Comparative Evaluation of Efficacy, Safety, Cost Effectiveness and Acceptability of Ferric Carboxymaltose versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Pregnancy: A Multicenter Open Label Randomized Controlled Trial

Objectives: To evaluate the efficacy, safety, cost-effectiveness, and patient acceptability of ferric carboxymaltose (FCM) versus iron sucrose complex (ISC) for treatment of iron deficiency anaemia (IDA) in pregnancy. Methods: An open blind randomized controlled trial was conducted among pregnant women between 16-34 weeks of gestation with IDA and haemoglobin between 60 and 100 g/L, at two tertiary hospitals between November 2019 to December 2020. The participants were divided into two groups in a 1:1 ratio as FCM group and ISC group. Patients in the FCM group received 1000 mg of diluted IV FCM, whereas patients in the ISC group received 200 mg of IV ISC three times a week until their dosages were complete. The SPSS data processor was used to do the statistical analysis of the data. Mean and median of continuous data were analysed by Mann- Whitney or independent t tests, whereas categorical and quantitative data was analysed by using Chi-square/Exact Fischer s tests. Results: Both groups of patients had similar characteristics. FCM and ISC groups had similar iron needs (p = 0.3). There were considerably fewer doses required in the FCM group compared with the ISC group [1.0 (IQR: 1-1) vs. 4 (IQR: 4-5; p value 0.001)]. For the FCM group, the mean increase in Hb after 12 weeks was 3.26 gm% (p 0.001). Satisfaction of both group of patients were similar. However, the patient felt more convenient with FCM as it needed only single visit. No significant side effects were seen in either group. Conclusion: Treatment with ferric carboxymaltose in pregnancy is safe and effective, with a very good safety profile, and the added benefit of a large dosage being given in a single sitting. Further large-scale randomized trails are needed to find out the long-term effect on maternal and neonatal wellbeing of both forms of iron treatment.