| id | Study | Lib. in paper | Exposition period | Study type  | 
                Control type  | 
                Tags | OR 95%CI | x1/n1 x0/n0 | no cases | no exposed | ROB | Ref. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S18022 R76117  | 
                Leite (Phenobarbital) (Epilepsy), 2024 | Premature Delivery <37weeks | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, disease free | Adjustment: No | 0.60 [0.24;1.48] | -/70 98/492 | - | 70 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9160 R31483  | 
                Coste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Controls: mixed indications | 
                    0.95 [0.38;2.39] C  excluded (control group)  | 
                
                5/84 175/2,813 | 180 | 84 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9161 R31501  | 
                Coste (Phenobarbital) (Controls unexposed, NOS), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.12 [0.45;2.77] C | 5/84 91,255/1,710,441 | 91,260 | 84 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9138 R31383  | 
                Kilic (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No | 
                    1.12 [0.56;2.23] C  excluded (control group)  | 
                
                10/96 83/880 | 93 | 96 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9139 R31386  | 
                Kilic (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: No | 
                    2.10 [1.20;3.70]  excluded (control group)  | 
                
                10/96 33,974/676,834 | 33,984 | 96 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9140 R31389  | 
                Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 1.49 [0.77;2.89] C | 10/96 383/5,296 | 393 | 96 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9104 R31260  | 
                Endo (Phenobarbital) (Controls unexposed, disease free), 2004 | Preterm delivery (< week 37) | throughout pregnancy | retrospective cohort | unexposed, disease free excluded | Adjustment: No | 
                    0.59 [0.07;4.70] C  excluded (control group)  | 
                
                1/10 104/656 | 105 | 10 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9105 R31275  | 
                Endo (Phenobarbital) (Controls unexposed, sick), 2004 | Preterm delivery (< week 37) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.18 [0.00;12.84] C | 1/10 0/1 | 1 | 10 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9167 R31545  | 
                Koch (Phenobarbital), 1996 | Prematurity (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 6.05 [0.21;177.04] C | 0/4 1/65 | 1 | 4 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9172 R31562  | 
                Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991 | Gestational age (≤ 37 wk) | throughout pregnancy | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched | 
                    1.16 [0.12;11.40] C  excluded (control group)  | 
                
                1/12 4/55 | 5 | 12 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9173 R31587  | 
                Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 | Gestational age (≤ 37 wk) | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 0.91 [0.07;11.19] C | 1/12 2/22 | 3 | 12 | 
                    
                    
                         | 
                ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 6 studies | 1.10 [0.70;1.72] | 91,658 | 276 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1: Phenobarbital) (Epilepsy; 2: Phenobarbital) (Controls unexposed, NOS; 3: Phenobarbital) (Controls unexposed, sick) (Mixed indications; 4: Phenobarbital) (Controls unexposed, sick; 5: Phenobarbital; 6: Phenobarbital) (Controls unexposed, sick;
Asymetry test p-value = 0.7960 (by Egger's regression)
slope=0.1983 (0.4360); intercept=-0.2158 (0.7807); t=0.2764; p=0.7960
excluded 9172, 9104, 9138, 9139, 9160