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A Prospective Randomised Controlled Trial of a Single Intravenous Infusion of Ferric Carboxymaltose vs Single Intravenous Iron Polymaltose or Daily Oral Ferrous Sulphate in the Treatment of Iron Deficiency Anaemia in Pregnancy
Khalafallah AA, Hyppa A, Chuang A, Hanna F, Wilson E, Kwok C, Yan C, Gray Z, Mathew R, Falloon P, et al
Seminars in hematology. 2018;55((4):):223-234.
Abstract
Iron deficiency anaemia (IDA) is the most common nutritional deficiency affecting pregnant women worldwide. This study aims to compare the efficacy and safety of a newly available intravenous (IV) iron preparation, ferric carboxymaltose (FCM), against IV iron polymaltose (IPM), and standard oral iron (ferrous sulphate) for the treatment of IDA in pregnancy. This is an open-labelled prospective randomised controlled trial (RCT) with intention-to-treat analysis conducted at a primary health care facility with a single tertiary referral centre in Launceston. Tasmania, Australia. A 3-arm randomised controlled trial was conducted comparing a single IV infusion of 1000mg of FCM (n = 83 patients) over 15 minutes against a single IV infusion of 1000mg of IPM (n = 82) over 2 hours against 325mg daily oral ferrous sulphate (n = 81) until delivery, for the treatment of IDA in pregnancy. A total of 246 consecutive pregnant women were recruited between September 2013 and July 2014. The median age was 28 years, with a median and mean gestation of 27 weeks. The median serum ferritin was 9microg/L, with a mean of 13microg/L. The mean haemoglobin (Hb) was 114g/L. The primary outcome was the change in ferritin and Hb levels at 4 weeks after intervention. Secondary outcomes included ferritin and Hb improvements at predelivery, safety, tolerability, quality of life (QoL), cost utility, and fetal outcomes. The mean Hb level differences between the baseline intervention time point and 4 weeks thereafter were significantly higher in the FCM versus the oral group by 4.35g/L (95% CI: 1.64-7.05; P = 0.0006) and in the IPM vs the oral group by 4.08g/L (95% CI: 1.57-6.60; P = 0.0005), but not different between the FCM and IPM groups (0.26g/L; 95% CI: -2.59 to 3.11; P = 0.9740). The mean ferritin level differences were significantly higher at 4 weeks in the FCM vs oral iron group by 166microg/L (95% CI: 138-194; P < 0.0001) and in the IPM vs oral iron group by 145microg/L (95% CI: 109-1180, P < 0.0001), but not between the 2 IV groups (21.5microg/L; 95% CI: -23.9 to 66.9; P = 0.4989). Administration of IV FCM during pregnancy was safe and better tolerated than IV IPM or oral iron. Compliance to oral iron was the lowest amongst treatment groups with one-third of the patients missing doses of daily iron tablets. Significant improvement in overall QoL scores was observed in both IV iron supplement groups by achieving normal ferritin following effective and prompt repletion of iron stores, compared to the oral iron group (P = 0.04, 95% CI: 21.3, 1.8). The overall cost utility of IV FCM and IV IPM appear to be similar to oral iron. There were no differences in the fetal outcomes between the 3 trial arms. In conclusion, this study demonstrates that a single IV iron infusion is an effective and safe option for treatment of IDA during pregnancy. FCM was more convenient than other treatments. Rapid parenteral iron repletion can improve iron stores, Hb levels and QoL in pregnant women, with ongoing benefits until delivery. Integration of IV iron for IDA in pregnancy can potentially improve pregnancy outcomes for the mother. Update of guidelines to integrate the use of new IV iron preparations in pregnancy is warranted.
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Treatment of iron deficiency anaemia of late pregnancy with a single intravenous ferric carboxymaltose or iron polymaltose infusion versus daily oral iron sulphate (TIDAL): a prospective randomised controlled trial
Khalafallah A, Chuang A, Kwok C, Yan C, Gray Z, Hyppa A, Kirkby B, Mathew R, Falloon P, Pavlov T, et al
Haematology Society of Australia and New Zealand. 2016;:83.. 083.
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Treatment of iron deficiency anaemia of late pregnancy with a single intravenous iron polymaltose or ferric carboxymaltose versus oral iron sulphate: a prospective randomized controlled study (TIDAL)
Khalafallah A, Chuang A, Kwok C, Yan C, Hyppa A, Mathew R, Dennis A, Seaton D, Brain T, Pavlov T
Haematologica. 2014;99((S1):):793.. Abstract No. LB2441.
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Effect of IV iron polymaltose versus oral iron sulphate in the treatment of 200 women disagnosed with IDA during pregnancy
Khalafallah A, Dennis A
HSANZ, ANZSBT and ASTH Annual Scientific Meeting abstracts. 2012;: Abstract No. O061
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A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy
Khalafallah A, Dennis A, Bates J, Bates G, Robertson IK, Smith L, Ball MJ, Seaton D, Brain T, Rasko JE
Journal of Internal Medicine. 2010;268((3):):286-95.
Abstract
BACKGROUND Iron deficiency anaemia is the most common deficiency disorder in the world, affecting more than one billion people, with pregnant women at particular risk. OBJECTIVES AND DESIGN We conducted a single site, prospective, nonblinded randomized-controlled trial to compare the efficacy, safety, tolerability and compliance of standard oral daily iron versus intravenous iron. SUBJECTS We prospectively screened 2654 pregnant women between March 2007 and January 2009 with a full blood count and iron studies, of which 461 (18%) had moderate IDA. Two hundred women matched for haemoglobin concentration and serum ferritin level were recruited. INTERVENTIONS Patients were randomized to daily oral ferrous sulphate 250 mg (elemental iron 80 mg) with or without a single intravenous iron polymaltose infusion. RESULTS Prior to delivery, the intravenous plus oral iron arm was superior to the oral iron only arm as measured by the increase in haemoglobin level (mean of 19. 5 g/L vs. 12 g/L; P < 0. 001); the increase in mean serum ferritin level (222 microg/L vs. 18 ug/L; P < 0. 001); and the percentage of mothers with ferritin levels below 30 microg/L (4. 5% vs. 79%; P < 0. 001). A single dose of intravenous iron polymaltose was well tolerated without significant side effects. CONCLUSIONS Our data indicate that intravenous iron polymaltose is safe and leads to improved efficacy and iron stores compared to oral iron alone in pregnancy-related IDA.
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A prospective randomised-controlled trial evaluating the effect of intravenous versus oral iron on haemoglobin and ferritin levels in the management of iron deficiency anaemia during pregnancy
Khalafallah A, Dennis A, Bates J, Bates G, Robertson I, Smith L, Ball M, Seaton D, Brain T
HSANZ Meeting. 2009;:A351.. Abstract No. P119.
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Compliance and tolerability of iron therapy during pregnancy
Khalafallah A, Bates G, Dennis A, Bates J, Smith L, Shaw S, Bertram J, Beamish M, Rooney K
HSANZ Meeting. 2008;:A200.. Abstract No. O105.
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A prospective randomised trial of intravenous iron therapy versus oral iron for iron deficiency anaemia in pregnant women
Khalafallah A, Dennis A, Bates G, Bates J, Shaw S, Smith L, Bertram J, Seaton D, Brain T, Beamish M, et al
HSANZ Meeting. 2008;:A199.. Abstract No. O104.
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A prospective randomised trial of intravenous iron therapy versus oral iron for iron deficiency anaemia in pregnant Australian women
Khalafallah AA, Dennis A, Bates J, Bates G, Smith L, Shaw S, Seaton D, Berteram J, Robertson I, Ball M, et al
Blood. 2007;110((11):): Abstract No. 3750.