Remarks y Major congenital malformations include malformations present from birth with surgical, medical, functional or cosmetic importance (cardiac malformations, cleft lip/palate, club foot, hypospadias, inguinal hernia, and undescended testes in boys). Minor congenital malformations include any congenital malformation that did not qualify as major congenital malformation.

Implementation considerations y The choice of medicine is affected by a number of factors, including seizure semiology, comorbidities, availability, cost and side-effects. y Women and girls of childbearing potential who are prescribed sodium valproate should be advised to use effective contraception without interruption, for the entire duration of treatment. Further information on contraception is available in the WHO fact sheet on family planning and contraceptive methods (185). They must be provided with information on pregnancy prevention and risks associated with use of sodium valproate during pregnancy, and referred for contraceptive advice if they are not using effective contraception. When choosing the contraception method, individual circumstances should be evaluated in each case, involving the woman in the discussion to guarantee her engagement and compliance with the chosen measures. y If a woman taking sodium valproate is planning to become pregnant, a person trained in the management of epilepsy in pregnant women should consider alternative treatment options. Women should be informed of the need to consult their physician as soon as they are planning pregnancy and to urgently consult their physician in case of pregnancy. y Every effort should be made to switch from sodium valproate to appropriate alternative treatment prior to conception. If switching is not possible, the woman should receive further counselling regarding the risks of sodium valproate for the unborn child to support her informed decision-making. y A specialist should periodically review whether sodium valproate is the most suitable treatment for all women of childbearing potential taking sodium valproate. y ASM polytherapy is, in general, associated with higher risks of congenital malformations than ASM monotherapy.