Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Iron Sucrose in the Management of Iron Deficiency Anemia During Pregnancy: A Prospective Interventional Study

Abstract

Background: Iron deficiency anemia (IDA) is the most common hematological disorder in pregnancy, contributing to increased maternal morbidity, preterm births, and low birth weight. While oral iron supplementation is the first-line therapy, its efficacy is often limited by poor gastrointestinal tolerance and low absorption rates. Intravenous (IV) iron formulations, such as iron sucrose (IS) and ferric carboxymaltose (FCM), offer a more effective approach to rapid hemoglobin correction. This study aims to compare the efficacy, safety, and biochemical response of IS versus FCM in the management of moderate iron deficiency anemia (Hb: 7–9 g/dL) during pregnancy.

Methods: A prospective, enrolled 100 pregnant women between 16–34 weeks of gestation diagnosed with moderate IDA. Participants were randomized into two groups: Group I (IS, n=50) received intravenous iron sucrose (200 mg per infusion on alternate days, cumulative dose of 1000 mg). Group II (FCM, n=50) received intravenous ferric carboxymaltose (1000 mg single dose infusion, with a repeat dose if required after one week). Primary outcomes included changes in hemoglobin and serum ferritin levels at 3 and 6 weeks post-treatment. Secondary outcomes included inflammatory markers (C-reactive protein [CRP], hepcidin levels), hematological indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin concentration [MCHC], transferrin saturation), adverse reactions, and hospital stay duration. Statistical analysis was performed using SPSS v24.0, with a p-value <0.05 considered significant.

Results: At six weeks post-treatment, the mean hemoglobin increase was significantly higher in the FCM group (2.7 ± 0.3 g/dL) compared to the IS group (1.8 ± 0.2 g/dL, p < 0.0001). Serum ferritin levels also showed a greater rise in FCM-treated patients (111.7 ± 5.2 mcg/L) compared to IS-treated patients (79.2 ± 4.8 mcg/L, p < 0.0001), indicating better iron store replenishment with FCM. Inflammatory markers showed significant improvement in the FCM group, with CRP levels reducing to 3.9 ± 1.2 mg/L (vs. 4.8 ± 1.5 mg/L in IS, p < 0.05) and hepcidin levels increasing to 35.2 ± 3.8 ng/mL (vs. 30.1 ± 2.6 ng/mL in IS, p < 0.001), suggesting better iron metabolism regulation. Hematological indices improved significantly, with a greater increase in MCV (76.9 ± 2.4 fL in FCM vs. 75.2 ± 1.9 fL in IS, p = 0.01) and transferrin saturation (27.5% vs. 24.8%, p < 0.001) in the FCM group. The incidence of adverse effects was lower in FCM (16%) compared to IS (28%), with thrombophlebitis and nausea being the most common side effects. The mean hospital stay was significantly shorter in FCM-treated women (3.2 ± 0.8 days) compared to IS-treated women (10.2 ± 1.5 days, p < 0.0001).

Conclusion: Ferric carboxymaltose (FCM) was found to be more effective, safer, and better tolerated than iron sucrose (IS) for treating iron deficiency anemia in pregnancy. FCM resulted in a greater and faster increase in hemoglobin, superior iron store replenishment, lower inflammatory response, and reduced hospital visits. Given its single-dose administration, improved compliance, and fewer adverse effects, FCM should be considered the preferred IV iron therapy for pregnant women with moderate anemia. Further studies should evaluate the long-term impact on neonatal outcomes and cost-effectiveness in resource-limited settings.