Hindawi Publishing Corporation Journal of Pregnancy Volume 2013, Article ID 294312, 9 pages http://dx.doi.org/10.1155/2013/294312 Clinical Study Effect of Folic Acid Supplementation in Pregnancy on Preeclampsia: The Folic Acid Clinical Trial Study Shi Wu Wen, 1,2,3,4 Josee Champagne, 1,2 Ruth Rennicks White, 1,2 Doug Coyle, 4 William Fraser, 5 Graeme Smith, 6 Dean Fergusson, 2,3,7 and Mark C. Walker 1,2,4 1 OMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 2 Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 3 Department of Epidemiology, Biostatistics and Occupational Health and Department of Pediatrics, McGill University Faculty of Medicine, 3175 Cote Ste. Catherine, Montreal, QC, Canada H3T 1C5 4 Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada 5 Department of Obstetrics and Gynecology, Ste. Justine Hospital, 3175 Cote Ste. Catherine, Montreal, QC, Canada H3T 1C5 6 Queen’s Perinatal Research Unit, Department of Obstetrics and Gynecology, Queen’s University, 76 Stuart Street, Connell 4, Kingston, ON, Canada K7L 2V7 7 Department of Medicine, Faculty of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 Correspondence should be addressed to Shi Wu Wen; swwen@ohri.ca Received 26 March 2013; Accepted 8 July 2013 Academic Editor: Fabio Facchinetti Copyright © 2013 Shi Wu Wen et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Preeclampsia (PE) is hypertension with proteinuria that develops during pregnancy and afects at least 5% of pregnancies. Te Efect 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 8 0/7 and 16 6/7 weeks of gestation are randomized in a 1 : 1 ratio to folic acid 4.0 mg or placebo afer written consent is obtained. Intent-to-treat population will be analyzed. Te FACT study was funded by the Canadian Institutes of Health Research in 2009, and regulatory approval from Health 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. Tis trial is registered with NCT01355159. 1. Introduction Preeclampsia (PE) is a leading cause of maternal and neonatal morbidity and mortality [1, 2]. It accounts for about one-third of maternal deaths, ranking second amongst causes of preg- nancy associated deaths in industrialized countries [3, 4]. A 3- to 25-fold increased risk of abruptio placentae, thrombocy- topenia, disseminated intravascular coagulation, pulmonary edema, and aspiration pneumonia [5] is associated with PE. Furthermore, women with a history of PE continue to be at increased risk for future cardiovascular events [6, 7]. Since delivery is the only known cure, PE is a leading cause of indicated preterm delivery [8]. PE accounts for 25% of very low birth weight infants [9], and as many as 60% of these infants sufer from learning disabilities and are associated with a low IQ [10]. PE may also increase the risk of cardiovas- cular disease in the ofspring through “fetal origins of adult diseases” [11, 12]. Tere is strong evidence from both animal and human studies, including our own large cohort studies [13, 14] to