Abstract

During pregnancy iron requirement increases for meet the needs of mother and fetus development and growth. Often iron stores of pregnant women are not sufficient, inducing a major risk of occurrence of iron deficiency (ID) and iron deficiency anemia (IDA), that have been associated with major risk of adverse pregnancy outcomes. The aim of this study was to verify the effect of the administration of 1 tablet a day of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte^®), on the hematological status of pregnant women, with reference to the prevention of IDA in pregnancy. Pregnant non-anemic women (N=100) were enrolled and randomized to treatment with Ferric Sodium EDTA combination (Group A, N=50) or with folic acid (Group B, N=50). Blood parameters of hemoglobin (Hb), total number of red blood cells (RBCs), ferritin, and transferrin were evaluated at T0: before starting therapy (<12th week), T1 at 20-24 weeks, T2 at 30-32 weeks, and T3 at 36 weeks. Degree of tolerability in treatment group and adverse events eventually reported were added as evaluation of safety. Results showed that Group A maintained almost unchanged blood parameters evaluated and the therapy was effective to prevent IDA on A. Group B results showed a worsening statistically significant (P < 0.001) of all parameters evaluated. In Group a most women reported that treatment was safe and well tolerated. In conclusion, this study confirmed the efficacy and safety of supplementation with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate, and selenomethionine (Ferachel Forte®), for preventing anemia in pregnant women.