Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial

Abstract

Objective To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage. Design Randomised non-inferiority trial. Setting Thirty-seven Dutch university and general hospitals. Population Women 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. Methods Women were allocated to RBC transfusion or non-intervention. Main outcome measures Primary 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. Results In 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. Conclusions Statistically, 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.