Well Being of Obstetric Patients on Minimal Blood Transfusions - Full Text View

Sponsor:	Sanquin Research & Blood Bank Divisions
Information provided by:	Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:	NCT00335023

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
Postpartum Hemorrhage	Procedure: Red blood cell transfusion	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Well Being of Obstetric Patients on Minimal Blood Transfusions (WOMB Study)

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Postpartum Care

U.S. FDA Resources

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

Primary Outcome Measures:

Physical Fatigue, measured with the MFI questionnaire on day 3 postpartum

Secondary Outcome Measures:

Health related quality of life
Blood usage and the costs
Hemoglobin increase after transfusion
Heart beat, blood pressure, temperature, platelet count
Development of RBC allo-antibodies
Hospital stay
Physical complications (infections, thrombo-embolism, hemodynamic complications) with WHO CTC grade 2 or more.

Estimated Enrollment:	400
Study Start Date:	May 2004
Estimated Study Completion Date:	December 2008

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) 3.0 ≤Hb≤ 5.0 mmol/l; 3) blood loss ≥ 1000mL; 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 as well as a screening on irregular antibodies. 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 400 patients: 200 patients after a VD (where 100 patients receive a RBC transfusion and 100 patients not) and 200 patients after a CS (also 100 patients with en 100 patients without a RBC transfusion).

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
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 HELLP syndrome
Patients with a RBC transfusion during delivery or before 12 hours after delivery
Patients with a malignancy
Patients with congenital severe hemolytic anemia, like thalassemia or sickle cell anemia
Patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder
Severe active infections at the moment of inclusion
Severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion (ASA II/III)

Contacts and Locations

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

Contacts

Contact: Gerard Jansen, M.D. Ph.D	0031 10 4630630	ajgjansen@yahoo.com
Contact: Dick J van Rhenen, M.D. Ph.D	0031 10 4630640	d.vanrhenen@sanquin.nl

Locations

Netherlands
Sanquin Blood Bank South West Region	Recruiting
Rotterdam, Netherlands, 3001 KJ
Contact: Dick J van Rhenen, Prof MD PhD 0031 10 4630630 d.vanrhenen@sanquin.nl
Contact: Gerard Jansen, M.D. Ph.D 0031 10 4630630 ajgjansen@yahoo.com
Principal Investigator: Gerard Jansen, M.D. Ph.D

Sponsors and Collaborators

Sanquin Research & Blood Bank Divisions

Investigators

Study Chair:

Dick J van Rhenen, Prof MD PhD

Sanquin Blood Bank South West Region

More Information

No publications provided

Responsible Party:	Sanquin Blood Bank South West Region ( Dick van Rhenen )
Study ID Numbers:	01-021b
Study First Received:	June 7, 2006
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00335023 History of Changes
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

Additional relevant MeSH terms:

Postpartum Hemorrhage
Pregnancy Complications
Pathologic Processes
Uterine Hemorrhage

Puerperal Disorders
Obstetric Labor Complications
Hemorrhage

ClinicalTrials.gov processed this record on February 08, 2010