Well Being of Obstetric Patients on Minimal Blood Transfusions

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.

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