Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an international, open-label, randomized controlled trial (FER-ASAP)

Breymann, Christian; Milman, Nils; Mezzacasa, Anna; Bernard, Roubert; Dudenhausen, Joachim; FER-ASAP investigators

doi:10.1515/jpm-2016-0050

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Breymann, C., Milman, N., Mezzacasa, A., Bernard, R., Dudenhausen, J., & FER-ASAP investigators. (2016). Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an international, open-label, randomized controlled trial (FER-ASAP). Journal of Perinatal Medicine, 45(4), 443–453. https://doi.org/10.1515/jpm-2016-0050

Abstract

Objective: To compare the efficacy and safety of intravenous ferric carboxymaltose (FCM) with first-line oral ferrous sulfate (FS) in pregnant women with iron deficiency anemia (IDA). Materials and methods: Pregnant women (n=252; gestational weeks 16–33) with IDA were randomized 1:1 to FCM (1000–1500 mg iron) or FS (200 mg iron/day) for 12 weeks. The primary objective was to compare efficacy; secondary objectives included safety and quality of life. Results: Hemoglobin (Hb) levels improved at comparable rates across both treatments; h