| 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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| S9287 R32239 |
Aydin (Valproate) (Controls exposed to Lamotrigine, sick), 2020 | Preterm delivery (before 37 weeks of gestation) | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9288 R32249 |
Aydin (Valproate) (Controls unexposed, sick), 2020 | Preterm delivery (before 37 weeks of gestation) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.37 [0.02;8.48] C | 0/11 2/22 | 2 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9391 R32873 |
Coste (Valproate) (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 |
1.16 [0.86;1.57] C excluded (control group) |
71/991 131/2,108 | 202 | 991 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9392 R32891 |
Coste (Valproate) (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 | 1.37 [1.08;1.74] C | 71/991 91,255/1,710,441 | 91,326 | 991 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9315 R32456 |
Cohen (Valproate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) | early pregnancy | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
1.32 [1.09;1.60] excluded (control group) |
399/2,398 392/2,682 | 791 | 2,398 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9316 R32463 |
Cohen (Valproate) (Controls unexposed NOS) (Mixed indications), 2019 | Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 1.04 [0.95;1.15] | 399/2,398 160,604/1,440,631 | 161,003 | 2,398 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9324 R32499 |
Putignano (Valproate), 2019 | Preterm birth (<37 weeks) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 1.18 [0.54;2.55] | 8/131 48/917 | 56 | 131 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9314 R32445 |
Bank (Valproate) (Mixed indications), 2017 | Premature (<37 weeks gestation) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 2.09 [0.08;58.11] C | 0/6 1/36 | 1 | 6 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9282 R32196 |
Arkilo (Valproate), 2015 | Premature delivery | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 1.95 [0.07;58.24] C | 0/2 3/24 | 3 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9445 R33172 |
Kilic (Valproate) (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 |
0.69 [0.43;1.12] C excluded (control group) |
23/343 83/880 | 106 | 343 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9446 R33175 |
Kilic (Valproate) (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: Yes |
1.30 [0.90;2.00] excluded (control group) |
23/343 33,974/676,834 | 33,997 | 343 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9447 R33178 |
Kilic (Valproate) (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 | 0.92 [0.60;1.43] C | 23/343 383/5,296 | 406 | 343 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9283 R32209 |
Artama (Valproate) (Controls exposed to Lamotrigine, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.24 [0.57;2.71] C excluded (control group) |
40/703 8/173 | 48 | 703 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9284 R32221 |
Artama (Valproate) (Controls unexposed, disease free), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
1.24 [0.90;1.71] excluded (control group) |
40/703 30,027/719,509 | 30,067 | 703 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9285 R32233 |
Artama (Valproate) (Controls unexposed, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.11 [0.74;1.65] | 40/703 85/1,793 | 125 | 703 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9424 R33069 |
Veiby (Valproate) (Controls exposed to Lamotrigine, sick) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.11 [0.27;4.53] C excluded (control group) |
3/40 7/103 | 10 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9426 R33087 |
Veiby (Valproate) (Controls unexposed, disease free) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.70 [0.20;3.00] excluded (control group) |
3/40 7,269/106,899 | 7,272 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9427 R33101 |
Veiby (Valproate) (Controls unexposed, sick) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.96 [0.28;3.31] C | 3/40 30/386 | 33 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9323 R32487 |
Pennell (Valproate), 2012 | Preterm Birth (< 37 weeks GA) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.35 [0.39;4.61] C | 5/62 6/98 | 11 | 62 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9394 R32922 |
Cummings (Valproate) (Controls exposed to Lamotrigine, sick), 2011 | Preterm (35-37 weeks) | throughout pregnancy | retrospective cohort (registry) | exposed to other treatment, sick excluded | Adjustment: No |
0.33 [0.07;1.47] C excluded (control group) |
3/58 5/35 | 8 | 58 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9395 R32925 |
Cummings (Valproate) (Controls unexposed, disease free), 2011 | Preterm (35-37 weeks) | throughout pregnancy | retrospective cohort (registry) | unexposed, disease free | Adjustment: No | 5.59 [0.28;111.10] C | 3/58 0/44 | 3 | 58 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9415 R33015 |
Nadebaum (Valproate), 2011 | Born premature (<37 wk) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.19 [0.04;32.08] C | 1/23 0/9 | 1 | 23 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9411 R32996 |
McVearry (Valproate), 2009 | Premature birth | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.94 [0.04;106.66] C | 0/9 0/17 | 0 | 9 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9300 R32381 |
Endo (Valproate) (Controls unexposed, disease free), 2004 | Preterm delivery (< week 37) | at least 1st trimester | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
1.33 [0.15;11.99] C excluded (control group) |
1/5 104/656 | 105 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9301 R32396 |
Endo (Valproate) (Controls unexposed, sick), 2004 | Preterm delivery (< week 37) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.43 [0.01;33.60] C | 1/5 0/1 | 1 | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9308 R32418 |
Jäger-Roman (Valproate), 1986 | Prematurity | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 0.54 [0.03;9.92] C | 0/14 7/116 | 7 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 15 studies | 1.08 [0.99;1.17] | 252,978 | 4,796 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (Controls unexposed, sick; 2: Valproate) (Controls unexposed, NOS; 3: Valproate) (Controls unexposed NOS) (Mixed indications; 4: Valproate; 5: Valproate) (Mixed indications; 6: Valproate; 7: Valproate) (Controls unexposed, sick) (Mixed indications; 8: Valproate) (Controls unexposed, sick; 9: Valproate) (Controls unexposed, sick) ; 10: Valproate; 11: Valproate) (Controls unexposed, disease free; 12: Valproate; 13: Valproate; 14: Valproate) (Controls unexposed, sick; 15: Valproate;
Asymetry test p-value = 0.4949 (by Egger's regression)
slope=0.0600 (0.0375); intercept=0.1588 (0.2262); t=0.7022; p=0.4949
excluded 9300, 9394, 9283, 9284, 9424, 9426, 9445, 9446, 9315, 9287, 9391