Author:
Prick Babette W,Steegers Eric AP,Jansen AJ Gerard,Hop Wim CJ,Essink-Bot Marie-Louise,Peters Nina CJ,Uyl-de Groot Carin A,Papatsonis Dimitri NM,Akerboom Bettina MC,Metz Godfried CH,Bremer Henk A,van Loon Aren J,Stigter Rob H,van der Post Joris AM,van Alphen Marcel,Porath Martina,Rijnders Robbert JP,Spaanderman Marc EA,Schippers Daniela H,Bloemenkamp Kitty WM,Boers Kim E,Scheepers Hubertina CJ,Roumen Frans JME,Kwee Anneke,Schuitemaker Nico WE,Mol Ben Willem J,van Rhenen Dick J,Duvekot Johannes J
Abstract
Abstract
Background
Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands.
Methods/Design
The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs.
The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%).
Discussion
This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.
Trial registration
ClinicalTrials.gov NCT00335023, Nederlands Trial Register NTR335
Publisher
Springer Science and Business Media LLC
Subject
Obstetrics and Gynecology
Reference24 articles.
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3. Jansen AJ, van Rhenen DJ, Steegers EA, Duvekot JJ: Postpartum hemorrhage and transfusion of blood and blood components. Obstet Gynecol Surv. 2005, 60: 663-71. 10.1097/01.ogx.0000180909.31293.cf.
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