Authors : Naimisha Reddy, Vathsala Kamath, Nishita Shettian
DOI : 10.18231/j.ijogr.2021.094
Volume : 8
Issue : 4
Year : 2021
Page No : 448-453
Background and Objectives: Iron deficiency is the most common cause of anaemia worldwide and is associated with significant maternal and fetal morbidity. Current options for treatment include oral iron supplementation which can be ineffective and poorly tolerated, intravenous iron which can be used in patients who are intolerant to or unresponsive to oral iron and red blood cell transfusions which carry an inherent risk because of which it should be avoided. Intravenous iron therapy may reduce the requirement for allogenic blood transfusion. Ferric carboxymaltose is a new intravenous iron formulation promising to be more effective and as safe as iron sucrose. It may even have a better compliance as it offers the administration of a much higher iron dosage at a time.
Materials and Methods: The study was designed to compare the efficacy and safety of IV ferric carboxymaltose versus iron sucrose in the treatment of iron deficiency anaemia of pregnant women with moderate anaemia in the second and third trimester.
A hospital based randomized prospective study was done from July 2013 to June 2015 in the department of Obstetrics and Gynaecology, A.J. Institute of Medical Sciences, Mangalore. Baseline haemoglobin, peripheral smear and serum ferritin levels were measured to diagnose iron deficiency anaemia. 60 pregnant women who met the inclusion criteria and who formed the study subjects were randomly allocated into two groups comprising of 30 in Group C (Received ferric carboxymaltose) and 30 in Group S (Received iron sucrose). Outcome was assessed by measuring haemoglobin 3 weeks after treatment and a comparison of the safety and efficacy between the two groups was made.
Results: In the present study the commonest age group was 21 to 30 years: 80% in group C and 73.3% in group S and mean age of the study population in group C and S was comparable (25.2±3.54 vs 24.8±4.58 years). The socio demographic characteristics, obstetric history, vitals and pretreatment haemoglobin were comparable in both the groups (p>0.050). The post treatment haemoglobin levels in 63.3% of the women in group C compared to 46.7% in group S were found to be 11 or more and mean post treatment haemoglobin levels were comparable in group C and group S (11.016±0.789 vs 10.73±0.821 gm%; p=0.174). In the present study, post treatment mean increase in haemoglobin levels was noted between 2.0 to 2.5 gm% in 43.3% of the women in group C compared to 50.0% in group S.
Conclusion: Ferric carboxymaltose administration in pregnant women in the second and third trimesters is well tolerated and is not associated with any clinical safety concerns. Both ferric carboxymaltose and iron sucrose have a comparable safety profile even when ferric carboxymaltose was administered in a much higher dosage compared to iron sucrose. Ferric carboxymaltose should be considered as the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.
Keywords: Intravenous iron sucrose, Ferric carboxymaltose, Iron deficiency anaemia.