| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| S10172 R37157 |
Blotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
12.56 [0.51;310.72] C excluded (control group) |
0/80 1/2,997 | 1 | 80 |
|
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| S10042 R36293 |
Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 | Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 26.90 [1.67;434.48] C | 0/80 438/1,875,733 | 438 | 80 |
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| S9109 R31290 |
Holmes (Phenobarbital) (Controls unexposed, disease free), 2001 | Microcephaly at birth (Head circumference more than 2 SD below the mean value for the same race, sex and gestational age) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
3.18 [0.82;12.31] C excluded (control group) |
3/62 8/508 | 11 | 62 |
|
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| S9110 R31299 |
Holmes (Phenobarbital) (Controls unexposed, sick), 2001 | Microcephaly at birth (Head circumference more than 2 SD below the mean value for the same race, sex and gestational age) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 2.39 [0.39;14.73] C | 3/62 2/96 | 5 | 62 |
|
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| S9157 R31474 |
Battino (Phenobarbital), 1999 | Small head circumferences (at birth < 10th percentile) | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 1.88 [0.50;7.07] C | 14/81 3/30 | 17 | 81 |
|
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| S9158 R31475 |
Díaz-Romero (Phenobarbital), 1999 | Head circumference <2 SD at birth (measured by a physician and correlated with sex and with gestational age) | during pregnancy (anytime or not specified) | cohort | unexposed, sick | Adjustment: No | 5.00 [0.07;366.35] C | 0/2 0/8 | 0 | 2 |
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| S9129 R31363 |
Dravet (Phenobarbital), 1992 | Isolated microcephaly at birth (head circumference >2 SD lower than those given in the reference tables adjusted for gestational age at birth) | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 3.55 [0.42;29.89] C | 12/56 1/14 | 13 | 56 |
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| S9132 R31368 |
Kelly (Phenobarbital), 1984 | Microcephaly at unknown age (head circumference < 5th centile) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 3.64 [0.30;44.78] C | 2/13 1/21 | 3 | 13 |
|
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| Total | 6 studies | 3.09 [1.34;7.13] | 476 | 294 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (Controls unexposed NOS) (Mixed indications; 2: Phenobarbital) (Controls unexposed, sick; 3: Phenobarbital; 4: Phenobarbital; 5: Phenobarbital; 6: Phenobarbital;
Asymetry test p-value = 0.1299 (by Egger's regression)
slope=-0.3080 (0.8015); intercept=1.4613 (0.7681); t=1.9025; p=0.1299
excluded 9109, 10172