Abstract
BackgroundAcute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear.Methods/designIIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire.DiscussionIf equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12615001370594 on 16th December, 2015 (prospective approval).
Highlights
Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression
If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs
Primary objectives To determine if intravenous iron is non-inferior to Red blood cell (RBC) transfusion in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with acute post-partum anaemia without increasing the rate of adverse outcomes
Summary
Moderate to severe acute post-partum anaemia is associated with a number of short and long-term adverse health outcomes active treatment is necessary and is commonly indicated by a combination of haemoglobin and iron deficit and symptom severity. If our study hypotheses are true intravenous iron presents as a safer, sustained and more cost-effective alternative to blood transfusion in the management of hemodynamically stable women with acute post-partum anaemia. Our findings will be useful for patients ineligible for treatment with blood products due to clinical or religious reasons and in under-resourced settings both within Australia and internationally. We would hope these findings support the widespread implementation of parenteral iron into routine post-natal practice policies in an effort to improve patient safety and minimise resource wastage
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