Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial
Article first published online: 10 JAN 2014
© 2014 Royal College of Obstetricians and Gynaecologists
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 121, Issue 8, pages 1005–1014, July 2014
How to Cite
Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial. BJOG 2014;121:1005–1014., , , , , , , , , , , , , , , , , , , , , , , , , , .
- Issue published online: 24 JUN 2014
- Article first published online: 10 JAN 2014
- Manuscript Accepted: 22 SEP 2013
- blood transfusion;
- postpartum haemorrhage;
- quality of life
To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.
Randomised non-inferiority trial.
Thirty-seven Dutch university and general hospitals.
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.
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.
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.
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.