| 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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| S15218 R62392 |
Bromley (Lamotrigine) (Epilepsy), 2023 | Preterm birth (gestational age < 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 1.03 [0.45;2.39] C | 15/106 11/80 | 26 | 106 |
|
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| S12611 R47525 |
Van Marter (Lamotrigine) (Controls unexposed, disease free), 2021 | Premature (≤36 wk) | at least 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.77 [0.31;1.94] C excluded (control group) |
9/110 11/106 | 20 | 110 |
|
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| S12613 R47537 |
Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 | Premature (≤36 wk) | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 1.25 [0.15;10.61] C | 9/110 1/15 | 10 | 110 |
|
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| S8904 R30079 |
Aydin (Lamotrigine), 2020 | Preterm delivery (before 37 weeks of gestation) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.60 [0.03;14.19] C | 0/7 2/22 | 2 | 7 |
|
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| S8978 R30431 |
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.18 [1.01;1.37] C | 175/2,813 90,991/1,707,707 | 91,166 | 2,813 |
|
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| S8963 R30355 |
Cohen (Lamotrigine) (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 | 0.96 [0.87;1.06] | 392/2,682 160,604/1,440,631 | 160,996 | 2,682 |
|
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| S12464 R46884 |
Kernizan, 2019 | Premature delivery (<37 weeks) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 0.42 [0.09;2.00] C | 2/13 42/140 | 44 | 13 |
|
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| S8913 R30122 |
Miškov (Lamotrigine) (Controls unexposed, disease free), 2016 | Premature deliveries | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No |
2.58 [0.45;14.91] C excluded (control group) |
2/26 4/128 | 6 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8914 R30128 |
Miškov (Lamotrigine) (Controls unexposed, sick), 2016 | Premature deliveries | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.74 [0.03;18.97] C | 2/26 0/4 | 2 | 26 |
|
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| S8974 R30417 |
Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 | Preterm (< 37 weeks) | throughout pregnancy | prospective cohort | unexposed, disease free | Adjustment: No | 1.30 [0.84;2.00] C | 119/1,581 27/457 | 146 | 1,581 |
|
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| S8975 R30422 |
Kilic (Lamotrigine) (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 |
1.60 [1.30;2.00] excluded (control group) |
83/880 33,974/676,834 | 34,057 | 880 |
|
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| S8976 R30425 |
Kilic (Lamotrigine) (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 | 1.34 [1.04;1.71] C | 83/880 383/5,296 | 466 | 880 |
|
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| S8902 R30062 |
Artama (Lamotrigine) (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 |
0.98 [0.48;2.00] excluded (control group) |
8/173 30,027/719,509 | 30,035 | 173 |
|
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| S8903 R30074 |
Artama (Lamotrigine) (Controls unexposed, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.00 [0.46;2.16] | 8/173 85/1,793 | 93 | 173 |
|
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| S8953 R30311 |
Veiby (Lamotrigine) (Controls unexposed, disease free) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.90 [0.40;2.00] excluded (control group) |
7/103 7,269/106,899 | 7,276 | 103 |
|
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| S8954 R30325 |
Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.87 [0.37;2.03] C | 7/103 30/386 | 37 | 103 |
|
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| S8942 R30233 |
Cummings (Lamotrigine), 2011 | Preterm (35-37 weeks) | throughout pregnancy | retrospective cohort (registry) | unexposed, disease free | Adjustment: No | 16.22 [0.86;304.56] C | 5/35 0/44 | 5 | 35 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 12 studies | 1.11 [0.97;1.26] | 252,993 | 8,529 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Lamotrigine) (Epilepsy; 2: Lamotrigine) (Controls unexposed, sick; 3: Lamotrigine; 4: Lamotrigine) (Controls unexposed NOS) (Mixed indications; 5: Lamotrigine) (Mixed indications; 6: Lamotrigine) (Controls unexposed, sick; 7: Lamotrigine) (Mixed indications; 8: Lamotrigine) (Controls unexposed, sick) (Mixed indications; 9: Lamotrigine) (Controls unexposed, sick; 10: Lamotrigine) (Controls unexposed, sick) ; 11: Lamotrigine;
Asymetry test p-value = 0.5191 (by Egger's regression)
slope=0.0251 (0.0600); intercept=0.2977 (0.4454); t=0.6683; p=0.5191
excluded 8902, 8953, 8975, 8913, 12611