None listed
Conditions
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.
Interventions
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 f
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.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Women whose primary care givers are hospital-based midwives and who are not being cared for by a PPEM.
Outcome results
None listed