Contact information
Type
Scientific
Primary contact
Prof Sophie Alexander
ORCID ID
Contact details
CP 597
808
Route de Lennik
Brussels
1070
Belgium
+32 25554079
salexand@ulb.ac.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EUPHRATES
Study hypothesis
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.
Ethics approval
Ethical approval was obtained in each country from relevant local or national research ethics committees
Study design
Randomised Controlled Trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Severe post-partum haemorrhage
Intervention
A collector bag, placed under the pelvis (buttocks) of each woman just after birth.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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)
Secondary outcome measures
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
Overall trial start date
01/10/2005
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
82
Participant exclusion criteria
Maternity units with less than 400 births per year or unable to collect outcome data
Recruitment start date
01/10/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
Belgium
Trial participating centre
CP 597
Brussels
1070
Belgium
Sponsor information
Organisation
European Union DG Research
Sponsor details
Square de Meeus
SDME 7/20
Brussels
1049
Belgium
+32 22955873
Veronique.Bernard@cec.eu.int
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
European Union (EU) (ref: QLG4-CT-2001-01352)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20123835
Publication citations
-
Results
Zhang WH, Deneux-Tharaux C, Brocklehurst P, Juszczak E, Joslin M, Alexander S, , Effect of a collector bag for measurement of postpartum blood loss after vaginal delivery: cluster randomised trial in 13 European countries., BMJ, 2010, 340, c293.