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Trial registered on ANZCTR


Registration number
ACTRN12621000334808
Ethics application status
Approved
Date submitted
24/01/2021
Date registered
24/03/2021
Date last updated
7/02/2023
Date data sharing statement initially provided
24/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregnant woman's experience of using the Labour Support Chair.
Scientific title
A feasibility randomised controlled trial of pregnant women's experience of an innovative Labour Support Chair.
Secondary ID [1] 297453 0
Nil Known
Universal Trial Number (UTN)

U1111-1229-9942
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The first stage of Labour 311637 0
Childbirth 321196 0
Condition category
Condition code
Reproductive Health and Childbirth 310259 310259 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention;
The Labour Support Chair
Appliance for use in supporting a woman during the first stage of Labour.
Patent No's: USA, US 9,901,504 B2. Europe, EP 3 182 948 B1, Australia No. 2015306079 and patent-pending in New Zealand.
This is a first in human, acceptability, feasibility randomised controlled trial, with 40 participants.
The Labour Support Chair is designed to be straddled or sat on backwards in comparison to a conventional chair. This positioning promotes in the woman a posture that biomechanically benefits the process of her labour.
The seat portion is flat and horizontal, longer and wider than a conventional chair seat, to accommodate the woman's pregnant abdomen. Rising vertically from the seat, between the woman's legs, is a front support panel. This panel has a narrow waist at the base for self-adjustment of the spread of the woman’s knees, then broadens out, to rest her chest against. The top of the front support panel is folded away from the woman, forming a ledge upon which she can rest her arms and head.
Below this ledge, at approx. 15 cm from the ground is a footplate with hinged flaps on which the woman can rest her feet out wide or centrally when wrapping her legs around the narrow waist of the front support panel. The hinged flaps can be folded up, out of the way if not required. The woman’s back is readily accessible for massage and the Labour Support Chair is waterproof so can be used in the shower.
The Labour Support Chair will only be available for use by the women randomised to the intervention arm.
During labour, all participants will be provided with a Pictogram Chart which has 17 line drawings of activities and positions that women use in labour. The participants are asked to tick the positions or activities that they used during their labour. Sitting straddled a chair is not one of the line drawings, as this closely resembles the intervention of the Labour Support Chair. The Pictogram Chart will benchmark the usual labour care for the trial.
Approximately two weeks after giving birth, all participants will be sent a survey named the Labour Agentry Scale (LAS). The LAS is a validated tool that produces a quantitative analysis of the participant woman’s experience of personal power during her labour. The LAS has 10 short statements and the participant will grade her experience from ‘ almost always’ to rarely’ on a 7 point Likert scale. There are also four supplementary questions for the intervention arm and only one for the non-intervention arm to answer.
The Study introduction and training of midwives will occur across all shift times. The actual Labour support Chair will be present for teaching and practice purposes. A CardioTocoGraph (CTG) monitor will be borrowed from the birth unit if available, to demonstrate and practise performing fetal monitoring whist the woman is using the Labour Support Chair. Discussions around how to incorporate required clinical observations and usual midwifery care into the midwives practise, for the woman in the intervention are will be held during training as well.
The midwives caring for the women in labour will complete a Tracking Chart specific for participants in both arms of the trial. The midwife is asked to record three (3) clinical observations common to both arms of the trial. These are the fetal position determined by abdominal palpation on admission to the birth unit, during the active second stage and at birth observed from the restitution of the fetal head. No additional vaginal examination will be requested for the Trial.
The intervention arm’s Tracking Chart will also have a table called the Labour Chair Usage Table. Training will incorporate how to complete this table.
Demonstrations during the training of the midwives will also incorporate, how to verbally instruct the participant to confidently, sit on and alight from the chair. Along with massage techniques the partner can perform on the back of participant, manoeuvring the chair into the shower for the comfort of warm water, the use of inhalational analgesia whilst resting on the Labour Support Chair as well as cleaning and storage.
Registered midwives who care for women in labour at the Trial Site, will be delivering the intervention. These registered midwives will have attended a Study Training Session and signed the Study Training Log. These midwives will also be responsible for ‘posting’ the Tracking Chart and the Pictogram chart through the slot of the locked Study Box, located in the Birth Unit for collection by the research student.
The midwife will bring the Labour Support Chair into the birth room of the participants who are randomised into the intervention arm of the trial. Here the midwife will instruct the participant how to sit on and alight from the Labour Support Chair. The participants in the intervention arm are free to use the Labour Support Chair as much as they choose.
The protocol states that for compliance to the trial, a participant randomised to the intervention arm, is required to sit straddling the Labour Support Chair for a minimum of 20 minutes, whilst she is in the active, first stage of labour. The active, first stage of labour is defined in the protocol as at least three (3) strong contractions in 10 minutes. Therefore the participant would experience at least six (6) strong contractions, whilst she is straddling the chair. The midwife caring for her will guide the participant in this compliance feature and document these observations in 10-minute blocks, on the Labour Chair Usage Table, contained on the Tracking Chart- Intervention Arm. The participant in the intervention arm is free to use the Labour Support Chair as much as she chooses, before and after the compliance point.
The intervention will occur in the room in which the participants will labour and birth. The Labour Support Chair will only be brought into the room of the participants randomised to the intervention arm. When trial participants are admitted to the Birth Unit either, in spontaneous labour or for a scheduled induction of labour, they will know which arm of the trial they belong. As a back-up, a document named ‘Randomisation Outcomes’, will be in the Site Investigators File (SIF) for the midwives to check the randomisation outcomes of participants, while waiting for the participant to arrive.
The midwife will be asked to fill out a Labour Chair Usage Tracking Chart by shading in boxes that represent 10 minutely intervals. It is from this document that trial intervention adherence and fidelity will be assessed. If the participant does not fulfil the 20-minute requirement, she will be placed in the intention to treat group for analysis. No strategies will be employed by the midwives to ensure women stay on the chair for 20 minutes – this is entirely the woman’s choice.
Intervention code [1] 313708 0
Treatment: Devices
Comparator / control treatment
The control group named the Non-intervention Arm will not be able to use the Labour Support Chair during their Labour.
As both arms of the trial will be receiving the usual midwifery care during their labour, which they expected when they booked into the health facility, a benchmark tool was developed. The Pictogram Chart has 17 different line drawings of activities and positions, women use during labour and all participants are asked to tick the positions or activities that they used during their own labour. Sitting straddled a chair is not one of the line drawings, as this closely resembles the intervention of the Labour Support Chair. The Pictogram Chart will be given to all participants on receipt of sign consent, spare charts will be found in the Site Investigators File (SIF).
Control group
Active

Outcomes
Primary outcome [1] 325281 0
To investigate the experience of labour (sense of personal power) of the participants who are randomised to use the Labour Support Chair and of the participants randomised to in the control group.
Timepoint [1] 325281 0
The participants will rate their experience of labour using the Labour Agentry Score (LAS), two weeks after she gives birth.
Secondary outcome [1] 387388 0
To investigate the duration of the first stage of labour in both groups.
Timepoint [1] 387388 0
The data will be sourced from the participant's birth records, soon after birth.
Secondary outcome [2] 387389 0
To investigate the acceptability of the intervention (Labour Support Chair) to participant women.
Timepoint [2] 387389 0
The opportunity for the women participants to comment will be provided with the LAS, two weeks after birth.
Secondary outcome [3] 387390 0
To investigate the acceptability of the intervention (Labour Support Chair) to midwives’ practice.
Timepoint [3] 387390 0
The opportunity for the midwives to make their written comments will be during or straight after the birth.
Secondary outcome [4] 392109 0
To investigate the duration of the second stage of labour in both groups.
Timepoint [4] 392109 0
The data will be sourced from the participant's birth records, soon after birth.
Secondary outcome [5] 392110 0
To investigate the mode of birth in both groups.
Timepoint [5] 392110 0
The data will be sourced from the participant's birth records, soon after birth.
Secondary outcome [6] 392113 0
To investigate the Apgar Scores of the neonate in both groups.
Timepoint [6] 392113 0
The data will be sourced from the participants birth records, soon after birth.

Eligibility
Key inclusion criteria
Are greater than or equal to 37 completed weeks of gestation.
Are at least 18 years old.
Are planning a vaginal delivery.
Are willing to use the Labour Support Chair during their first stage of labour.
Are willing to complete the Pictogram Chart and LAS survey.
Have access to an interpreter during the recruitment
Have literacy in Arabic, English, Chinese or Vietnamese
Have read the Participant Information Sheet and Consent in their preferred language.
Have signed the consent form in their preferred language
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Are less than 37 completed weeks of gestation, i.e 36 weeks and 6 days and less.
Are planning an elective caesarean section
Do not have literacy in Arabic, English, Chinese or Vietnamese.
Have not signed the consent form in their preferred language

NB. Desire to have the option of an epidural block as pain relief is not a criterion for exclusion. This will simply mean that the woman will no longer use the chair during her labour (if she was randomised into the intervention arm).

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)
Central randomisation by phone/fax/computer
Allocation concealment guaranteed as randomisation is performed by REDCap a computer-based randomisation tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation = 1:1.
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
N=40.
As this is a first in human, proof of concept, feasibility trial the low numbers will not achieve statistical significance. The usual number for a Pilot trial being 20 participants. Simple descriptive statistical analysis will be used.
Though the research student wanted to have as many participants as she could reasonably manage. In consultation with her supervisors, the number arrived at was 40 participants,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2021
Actual
17/01/2022
Date of last participant enrolment
Anticipated
16/06/2021
Actual
26/05/2022
Date of last data collection
Anticipated
11/08/2021
Actual
3/08/2022
Sample size
Target
40
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18458 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 32568 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 302025 0
University
Name [1] 302025 0
University of Technology Sydney
Country [1] 302025 0
Australia
Funding source category [2] 307934 0
Hospital
Name [2] 307934 0
Bankstown-Lidcombe Hospital
Country [2] 307934 0
Australia
Funding source category [3] 307935 0
Self funded/Unfunded
Name [3] 307935 0
Marie Colette Lamberton
Country [3] 307935 0
Australia
Primary sponsor type
University
Name
The University of Technology Sydney
Address
PO Box 123
Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 301979 0
None
Name [1] 301979 0
Address [1] 301979 0
Country [1] 301979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302703 0
South West Sydney Local Health District Research Directorate SWSLHD
Ethics committee address [1] 302703 0
Ethics committee country [1] 302703 0
Australia
Date submitted for ethics approval [1] 302703 0
31/07/2020
Approval date [1] 302703 0
18/11/2020
Ethics approval number [1] 302703 0
2020/ETH013313

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

Contacts
Principal investigator
Name 91110 0
Dr Christine Catling
Address 91110 0
UTS Building 10, Jones Street, Broadway, Sydney, 2007, NSW
Country 91110 0
Australia
Phone 91110 0
+61 0295144912
Fax 91110 0
Email 91110 0
[email protected]
Contact person for public queries
Name 91111 0
Marie Colette Lamberton
Address 91111 0
UTS Building 10, Jones Street, Broadway, Sydney, 2007, NSW
Country 91111 0
Australia
Phone 91111 0
+61 455 982 361
Fax 91111 0
Email 91111 0
[email protected]
Contact person for scientific queries
Name 91112 0
Karen Harris
Address 91112 0
Bankstown-Lidcombe Hospital
South Western Sydney Local Health District
South Western Sydney Local Health District Administration Building
Eastern Campus, Liverpool Hospital, Locked Bag 7279
Liverpool BC 1871
Country 91112 0
Australia
Phone 91112 0
+61 02 97228000
Fax 91112 0
+61 02 97228570
Email 91112 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9329Study protocol    Attachment 377013-(Uploaded-24-01-2021-18-41-51)-Study-related document.DOC
9330Ethical approvalAttachment   Attachment 377013-(Uploaded-24-01-2021-18-41-04)-Study-related document.docx
10332Informed consent form    Attachment 377013-(Uploaded-24-01-2021-18-43-25)-Study-related document.DOC



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.