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Intravenous ferric carboxymaltose rapidly increases haemoglobin and serum ferritin among pregnant females with moderate-to-severe anaemia: A single-arm, open-label trial

Background. Infusion of ferric carboxymaltose (FCM) can correct iron deficiency anaemia in the second or third trimester of pregnancy. However, large-scale public health use of FCM is constrained by two issues. First, there is limited evidence on the efficacy and safety profile of FCM in the Indian context. Second, logistic challenges in administering FCM at a subdistrict healthcare setting have not been assessed. We aimed to measure the mean increase in haemoglobin (Hb) level 2 weeks after infusion of FCM to pregnant females with moderate-to-severe anaemia attending a subdistrict hospital in India. Methods. During June–December 2016, we did a single-arm, open-label trial among pregnant females with a gestation of 16–32 weeks, Hb 5.0–9.9 g/dl. FCM was infused (per Ganzoni formula) in a single session up to a maximum of 1000 mg of iron. Hb and s-ferritin levels were measured at recruitment, 2 weeks post-infusion and at delivery. Adverse events were noted. Results. Seventy-seven pregnant females were enrolled with mean (SD) age 23.2 (3.1) years, gestation 27.6 (3.8) weeks and Hb 8.4 (0.9) g/dl. At 2 weeks post-infusion (n=63), the mean Hb level increased by 1.9 g/dl (95% confidence interval [CI] 1.6–2.3) and at delivery (n = 64) by 2.9 g/dl (95% CI 2.4–3.4). The median (interquartile range) (in ng/ml) for serum ferritin at baseline (n = 68), 2 weeks post-FCM infusion (n = 61) and at delivery (n = 39) was 6.3 (5.1–11.7), 275.4 (186.4–330.3) and 61.3 (42.5–132.0), respectively. No major adverse effects were reported. Conclusion. Infusion of FCM rapidly corrected anaemia, sustained its effect till delivery and replenished body iron reserves. FCM is safe and effective in treating anaemia in pregnant females in the second and third trimester at the subdistrict healthcare setting in India.