Well Being of Obstetric Patients on Minimal Blood Transfusions (WOMB)
Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Well Being of Obstetric Patients on Minimal Blood Transfusions|
- Physical Fatigue [ Time Frame: on day 3 postpartum ] [ Designated as safety issue: No ]measured with the MFI questionnaire
- Health related quality of life [ Time Frame: delivery - six weeks postpartum ] [ Designated as safety issue: No ]Health related quality of life measured with the following questionnaires: Euro-Qol, SF-36 and the MFI
- Blood usage and the costs [ Time Frame: delivery - six weeks postpartum ] [ Designated as safety issue: No ]
- Hemoglobin increase after transfusion [ Time Frame: before- after transfusion ] [ Designated as safety issue: No ]Hb value and platelet count will be measured before and after red blood cell transfusion
- Heart beat, blood pressure, temperature [ Time Frame: before- after transfusion ] [ Designated as safety issue: No ]heart beat per minute, blood pressure, temperature will be measured before and after red blood cell transfusion
- Hospital stay [ Time Frame: delivery - six weeks postpartum ] [ Designated as safety issue: Yes ]the hospital stay after delivery will be compared between both arms. All admissions in the first 6 weeks postpartum will be registered
- Physical complications (infections, thromboembolic events, hemodynamic events, cardiac events, neurologic events, secondary HPP, obstetric interventions, 'rescue' RBC transfusion) with WHO CTC grade 2 or more. [ Time Frame: delivery - six weeks postpartum ] [ Designated as safety issue: Yes ]all complications and admissions in the first 6 weeks postpartum will be registered
|Study Start Date:||May 2004|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Red blood cell transfusion
At least one unit of red blood cells will be administered.
Other: Red blood cell transfusion
At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.
No Intervention: Control
No red blood cell transfusion. Iron suppletion is allowed and can be administered according to local protocol. If suppletion is prescribed, the type and duration will be registered
The WOMB study is a multicenter trial in patients with PPH, where a restrictive RBC transfusion policy will be compared with a more liberal RBC transfusion policy. Primary outcome in this study is fatigue measured with the MFI questionnaire. Inclusion criteria are: 1) 12-24 h after VD or CS; 2) 4.8 ≤Hb≤ 7.9 g/dL; 3) blood loss ≥ 1000mL or Hb decrease ≥ 1,9 g/dL; 4) age≥ 18 years; 5) no anaemic symptoms. Patients will be randomised for a RBC transfusion or not. The total follow-up period is 6 weeks. HRQoL will be measured at T=0 (12-24 hours postpartum) 3 days, 1, 3 and 6 weeks postpartum. At T=0 and 6 weeks postpartum Hb value will be measured. For the patients who receive a RBC transfusion, the effect of the RBC transfusion will be measured with the Hb value, Hct, platelet and leukocyte count, and the temperature of the patient before and after the RBC transfusion. The sample size is 500 patients: 250 allocated to a RBC transfusion and 250 patients allocated to a restrictive policy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335023
|Sanquin Blood Bank South West Region|
|Rotterdam, Netherlands, 3001 KJ|
|Study Chair:||Dick J van Rhenen, Prof MD PhD||Sanquin Blood Bank South West Region|
|Study Chair:||Johannes J Duvekot, MD, PhD||Department Obstetrics of Erasmus Medical center|
|Principal Investigator:||Babette W Prick, M.D.||Department Obstetrics of Erasmus Medical center|