European project on obstetric haemorrhage reduction: attitudes, trial, and early warning system

ISRCTN	ISRCTN66197422
DOI	https://doi.org/10.1186/ISRCTN66197422
Protocol serial number	N/A
Sponsor	European Union DG Research
Funder	European Union (EU) (ref: QLG4-CT-2001-01352)

Submission date: 06/09/2005
Registration date: 05/01/2006
Last edited: 25/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sophie Alexander
Scientific

CP 597
808, Route de Lennik
Brussels
1070
Belgium

Phone	+32 25554079
Email	salexand@ulb.ac.be

Study information

Primary study design	Interventional
Study design	Randomised Controlled Trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EUPHRATES
Study objectives	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(s)	Ethical approval was obtained in each country from relevant local or national research ethics committees
Health condition(s) or problem(s) studied	Severe post-partum haemorrhage
Intervention	A collector bag, placed under the pelvis (buttocks) of each woman just after birth.
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	82
Key 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.
Key exclusion criteria	Maternity units with less than 400 births per year or unable to collect outcome data
Date of first enrolment	01/10/2005
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

Belgium

Study participating centre

CP 597

Brussels
1070
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No