| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S16079 R66726 |
Christensen (Valproate) (Epilepsy) (Controls exposed to LTG), 2024 | Small for gestational age (a z-score for birth weight ≤10th 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 |
1.16 [0.98;1.36] C excluded (control group) |
229/1,953 546/5,299 | 775 | 1,953 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16023 R66514 |
Christensen (Valproate) (Epilepsy) (Controls unexposed, general population), 2024 | Small for gestational age (a z-score for birth weight ≤10th percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.07 [0.90;1.26] | 229/1,953 2,416/22,227 | 2,645 | 1,953 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8087 R24743 |
Aydin (Valproate) (Controls exposed to Lamotrigine, sick), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.62 [0.01;35.19] C excluded (control group) |
0/11 0/7 | 0 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7922 R24605 |
Aydin (Valproate) (Controls unexposed, sick), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 2.05 [0.04;110.56] C | 0/11 0/22 | 0 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7799 R23027 |
Coste (Valproate) (Controls unexposed, NOS), 2020 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.63 [1.37;1.94] C | 149/991 167,376/1,710,441 | 167,525 | 991 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8143 R25027 |
Cohen (Valproate) (Controls exposed to Lamotrigine, sick), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
1.55 [0.57;4.16] excluded (control group) |
-/- -/- | - | - |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8139 R24999 |
Cohen (Valproate) (Controls unexposed NOS), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.97 [0.49;1.95] | -/- 41,653/1,440,631 | - | - |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S7460 R25139 |
Putignano (Valproate), 2019 | Small for gestational age (SGA) (weight) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 2.27 [1.35;3.79] C | 22/131 75/917 | 97 | 131 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6353 R17323 |
Veiby (Valproate) (Controls exposed to Lamotrigine, sick) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.03 [0.19;5.55] C excluded (control group) |
2/40 5/103 | 7 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S5506 R17327 |
Veiby (Valproate) (Controls unexposed, disease free) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: Yes |
0.90 [0.20;3.70] excluded (control group) |
2/40 8,017/106,899 | 8,019 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6350 R17331 |
Veiby (Valproate) (Controls unexposed, sick) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.60 [0.14;2.62] C | 2/40 31/386 | 33 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6416 R17611 |
Pennell (Valproate), 2012 | Small for gestational age (SGA) (at birth) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 4.08 [1.11;14.96] | 9/62 4/98 | 13 | 62 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6623 R18198 |
Burja (Valproate) (Controls unexposed, disease free), 2006 | Small for date (NOS) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
8.17 [0.49;135.15] C excluded (control group) |
1/2 23/211 | 24 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S6619 R18178 |
Burja (Valproate) (Controls unexposed, sick), 2006 | Small for date (NOS) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 31.00 [1.02;941.06] C | 1/2 1/32 | 2 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8221 R25733 |
Endo (Valproate) (Controls unexposed, disease free), 2004 | Intrauterine growth retardation (NOS) | at least 1st trimester | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
2.00 [0.11;37.93] C excluded (control group) |
0/5 34/656 | 34 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8311 R26290 |
Endo (Valproate) (Controls unexposed, sick), 2004 | Intrauterine growth retardation (NOS) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.11 [0.00;14.76] C | 0/5 0/1 | 0 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 9 studies | 1.47 [1.04;2.06] | 170,315 | 3,195 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Valproate) (Epilepsy) (Controls unexposed, general population; 2: Valproate) (Controls unexposed, sick; 3: Valproate) (Controls unexposed, NOS; 4: Valproate) (Controls unexposed NOS; 5: Valproate; 6: Valproate) (Controls unexposed, sick) ; 7: Valproate; 8: Valproate) (Controls unexposed, sick; 9: Valproate) (Controls unexposed, sick;
Asymetry test p-value = 0.6190 (by Egger's regression)
slope=0.2467 (0.1451); intercept=0.4281 (0.8231); t=0.5201; p=0.6190
excluded 8221, 6623, 6353, 5506, 8143, 8087, 16079