Well Being of Obstetric Patients on Minimal Blood Transfusions (WOMB)

This study has been completed.
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by:
Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT00335023
First received: June 7, 2006
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Anemia
Other: Red blood cell transfusion
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:
  • Physical Fatigue [ Time Frame: on day 3 postpartum ] [ Designated as safety issue: No ]
    measured with the MFI questionnaire


Secondary Outcome Measures:
  • 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


Enrollment: 500
Study Start Date: May 2004
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335023

Locations
Netherlands
Sanquin Blood Bank South West Region
Rotterdam, Netherlands, 3001 KJ
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Erasmus Medical Center
Investigators
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
  More Information

Additional Information:
No publications provided by Sanquin Research & Blood Bank Divisions

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dick van Rhenen, Sanquin Blood Bank South West Region
ClinicalTrials.gov Identifier: NCT00335023     History of Changes
Other Study ID Numbers: 01-021b, 0904, NTR335
Study First Received: June 7, 2006
Last Updated: July 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin Research & Blood Bank Divisions:
postpartum hemorrhage
red blood cell transfusion
health related quality of life

ClinicalTrials.gov processed this record on September 18, 2014