The promotion of preconception care and health: an update on the preconception counseling and recruitment of participants in rcts that evaluate the efficacy of high dose folic acid on the prevention of congenital malformations.

Backgrounds: Periconceptional folic acid (FA) supplementation reduces the risk of neural tube defects (NTD). Observational studies suggest that,compared to the standard dose of 0.4 mg daily,a dose of 4.0 mg/day, could further reduce the risk of first NTD occurrence as well as the risk of other birth defects. We present an update on the RCTs that are conducted in Italy (I) and in the Netherlands (NL). Methods: The study evaluates the overall rate of congenital malformations (CM) and that of selected CM, miscarriage, recurrent abortion, pre-eclampsia, abruptio placentae, small-for-gestational age, preterm birth and twinning in women intending to get pregnant. In Italy, all women in this study receive extensive preconception counselling and are then invited to participate. To date, 1000 women received this counselling . In NL the inclusion for the study started in April 2012 via community pharmacies (CPs), embedded in a broader preconception care project. All CPs in Northern NL are invited to participate. In both countries, women are randomly double-blind assigned to use FA-supplements of 4 mg or 0.4 mg daily. Results: The characteristics of women who received preconception counselling in I and the results of the public information and recruitment campaign in NL will be described in detail. Acknowledgement: these studies are supported by the Italian Medicines Agency (AIFA) under contract no. FARM6KWTC and The Netherlands Organisation for Health Research and Development resepectively.