Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000807651
Ethics application status
Approved
Date submitted
9/06/2023
Date registered
27/07/2023
Date last updated
27/07/2023
Date data sharing statement initially provided
27/07/2023
Date results information initially provided
27/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of midwives delivering perineal acupressure on the acupuncture point Conception Vessel 1 (CV1) for birthing women during the pushing phase of labour on birthing outcomes and the incidence of perineal tearing.
Scientific title
Exploring outcomes for women having perineal acupressure on the acupuncture point Conception Vessel 1 (CV1) during the active second stage of labour: A pilot quasi-experimental design and qualitative study.
Secondary ID [1] 309870 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
birth 330321 0
perineal lacerations 330322 0
Condition category
Condition code
Reproductive Health and Childbirth 327174 327174 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Conception Vessel 1 (CV1) is located at the midpoint of the perineum on the perineal body. The perineal body is an attachment point or conduit of interlaced and interdependent perineal muscle fibres, tendons and fascia (the pelvic floor). CV 1 is located by the Midwife with flat finger palpation along the length of the perineum until a nodule or “knot” is felt, or CV1 is visualized as a “dimple” in the centre of the perineal body once the fetal head is on view exerting force upon the pelvic floor.

The perineal acupressure on Conception Vessel 1 (PACV) technique involves the Midwife who is trained in acupressure applying continual acupressure to CV1 using the middle or index finger of their dominant hand when the fetal head is visible and low on the perineum. Simultaneously, the Midwife places their non-dominant hand on the baby’s head to apply counter-pressure. PACV1 is a slow and controlled hands-on technique that is integrated into the current birth practice used by Midwives outlined in the Perineal Protection Bundle (Women's Healthcare Australasia 2019). The Midwife continues PACV1 until myofascial release of the transverse perineal muscles is observed resulting in progress with fetal descent, rotation and extension. The maximum duration of time for the application of PACV1 is 20 minutes or 8 contractions. PACV1 is applied by the Midwife with the woman supine, semi recumbent, lateral or in lithotomy position.

Data was obtained from the electronic medical records of e-Maternity and Powerchart. Verbal informed consent was obtained from the birthing women in the study that received PACV1 and a waiver of consent was obtained for the data generated from a random sample of women who birthed without PACV1.
Intervention code [1] 326294 0
Treatment: Other
Intervention code [2] 326514 0
Prevention
Comparator / control treatment
A historical random sample of women who birthed at Nepean Hospital during September 2020 until September 2022 formed the control group (n=49). The women in the control group did not receive perineal acupressure on CV1 and received standard midwifery or obstetric care during birth. The control group was obtained from the electronic medical record e-Maternity.
Control group
Historical

Outcomes
Primary outcome [1] 335053 0
Perineal status was identified in the electronic medical record e-Maternity.
Timepoint [1] 335053 0
PACV1 was provided to birthing women until myofascial release of the transverse perineal muscles was achieved and progress with birth was observed, for a maximum of 20 minutes post commencement.
Primary outcome [2] 335412 0
Genital tract trauma was identified in the electronic medical record e-Maternity.
Timepoint [2] 335412 0
PACV1 was provided to birthing women until myofascial release of the transverse perineal muscles was achieved and progress with birth was observed, for a maximum of 20 minutes post commencement.
Secondary outcome [1] 422870 0
The birth outcome of a normal vaginal birth or an instrumental birth was identified in the electronic medical record e-Maternity.
Timepoint [1] 422870 0
Upon completion of normal vaginal birth or instrumental birth.
Secondary outcome [2] 424117 0
Face-to-face and telephone interviews with Midwives who were trained in acupressure and provided PACV1 for birthing women. The interviews were semi structured and were conducted by the primary researcher. The duration of the interviews was approximately 30 minutes and were audio recorded with written informed consent.
Timepoint [2] 424117 0
In-depth interviews were conducted after a midwife had performed PACV1 on one woman during birth.

Eligibility
Key inclusion criteria
Inclusion criteria. The inclusion criteria required that the mother had a term (>36 weeks gestation) singleton pregnancy who birthed vaginally who verbally consented to receive PACV1 during the active second stage of labour and had a baby between October 2020 and August 2022 and who was 18 years and over. One woman with a term fetal death in utero was included in this study.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria included; women who had a waterbirth; a pathological cardiotocograph (CTG); foetal bradycardia; shoulder dystocia; perineal button-holing or infectious lesions on the perineum.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics provided information by way of percentages for parity, genital tract trauma and perineal status. Independent t-tests were conducted to compare the continuous variables (age, Body Mass Index (BMI), gestation, active pushing) for the two samples. Chi-square analyses were conducted to establish women who were more likely to have an intact perineum or episiotomy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/09/2020
Date of last participant enrolment
Anticipated
Actual
22/08/2022
Date of last data collection
Anticipated
Actual
22/08/2022
Sample size
Target
50
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24893 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 40542 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 314053 0
Hospital
Name [1] 314053 0
Nepean Hospital
Country [1] 314053 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Derby STreet Kingswood 2747 NSW
Country
Australia
Secondary sponsor category [1] 315957 0
None
Name [1] 315957 0
none
Address [1] 315957 0
none
Country [1] 315957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313190 0
Nepean Blue Mountains Human Research Ethics Committee (HREC)
Ethics committee address [1] 313190 0
Derby STreet Kingswood 2747 NSW
Ethics committee country [1] 313190 0
Australia
Date submitted for ethics approval [1] 313190 0
22/06/2020
Approval date [1] 313190 0
17/08/2020
Ethics approval number [1] 313190 0
2020/ETH02967

Summary
Brief summary
Birthing women experience perineal tears and episiotomy (cutting the vaginal opening during childbirth) that may impact upon a woman's physical, emotional and sexual well being. This study began after the author (who is both a Midwife and an acupuncturist) observed acupressure that she offered to birthing women on the perineal acupuncture point Conception Vessel 1 (CV1) facilitated normal vaginal birth and women were less likely to have severe perineal tears and did not require an episiotomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127290 0
Ms Kathryn Taylor
Address 127290 0
Nepean Hospital Derby STreet Kingswood 2747 NSW
Country 127290 0
Australia
Phone 127290 0
+61 0247344017
Fax 127290 0
Email 127290 0
kathryn.taylor2@health.nsw.gov.au
Contact person for public queries
Name 127291 0
Ms Kathryn Taylor
Address 127291 0
Nepean Hospital Derby STreet Kingswood 2747 NSW
Country 127291 0
Australia
Phone 127291 0
+61 0247344017
Fax 127291 0
Email 127291 0
kathryn.taylor2@health.nsw.gov.au
Contact person for scientific queries
Name 127292 0
Ms Kathryn Taylor
Address 127292 0
Nepean Hospital Derby STreet Kingswood 2747 NSW
Country 127292 0
Australia
Phone 127292 0
+61 0247344017
Fax 127292 0
Email 127292 0
kathryn.taylor2@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
privacy for women


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.