A randomised control trial to compare the role of Intravenous iron sucrose vs oral ferrous ascorbate For prophylaxis of anemia in pregnant women

Abstract

Background: Anemia in pregnancy is a significant health concern, particularly in low- and middle-income countries like India. Iron deficiency anemia (IDA) is the most common cause, leading to adverse maternal and fetal outcomes. Though oral iron 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. The study attempts to assess the efficacy, safety, and tolerability of intravenous iron sucrose vs oral ferrous ascorbate for prophylaxis of anaemia in pregnant women. Methods: This Randomised controlled trial study was done in the Department of Obstetrics and Gynaecology B.L.D.E (DU) Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka. One hundred antenatal women with confirmed intrauterine pregnancy with hemoglobin >11g/dL were randomized into IV Iron Sucrose (Group A) and Oral Iron Ascorbate groups (Group B). Group A pregnant women received three doses of Intravenous iron sucrose 200mg in 100ml normal saline as an infusion over 15-20 minutes at 20-24 weeks, 24-28 weeks, and 28-32 weeks of gestation. Group B pregnant women received oral ferrous ascorbate, providing 100 mg of elemental iron daily at bedtime, one hour before meals till delivery. Hb, RBC COUNT, PCV, MCV, MCH, MCHC and Serum Ferritin were assessed at baseline, later at 4 weeks and 12 weeks. Results: Most cases belonged to 21-25 years in the IV Sucrose group (54%) and Oral Ascorbate group (50%). Most cases belonged to primigravida, i.e., 62% of cases in the IV group and 56% in the Oral group. All the blood indices, such as the mean Hb, RBC, PCV, MCV, MCH, MCHC, and Ferritin, had increased from baseline to 12 weeks in the IV sucrose and in the oral group only mean ferritin was increased while remaining all the parameters were maintained more or less in the same level, but the increment was higher in the IV group than the Oral group. Of the total cases, anaemia was seen in 6.8% of cases of the IV sucrose group and 17% of cases of an oral group that showed improved Hb, which was more with IV sucrose than with an oral group. Regarding side effects, the IV Sucrose group had fewer side effects than the Oral group. Compliance was more in the oral group (94%) than in the IV I.S group (88%). The cost of the treatment in the IV group was lower than in the oral group. Conclusion: Intravenous iron sucrose is more effective, better tolerated, and improves iron stores significantly with fewer side effects compared to oral ferrous ascorbate for prophylaxis of anemia in pregnancy. The cost of the treatment in the IV group was less than that in the Oral group.