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

Completed

Conditions: Severe post-partum haemorrhage
Pregnancy and Childbirth
Postpartum haemorrhage

Registration Number: ISRCTN66197422

Lead Sponsor: European Union DG Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 82

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.

Exclusion Criteria

Maternity units with less than 400 births per year or unable to collect outcome data

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a composite marker of severe post-partum haemorrhage. This includes all women who experience one or more of the following:<br>1. Death from post-partum haemorrhage<br>2. Blood transfusion<br>3. Receipt of an intravenous plasma expander in the post-partum period<br>4. Admission to intensive care because of post-partum haemorrhage<br>5. Embolisation or surgical procedures for post-partum haemorrhage, such as emergency hysterectomy<br>6. Treatment with recombinant factor VII (Novo7)

Secondary Outcome Measures

Name	Time	Method
1. Each of the components of the primary outcome<br>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)<br>3. Manual removal of placenta<br>4. Use of prostaglandins<br>5. Maternal death