ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Diagnosis / Prognosis

Intervention code [2]

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]

Degree of difference in Mean (or Median) total estimated (standard care) and measured (drape) blood loss.

Timepoint [1]

Within 30 minutes of cessation of third stage of labour

Secondary outcome [1]

Evaluation of midwives attitudes toward the use of ‘the drape’ via 10 questions on a Likert scale.

Timepoint [1]

During third stage labour

Secondary outcome [2]

Evaluation of midwives attitudes towards standard third stage blood loss estimation via 10 questions on a Likert scale.

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

Locked Bag 4115, Fitzroy MDC, VIC 3065

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St Vincents Hospital HREC-D

Ethics committee address [1]

St Vincent's PO Box 2900, Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/06/2013

Approval date [1]

Ethics approval number [1]

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

Dr Sharon Licqurish

Address

Midwifery Lecturer
Australian Catholic University
School of Nursing, Midwifery & Paramedicine
Locked Bag 4115
Fitzroy MDC, VIC 3065

Country

Australia

Phone

+61 3 9953 3191

Fax

sharon.licqurish@acu.edu.au

Contact person for public queries

Name

Sharon Licqurish

Address

Midwifery Lecturer
Australian Catholic University
School of Nursing, Midwifery & Paramedicine
Locked Bag 4115
Fitzroy MDC, VIC 3065

Country

Australia

Phone

+61 3 9953 3191

Fax

sharon.licqurish@acu.edu.au

Contact person for scientific queries

Name

Sharon Licqurish

Address

Midwifery Lecturer
Australian Catholic University
School of Nursing, Midwifery & Paramedicine
Locked Bag 4115
Fitzroy MDC, VIC 3065

Country

Australia

Phone

+61 3 9953 3191

Fax

sharon.licqurish@acu.edu.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically