A Randomized Controlled Trial to Compare the Role of Intravenous Iron Sucrose Versus Oral Ferrous Ascorbate for the Prophylaxis of Anemia in Pregnant Women

TL;DR

This study compares intravenous iron sucrose and oral iron for preventing anemia in pregnant women, finding intravenous iron more effective and better tolerated.

Contribution

Demonstrates that intravenous iron sucrose improves hemoglobin and iron stores more effectively than oral iron in pregnant women.

Findings

Intravenous iron sucrose significantly increased hemoglobin levels compared to oral iron.

Serum ferritin levels were significantly higher in the intravenous group.

Oral iron caused more gastrointestinal side effects and was less cost-effective.

Abstract

Background and objective

Anemia in pregnancy is a significant health concern, particularly in low- and middle-income countries such as India. Iron deficiency anemia (IDA) is its most common cause, leading to adverse maternal and fetal outcomes. While oral iron (OI) therapy is the standard prophylaxis, poor compliance due to gastrointestinal side effects limits its effectiveness. Intravenous iron sucrose (IVIS) may provide an alternative with better tolerability. This study aimed to compare the efficacy, safety, and compliance of IVIS versus OI for anemia prophylaxis in pregnant women.

Materials and methods

A randomized controlled trial was conducted at Shri BM. Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka, over 12 months. A total of 100 antenatal women with hemoglobin (Hb) ≥11 g/dL were randomized into two groups: Group A received IVIS 200 mg in 100 mL normal saline at 20-24, 24-28, and 28-32 weeks, and Group B received OI 100 mg daily till 32 weeks. Hematological parameters and serum ferritin were measured at baseline, four weeks, and 12 weeks of treatment. Side effects, compliance, and cost of the treatment were assessed.

Results

Group A showed a significantly greater increase in Hb (12.19 ± 0.68 g/dL) compared to Group B (11.63 ± 0.74 g/dL) at 12 weeks (p<0.0001). Serum ferritin levels were significantly higher in Group A (163.26 ± 76.28 ng/mL) versus Group B (81.28 ± 65.98 ng/mL) (p<0.0001). Gastrointestinal side effects were more common in the oral group. Notably, the cost of treatment for Group A was also lower

Conclusions

Based on our findings, IVIS is more effective, better tolerated, and improves iron stores significantly compared to OI for the prophylaxis of anemia in pregnancy.

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