| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S16068 R66683 |
Christensen (All indications) (Controls exposed to LTG), 2024 | Microcephaly (z-score for head circumference ≤3rd percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.21 [0.94;1.55] C excluded (control group) |
83/2,214 274/8,756 | 357 | 2,214 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16025 R66522 |
Christensen (All indications) (Controls unexposed, general population), 2024 | Microcephaly (z-score for head circumference ≤3rd percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes | 1.01 [0.80;1.27] | 83/2,214 134,023/4,467,848 | 134,106 | 2,214 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10045 R36362 |
Blotière (Controls exposed to Lamotrigine, sick) (Other 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 Controls: mixed indications |
0.60 [0.02;14.68] C excluded (control group) |
0/1,671 1/2,997 | 1 | 1,671 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10046 R36385 |
Blotière (Controls unexposed NOS) (Other 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 | 1.28 [0.08;20.51] C | 0/1,671 438/1,875,733 | 438 | 1,671 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S18025 R75961 |
Margulis (Pregabalin) (Indications other than epilepsy), 2019 | Microcephaly (a head circumference of two or more SDs below the mean for gestational age at birth, using a local standard) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick | Adjustment: Yes | 0.80 [0.30;2.10] | -/487 -/1,767 | - | 487 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 3 studies | 1.00 [0.80;1.25] | 134,544 | 4,372 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: All indications) (Controls unexposed, general population; 2: Controls unexposed NOS) (Other indications; 3: Pregabalin) (Indications other than epilepsy;
Funnel plot not drawn. Less than 3 points.
Asymetry test p-value = NaN (by Egger's regression)
not enought points
Funnel plot not drawn. Less than 3 points.
excluded 10045, 16068