// file intentionally left blank ?>
From large scale randomized controlled trials, folic acid supplementation in the first trimester of pregnancy to prevent neural tube defects (NTDs) is unequivocally recommended worldwide: 0.4-1 mg/daily supplementation for women at low-risk, and 4-5 mg/daily for women at high-risk.
There is inconsistent evidence to suggest that maternal folate may have beneficial effects on other outcomes which may require supplementation beyond first trimester. Indeed, many women exceed recommended dosing and duration of folic acid supplementation in pregnancy without sufficient evidence for this practice. In 2009, our Folic Acid Clinical Trial (FACT) was funded to examine whether high-dose folic acid supplementation throughout pregnancy (4-5.1 mg daily) could lower the incidence of preeclampsia among women at high-risk of the syndrome.
In this pillar we are conducting additional analyses on FACT data to evaluate the effect of high-dose folic acid supplementation on risk of pre-eclampsia among specific sub-populations (e.g. diabetes, obesity). The global variations in other medication use in pregnancy their association with obstetrical and neonatal outcomes in this unique, high-risk population are also being examined.
Importantly we are evaluating the safety and efficacy of high-dose daily folic acid supplementation throughout pregnancy on the risk of social impairments, as well as executive function, emotional and behavioral challenges associated with autism spectrum disorders and other developmental disorders, and death in offspring of mothers who participated in FACT. In this ‘FACT 4 Child’ study, children will be evaluated at 4-6 years of age using validated SRS-2, BRIEF-P, and CBCL/1½-5 tools. Data on mortality and severe morbidity will be collected to address safety considerations.
Health professionals, researchers, policy makers, and patients consulted for the FACT 4 Child study unanimously support our plan to follow the children to determine the safety and effectiveness of high dose folic acid supplementation. Our findings will definitively prove or disprove the safety and effectiveness of high-dose folic acid daily supplementation beyond first trimester for pregnant women and their children. This practice has become prematurely commonplace; our trial will fill an imperative void. Using our findings, we will develop policies and guidelines related to folic acid supplementation throughout pregnancy that will be relevant worldwide.