European project on obstetric haemorrhage reduction: attitudes, trial, and early warning system
| ISRCTN | ISRCTN66197422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66197422 |
| Secondary identifying numbers | N/A |
- 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
Scientific
CP 597
808, Route de Lennik
Brussels
1070
Belgium
| Phone | +32 25554079 |
|---|---|
| salexand@ulb.ac.be |
Study information
| Study design | Randomised Controlled Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | 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 study start date | 01/10/2005 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
1070
Belgium
Sponsor information
European Union DG Research
Other
Other
Square de Meeus
SDME 7/20
Brussels
1049
Belgium
| Phone | +32 22955873 |
|---|---|
| Veronique.Bernard@cec.eu.int | |
| Website | http://www.cordis.lu |
"ROR" |
https://ror.org/019w4f821 |
Funders
Funder type
Other
European Union (EU) (ref: QLG4-CT-2001-01352)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
