O28. Effect of folic acid supplementation in pregnancy on preeclampsia – Folic Acid Clinical Trial (FACT)

Abstract

FACT is an international, multi-centre, 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). FACT is the first and only trial to date to examine the effect of folic acid supplementation for at-risk women in late pregnancy on the primary outcome of PE. FACT (trial registration: NCT 01355159) aims to determine efficacy of a PE prevention strategy using high dose (4 mg per day) folic acid supplementation from early pregnancy until delivery in women at high risk of developing PE. Subjects Pregnant women between 80/7-166/7 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 hrs apart and proteinuria developed in pregnancy ⩾200/7 weeks gestation. Or HELLP (Haemolysis, Elevated Liver Enzymes, Low Platelets) • Haemolysis. • Serum LDH ⩾ 600 U/L. • Serum AST ⩾ 70 U/L. • Platelets <100 × 109/L. Or Superimposed PE, defined as history of pre-existing hypertension with new proteinuria. Proteinuria is defined as: • Urinary protein ⩾300 mg/24 hrs, or • ⩾2+ protein dipstick, or • Random protein-creatinine ratio⩾30 mg protein/mmol As of May 19th, 1833 participants (1,058 Canadian, 220 Australian, 111 Argentinean, 49 Jamaican and 395 UK participants) have been randomized into the trial. To date, 63 sites across 5 countries are recruiting in FACT, with a total monthly recruitment averaging 80 participants. In June 2015, 16 sites in the Netherlands and 12 additional sites in the UK will begin recruiting thereby increasing anticipated recruitment to an average of 100 participants per month for a projected completion in November 2016. The Data and Safety Monitoring Board (DSMB) has recommended that FACT continue without modifications and interim analysis is anticipated in December 2015. To date, there are no reported Serious Adverse Events related to the use of study treatment and only 0.52% of the 786 participants who have completed the trial have incomplete outcome data. Results will establish if high dose folic acid supplementation is an effective preventative strategy in women at high risk of developing PE.