Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000662268
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
24/04/2018
Date last updated
24/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of using a peanut ball with women having epidurals during labour.
Scientific title
The effect of using a peanut ball during labour for women having an epidural: a randomised controlled pilot study.
Secondary ID [1] 294417 0
Nil known.
Universal Trial Number (UTN)
U1111-1211-2367
Trial acronym
PBT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Vaginal birth rate 307151 0
Condition category
Condition code
Alternative and Complementary Medicine 306272 306272 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 306605 306605 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group uses the peanut ball.
Control group does not use the peanut ball.
The group of women using the peanut ball will be provided an information and consent form about the background of the peanut ball. The midwives implementing the use of the peanut ball will be provided an education package about using the peanut ball covering storage, safety, maintenance and measurement on inflation of the peanut balls. Myself as the Chief Investigator of the project (midwife with 28 years’ experience) have educated midwives and doctors about the use of the peanut ball (via face to face education sessions). The midwife will administer the peanut ball individually to each woman following effective pain relief from the epidural during labour. The peanut ball will be administered once only to each participant during labour. The woman will be required to change positions using the peanut ball every 30 minutes. The peanut ball will be used in the hospital birthing suites at two low risk maternity units. The intervention will be personalised by offering different positions to the woman using the peanut ball depending upon individual comfort. One of the positions facilitates pushing the baby in second stage of labour.
The midwives have been educated about the positions that the woman can adapt whilst using the epidural. A component of this education package included documentation. If the woman has used the peanut ball during labour with an epidural, the midwife needs to document in the Powerchart – Citrix notes as progress notes. The documentation should include the wording: peanut ball. The midwife should also document in this section- the commencement time that the woman used the peanut ball post-epidural insertion. Ideally the woman should commence using the peanut ball following insertion of the epidural, when the epidural has taken effect, so that the woman is comfortable and pain-free. If the woman stops using the peanut ball for any reason prior to birthing, the time should also be documented, including the reason why she stopped using the peanut ball. Access to the progress notes will occur via the databases. There will be no direct observation of women during labour by research personnel as this is inappropriate.
Intervention code [1] 300706 0
Treatment: Devices
Intervention code [2] 300707 0
Lifestyle
Intervention code [3] 300708 0
Behaviour
Comparator / control treatment
The control group of women will receive standard care. The standard care includes monitoring the woman's fetus on a cardiotocograph, intravenous therapy in labour, attending blood pressures to detect low blood pressure as a result of the epidural. This standard care will also be provided to the intervention group using the peanut ball. The only difference is that the control group will not use the peanut ball. We are not comparing the standards of care as they are exactly the same, except that one group will not use the peanut ball and the other group will use the ball.
Control group
Active

Outcomes
Primary outcome [1] 305274 0
Vaginal birth rate - data-lnkage to medical records, We will be comparing vaginal birth rate to caesarean section rate.
Timepoint [1] 305274 0
Following birth of the baby - within four hours of birth.
Secondary outcome [1] 344675 0
Length of three stages of labour - data-lnkage to medical records, We will be comparing length of each stage of labour between the two groups.
Timepoint [1] 344675 0
During labour and at birth

Eligibility
Key inclusion criteria
The sample will include women who are English and non-English speaking, at least 36 weeks gestation with a live fetus and present with a cephalic presentation. Pregnant primiparous and multiparous women.
Minimum age
13 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded if they develop moderate to severe pre-eclampsia, or experience severe essential hypertension and if they are being treated for insulin dependent diabetes (gestational or pre-pregnant). Women will also be excluded if the fetal heart rate trace is abnormal or suspicious or if they experience an intra-uterine death. Women having twin pregnancies will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation is being done by simple randomisation (created by computer software).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographics will be reported using descriptive statistics. To reiterate, the main aims for this pilot study are to assess recruitment techniques and detect potentially clinically significant differences that would warrant further investigation in a larger randomised control trial.

It is not the main aim of the pilot to obtain statistically significant results for the clinical outcomes. Nonetheless, standard statistical techniques will be undertaken as would be if going to full trial, for exposition, and online survey results will provide complementary data from the woman’s perspective of using the peanut ball during labour and health and quality of life. Regarding statistical tests, independent t tests and Chi-square analyses will be used to determine differences between the two groups.

Economic measures and analysis
An economic analysis will be conducted alongside the trial to establish feasibility of economic data collection, provide indicative cost effectiveness results, and to inform whether investment in a larger definitive trial is value for money. Across both trial arms, health service use, staff time, medications, associated procedures, and length of stay in hospital will be measured over one year. Further, economic measure of health related quality of life, the EQ5D5D, will assess health utilities between trial arms.

It is hypothesised that the peanut ball will lead to clinically significant results in most women but given the small trial size there will likely be considerable statistical uncertainty regarding mean cost effectiveness. Statistical uncertainty will likely be driven by variation in clinical outcomes, costs, and health utilities. The consequence of uncertainty is the risk of making a wrong decision whether to accept / reject the peanut ball in routine practice. Therefore, following international best practice guidelines (Caro, Briggs, Siebert & Kuntz, 2012), this uncertainty will be thoroughly investigated with a view to assess the need for further research. First, a probability sensitivity analysis will identify the key drivers of uncertainty, including parameter and heterogeneity. Next, a value of information (VOI) analysis will convert statistical uncertainty, whether the peanut ball is cost effective, into dollar values. This represents the ‘opportunity cost’ of a wrong decision (e.g. reject peanut ball) that leads to lower clinical outcomes, lower quality of life, and higher health service costs. This dollar value represents the business-case whether investing in a definitive trial (and what size of trial) is justified to reduce uncertainty and increase confidence that the peanut ball is, not only clinically effective, but also cost effective.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
1/05/2019
Actual
Date of last data collection
Anticipated
3/05/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10444 0
Blue Mountains District ANZAC Memorial Hospital - Katoomba
Recruitment hospital [2] 10445 0
Lithgow Integrated Health Service - Lithgow
Recruitment postcode(s) [1] 22151 0
2780 - Katoomba
Recruitment postcode(s) [2] 22152 0
2790 - Lithgow

Funding & Sponsors
Funding source category [1] 299044 0
University
Name [1] 299044 0
Western Sydney University
Country [1] 299044 0
Australia
Primary sponsor type
Individual
Name
Virginia Skinner
Address
Centre for Nursing and Midwifery Research,
Nepean hospital, School of Nursing and Midwifery
PO Box 63, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 298278 0
Individual
Name [1] 298278 0
David Campbell
Address [1] 298278 0
Nepean Hospital,
Derby St, Kingswood, NSW, 2747
Country [1] 298278 0
Australia
Other collaborator category [1] 280037 0
Individual
Name [1] 280037 0
Kenny Lawson
Address [1] 280037 0
Translational Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia
Country [1] 280037 0
Australia
Other collaborator category [2] 280038 0
Individual
Name [2] 280038 0
David Campbell
Address [2] 280038 0
Anzac Memorial District Blue Mountains hospital,

corner Great Western Highway and Woodlands Road, Katoomba New South Wales 2780
Country [2] 280038 0
Australia
Other collaborator category [3] 280039 0
Individual
Name [3] 280039 0
Biing Yin
Address [3] 280039 0
Lithgow Hospital,
Corner Col Drewe Drive and Great Western Highway, Lithgow New South Wales 2790
Country [3] 280039 0
Australia
Other collaborator category [4] 280040 0
Individual
Name [4] 280040 0
Wafa Al Omari
Address [4] 280040 0
Nepean hospital,
Derby Street, Kingswood New South Wales 2747
Country [4] 280040 0
Australia
Other collaborator category [5] 280073 0
Individual
Name [5] 280073 0
Robin Burr
Address [5] 280073 0
Nepean hospital,
Derby Street, Kingswood New South Wales 2747
Country [5] 280073 0
Australia
Other collaborator category [6] 280074 0
Individual
Name [6] 280074 0
Justine Elliott
Address [6] 280074 0
Nepean hospital,
Derby Street, Kingswood New South Wales 2747
Country [6] 280074 0
Australia
Other collaborator category [7] 280075 0
Individual
Name [7] 280075 0
Madeleine Simpson
Address [7] 280075 0
Anzac District Memorial Blue Mountains hospital,
corner Great Western Highway and Woodlands Road, Katoomba New South Wales 2780
Country [7] 280075 0
Australia
Other collaborator category [8] 280076 0
Individual
Name [8] 280076 0
Sarah Cachia
Address [8] 280076 0
Anzac District Memorial Blue Mountains hospital,
corner Great Western Highway and Woodlands Road, Katoomba New South Wales 2780
Country [8] 280076 0
Australia
Other collaborator category [9] 280077 0
Individual
Name [9] 280077 0
Heather Borradale
Address [9] 280077 0
Setpoint Clinical Solutions,
8  Warung  Ave Contact Maroochydore Qld 4558
Country [9] 280077 0
Australia
Other collaborator category [10] 280078 0
Individual
Name [10] 280078 0
Deborah Gaynor
Address [10] 280078 0
Lithgow hospital,

Corner Col Drewe Drive and Great Western Highway, Lithgow New South Wales 2790
Country [10] 280078 0
Australia
Other collaborator category [11] 280079 0
Individual
Name [11] 280079 0
Heather Reilly
Address [11] 280079 0
Centre for Nursing and Midwifery Research,
Nepean hospital,
PO Box 63, Penrith NSW 2751
Country [11] 280079 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299980 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 299980 0
Derby St, Kingswood, NSW, 2747
Ethics committee country [1] 299980 0
Australia
Date submitted for ethics approval [1] 299980 0
05/02/2018
Approval date [1] 299980 0
17/04/2018
Ethics approval number [1] 299980 0
HREC/18/Nepean/30

Summary
Brief summary
The aims of this pilot study are three-fold: the practicality of conducting a formal trial and information needed including recruitment rates, to determine whether using a peanut ball for pregnant women who have an epidural during labour makes clinically significant different outcomes and inform whether to conduct a larger randomised controlled trial (RCT) to establish clinical and statistical significance.
The assessment of endpoints is to determine if the peanut ball makes clinically significant different outcomes by comparing the intervention group that uses the peanut ball and the control group that does not use the peanut ball. Specifically it asks:
Is there a difference between women using the peanut ball and those who do not in the rate of vaginal births?
Is there a difference between women using the peanut ball and those who do not in the length of labour?
Is there a difference in health service usage between arms, regarding staff time, medications, procedures and length of stay in hospital. Is there a difference in experience in labour, including health related quality of life?

We hypothesise that placing the peanut ball between the labouring woman’s legs who has an epidural may facilitate the progress of labour (Tussey et al., 2015) and would be more likely to have a vaginal birth as opposed to a caesarean birth. We also hypothesise that women’s views about their own experience and health related quality of life will be more positive. Evidence of these outcomes will be evaluated more closely in the larger randomised control trial.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2602 2602 0 0
/AnzctrAttachments/374773-Additional file 1 SPIRIT Checklist.docx (Other)
Attachments [2] 2603 2603 0 0
/AnzctrAttachments/374773-Additional file 2 SPIRIT-Protocol.pdf (Other)
Attachments [3] 2604 2604 0 0
/AnzctrAttachments/374773-Approval letter Study 18-30 HREC Final Approval letter..pdf (Ethics approval)
Attachments [4] 2605 2605 0 0
/AnzctrAttachments/374773-Participant Information Sheet and Consent for BMADMH peanut ball version 3 dated 20.3.2018.docx (Participant information/consent)
Attachments [5] 2606 2606 0 0
/AnzctrAttachments/374773-Participant Information Sheet and Consent for BMADMH peanut ball version 6 dated 20.3.2018.docx (Participant information/consent)

Contacts
Principal investigator
Name 82150 0
A/Prof Virginia Skinner
Address 82150 0
Centre for Nursing and Midwifery Research
First Floor - Court Building - Nepean Hospital
Nepean Blue Mountains Local Health District
PO Box 63, Penrith NSW 2751
Country 82150 0
Australia
Phone 82150 0
+61 0408427612
Fax 82150 0
Email 82150 0
v.skinner@westernsydney.edu.au
Contact person for public queries
Name 82151 0
A/Prof Virginia Skinner
Address 82151 0
Centre for Nursing and Midwifery Research
First Floor - Court Building - Nepean Hospital
Nepean Blue Mountains Local Health District
PO Box 63, Penrith NSW 2751
Country 82151 0
Australia
Phone 82151 0
+61 0408427612
Fax 82151 0
Email 82151 0
v.skinner@westernsydney.edu.au
Contact person for scientific queries
Name 82152 0
A/Prof Virginia Skinner
Address 82152 0
Centre for Nursing and Midwifery Research
First Floor - Court Building - Nepean Hospital
Nepean Blue Mountains Local Health District
PO Box 63, Penrith NSW 2751
Country 82152 0
Australia
Phone 82152 0
+61 0408427612
Fax 82152 0
Email 82152 0
v.skinner@westernsydney.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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