Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000628741
Ethics application status
Not yet submitted
Date submitted
28/05/2013
Date registered
3/06/2013
Date last updated
3/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An Australian study evaluating a specialised blood collection drape to improve midwives' estimation of blood loss during labour.
Scientific title
A pilot study to evaluate Australian midwives' experiences of using a calibrated blood collection drape to improve estimation of third stage blood loss in labour.
Secondary ID [1] 282586 0
Nil Known
Universal Trial Number (UTN)
U1111-1143-6400
Trial acronym
BLEED trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childbirth 289277 0
Condition category
Condition code
Reproductive Health and Childbirth 289601 289601 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A calibrated plastic drape (the Evergrand Underbuttocks Surgical Drape) will be placed under the buttocks of the woman at the commencement of third stage labour. It will measure blood loss in the collection pouch and be removed 30 minutes post birth of the placenta and membranes.
Intervention code [1] 287253 0
Diagnosis / Prognosis
Intervention code [2] 287277 0
Treatment: Devices
Comparator / control treatment
Visual estimation of blood loss at 30 minutes post completion of birth of the placenta and membranes.
Control group
Active

Outcomes
Primary outcome [1] 289693 0
Degree of difference in Mean (or Median) total estimated (standard care) and measured (drape) blood loss.
Timepoint [1] 289693 0
Within 30 minutes of cessation of third stage of labour
Secondary outcome [1] 303035 0
Evaluation of midwives attitudes toward the use of ‘the drape’ via 10 questions on a Likert scale.
Timepoint [1] 303035 0
During third stage labour
Secondary outcome [2] 303036 0
Evaluation of midwives attitudes towards standard third stage blood loss estimation via 10 questions on a Likert scale.
Timepoint [2] 303036 0
During third stage labour

Eligibility
Key inclusion criteria
Midwives working in birth suite
Minimum age
21 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to participate either in person, via mail or telephone and provided a plain language statement and consent form by the midwife researcher not affiliated with the hospital. A consent form will be attached to the letter. Participants will be asked to return the consent form in a secure manner to the research midwife.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An associate investigator will place an equal number of data sheets for each group in sealed blank envelopes, place them in a sealed box and shuffle them.
The chief investigator will, on receipt of signed consent form, draw an envelope from the box and assign the participant to the group in the envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A Bland and Altman plot and intra-class correlations will be calculated using SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1066 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne

Funding & Sponsors
Funding source category [1] 287369 0
University
Name [1] 287369 0
Australian Catholic University
Country [1] 287369 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
St Vincent's PO Box 2900, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 286115 0
None
Name [1] 286115 0
Address [1] 286115 0
Country [1] 286115 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289344 0
St Vincents Hospital HREC-D
Ethics committee address [1] 289344 0
St Vincent's PO Box 2900, Fitzroy VIC 3065
Ethics committee country [1] 289344 0
Australia
Date submitted for ethics approval [1] 289344 0
24/06/2013
Approval date [1] 289344 0
Ethics approval number [1] 289344 0

Summary
Brief summary
This pilot study aims to determine the accuracy of midwives' third stage labour blood loss estimations and the feasibility of a using a calibrated blood collection drape to measure third stage blood loss in the Australian setting.
Australian clinicians tend to estimate third stage blood loss using visual estimation, which underestimates blood loss. Third stage blood loss, postpartum haemorrhage (PPH) and associated anaemia significantly contributes to serious postnatal health complications and maternal mortality.
In Australia, PPH occurs in 6.8-9.2% of all births, with variation between states. However, Australian and overseas data has shown a trend increase in PPH and associated morbidity which have triggered a call for further research and improved management of the third stage of labour. One area that needs further research is blood loss estimation accuracy, as visual estimation of third stage blood loss leads to an under-diagnosis of PPH and poor identification of women at risk of complications from anaemia.
Overseas researchers have piloted blood collection drapes, which have been found to be accurate for measuring third stage blood loss when compared to visual methods. No studies of the acceptability of these drapes have been conducted and they are untested in Australia. Furthermore, accuracy of Australian clinicians’ visual estimations has not been tested in the clinical setting.
This study will compare the mean difference between clinician's visual estimation of third stage blood loss to third stage blood loss measured in a calibrated blood collection drape. Clinican's attitudes towards visual blood estimation and the acceptability of the drape will be surveyed. A cost benefit analysis will also be conducted. The results from this pilot study will inform the design of a multi-centre study involving a larger number of participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40394 0
Dr Sharon Licqurish
Address 40394 0
Midwifery Lecturer
Australian Catholic University
School of Nursing, Midwifery & Paramedicine
Locked Bag 4115
Fitzroy MDC, VIC 3065
Country 40394 0
Australia
Phone 40394 0
+61 3 9953 3191
Fax 40394 0
Email 40394 0
[email protected]
Contact person for public queries
Name 40395 0
Dr Sharon Licqurish
Address 40395 0
Midwifery Lecturer
Australian Catholic University
School of Nursing, Midwifery & Paramedicine
Locked Bag 4115
Fitzroy MDC, VIC 3065
Country 40395 0
Australia
Phone 40395 0
+61 3 9953 3191
Fax 40395 0
Email 40395 0
[email protected]
Contact person for scientific queries
Name 40396 0
Dr Sharon Licqurish
Address 40396 0
Midwifery Lecturer
Australian Catholic University
School of Nursing, Midwifery & Paramedicine
Locked Bag 4115
Fitzroy MDC, VIC 3065
Country 40396 0
Australia
Phone 40396 0
+61 3 9953 3191
Fax 40396 0
Email 40396 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.