• B W Prick, A J G Jansen, E A P Steegers, W C J Hop, M L Essink-Bot, C A Uyl-de Groot, B M C Akerboom, M van Alphen, K W M Bloemenkamp, K E Boers, H A Bremer, A Kwee, A J van Loon, G C H Metz, D N M Papatsonis, J A M van der Post, M M Porath, R J P Rijnders, F J M E Roumen, H C J Scheepers, D H Schippers, N W E Schuitemaker, R H Stigter, M D Woiski, B W J Mol, D J van Rhenen, and J J Duvekot.
• Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands; Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands.
• BJOG. 2014 Jul 1;121(8):1005-14.

ObjectiveTo assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.DesignRandomised non-inferiority trial.SettingThirty-seven Dutch university and general hospitals.PopulationWomen with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities.MethodsWomen were allocated to RBC transfusion or non-intervention.Main Outcome MeasuresPrimary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum.ResultsIn all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable.ConclusionsStatistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.© 2014 Royal College of Obstetricians and Gynaecologists.

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