Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia - randomized controlled trial.

Abstract

BACKGROUND\nStudies which have compared the effectiveness of oral versus intravenous iron supplements to treat postpartum anemia have shown mixed results. The superiority of one mode of treatment versus the other has yet to be demonstrated. Therefore, despite guidelines and standards of care, treatment approaches vary across practices. A single 500mg dose of iron sucrose, which is a higher dose than that which is usually administered, has not been evaluated to treat postpartum moderate-severe anemia.\n\n\nOBJECTIVE\nTo compare the efficacy of intravenous iron sucrose alone versus intravenous iron sucrose in combination with oral iron bisglycinate supplementation in treating moderate to severe postpartum anemia.\n\n\nSTUDY DESIGN\nA randomized controlled trial was conducted between February 2015 and June 2020. Women with postpartum hemoglobin <9.5g/dL were treated with 500 mg intravenous iron sucrose after an anemia workup, which ruled out other causes for anemia. In addition to receiving intravenous iron, women were randomly allocated to receive either oral 60 mg of iron bisglycinate for 45 days, or no further iron supplementation. The primary outcome was hemoglobin level at 6 weeks postpartum. Secondary outcomes were iron storage parameters and quality of life.\n\n\nRESULTS\nOut of 158 patients who participated, 63 women receiving intravenous and oral iron and 44 women receiving intravenous iron only, completed the study and were included in the analysis. Baseline and obstetric characteristics were similar between the study cohorts. Although statically significant, postpartum hemoglobin levels were only 0.4 g/dL higher in the intravenous and oral iron compared to intravenous iron-only cohort (12.4 g/dL versus 12.0 g/dL, respectively; p=0.03), with a respective increase from baseline of 4.2 g/dL versus 3.7 g/dL (p=0.03). There was no difference in the rate of women with hemoglobin<12.0 or 11.0 g/dL. Iron storage and health quality were also not different between the cohorts. Oral iron treatment was associated with 29% rate of adverse effects. Compliance and satisfaction from treatment protocol were high in both cohorts.\n\n\nCONCLUSIONS\nIntravenous 500 mg iron sucrose treatment alone is sufficient to treat postpartum anemia without the necessity of adding oral iron treatment.