Intravenous iron versus packed cells in acute post-partum anemia

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Acute post partum anaemia is a common complication of pregnancy. It is principally iron deficient and is largely predicted by blood loss >1000mL. Ten percent of women with post partum anaemia develop severe anaemia (haemoglobin Hb<8g/dL) and this is associated with significant lethargy, fatigue and poor concentration which impair women from being able to care for their newborn and place them at increased risk of post natal depression. Current management of hemodynamically stable women with acute post partum anaemia is highly variable. Most clinicians opt to administer multiple red blood cell (RBC) transfusions to correct symptoms and restore Hb. No guideline or consensus exists to inform clinicians exactly when to transfuse women and the inherent risks associated with RBC transfusion, including life threatening adverse reactions, infection and thromboembolism, warrant investigation into alternative therapies. Currently, intravenous iron has been proposed as one alternative therapy to RBC transfusion in selected women though the comparative clinical efficacy and safety of this method has not yet been evaluated. Our study aims to compare intravenous iron polymaltose with RBC transfusion in women who sustain peri-partum blood loss >1000mL with resultant Hb 5.5-8.9g/dL after stabilisation and are symptomatic for anaemia. The study will employ an open label randomised design and be carried out at Westmead Hospital. Primary outcomes will measure Hb, CRP and ferritin levels at Day 7. Secondary outcome will measure Hb ferritin and CRP levels at Day 14 & 28 as well as improvement in anaemia symptoms as measured by Health Related Quality of Life (HRQoL) questionnaires at the same time points.. Treatment safety will also be compared between the groups by looking at incidence and severity of adverse events including infection. All women with blood loss >1000mL will be identified by Obstetrix, the mandatory hospital record. Once stabilised, these women will be consented by the study researcher and baseline bloods (Hb, reticulocytes count and ferritin) and symptom data will be collected. Women with resultant Hb 5.5-8.9g/dL who remain clinically stable but symptomatic will then be randomised to receive either RBC or intravenous iron polymaltose All adverse reactions will be recorded during and immediately after treatment and again by telephone at Day 1 and 2. Participants will then be reviewed by a midwife or doctor on Day 7, Day 14 and Day 28 where they will have repeat bloods. repeat symptom scores and clinical assessment for infection. Outcomes between treatment groups will then be compared and statistically analysed.