Well Being of Obstetric Patients on Minimal Blood Transfusions

Anemia Clinical Trial

— WOMB  

Official title:

Well Being of Obstetric Patients on Minimal Blood Transfusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335023
• Other study ID #: 01-021b
• Secondary ID: 0904NTR335
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2006
• Last updated: July 19, 2011
• Start date: May 2004

Study information

• Verified date: July 2011
• Source: Sanquin Research & Blood Bank Divisions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Sanquin Blood Bank South West Region	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Sanquin Research & Blood Bank Divisions	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Fatigue	measured with the MFI questionnaire	on day 3 postpartum	No
Secondary	Health related quality of life	Health related quality of life measured with the following questionnaires: Euro-Qol, SF-36 and the MFI	delivery - six weeks postpartum	No
Secondary	Blood usage and the costs		delivery - six weeks postpartum	No
Secondary	Hemoglobin increase after transfusion	Hb value and platelet count will be measured before and after red blood cell transfusion	before- after transfusion	No
Secondary	Heart beat, blood pressure, temperature	heart beat per minute, blood pressure, temperature will be measured before and after red blood cell transfusion	before- after transfusion	No
Secondary	Hospital stay	the hospital stay after delivery will be compared between both arms. All admissions in the first 6 weeks postpartum will be registered	delivery - six weeks postpartum	Yes
Secondary	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.	all complications and admissions in the first 6 weeks postpartum will be registered	delivery - six weeks postpartum	Yes

External Links

•   study website