1. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial
- Author
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A. J. G. Jansen, Nico W.E. Schuitemaker, D. H. Schippers, M. L. Essink-Bot, Kim E. Boers, M. van Alphen, C.A. Uyl-de Groot, M. Porath, Frans J.M.E. Roumen, Mallory Woiski, Kitty W.M. Bloemenkamp, Godfried C.H. Metz, J. A. M. van der Post, D.J. van Rhenen, Babette W. Prick, H.A. Bremer, H. C. J. Scheepers, A.J. van Loon, Bettina M.C. Akerboom, Anneke Kwee, Johannes J. Duvekot, R.J. Rijnders, R.H. Stigter, D. N. M. Papatsonis, B. W. J. Mol, W. C. J. Hop, Eric A. P. Steegers, Obstetrics & Gynecology, Hematology, Epidemiology, Public Health, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrie & Gynaecologie, RS: GROW - Developmental Biology, RS: GROW - R4 - Reproductive and Perinatal Medicine, APH - Amsterdam Public Health, Public and occupational health, ARD - Amsterdam Reproduction and Development, and Obstetrics and Gynaecology
- Subjects
Adult ,Pediatrics ,medicine.medical_specialty ,Blood transfusion ,medicine.medical_treatment ,Population ,Anaemia ,blood transfusion ,Hospitals, General ,Risk Assessment ,Severity of Illness Index ,Hospitals, University ,Quality of life ,medicine ,Humans ,education ,Maternal Welfare ,Fatigue ,Netherlands ,education.field_of_study ,business.industry ,Postpartum Hemorrhage ,Other Research Radboud Institute for Health Sciences [Radboudumc 0] ,Obstetrics and Gynecology ,Anemia ,Postpartum haemorrhage ,Confidence interval ,Treatment Outcome ,Physical Fatigue ,Mode of delivery ,quality of life ,postpartum haemorrhage ,Practice Guidelines as Topic ,Non inferiority trial ,Female ,Erythrocyte Transfusion ,business ,Follow-Up Studies - Abstract
Item does not contain fulltext 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.
- Published
- 2014