NCT00335023

Well Being of Obstetric Patients on Minimal Blood Transfusions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Sanquin Research & Blood Bank Divisions · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-05-01
• Primary completion: 2011-03-01
• First posted: 2006-06-08
• Last updated: 2011-07-20

Locations

1 site across 1 country: Netherlands