title: Effect of folic acid supplementation in pregnancy on preeclampsia: the folic acid clinical trial study.
abstract: Preeclampsia (PE) is hypertension with 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 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 after written consent is obtained. Intent-to-treat population will be analyzed. The 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. This trial is registered with NCT01355159.
authors.affiliation: OMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; 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 ; Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
authors.forename: Shi Wu
authors.initials: SW
authors.lastname: Wen
authors.affiliation: OMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6.
authors.forename: Josee
authors.initials: J
authors.lastname: Champagne
authors.affiliation: OMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6.
authors.forename: Ruth
authors.initials: R
authors.lastname: Rennicks White
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
authors.forename: Doug
authors.initials: D
authors.lastname: Coyle
authors.affiliation: Department of Obstetrics and Gynecology, Ste. Justine Hospital, 3175 Cote Ste. Catherine, Montreal, QC, Canada H3T 1C5.
authors.forename: William
authors.initials: W
authors.lastname: Fraser
authors.affiliation: Queen's Perinatal Research Unit, Department of Obstetrics and Gynecology, Queen's University, 76 Stuart Street, Connell 4, Kingston, ON, Canada K7L 2V7.
authors.forename: Graeme
authors.initials: G
authors.lastname: Smith
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; 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 ; Department of Medicine, Faculty of Medicine, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6.
authors.forename: Dean
authors.initials: D
authors.lastname: Fergusson
authors.affiliation: OMNI Research Group, Department of Obstetrics and Gynecology, Faculty of Medicine, Ottawa Hospital, University of Ottawa, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6 ; Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Walker
mesh_terms: D002170:Canada; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use*; D006801:Humans; D011225:Pre-Eclampsia / Q000517:prevention & control*; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011262:Pregnancy Trimester, Second; D012306:Risk; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000627:therapeutic use*
chemical_list: D014803:Vitamin B Complex; D005492:Folic Acid