Well Being of Obstetric Patients on Minimal Blood Transfusions

Phase 4

Completed

• Conditions: Anemia
• Interventions: Other: Red blood cell transfusion

• Registration Number: NCT00335023
• Lead Sponsor: Sanquin Research & Blood Bank Divisions

Brief 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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2006-06-07
• Study First Submitted QC: 2006-06-07
• Study First Posted: 2006-06-08
• Primary Completion: 2011-03
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Women older than 18 years
• 12-24 hours after delivery (vaginal or caesarean section)
• Patients are in a clinical obstetric setting
• Blood loss of more than 1000 mL or Hb decrease ≥ 1,9 g/dL
• Hb value between 4.8 g/dL and 7.9 g/dL
• Working knowledge of the national language
• Written consent for participating this study (informed consent)

Exclusion Criteria

• Patients with severe preeclampsia/ HELLP syndrome
• RBC transfusion during or after delivery but before t=0
• Patients with malignancy
• Patients with severe congenital haemolytic disease, like thalassemia or sickle cell disease
• Patients with compromised immunological status, congenital or acquired by medical treatment or infectious disease (eg. HIV)
• Severe active infectious disease at the time of proposed inclusion
• Severe cardiac, pulmonary, neurological, metabolic or psychiatric co- morbidity (ASA II/III) at the time of proposed inclusion
• Severe physical complaints (tachycardia of more than 100 bpm, dyspnoea, syncope, heart problems) at the time of intended inclusion
• Peripartum death of the newborn, or the newborn being in critical condition on neonatal intensive care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red blood cell transfusion	Red blood cell transfusion	At least one unit of red blood cells will be administered.

Primary Outcome Measures

Name	Time	Method
Physical Fatigue	on day 3 postpartum	measured with the MFI questionnaire

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	delivery - six weeks postpartum	Health related quality of life measured with the following questionnaires: Euro-Qol, SF-36 and the MFI
Blood usage and the costs	delivery - six weeks postpartum
Hemoglobin increase after transfusion	before- after transfusion	Hb value and platelet count will be measured before and after red blood cell transfusion
Heart beat, blood pressure, temperature	before- after transfusion	heart beat per minute, blood pressure, temperature will be measured before and after red blood cell transfusion
Hospital stay	delivery - six weeks postpartum	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.	delivery - six weeks postpartum	all complications and admissions in the first 6 weeks postpartum will be registered

Trial Locations

Locations (1)

Sanquin Blood Bank South West Region; 🇳🇱 Rotterdam, Netherlands