Status:
COMPLETED
Well Being of Obstetric Patients on Minimal Blood Transfusions
Lead Sponsor:
Sanquin Research & Blood Bank Divisions
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 dec...
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 fat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00335023
Start Date
May 1 2004
Last Update
July 20 2011
Active Locations (1)
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1
Sanquin Blood Bank South West Region
Rotterdam, Netherlands, 3001 KJ