344not evaluable ROB-
Neuro-developmental disorders (as a whole)0.96 [0.44, 2.10]32%4 studies10,4751,345not evaluable ROB-
Language disorders/delay0.62 [0.36, 1.05]0%2 studies72,028392not evaluable ROB-
6 non statistically significant endpoints reported in only one study

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