EFFECT OF HIGH DOSE FOLIC ACID SUPPLEMENTATION IN PREGNANCY ON PRE-ECLAMPSIA (FACT): DOUBLE-BLIND, PHASE III, RANDOMIZED CONTROLLED, INTERNATIONAL, MULTICENTRE TRIAL

To regulate the high dose folic acid supplementation’s efficacy for the deterrence of women pre-eclampsia with many risk factors like; twin pregnancy, pre-existing hypertension, type 1 or type 2 pre-pregnancy diabetes, pre-eclampsia in some past pregnancy or BMI ≥35. Randomized, double-blinded international, phase III, multicentre clinical trial.

Through Medline Database records of five countries, seventy obstetrical centers 2464 pregnant women with a risk factor for pre-eclampsia were randomized from 2011 to 2015 (with 1157 placebo group and 1144 folic acid group). Eligible females were randomized to receive either placebo from 8 weeks of conception to 16^th week of gestation till the time of delivery or daily folic acid high dose (oral tables of four 1mg).

The major results were pre-eclampsia described as 20 weeks gestation hypertension exhibiting with main proteinuria or (“hemolysis, elevated liver enzymes, low platelets) HELLP syndrome.

Pre-eclampsia happened in 14.8% (169-1114) female in the group of folic acid and 13.5% (156/1157) in the group of placebo (95% CI 0.90 to 1.34; P=0.37, relative risk 1.10). Evidence of difference in between groups is absent for any other severe or neonatal maternal outcomes. Supplementation with folic acid 4.0 mg per day beyond the 1^st trimester does not avert pre-eclampsia in female according to high risk for the situation.