Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001107718
Ethics application status
Approved
Date submitted
18/07/2022
Date registered
10/08/2022
Date last updated
6/02/2023
Date data sharing statement initially provided
10/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The APP (Acuneedling for Posterior Position) Trial pilot study. Acuneedling (midwife administered acupuncture) for fetal malposition during labour and birth.
Scientific title
The feasibility, acceptability and experiences of acuneedling (midwife administered acupuncture) for fetal malposition during labour and birth: A mixed method approach incorporating the Acuneedling for Posterior Position (APP) Trial pilot study.
Secondary ID [1] 307607 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
APP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal malposition 327071 0
Fetal posterior position 327072 0
Fetal asynclitism 327073 0
Fetal deflexion 327074 0
Condition category
Condition code
Alternative and Complementary Medicine 324231 324231 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 324232 324232 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description: Acuneedling (midwife administered acupuncture) using press needles for fetal malposition (occipito posterior, asynclitism, deflexion).
Expert opinion focus group: Attendance by acupuncturists/consumers (maximum six) with an interest in maternity, at a one hour focus group or interview to seek their opinion on the most appropriate acupoints for the intervention, and finalise the study-specific questionnaire (designed specifically for the study). Participants are invited to provide feedback on press needles to be used, which midwives in the hospital setting are the most appropriate to administer the acuneedling, which health professional is the most appropriate to train/educate midwives in administering the intervention, and their expert opinion on safety aspects of the intervention.
Pilot RCT location/setting: Home, birth centre and hospital setting with Privately Practicing Endorsed Midwives throughout Australia.
Midwifery education/training: Midwives will be educated by watching an online presentation about the study's aim, background, method, potential findings, professional standards, good clinical practice, the pilot RCT steps, and trained by watching a video on how to locate the points, administer acuneedling and its safety, plus the completion of the questionnaire using a case history to test inter-rater reliability. They will be deemed competent by providing a video of them acuneedling the points to the research team and consultant acupuncturist, and then provided with a certificate. This will occur at a time that is suitable for the midwife, anytime before the 1st September 2023 when the trial begins.
Type and size of needles: Vinco press tacks (0.22x1.5) and/or Seirin Pyonex Press Needles (0.20x1.5). The press needles will be positioned on the participant using the midwives knowledge/competency. The acupoints have been decided upon from a key stakeholder expert opinion focus group involving acupuncturists. The acupoints decided upon will not deviate from their location.
Frequency/duration/timing: In labour and/or birth. The needles will remain in place from the time of insertion until after the placenta is birthed, unless they fall out or are requested to be taken out. The press needles can be reinserted if the participant consents.
Monitoring adherence: Study-specific questionnaire (designed specifically for the study) completed by midwives.
Intervention code [1] 324058 0
Treatment: Devices
Comparator / control treatment
Standard care may include the woman physiologically labouring/birthing, non-pharmacological techniques (acupressure, aromatherapy, fit ball, bath, calmbirth/hypnobirthing, heat, homeopathy, naturopathy, massage, sterile water injections, positioning, reflexology, shower, TENS machine), pharmacological analgesia (non-opioids, nitrous oxide, morphine, epidural), manual rotation of the fetal head, trial of forceps, caesarean section.
Control group
Active

Outcomes
Primary outcome [1] 332050 0
Feasibility of implementation strategy - ease and difficulties of using press needles, difficulties using tape to secure press needles; assessed by a study-specific questionnaire (designed specifically for the study).
Timepoint [1] 332050 0
The questionnaire will be completed during labour and within four hours post birth, by the midwife, and assessed by the study team within one week after the questionnaire has been uploaded.
Primary outcome [2] 332146 0
Acceptability of implementation strategy - complaints about needles; assessed independently by the study specific questionnaire (designed specifically for the study), semi-structured interviews and focus group, and an audit of the study records.

The study researcher will administer the semi-structured interviews for one hour with the pilot RCT participant, either face to face, via video link, or over the telephone, at an arranged time. The focus group (a maximum of six) will be via video link from a setting of their choice, at an arranged time. Questions for the semi-structured interviews and focus group have been specifically designed for the study.
Timepoint [2] 332146 0
The questionnaire will be completed during labour and within four hours post birth, by the midwife, and assessed by the study team within one week after the questionnaire has been uploaded. The audit of study records will occur within six weeks post birth. The semi-structured interviews and focus group will be completed during the twelve-month pilot RCT and before the end of 2024.
Primary outcome [3] 332262 0
Acceptability of implementation strategy - consent and acceptance of the trial; assessed independently by the study specific questionnaire (designed specifically for the study), semi-structured interviews and focus group, and an audit of the study records.

The study researcher will administer the semi-structured interviews for one hour with the pilot RCT participant, either face to face, via video link, or over the telephone, at an arranged time. The focus group (a maximum of six) will be via video link from a setting of their choice, at an arranged time. Questions for the semi-structured interviews and focus group have been specifically designed for the study.
Timepoint [3] 332262 0
The questionnaire will be completed during labour and post birth, by the midwife, and assessed by the study team within one week after the questionnaire has been uploaded. The audit of study records will occur within six weeks post birth. The semi-structured interviews and focus group will be completed during the twelve-month pilot RCT and before the end of 2024.
Secondary outcome [1] 411983 0
Intrapartum fetal position (occipito transverse/anterior or posterior, flexion) outcome assessed by a study-specific questionnaire (designed specifically for the study).
Timepoint [1] 411983 0
Insertion of press needles to within five minutes, thirty minutes, one hour, at second stage, at birth, and stimulation of press needles.
Secondary outcome [2] 412366 0
Time from insertion of press needles till birth using a study-specific questionnaire (designed specifically for the study).
Timepoint [2] 412366 0
The questionnaire will be completed during labour and within four hours post birth, by the midwife,
Secondary outcome [3] 412367 0
Time from birth until placenta birthed using a study-specific questionnaire (designed specifically for the study).
Timepoint [3] 412367 0
The questionnaire will be completed during labour and within four hours post birth, by the midwife,
Secondary outcome [4] 412368 0
Treatment compliance: time from insertion of press needles until taken out using a study-specific questionnaire (designed specifically for the study).
Timepoint [4] 412368 0
The questionnaire will be completed during labour and within four hours post birth, by the midwife,
Secondary outcome [5] 412369 0
Participants experiencing adverse effects and/or events using a study-specific questionnaire (designed specifically for the study). For example: dizziness, nausea, and pain, irritation or infection at the needle site. A midwife needle stick injury.
Timepoint [5] 412369 0
The questionnaire will be completed during labour and within four hours post birth, by the midwife,

Eligibility
Key inclusion criteria
Women whose obstetric risk profile is reflected in any category of the
Australian College of Midwives National Midwifery Guidelines for Consultation and Referral, 4th edition, who present or experience a malpositioned fetus during labour or birth.
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women whose primary care givers are hospital-based midwives and who are not being cared for by a PPEM.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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 non-probability convenience sampling technique. Sample size 298: Confidence level 95 percent, 2701 births in 2020 classed as at home, other or did not state, 32 percent (0.32) proportion based on the maximum percentage of women with fetus in occipito posterior position at the beginning of labour, confidence interval of 5 percent (0.05). Pre-made measurement tool questionnaire with key stakeholder involvement. Descriptive statistics and inferential statistics (if warranted). 'Intention to treat' analysis..

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
298
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311876 0
University
Name [1] 311876 0
Edith Cowan University
Country [1] 311876 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 313353 0
None
Name [1] 313353 0
Address [1] 313353 0
Country [1] 313353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311311 0
Edith Cowan University Human Research Ethics Committee (HREC)
Ethics committee address [1] 311311 0
270 Joondalup Drive
Joondalup WA 6027
Ethics committee country [1] 311311 0
Australia
Date submitted for ethics approval [1] 311311 0
17/06/2022
Approval date [1] 311311 0
12/07/2022
Ethics approval number [1] 311311 0
2021-02480-WILLIAMS

Summary
Brief summary
Acupuncture is known as a safe, non-pharmacological treatment for a range of conditions that occur in pregnancy, labour, birth and the postpartum period. Acupuncture is currently not offered in maternity and obstetric units in Australia. A dearth in the literature exists about the use of acupuncture for fetal malposition (occipito posterior, deflexion, asynclitism) when administered by a midwife (acuneedling).

The aim of the research is to develop an expert opinion-based protocol for acuneedling using press needles for managing intrapartum fetal malposition, evaluate its feasibility and acceptability, explore women’s feelings and experiences of receiving intrapartum acuneedling in semi-structured interviews and explore midwives’ feelings and experiences of administering intrapartum acuneedling and how it impacts on job satisfaction with a focus group..

For the quantitative (RCT) arm, a double-consent Zelen design will be used. The qualitative aspect will follow a generic qualitative descriptive design.

The pilot RCT will take place with privately practicing endorsed midwives. A non-probability convenience sampling technique will be employed for the twelve-month duration of the pilot RCT. A Participant Information Statement and Consent Form (PICF) for midwives to administer the intervention will be signed and collected before the pilot RCT begins to provide education and training. Women will be recruited through midwife antenatal visits with a PICF for women.

Quantitative data will be gathered using a newly designed measurement tool created in the form of a questionnaire. All documentation emailed/text will be uploaded to a centrally provisioned secure storage solution as per the university's data management plan.
Trial website
Trial related presentations / publications
Public notes
Women 15 years of age are classed as being of reproductive age https://www.aihw.gov.au/getmedia/aa54e74a-bda7-4497-93ce-e0010cb66231/aihw-per-108.pdf.aspx?inline=true

Contacts
Principal investigator
Name 120666 0
Ms Heidi Williams
Address 120666 0
Edith Cowan University
School of Nursing and Midwifery
270 Joondalup Drive
Joondalup WA 6027
Country 120666 0
Australia
Phone 120666 0
+61 402 443 540
Fax 120666 0
Email 120666 0
hwilli14@our.ecu.edu.au
Contact person for public queries
Name 120667 0
Dianne Bloxsome
Address 120667 0
Edith Cowan University
School of Nursing and Midwifery
270 Joondalup Drive
Joondalup WA 6027
Country 120667 0
Australia
Phone 120667 0
+61 8 6304 2360
Fax 120667 0
Email 120667 0
d.bloxsome@ecu.edu.au
Contact person for scientific queries
Name 120668 0
Heidi Williams
Address 120668 0
Edith Cowan University
School of Nursing and Midwifery
270 Joondalup Drive
Joondalup WA 6027
Country 120668 0
Australia
Phone 120668 0
+61 402 443 540
Fax 120668 0
Email 120668 0
hwilli14@our.ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data obtained through this study may be provided to qualified researchers with academic interest in acupuncture/acuneedling within midwifery and/or obstetrics. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
When will data be available (start and end dates)?
Available for 10 years after publication.
Available to whom?
Qualified researchers engaging in independent scientific research, provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Available for what types of analyses?
Submission of a Statistical Analysis Plan (SAP) - all types of deidentified analysis will be considered.
How or where can data be obtained?
For more information or to submit a request, please contact hwilli14@our.ecu.edu.au or dbloxsome@ecu.edu.au.


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.