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WOMB

 

Well being of Obstetric patients on Minimal Blood transfusions

MEC ErasmusMC 2003-247 / Nederlands Trial Register 335 / Clinical Trials.gov NCT00335023

 

Objective
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.

 

Study design
Multicenter prospective randomised controlled trial.

The study started in May 2004 and is at the moment ongoing in 37 hospitals in The Netherlands, which are collaborating in several proposed studies.

 

Study population

Women with PPH or a decrease in Hb, 12 to 24 hours after delivery or caesarean section.

The sample size will be 500 (where 250 patients receive a RBC transfusion and 250 patients not) after vaginal or CS delivery.

 

Inclusion criteria:

• Blood loss during delivery = at least 1000 mL and/or

a peripartum decrease in Hb of at least 1.2 mmol/L

• Hb level of 3.0 - 4.9 mmol/L, 12 to 24 hours after a vaginal delivery or caesarean section

• Women older than 18 years of age

• Good working knowledge of the Dutch language

 

Exclusion criteria:

• Severe preeclampsia or HELLP syndrome

• RBC transfusions during or after delivery but before the time of proposed inclusion

• Serious physical complaints (tachycardia of more than 100 bpm, dyspnoea, syncope,

   heart problems)

• Severe active infectious disease at the time of proposed inclusion

• Compromised immunological status, congenital or acquired by medical treatment or

   infectious disease (eg. HIV)

• Malignancy

• Severe cardiac, pulmonary, neurological, metabolic or psychiatric co-morbidity (ASA II/III)

• Haemoglobinopathies

• Peripartum death of the newborn, or the newborn being in critical condition on

   neonatal intensive care

 

Intervention:

Patients will be randomised for a RBC transfusion or no transfusion.

 

Outcome measures

Primary outcome in this study is fatigue measured with the MFI questionnaire.

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.

 

Keywords
PPH, RBC transfusion, HRQoL

Principle investigators
Sanquin Blood Bank South West Region: DJ van Rhenen
Erasmus MC: JJ Duvekot, BW Prick

Participants of the study
Sanquin Blood Bank South West Region
Prof. dr. D.J. van Rhenen, director

Erasmus Medical Center, department of Epidemiology and Biostatistics
Dr. W.C.J. Hop, Erasmus Medical Center Rotterdam, biostatistician

Erasmus Medical Center, department of Public Health
Dr. ML Essink- Bot, Erasmus Medical Center Rotterdam, epidemiologist

 

Trial registration

Dutch Trial Register, www.ntr.nl, NTR 335

 

 

The medical ethical review board of Erasmus MC, University Medical Center Rotterdam, approved this study.