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 ۱۶-۳۴ weeks of gestation with IDA and haemoglobin between >۶۰ and <۱۰۰ g/L, at two tertiary hospitals between November ۲۰۱۹ to December ۲۰۲۰. The participants were divided into two groups in a ۱:۱ ratio as FCM group and ISC group. Patients in the FCM group received ۱۰۰۰ mg of diluted IV FCM, whereas patients in the ISC group received ۲۰۰ 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 = ۰.۳). There were considerably fewer doses required in the FCM group compared with the ISC group [۱.۰ (IQR: ۱-۱) vs. ۴ (IQR: ۴-۵; p value < ۰.۰۰۱)]. For the FCM group, the mean increase in Hb after ۱۲ weeks was ۳.۲۶ gm% (p < ۰.۰۰۱). 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.

Keywords:

treatment efficacy , Patient safeties , Iron carboxymaltose , Iron Sucrose , iron deficiency anemia , pregnancies , randomized controlled trial