Efficacy and Safety of Single-Dose Intravenous Ferric Carboxymaltose versus Oral Ferrous Sulfate for Moderate Iron Deficiency Anemia in the Third Trimester

International Journal of Obstetrics and Gynecology | Vol. 14, No. 5, May 2026 | pp. 25–36

DOI: 10.46882/2026/IJOG/000479

Original Research Article

Title: Efficacy and Safety of Single-Dose Intravenous Ferric Carboxymaltose versus Oral Ferrous Sulfate for Moderate Iron Deficiency Anemia in the Third Trimester

Names of Authors: Mariam T. Bello¹, Grace E. Effiong²

Authors’ Affiliations:
¹ Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria
² Department of Public Health, University of Calabar, Calabar, Nigeria

Abstract:
Iron Deficiency Anemia (IDA) during the third trimester is strongly linked with low birth weight, preterm delivery, and increased maternal blood transfusion requirements. This open-label, randomized controlled trial compared the clinical efficacy, hematological response, and safety profile of a single total-dose infusion of intravenous (IV) ferric carboxymaltose against standard oral ferrous sulfate therapy. Two hundred and sixty pregnant women in their third trimester (28 to 32 weeks of gestation) presenting with a baseline hemoglobin (Hb) between 7.0 and 9.0 g/dL and serum ferritin < 15 μg/L were randomized into two equal groups (n = 130 per group). The IV group received a single 1,000 mg infusion of ferric carboxymaltose, while the oral group received oral ferrous sulfate (200 mg) twice daily for a total duration of six weeks. The primary outcome was the mean increase in Hb levels from baseline to delivery. At the 4-week post-treatment evaluation, the mean Hb increase was significantly higher in the IV group compared to the oral group (2.4 ± 0.5 g/dL vs. 1.2 ± 0.4 g/dL, p < 0.001). Similarly, target Hb levels (≥ 11.0 g/dL) at delivery were achieved by 91.5% of women in the IV group compared to only 62.3% in the oral group (p < 0.001). Serum ferritin stores were significantly more restored in the IV cohort (median 112.4 μg/L vs. 24.8 μg/L, p < 0.001). Gastrointestinal adverse effects were reported by 41.5% of women in the oral group, leading to non-compliance in 15.4% of cases, whereas transient mild injection-site reactions occurred in only 3.8% of the IV group. A single total-dose infusion of ferric carboxymaltose in the third trimester provides rapid, superior hematological correction and superior restoration of iron reserves with excellent compliance and safety compared to conventional oral iron.

Keywords: Iron Deficiency Anemia; Ferric Carboxymaltose; Ferrous Sulfate; Hemoglobin; Ferritin; Third Trimester.

Manuscript Timeline: Received: January 25, 2026; Revised: March 15, 2026; Accepted: April 14, 2026; Published: May 24, 2026.

Citation: Bello MT, Effiong GE. Efficacy and Safety of Single-Dose Intravenous Ferric Carboxymaltose versus Oral Ferrous Sulfate for Moderate Iron Deficiency Anemia in the Third Trimester. International Journal of Obstetrics and Gynecology. 2026; 14(5): 25–36.

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