Overall major congenital malformation rates by type of antiepileptic drug exposure
Drug exposure | Informative outcome* (n) | MCMs (n) | Crude 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. | ||||||||||||||
AED, antiepileptic drug; CI, confidence interval; MCM, major congenital malformation; OR, odds ratio. | ||||||||||||||
No AED | 227 | 8 | 3.5 (1.8 to 6.8) | 1.0 | – | 1.0 | – | |||||||
Monotherapy | 2468 | 91 | 3.7% (3.0 to 4.5) | 1.05 (0.50 to 2.19) | 0.90 | 1.03 (0.49 to 2.17) | 0.94 | |||||||
Polytherapy | 718 | 43 | 6.0% (4.5 to 8.0) | 1.71 (0.79 to 3.69) | 0.17 | 1.76 (0.80 to 3.86) | 0.16 |