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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to. Objective To determine the efficacy of high dose folic acid supplementation for prevention of pre-eclampsia in women with at least one risk factor: pre-existing hypertension, prepregnancy diabetes (type 1 or 2), twin pregnancy, pre-eclampsia in a previous pregnancy, or body mass index ≥35. Design Randomised, phase III, double blinded international, multicentre clinical trial. Setting 70 obstetrical centres in five countries (Argentina, Australia, Canada, Jamaica, and UK). Participants 2464 pregnant women with at least one high risk factor for pre-eclampsia were randomised between 2011 and 2015 (1144 to the folic acid group and 1157 to the placebo group); 2301 were included in the intention to treat analyses. Intervention Eligible women were randomised to receive either daily high dose folic acid (four 1.0 mg oral tablets) or placebo from eight weeks of gestation to the end of week 16 of gestation until delivery. Clinicians, participants, adjudicators, and study staff were masked to study treatment allocation. Main outcome measure The primary outcome was pre-eclampsia, defined as hypertension presenting after 20 weeks' gestation with major proteinuria or HELLP syndrome (haemolysis, elevated liver enzymes, low platelets). Results Pre-eclampsia occurred in 169/1144 (14.8%) women in the folic acid group and 156/1157 (13.5%) in the placebo group (relative risk 1.10, 95% confidence interval 0.90 to 1.34; P=0.37). There was no evidence of differences between the groups for any other adverse maternal or neonatal outcomes. Conclusion Supplementation with 4.0 mg/day folic acid beyond the first trimester does not prevent pre-eclampsia in women at high risk for this condition. Trial registration Current Controlled Trials ISRCTN23781770 and ClinicalTrials.gov NCT01355159.
Author(s): Wen SW, White RR, Rybak N, Gaudet LM, Robson S, Hague W, Simms-Stewart D, Carroli G, Smith G, Fraser WD, Wells G, Davidge ST, Kingdom J, Coyle D, Fergusson D, Corsi DJ, Champagne J, Sabri E, Ramsay T, Mol BWJ, Oudijk MA, Walker MC
Publication type: Article
Publication status: Published
Journal: BMJ
Year: 2018
Volume: 362
Issue: 8167
Print publication date: 15/09/2018
Online publication date: 12/09/2018
Acceptance date: 11/07/2018
Date deposited: 19/01/2021
ISSN (print): 0959-8146
ISSN (electronic): 1756-1833
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/bmj.k3478
DOI: 10.1136/bmj.k3478
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