Preeclampsia (PE) is hypertensionwith proteinuria that develops during pregnancy and affects at least 5%of pregnancies.The Effect
of Folic Acid Supplementation in Pregnancy on Preeclampsia: the Folic Acid Clinical Trial (FACT) aims to recruit 3,656 high risk
women to evaluate a new prevention strategy for PE: supplementation of folic acid throughout pregnancy. Pregnant women with
increased risk of developing PE presenting to a trial participating center between 80/7 and 166/7 weeks of gestation are randomized
in a 1 : 1 ratio to folic acid 4.0mg or placebo after written consent is obtained. Intent-to-treat population will be analyzed.The FACT
study was funded by the Canadian Institutes ofHealth Research in 2009, and regulatory approval fromHealth Canada was obtained
in 2010. A web-based randomization system and electronic data collection system provide the platform for participating centers to
randomize their eligible participants and enter data in real time. To date we have twenty participating Canadian centers, of which
eighteen are actively recruiting, and seven participating Australian centers, of which two are actively recruiting. Recruitment in
Argentina, UK, Netherlands, Brazil,West Indies, and United States is expected to begin by the second or third quarter of 2013.This
trial is registered with NCT01355159.