Hema Divakar1, Arulmozhi Ramarajan2, Ambarish Bhandiwad3, Vidya Thobbi4, Shelly Dutta5, Isaac Manyonda6
BACKGROUND
The aim of the study is to determine the non-inferiority of a single dose of 500 mg Ferric Carboxymaltose (FCM) (Group 1) to a single dose of 1000 mg (Group 2) in treating women with postpartum anaemia.
MATERIALS AND METHODS
Women were recruited within 24 hours of delivery and randomised to one of the two study groups excluded were mothers with non-iron deficiency anaemia, iron intolerance and haematological disease. Haematological markers were measured at baseline and at 6 weeks after treatment.
Main Outcome Measures- The primary outcome was an Hb increase ≥20 g/L. Secondary outcomes included the proportion of patients attaining Hb ≥120 g/L and the mean Hb change.
Design- Open label, randomised, non-blinded, prospective study.
Setting- Maternity units of four hospitals in Southern India.
Population- Women ≥18 years old with haemoglobin of >60 - <100 g/L.
RESULTS
There was no difference in the proportion of women achieving an Hb increase of >20 g/L between Groups 1 and 2 (91.4% versus 96.7%). Similar proportions of women in both groups became non-anaemic achieving an Hb of >120 g/L (57% versus 45.7%). The mean Hb change was comparable between the groups and both doses were well tolerated.
CONCLUSION
A single dose of 500 mg FCM (cost INR 2000.00) is non-inferior to a 1000 mg dose (cost INR 5000.00) in the treatment of postpartum anaemia. This has major implications for the scaling up of the eradication of iron-deficiency anaemia in India, since double the number of women who would otherwise have been treated with the 1000 mg dose can be treated with half the dose at less than half the cost with similar outcomes.
Tweetable Abstract- A single dose of 500 mg FCM is a safe, efficacious and cost-effective treatment for PPA in India.
