Condition category
Pregnancy and Childbirth
Date applied
06/09/2005
Date assigned
05/01/2006
Last edited
25/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.cordis.lu

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20123835

Publication citations

  1. 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.

Additional files

Editorial Notes