Efficacy and safety of oral iron(iii) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia:a multicenter, randomized, controlled study


  • Ricardo Ortiz Hospital Local del Norte, Bucaramanga, Colombia, Colombia
  • Jorge Eduardo Toblli Hospital Alemán, Buenos Aires, Argentina, Argentina
  • Juan Diego Romero Centro de Atención Medica Inmediata Vista Hermosa, Bogotá, Colombia, Colombia
  • Beatriz Monterrosa Centro de Atención Medica Inmediata Vista Hermosa, Bogotá, Colombia, Colombia
  • Cristina Frer Hospital Alemán, Buenos Aires, Argentina, Argentina
  • Eugenia Macagno Hospital Alemán, Buenos Aires, Argentina, Argentina
  • Christian Breymann Universitäts Spital Zürich, Klinik für Geburtshilfe, Feto Maternal Research Group, Obstetric Research, Zurich, Switzerland, Switzerland




anemia, deficiency, ferrous, IPC, pregnancy, pregnant, iron, sulfate


Objective: To evaluate the efficacy and safety of iron (III) polymaltose complex (Maltofer) versus ferrous sulfate in iron-deficient pregnant women using recommended doses. Methods: An exploratory, open-label, randomized, controlled, multicenter study was undertaken in 80 pregnant women with iron-deficiency anemia (hemoglobin ≤ 10,5 g/dL, serum ferritin ≤ 15 ng/mL and mean corpuscular volume < 80 fL). Patients were randomized 1:1 to oral iron(III) polymaltose complex or ferrous sulfate (each 100 mg iron twice daily) for 90 days. Results: The primary endpoint, change in hemoglobin from baseline to days 60 and 90, did not differ significantly between treatment groups. The mean change to day 90 was 2,16 (0,67) g/dL in the iron (III) polymaltose complex group and 1,93 (0,97) g/dL in the ferrous sulfate group. Mean serum ferritin at day 90 was 179 (38) ng/mL and 157 (34) ng/mL with iron (III) polymaltose complex and ferrous sulfate, respectively (p = 0,014). Adverse events were significantly less frequent in the iron (III) polymaltose group, occurring in 12/41 (29,3%) patients, than in the ferrous sulfate group (22/39 [56,4%]) (p = 0,015). Conclusions: Oral iron (III) polymaltose complex offers at least equivalent efficacy and a superior safety profile compared to ferrous sulfate for the treatment of iron-deficiency anemia during pregnancy.


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How to Cite

Ortiz, R., Toblli, J. E., Romero, J. D., Monterrosa, B., Frer, C., Macagno, E., & Breymann, C. (2014). Efficacy and safety of oral iron(iii) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia:a multicenter, randomized, controlled study. REPRODUCTIVE ENDOCRINOLOGY, (17), 118–125. https://doi.org/10.18370/2309-4117.2014.17.118-125