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.
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.
• 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
• 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,
• Severe active infectious disease at the time of proposed inclusion
• Compromised immunological status, congenital or acquired by medical treatment or
infectious disease (eg. HIV)
• Severe cardiac, pulmonary, neurological, metabolic or psychiatric co-morbidity (ASA II/III)
• Peripartum death of the newborn, or the newborn being in critical condition on
neonatal intensive care
Patients will be randomised for a RBC transfusion or no transfusion.
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.
PPH, RBC transfusion, HRQoL
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
Dutch Trial Register, www.ntr.nl, NTR 335
The medical ethical review board of Erasmus MC, University Medical Center Rotterdam, approved this study.