| 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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| S18702 R79555 |
Mazzone (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2025 | Preterm birth | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.27 [0.95;1.69] C excluded (control group) |
87/832 124/1,469 | 211 | 832 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S18703 R79563 |
Mazzone (Levetiracetam) (Controls unexposed, NOS) (Mixed indications), 2025 | Preterm birth | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes | 1.87 [1.37;2.55] | 87/832 36,613/624,794 | 36,700 | 832 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16185 R79421 |
The NAAED (Levetiracetam) (Controls exposed to LTG) (Indications NOS), 2025 | Preterm (<37 wk) | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.96 [0.76;1.21] C excluded (control group) |
121/1,283 241/2,461 | 362 | 1,283 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16175 R79437 |
The NAAED (Levetiracetam) (Controls unexposed, disease free) (Indications NOS), 2025 | Preterm (<37 wk) | at least 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 0.62 [0.49;0.79] C | 121/1,283 189/1,311 | 310 | 1,283 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16096 R66789 |
Hoeltzenbein (Levetiracetam), 2024 | Preterm birth (birth before completed gestational week 37) | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 1.47 [0.74;2.93] | 21/197 30/432 | 51 | 197 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S15220 R62418 |
Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023 | Preterm birth (gestational age < 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.67 [0.26;1.75] C excluded (control group) |
7/70 15/106 | 22 | 70 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S15219 R62405 |
Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 | Preterm birth (gestational age < 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.70 [0.25;1.91] C | 7/70 11/80 | 18 | 70 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12618 R47567 |
Van Marter (Levetiracetam) (Controls unexposed, disease free), 2021 | Premature (≤36 wk) | at least 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
1.10 [0.46;2.68] C excluded (control group) |
11/97 11/106 | 22 | 97 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12615 R47549 |
Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 | Premature (≤36 wk) | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.79 [0.21;14.97] C | 11/97 1/15 | 12 | 97 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8986 R30511 |
Aydin (Levetiracetam) (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 |
0.68 [0.01;39.07] C excluded (control group) |
0/10 0/7 | 0 | 10 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8987 R30521 |
Aydin (Levetiracetam) (Controls unexposed, sick), 2020 | Preterm delivery (before 37 weeks of gestation) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.41 [0.02;9.43] C | 0/10 2/22 | 2 | 10 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10071 R36651 |
Coste (Levetiracetam) (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 |
1.35 [0.96;1.89] C excluded (control group) |
51/621 131/2,108 | 182 | 621 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9020 R30708 |
Coste (Levetiracetam) (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 | 1.59 [1.19;2.11] C | 51/621 91,255/1,710,441 | 91,306 | 621 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S18026 R75962 |
Margulis (Levetiracetam) (Epilepsy), 2019 | Preterm birth (delivery before 37 completed weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick | Adjustment: Yes | 1.40 [0.70;2.80] | -/126 -/1,787 | - | 126 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9029 R30779 |
Bank (Levetiracetam) (Mixed indications), 2017 | Premature (<37 weeks gestation) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.77 [0.06;48.38] C | 0/7 1/36 | 1 | 7 |
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| S8982 R30469 |
Arkilo (Levetiracetam), 2015 | Premature delivery | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 1.56 [0.22;10.96] C | 2/11 3/24 | 5 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9030 R30788 |
Kilic (Levetiracetam) (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 |
0.38 [0.05;2.87] C excluded (control group) |
1/26 83/880 | 84 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9031 R30791 |
Kilic (Levetiracetam) (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: No |
0.76 [0.10;5.59] C excluded (control group) |
1/26 33,974/676,834 | 33,975 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9032 R30794 |
Kilic (Levetiracetam) (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 | 0.51 [0.07;3.80] C | 1/26 383/5,296 | 384 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8983 R30482 |
Artama (Levetiracetam) (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 |
3.75 [0.71;19.83] C excluded (control group) |
2/13 8/173 | 10 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8984 R30494 |
Artama (Levetiracetam) (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 |
3.54 [0.77;16.36] excluded (control group) |
2/13 30,027/719,509 | 30,029 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8985 R30506 |
Artama (Levetiracetam) (Controls unexposed, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 3.33 [0.67;16.56] | 2/13 85/1,793 | 87 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 12 studies | 1.24 [0.82;1.88] | 128,876 | 3,293 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Levetiracetam) (Controls unexposed, NOS) (Mixed indications; 2: Levetiracetam) (Controls unexposed, disease free) (Indications NOS; 3: Levetiracetam; 4: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 5: Levetiracetam) (Controls unexposed, sick; 6: Levetiracetam) (Controls unexposed, sick; 7: Levetiracetam) (Controls unexposed, NOS; 8: Levetiracetam) (Epilepsy; 9: Levetiracetam) (Mixed indications; 10: Levetiracetam; 11: Levetiracetam) (Controls unexposed, sick) (Mixed indications; 12: Levetiracetam) (Controls unexposed, sick;
Asymetry test p-value = 0.6899 (by Egger's regression)
slope=0.0503 (0.2339); intercept=0.3689 (0.8982); t=0.4108; p=0.6899
excluded 8983, 8984, 9030, 9031, 8986, 10071, 12618, 15220, 18702, 16185