OBJECTIVE: The aim of this study was to compare the efficacy of intravenous iron to oral iron in the treatment of anemia in pregnancy. METHODS: In this randomized open-label study, 90 women with hemoglobin levels between 8 and 10.5 g/dL and ferritin values less than 13 microg/L received either oral iron polymaltose complex (300 mg elemental iron per day) or intravenous iron sucrose. The iron sucrose dose was calculated from the following formula: weight before pregnancy (kg) x (110 g/L - actual hemoglobin [g/L]) x 0.24 + 500 mg. Treatment efficacy was assessed by measuring hemoglobin and ferritin on the 14th and 28th days and at delivery, and the hemoglobin on the first postpartum day. Adverse drug reactions, fetal weight, hospitalization time, and blood transfusions were also recorded. RESULTS:Hemoglobin values varied significantly with time between groups (interaction effect, P < .001). The change in hemoglobin from baseline was significantly higher in the intravenous group than the oral group at each measurement; the changes with respect to subsequent hemoglobin were significantly higher on the 14th (P = .004) and 28th (P = .031) days. Ferritin values were higher in patients receiving intravenous iron throughout pregnancy. No serious adverse drug reactions were observed. Fetal weight and hospitalization time were similar in the 2 groups. Blood transfusion was required for only one patient in the oral group. CONCLUSION: Intravenous iron treated iron-deficiency anemia of pregnancy and restored iron stores faster and more effectively than oral iron, with no serious adverse reactions.
RCT Entities:
OBJECTIVE: The aim of this study was to compare the efficacy of intravenous iron to oral iron in the treatment of anemia in pregnancy. METHODS: In this randomized open-label study, 90 women with hemoglobin levels between 8 and 10.5 g/dL and ferritin values less than 13 microg/L received either oral iron polymaltose complex (300 mg elemental iron per day) or intravenous iron sucrose. The iron sucrose dose was calculated from the following formula: weight before pregnancy (kg) x (110 g/L - actual hemoglobin [g/L]) x 0.24 + 500 mg. Treatment efficacy was assessed by measuring hemoglobin and ferritin on the 14th and 28th days and at delivery, and the hemoglobin on the first postpartum day. Adverse drug reactions, fetal weight, hospitalization time, and blood transfusions were also recorded. RESULTS: Hemoglobin values varied significantly with time between groups (interaction effect, P < .001). The change in hemoglobin from baseline was significantly higher in the intravenous group than the oral group at each measurement; the changes with respect to subsequent hemoglobin were significantly higher on the 14th (P = .004) and 28th (P = .031) days. Ferritin values were higher in patients receiving intravenous iron throughout pregnancy. No serious adverse drug reactions were observed. Fetal weight and hospitalization time were similar in the 2 groups. Blood transfusion was required for only one patient in the oral group. CONCLUSION: Intravenous iron treated iron-deficiency anemia of pregnancy and restored iron stores faster and more effectively than oral iron, with no serious adverse reactions.