Abstract
BackgroundTo evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.MethodsA randomized clinical trial was conducted from (January 2016–August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome.ResultsMean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group.ConclusionTreatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting.Clinical trial registration (www.ctri.nic.in)CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).
Highlights
To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy
The mean calculated iron requirement was comparable in the FCM and ISC group (1739.6 ± 105.5 vs 1730.4 ± 121.9 mg; p = 0.69), the number of doses required to build up the deficit was significantly less in FCM group compared to ISC group (2.0 ± 0 vs 6.04 ± 0.45; p value < 0.001)
The mean rise in Hb at 12 weeks was significantly higher in FCM group than ISC group (29 g/L vs 22 g/L; p value < 0.001 (Table 2)
Summary
To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy. One hundred patients were randomized to receive either intravenous FCM or ISC. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome. Results: Mean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. An estimate by WHO attributes about 591,000 perinatal deaths and 115,000 maternal deaths globally to iron deficiency anemia directly or indirectly [1]. About half of the global maternal deaths due to anemia occur in South Asian countries. The main issue with oral iron therapy is compliance due to associated gastrointestinal side
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