Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001167752
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
25/08/2022
Date last updated
11/06/2024
Date data sharing statement initially provided
25/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the REBozo TEChnique in second stage labour in relation to the incidence of assisted vaginal births for first time mothers: A concurrent mixed methods feasibility study
Scientific title
Use of the REBozo TEChnique in second stage labour in relation to the incidence of assisted vaginal births for nulliparous women: A concurrent mixed methods feasibility study
Secondary ID [1] 307535 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assisted vaginal births 326970 0
Vaginal delivery 327439 0
Fetal malposition 327440 0
Epidural analgesia 327441 0
Condition category
Condition code
Reproductive Health and Childbirth 324151 324151 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot trial will utilise the rebozo technique, which is used by some midwives to correct fetal malposition that contributes to rates of assisted vaginal birth (AVB). It will be used once, over a period of approximately 5 minutes. This technique will be used once second stage labour has been established, but before pushing begins. Midwives will be trained in the appropriate application of this intervention, and the lead researcher will be on site during business hours to assist and monitor. The rebozo is a standard sheet, placed underneath the woman’s back and hips. Once second stage is confirmed with full dilation, but before pushing commences, with two midwives on either side, the woman is to be rocked side to side using a standard sheet, placed underneath the woman' back and hips. The intervention is applied 4 times, then allow her to rest on her left side for 2 minutes, then immediately repeat.
Intervention code [1] 324216 0
Prevention
Intervention code [2] 324301 0
Treatment: Other
Comparator / control treatment
Standard care refers to actions the midwife would routinely use to try to correct the position of the baby, exclusive of the rebozo technique. This can include:
• periodically changing the woman from one side to the other;
• placing a pillow between the woman’s knees;
• placing a peanut ball between the woman’s knees;
• synthetic oxytocin augmentation;
• manual/digital rotation after full dilation;
• Expectant management.
Control group
Active

Outcomes
Primary outcome [1] 332286 0
Proportion of women who meet inclusion criteria and give consent to participate. This information will be collected at the bedside via the Case Report Form.
Timepoint [1] 332286 0
At conclusion of study.
Primary outcome [2] 332287 0
Proportion of women who give consent and are randomised. This information will be collected at the bedside via the Case Report Form.
Timepoint [2] 332287 0
At conclusion of study.
Primary outcome [3] 332288 0
Proportion of women who receive allocated intervention. This information will be collected at the bedside via the Case Report Form.
Timepoint [3] 332288 0
At conclusion of study.
Secondary outcome [1] 412801 0
Proportion of women who have an unassisted vaginal birth. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [1] 412801 0
At conclusion of study.
Secondary outcome [2] 412802 0
Proportion of women who have an assisted vaginal birth, ie. vacuum/forceps. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [2] 412802 0
At conclusion of study.
Secondary outcome [3] 412803 0
Proportion of women who have an emergency caesarean. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [3] 412803 0
At conclusion of study..
Secondary outcome [4] 412804 0
Maternal outcome (post party haemorrhage; perineal injury; pyrexia). Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [4] 412804 0
At conclusion of study.
Secondary outcome [5] 412805 0
Proportion of shoulder dystocia. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [5] 412805 0
At conclusion of study.
Secondary outcome [6] 412807 0
Fetal position at birth. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [6] 412807 0
At birth..
Secondary outcome [7] 412808 0
Maternal satisfaction via survey 1-2 weeks post birth. This is a study specific questionnaire and will be collected with the use of Qualtrics software.
Timepoint [7] 412808 0
14 days post intervention/birth.
Secondary outcome [8] 412810 0
Fetal wellbeing (APGAR) scores. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [8] 412810 0
One, five and ten minutes after birth.
Secondary outcome [9] 412811 0
Requirement and nature of fetal resuscitation. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [9] 412811 0
In the first 48 hours after birth. Collected via Queensland Health's integrated electronic medical record (ieMR).
Secondary outcome [10] 412812 0
Fetal admission with >24-48hrs to intensive care (NICU). Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [10] 412812 0
In the first 24 to 48 hours after birth.
Secondary outcome [11] 412813 0
Time of breastfeeding initiation. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [11] 412813 0
After birth until discharge from the hospital.
Secondary outcome [12] 412814 0
Fetal antibiotics required. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [12] 412814 0
After birth until discharge from the hospital.
Secondary outcome [13] 412815 0
Fetal weight in grams. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [13] 412815 0
At birth.
Secondary outcome [14] 412816 0
Fetal head circumference in cm. Collected via Queensland Health's integrated electronic medical record (ieMR) and Mater Mothers' Hospital electronic medical system, Matrix.
Timepoint [14] 412816 0
At birth.
Secondary outcome [15] 412828 0
Dislodgement of epidural catheter or cannula during the rebozo rocking process. This information will be collected at the bedside via the Case Report Form.
Timepoint [15] 412828 0
During rebozo rocking process.
Secondary outcome [16] 413296 0
Proportion of participants who withdraw from the study. This is a primary outcome which will be collected at the bedside via the Case Report Form.
Timepoint [16] 413296 0
On completion of study.
Secondary outcome [17] 413297 0
Proposition of participant data collection sheets completed. This is a primary outcome which will be collected at the bedside via the Case Report Form.
Timepoint [17] 413297 0
On completion of study.
Secondary outcome [18] 413298 0
Number and nature of adverse events. This is a primary outcome which will be collected at the bedside via the Case Report Form.
Timepoint [18] 413298 0
On completion of study.

Eligibility
Key inclusion criteria
• Term.
• Cephalic.
• Singleton.
• Epidural/combined spinal epidural.
• Nulliparous.
• >18 years.
• Spontaneous or induced labour.
• Requesting epidural analgesia in first stage labour.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for consent:
• Unable to provide informed consent.
• Serious medical complication(s) of pregnancy and/or chronic medical condition(s) eg.
pre-eclampsia, insulin controlled gestational diabetes, heart disease.
• Induction for pelvic instability/pubic symphysis separation.
• Small for gestational age, Intrauterine growth restriction.
• Maternal or fetal contraindications to vaginal birth.
• BMI >35.
• Culturally and linguistically diverse women without access to an interpreter.
Additional exclusion criteria at randomisation:
• Station equal to or higher than -3 at full dilation
• equal to or lower than +2 at full dilation
• Continued and prolonged patterns of variables/complicated variables/late
decelerations at full dilation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Variable block randomisation.
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
50 participants (25 per arm) will be sufficient to assess feasibility. As there are now two research sites, Logan Hospital and Mater Mothers' Hospital, the aim will be to have 25 recruited from Logan Hospital and 25 recruited from Mater Mothers' Hospital. Demographic and other baseline characteristics will be analysed for comparability between groups to assess the adequacy of randomisation. Descriptive statistical analysis will be used to assess the primary feasibility outcomes. Distribution will be assessed for normality with parametric or non-parametric tests applied accordingly. Differences in categorical variables will be explored using relative risk and T tests for continuous variables. The level of statistical significance will be set at <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2023
Actual
8/03/2023
Date of last participant enrolment
Anticipated
18/12/2023
Actual
28/03/2024
Date of last data collection
Anticipated
9/01/2024
Actual
19/04/2024
Sample size
Target
50
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22968 0
Logan Hospital - Meadowbrook
Recruitment hospital [2] 26674 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 38273 0
4131 - Meadowbrook
Recruitment postcode(s) [2] 42714 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 311810 0
University
Name [1] 311810 0
The University of Queensland
Country [1] 311810 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Nursing, Midwifery and Social Work
Level 3 Chamberlain Building
The University of Queensland,
St Lucia, Queensland, 4067
Country
Australia
Secondary sponsor category [1] 313285 0
None
Name [1] 313285 0
Address [1] 313285 0
Country [1] 313285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311255 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 311255 0
Ethics committee country [1] 311255 0
Australia
Date submitted for ethics approval [1] 311255 0
15/08/2022
Approval date [1] 311255 0
24/11/2022
Ethics approval number [1] 311255 0
88039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120474 0
Mrs Kathy Ball
Address 120474 0
The University of Queensland
School of Nursing, Midwifery and Social Work
Level 3 Chamberlain Building
St Lucia, Qld, 4067
Country 120474 0
Australia
Phone 120474 0
+61 437004331
Fax 120474 0
Email 120474 0
kathy.ball@uqconnect.edu.au
Contact person for public queries
Name 120475 0
Kathy Ball
Address 120475 0
The University of Queensland
School of Nursing, Midwifery and Social Work
Level 3 Chamberlain Building
St Lucia, Qld, 4067
Country 120475 0
Australia
Phone 120475 0
+61 437004331
Fax 120475 0
Email 120475 0
kathy.ball@uqconnect.edu.au
Contact person for scientific queries
Name 120476 0
Kathy Ball
Address 120476 0
The University of Queensland
School of Nursing, Midwifery and Social Work
Level 3 Chamberlain Building
St Lucia, Qld, 4067
Country 120476 0
Australia
Phone 120476 0
+61 437004331
Fax 120476 0
Email 120476 0
kathy.ball@uqconnect.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will be a pilot study for PhD studies, assessing the processes to determine whether a full RCT is appropriate.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16906Study protocol    384354-(Uploaded-06-07-2023-20-56-38)-Study-related document.docx
16908Informed consent form    384354-(Uploaded-06-07-2023-21-15-40)-Study-related document.docx
16980Informed consent form    384354-(Uploaded-21-08-2022-10-07-20)-Study-related document.docx



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.