The dose of ASM taken and the occurrence of major congenital malformations (MCMs)
| ASM dose | M | SD | M | SD | Z | p | r | ||
|---|---|---|---|---|---|---|---|---|---|
| LTG | No MCM (N= 386) | MCM (N = 27) | |||||||
| 206.60 | 248.38 | 123.30 | 212.78 | 249.07 | 91.06 | –0.26 | 0.793 | 0.01 | |
| VPA | No MCM (n = 279) | MCM (n = 29) | |||||||
| 154.53 | 832.08 | 405.21 | 154.21 | 815.52 | 355.84 | –0.02 | 0.985 | <0.01 | |
| CBZ | No MCM (n = 285) | MCM (n = 21) | |||||||
| 152.60 | 759.47 | 0.00 | 165.74 | 791.67 | 0.00 | –0.67 | 0.506 | 0.04 | |
| LEV | No MCM (n = 217) | MCM (n = 13) | |||||||
| 115.47 | 1792.40 | 794.80 | 116.08 | 1788.46 | 900.50 | –0.03 | 0.974 | <0.01 | |
| OXC | No MCM (n = 127) | MCM (n = 8) | |||||||
| 68.46 | 1116.73 | 507.15 | 60.69 | 993.75 | 423.79 | –0.55 | 0.582 | 0.05 | |
| TPM | No MCM (n = 70) | MCM (n = 7) | |||||||
| 39.36 | 217.14 | 112.17 | 35.43 | 210.71 | 144.23 | –0.45 | 0.651 | 0.05 |
Descriptive statistics of quantitative variables associated with pregnancy and the child
| Variable | M | Me | SD | Min. | Max. |
|---|---|---|---|---|---|
| Week of delivery – entire sample | 34.15 | 39.00 | 10.91 | 3.00 | 48.00 |
| Week of delivery – live births | 38.74 | 39.00 | 2.01 | 25 | 48 |
| Apgar – entire sample | 9.51 | 10.00 | 1.14 | 1 | 10 |
| Apgar – live births | 9.51 | 10.00 | 1.13 | 1 | 10 |
| Length – entire sample | 53.57 | 54.00 | 3.72 | 26.00 | 68.00 |
| Length – live births | 53.69 | 54.00 | 3.56 | 26.00 | 68.00 |
| Weight – entire sample | 3271.70 | 3280.00 | 553.07 | 440.00 | 4860.00 |
| Weight – live births | 3295.01 | 3300.00 | 525.51 | 450.00 | 4860.00 |
ASM use and major congenital malformations (MCMs)
| Use of ASM | No MCM | MCM | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | χ2 | p | df | φ | ||
| LTG | No | 984 | 71.7% | 67 | 71.3% | 1051 | 71.6% | 0.01 | 0.906 | 1 | < 0.01 |
| Yes | 389 | 28.3% | 27 | 28.7% | 416 | 28.4% | |||||
| Total | 1373 | 100.0% | 94 | 100.0% | 1467 | 100.0% | |||||
| VPA | No | 1091 | 79.5% | 65 | 69.1% | 1156 | 78.8% | 5.60 | 0.026 | 1 | 0.06 |
| Yes | 282 | 20.5% | 29 | 30.9% | 311 | 21.2% | |||||
| Total | 1373 | 100.0% | 94 | 100.0% | 1467 | 100.0% | |||||
| CBZ | No | 1084 | 79.0% | 73 | 77.7% | 1157 | 78.9% | 0.09 | 0.794 | 1 | <0.01 |
| Yes | 289 | 21.0% | 21 | 22.3% | 310 | 21.1% | |||||
| Total | 1373 | 100.0% | 94 | 100.0% | 1467 | 100.0% | |||||
| LEV | No | 1156 | 84.2% | 81 | 86.2% | 1237 | 84.3% | 0.26 | 0.769 | 1 | 0.01 |
| Yes | 217 | 15.8% | 13 | 13.8% | 230 | 15.7% | |||||
| Total | 1373 | 100.0% | 94 | 100.0% | 1467 | 100.0% | |||||
| OXC | No | 1246 | 90.8% | 86 | 91.5% | 1332 | 90.8% | 0.06 | 1.000 | 1 | <0.01 |
| Yes | 127 | 9.2% | 8 | 8.5% | 135 | 9.2% | |||||
| Total | 1373 | 100.0% | 94 | 100.0% | 1467 | 100,0% | |||||
| TPM | No | 1303 | 94.9% | 87 | 92.6% | 1390 | 94.8% | 0.98 | 0.334 | 1 | 0.03 |
| Yes | 70 | 5.1% | 7 | 7.4% | 77 | 5.2% | |||||
| Total | 1373 | 100.0% | 94 | 100.0% | 1467 | 100.0% | |||||
Frequency of variables associated with epilepsy, pregnancy, and treatment
| N | % | ||
|---|---|---|---|
| Type of epilepsy | Focal | 938 | 63.9% |
| Generalised | 529 | 36.1% | |
| Folic acid intake prior conception (percentages without missing data) | Yes | 841 | 61.4% |
| No | 528 | 38.6% | |
| Tonic-clonic seizures in the first trimester (percentages without missing data) | Yes | 157 | 10.9% |
| No | 1286 | 89.1% | |
| Mono/polytherapy in the first trimester | No treatment | 196 | 13.4% |
| Monotherapy | 1014 | 69.1% | |
| Polytherapy | 257 | 17.5% | |
| Termination of pregnancy dependent on the gestational week | Early miscarriage | 209 | 14.2% |
| Late miscarriage | 16 | 1.1% | |
| Premature birth | 102 | 7.0% | |
| Full-term birth | 1137 | 77.5% | |
| Post-term birth | 3 | 0.2% | |
| Pregnancy outcome | Live births | 1231 | 83.9% |
| Spontaneous miscarriage | 185 | 12.6% | |
| Induced miscarriage | 41 | 2.8% | |
| Perinatal death | 10 | 0.7% | |
| MCM | No | 1373 | 93.6% |
| Yes | 94 | 6.4% | |
| MCM type | Multiple malformations | 13 | 13.8% |
| Cardiovascular system | 31 | 33.0% | |
| Urogenital system | 20 | 21.3% | |
| Nervous system | 7 | 7.4% | |
| Musculoskeletal system | 9 | 9.6% | |
| Cleft palate | 5 | 5.3% | |
| Eye-ear-face | 3 | 3.2% | |
| Digestive system | 1 | 1.1% | |
| Other non-specific | 5 | 5.3% |
The most common drug combinations
| Drug combinations | N | % |
|---|---|---|
| LTG with VPA | 42 | 2.9% |
| LEV with LTG | 36 | 2.5% |
| CBZ with VPA | 20 | 1.4% |
| CBZ with LTG | 18 | 1.2% |
| CBZ with LEV | 14 | 1.0% |
| LEV with OXC | 12 | 0.8% |
| LEV with VPA | 10 | 0.7% |
| LTG with TPM | 10 | 0.7% |
| TPM with VPA | 9 | 0.6% |
| LTG with OXC | 8 | 0.5% |
| OXC with TPM | 7 | 0.5% |
| CBZ with TPM | 6 | 0.4% |
ASM usage frequency and descriptive statistics of their doses
| N | % | M | SD | Min. | Max. | |
|---|---|---|---|---|---|---|
| LTG | 416 | 26.90% | 248.43 | 121.37 | 25.00 | 700.00 |
| VPA | 311 | 20.10% | 830.52 | 400.32 | 150.00 | 2500.00 |
| CBZ | 311 | 20.10% | 761.16 | 355.27 | 50.00 | 1800.00 |
| LEV | 230 | 14.90% | 1792.17 | 798.96 | 200.00 | 4000.00 |
| OXC | 135 | 8.70% | 1109.44 | 502.07 | 75.00 | 2700.00 |
| TPM | 77 | 5.00% | 216.56 | 114.32 | 25.00 | 500.00 |
| GBP | 14 | 0.90% | 1642.86 | 848.27 | 400.00 | 3600.00 |
| VGB | 10 | 0.60% | 2125.00 | 489.47 | 1500.00 | 3000.00 |
| LCM | 9 | 0.60% | 322.22 | 100.00 | 400.00 | |
| PHT | 8 | 0.50% | 264.29 | 50.00 | 700.00 | |
| TGB | 5 | 0.30% | 27.00 | 15.00 | 30.00 | |
| CLN | 5 | 0.30% | 2.50 | 0.50 | 6.00 | |
| PB | 4 | 0.30% | 70.00 | 30.00 | 100.00 | |
| ESM | 4 | 0.30% | 625.00 | 500.00 | 1000.00 | |
| BNZ | 1 | 0.10% | 6.00 | 6.00 | 6.00 | |
| BRI | 1 | 0.10% | 300.00 | 300.00 | 300.00 | |
| BZN | 1 | 0.10% | 5.00 | 5.00 | 5.00 | |
| CNB | 1 | 0.10% | 300.00 | 300.00 | 300.00 | |
| PGB | 1 | 0.10% | 300.00 | 300.00 | 300.00 | |
| PRM | 1 | 0.10% | 250.00 | 250.00 | 250.00 |
Association between epilepsy type, folic acid intake, tonic-clonic seizures, and type of therapy with the occurrence of malformations in children
| Variable | No malformations | Malformation | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | χ2 | p | df | Vc/φ | ||
| Type of epilepsy | Focal | 879 | 64.1% | 59 | 62.1% | 938 | 63.9% | 0.15 | 0.741 | 1 | 0.01 |
| Generalised | 493 | 35.9% | 36 | 37.9% | 529 | 36.1% | |||||
| Total | 1372 | 100.0% | 95 | 100.0% | 1467 | 100.0% | |||||
| Folic acid intake prior conception | Yes | 787 | 61.5% | 54 | 60.0% | 841 | 61.4% | 0.08 | 0.823 | 1 | <0.01 |
| No | 492 | 38.5% | 36 | 40.0% | 528 | 38.6% | |||||
| Total | 1279 | 100.0% | 90 | 100.0% | 1369 | 100.0% | |||||
| Tonic-clonic seizures in the first trimester | Yes | 150 | 11.1% | 7 | 7.6% | 157 | 10.9% | 1.09 | 0.386 | 1 | 0.03 |
| No | 1201 | 88.9% | 85 | 92.4% | 1286 | 89.1% | |||||
| Total | 1351 | 100.0% | 92 | 100.0% | 1443 | 100.0% | |||||
| Mono/polytherapy in the first trimester | No treatment | 189 | 13.8% | 7 | 7.4% | 196 | 13.4% | 3.27 | 0.195 | 2 | 0.05 |
| Monotherapy | 945 | 68.9% | 69 | 72.6% | 1014 | 69.1% | |||||
| Polytherapy | 238 | 17.3% | 19 | 20.0% | 257 | 17.5% | |||||
| Total | 1372 | 100.0% | 95 | 100.0% | 1467 | 100.0% | |||||