| 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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| S9324 R32500 |
Putignano (Valproate), 2019 | Apgar score at 5 min < 7 | during pregnancy (anytime or not specified) | retrospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 1.17 [0.14;9.78] C | 1/131 6/917 | 7 | 131 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9314 R32448 |
Bank (Valproate) (Mixed indications), 2017 | Apgar < 7 at 5 minutes | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 6.45 [0.12;360.09] C | 0/6 0/36 | 0 | 6 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9438 R33147 |
Christensen (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2015 | Low Apgar score (≤ 7) at 5 min | during pregnancy (anytime or not specified) | population based cohort propective | exposed to other treatment, sick excluded | Adjustment: No |
1.83 [0.69;4.86] C excluded (control group) |
7/337 10/875 | 17 | 337 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9439 R33148 |
Christensen (Valproate) (Controls unexposed NOS) (Mixed indications), 2015 | Low Apgar score (≤ 7) at 5 min | during pregnancy (anytime or not specified) | population based cohort propective | unexposed (general population or NOS) excluded | Adjustment: No |
1.59 [0.77;3.29] excluded (control group) |
7/337 8,797/674,115 | 8,804 | 337 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9440 R33149 |
Christensen (Valproate) (Controls unexposed, sick) (Mixed indications), 2015 | Low Apgar score (≤ 7) at 5 min | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, sick | Adjustment: No | 1.64 [0.75;3.61] C | 7/337 67/5,261 | 74 | 337 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9283 R32205 |
Artama (Valproate) (Controls exposed to Lamotrigine, sick), 2013 | 5-min Apgar <7 | 3rd trimester | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.32 [0.34;5.19] C excluded (control group) |
7/235 3/132 | 10 | 235 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9284 R32217 |
Artama (Valproate) (Controls unexposed, disease free), 2013 | 5-min Apgar <7 | 3rd trimester | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
2.72 [1.28;5.81] excluded (control group) |
7/235 3,014/269,151 | 3,021 | 235 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9285 R32229 |
Artama (Valproate) (Controls unexposed, sick), 2013 | 5-min Apgar <7 | 3rd trimester | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 2.68 [0.91;7.94] | 7/235 3/652 | 10 | 235 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9424 R33068 |
Veiby (Valproate) (Controls exposed to Lamotrigine, sick) b, 2013 | Low Apgar score (< 7 at 5 min) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.66 [0.36;19.54] C excluded (control group) |
2/40 2/103 | 4 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9426 R33086 |
Veiby (Valproate) (Controls unexposed, disease free) b, 2013 | Low Apgar score (< 7 at 5 min) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No |
1.60 [0.20;11.80] excluded (control group) |
2/40 1,710/106,899 | 1,712 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9427 R33100 |
Veiby (Valproate) (Controls unexposed, sick) b, 2013 | Low Apgar score (< 7 at 5 min) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 2.20 [0.46;10.58] C | 2/40 9/386 | 11 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9323 R32492 |
Pennell (Valproate), 2012 | Apgar score (at 5 minutes < 7) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 8.11 [0.38;171.84] C | 2/62 0/97 | 2 | 62 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9432 R33128 |
Borthen (Valproate) (Controls exposed to Lamotrigine, sick), 2010 | Apgar < 7 after 5 minutes | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.46 [0.12;1.79] C excluded (control group) |
3/215 7/233 | 10 | 215 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9434 R33136 |
Borthen (Valproate) (Controls unexposed, disease free), 2010 | Apgar < 7 after 5 minutes | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
1.00 [0.30;3.20] excluded (control group) |
3/215 6,022/362,302 | 6,025 | 215 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9436 R33144 |
Borthen (Valproate) (Controls unexposed, sick), 2010 | Apgar < 7 after 5 minutes | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No | 0.86 [0.26;2.86] C | 3/215 30/1,863 | 33 | 215 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9308 R32421 |
Jäger-Roman (Valproate), 1986 | Low Apgar score (0 to 6 after 5 minute) | at least 1st trimester excluded | prospective cohort | unexposed (general population or NOS) | Adjustment: No |
11.09 [0.49;249.88] C excluded (exposition period) |
2/14 0/26 | 2 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 7 studies | 1.76 [1.06;2.91] | 137 | 1,026 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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; 2: Valproate) (Mixed indications; 3: Valproate) (Controls unexposed, sick) (Mixed indications; 4: Valproate) (Controls unexposed, sick; 5: Valproate) (Controls unexposed, sick) ; 6: Valproate; 7: Valproate) (Controls unexposed, sick;
Asymetry test p-value = 0.3378 (by Egger's regression)
slope=0.1496 (0.4373); intercept=0.6837 (0.6452); t=1.0596; p=0.3378
excluded 9432, 9434, 9283, 9284, 9424, 9426, 9438, 9439