301-POS

Abstract

Objectives FACT is an international, multi-center, double-blind, placebo-controlled, Phase III trial of 3656 women, sponsored by the Ottawa Hospital Research Institute (OHRI) and funded by the Canadian Institutes of Health Research (CIHR). Observational studies suggest that folic acid supplementation during pregnancy reduces the risk of preeclampsia (PE). No randomized controlled trial has been conducted to demonstrate the effect of folic acid supplementation on PE. FACT aims to determine efficacy of a PE prevention strategy using high dose folic acid supplementation from early pregnancy until delivery in women at high risk of developing PE. Methods Pregnant women between 80/7 and 166/7 weeks gestation, aged ⩾18 years, taking ⩽1.1 mg of folic acid supplementation with at least 1 of the following risk factors for PE: pre-existing hypertension, pre-pregnancy diabetes, twin pregnancy, history of PE, BMI ⩾35 kg/m2. Primary Outcome: PE, defined as ⩾d90 mmHg on 2 occasions ⩾4 h apart and proteinuria developed in pregnancy ⩾200/7 weeks gestation, or HELLP, hemolysis, serum LDH ⩾600 U/L, serum AST ⩾70 U/L, platelets Results As of June 30, 1018 participants (791 Canadian, 113 Australian, 61 Argentinean, 11 Jamaican and 42 UK participants) have been randomized. Conclusions Results will establish if high dose folic acid supplementation is an effective preventative strategy in women at high risk of developing PE. Disclosures S. Wen: None. L. Gaudet: None. J. Champagne: None. R. Rennicks White: None. N. Rybak: None. M. Walker: None.