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ISRCTN
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ISRCTN66197422
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ClinicalTrials.gov identifier
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Public title
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European project on obstetric haemorrhage reduction: attitudes, trial, and early warning system
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Scientific title
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Acronym
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EUPHRATES
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Serial number at source
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N/A
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Study hypothesis
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The objective of this trial is to test the effectiveness of the routine use of a collector bag in the third stage of labour. The hypothesis is that enhanced visual awareness of blood loss will induce more timely management, specifically when bleeding is excessive but before haemorrhage has become catastrophic, leading to a decrease in the incidence of severe post-partum haemorrhage.
Our null hypotheses is that using a collector bag will be no more effective than visual estimated in accurate measurement of blood loss.
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Ethics approval
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Ethical approval was obtained in each country from relevant local or national research ethics committees
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Study design
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Randomised Controlled Trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Severe post-partum haemorrhage
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Participants - inclusion criteria
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Maternity units in 14 countries; To ensure that the standard of care for management of the third stage of labour is similar across all participating units, the maternity units in each country will be required to comply with the EUPHRATES consensus statement on the prevention and management of post-partum haemorrhage. If centres are already using collector sacs routinely in the third stage of labour, they will be eligible to participate only if they are willing to stop using the sacs if they are randomised to that group.
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Participants - exclusion criteria
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Maternity units with less than 400 births per year or unable to collect outcome data
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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82
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Interventions
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A collector bag, placed under the pelvis (buttocks) of each woman just after birth.
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Primary outcome measure(s)
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The primary outcome is a composite marker of severe post-partum haemorrhage. This includes all women who experience one or more of the following:
1. Death from post-partum haemorrhage
2. Blood transfusion
3. Receipt of an intravenous plasma expander in the post-partum period
4. Admission to intensive care because of post-partum haemorrhage
5. Embolisation or surgical procedures for post-partum haemorrhage, such as emergency hysterectomy
6. Treatment with recombinant factor VII (Novo7)
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Secondary outcome measure(s)
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1. Each of the components of the primary outcome
2. Post-delivery haemoglobin (Note: these data will only be available from units where haemoglobin is routinely measured at two to three days after delivery)
3. Manual removal of placenta
4. Use of prostaglandins
5. Maternal death
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Sources of funding
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European Union (EU) (ref: QLG4-CT-2001-01352)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20123835
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Contact name
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Prof
Sophie
Alexander
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Address
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CP 597
808, Route de Lennik
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City/town
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Brussels
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Zip/Postcode
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1070
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Country
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Belgium
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Tel
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+32 25554079
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Email
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salexand@ulb.ac.be
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Sponsor
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European Union DG Research
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Address
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Square de Meeus
SDME 7/20
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City/town
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Brussels
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Zip/Postcode
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1049
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Country
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Belgium
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Tel
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+32 22955873
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Email
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Veronique.Bernard@cec.eu.int
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Sponsor website:
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http://www.cordis.lu
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Date applied
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06/09/2005
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Last edited
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25/02/2010
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Date ISRCTN assigned
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05/01/2006
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