3.2. Exclusion Criteria
(1) Women with known history or presence of clinically
significant disease or condition which would be acontraindication to folic acid supplementation of up
to 5.1mg daily for the duration of pregnancy.
(2) Women who have known major fetal anomaly or fetal
demise.
(3) Women who have a history ofmedical complications,
including renal disease with altered renal function,
epilepsy, cancer, or use of folic acid antagonists such
as valproic acid.
(4) Womenwho are using illicit drug or alcohol abuse (≥2
drinks per day) during current pregnancy.
(5) Women with a known hypersensitivity to folic acid.
(6) Women with a triplet or higher order of multiple
pregnancy.
(7) Women who have previously participated in this
study in a previous pregnancy.