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Well Being of Obstetric Patients on Minimal Blood Transfusions

NCT00335023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2011-07-20

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

Red blood cell transfusion

At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.

Sponsors & Collaborators

Principal Investigators

  • Dick J van Rhenen, Prof MD PhD · Sanquin Blood Bank South West Region

  • Johannes J Duvekot, MD, PhD · Department Obstetrics of Erasmus Medical center

  • Babette W Prick, M.D. · Department Obstetrics of Erasmus Medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2011-03-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00335023 on ClinicalTrials.gov