Major congenital malformation rate by monotherapy drug exposures
| Drug | Informative outcome* (n) | MCMs (n) | MCM rate (95% CI) | OR (95% CI) | p Value | Adjusted OR (95% CI)† | p Value† | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *Pregnancy losses with no MCM excluded. | ||||||||||||||
| †Adjusted for age at delivery, parity of mother, family history of MCM, periconceptional folic acid exposure, and sex of infant. | ||||||||||||||
| CI, confidence interval; MCM, major congenital malformation; OR, odds ratio. | ||||||||||||||
| Carbamazepine | 900 | 20 | 2.2% (1.4 to 3.4) | 1.0 | – | 1.0 | – | |||||||
| Valproate | 715 | 44 | 6.2% (4.6 to 8.2) | 2.78 (1.62 to 4.76) | <0.001 | 2.97 (1.65 to 5.35) | <0.001 | |||||||
| Lamotrigine | 647 | 21 | 3.2% (2.1 to 4.9) | 1.44 (0.77 to 2.67) | 0.253 | 1.71 (0.88 to 3.32) | 0.114 | |||||||
| Phenytoin | 82 | 3 | 3.7% (1.3 to 10.2) | 1.64 (0.48 to 5.62) | 0.433 | 1.60 (0.43 to 5.95) | 0.484 | |||||||
| Gabapentin | 31 | 1 | 3.2% (0.6 to 16.2) | 1.33 (0.17 to 10.20) | 0.782 | 1.76 (0.22 to 14.49) | 0.596 | |||||||
| Topiramate | 28 | 2 | 7.1% (2.0 to 22.6) | 2.75 (0.62 to 12.20) | 0.185 | 3.46 (0.73 to 16.39) | 0.119 | |||||||
| Levetiracetam | 22 | 0 | 0.0% (0.0 to 14.9) | – | – | – | – | |||||||