Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001020471p
Ethics application status
Submitted, not yet approved
Date submitted
19/08/2025
Date registered
15/09/2025
Date last updated
15/09/2025
Date data sharing statement initially provided
15/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Straddling for success: a Mixed Methods Feasibility Randomised Controlled Trial of the Labour Support Chair
Scientific title
Straddling for success: a Mixed Methods Feasibility Randomised Controlled Trial of the Labour Support Chair in pregnant women
Secondary ID [1] 315167 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
The study is a follow-up to ACTRN12621000334808 which was a study conducted by the owner of the Chair for a masters research project. The masters project was conducted during COVID-19 and had low participation, so we are conducting a new study at different sites.

Health condition
Health condition(s) or problem(s) studied:
First stage of labour 338602 0
Maternal health 338603 0
Neonatal health 338604 0
Condition category
Condition code
Reproductive Health and Childbirth 334904 334904 0 0
Normal pregnancy
Reproductive Health and Childbirth 334984 334984 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The labouring women will be randomised to either use the Labour Support Chair, or not. The Labour Support Chair is a supportive device intended to be straddled by a woman in the first stage of labour to encourage fetal alignment with the maternal pelvis; it is not intended for use during childbirth. It is a backwards orientated chair, with a narrow waist and a supportive front panel extending to a headrest/arm platform top, designed to help facilitate optimal maternal spine/pelvic angle and positioning before birth.

Participants in the intervention arm will be asked to straddle the chair when in active labour - for a period of time that is comfortable for them. There is no limitation or length of time that we are asking them to sit on the chair for. Midwives will be trained to facilitate the use of the chair, record how long they straddle the chair for, and ensure adherence to the intervention by direct observation.

For the focus groups, we will recruit 6-8 women who have used the chair to participate in a group 4-6 months after the birth. We hope to recruit a maximum of 8 women for three focus groups (8 in each group). Similarly we will recruit the same number of midwives who have facilitated the use of the chair to attend a focus group, and hope to have enough participants for three focus groups. The first 24 participants who agree to participate will be enrolled. The Focus groups will last around 45 minutes for each cohort.

For women - we will discuss their experience of using the chair, whether it met their expectations and whether it was comfortable. We will ascertain their perceived benefits or difficulties using the chair and whether they think it affected their labour in any way.

For midwives - we will ascertain their experience and Implementation of introducing the Labour Support Chair to women during labour, any challenges in incorporating the chair into routine care, and any perceived impact it may have had on the women they cared for. Also - whether there were any issues with the midwifery team regarding its use, whether they felt adequately trained to use the chair, and if they needed any more help/resources to facilitate its use.
Intervention code [1] 331785 0
Treatment: Devices
Comparator / control treatment
The control group are women in labour who do not use the Labour Support Chair.
Control group
Active

Outcomes
Primary outcome [1] 342526 0
Labour/birth outcome: Onset of labour, (spontaneous, or induced)
Timepoint [1] 342526 0
At birth.
Primary outcome [2] 342695 0
Labour/birth outcome: Length of first stage of labour
Timepoint [2] 342695 0
at birth
Primary outcome [3] 342696 0
Labour/birth outcome: Pain relief method, if used
Timepoint [3] 342696 0
at birth
Secondary outcome [1] 451843 0
Labour/birth outcome: Length of second stage of labour
Timepoint [1] 451843 0
at birth
Secondary outcome [2] 451844 0
Labour/birth outcome: Use of Syntocinon, if used after spontaneous onset of labour
Timepoint [2] 451844 0
at birth
Secondary outcome [3] 451845 0
Labour/birth outcome: Mode of birth
Timepoint [3] 451845 0
at birth
Secondary outcome [4] 451846 0
Labour/birth outcome: Reason for mode of birth if not normal (eg fetal distress, obstructed labour etc)
Timepoint [4] 451846 0
at birth
Secondary outcome [5] 451847 0
Labour/birth outcome: Maternal position at birth
Timepoint [5] 451847 0
at birth
Secondary outcome [6] 451848 0
Labour/birth outcome: Shoulder dystocia, if it occurred
Timepoint [6] 451848 0
at birth
Secondary outcome [7] 451849 0
Labour/birth outcome: Apgar scores
Timepoint [7] 451849 0
at birth
Secondary outcome [8] 451850 0
Labour/birth outcome: Birth weight
Timepoint [8] 451850 0
at birth
Secondary outcome [9] 451851 0
Labour/birth outcome: Parity
Timepoint [9] 451851 0
at birth
Secondary outcome [10] 451852 0
Labour/birth outcome: Previous mode of birth (if parous)
Timepoint [10] 451852 0
at birth
Secondary outcome [11] 451853 0
Labour/birth outcome: Maternal age
Timepoint [11] 451853 0
at birth
Secondary outcome [12] 451854 0
Labour/birth outcome: Gestation at birth
Timepoint [12] 451854 0
at birth
Secondary outcome [13] 451855 0
To explore the acceptability of the Labour Support Chair to women
Timepoint [13] 451855 0
6 months postpartum
Secondary outcome [14] 451856 0
to explore the feasibility and acceptability of the Labour Support Chair to midwives
Timepoint [14] 451856 0
six months after the beginning of the intervention period
Secondary outcome [15] 451857 0
How long women straddle the chair for during labour
Timepoint [15] 451857 0
at birth

Eligibility
Key inclusion criteria
Phase 1 (FRCT) - Inclusion criteria consist of pregnant women/people who:
• Are 37 completed weeks gestation
• Are equal to or over 18 years of age
• Anticipate a vaginal birth
• Are willing to use the Labour Support Chair during the active first stage of their labour if randomised to the intervention arm
• Have signed the consent form

Phase 2 (Qualitative)- Inclusion criteria includes:
• Participants who have used the Labour Support Chair within the FRCT and;
• Agree to be contacted for participation in an online Focus Group (by providing their contact details on the consent form)
• Midwives who have facilitated use of the Labour Support Chair and;
• Agree to participate in an online Focus Group.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase 1 (FRCT) - Exclusion criteria consist of women/people who:
• Are < 37 weeks gestation
• Are planning an elective caesarean section
• Do not have adequate English literacy
• Have not signed the consent form

Phase 2 (qualitative) – Exclusion criteria consist of:
• Participants who do not agree to participate in an online Focus Group (who have not put their contact details on the consent form)
• Participants and/or their babies who have had a serious adverse event/negative outcome during labour, birth or in the postnatal period*
• Midwives who do not consent to participate in an online Focus Group
• Midwives who have not facilitated use of the Labour Support Chair to participants

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)
yes, allocation was concealed - though central randomisation by a computer
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28344 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [2] 28345 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment postcode(s) [1] 44562 0
2077 - Hornsby
Recruitment postcode(s) [2] 44563 0
2086 - Frenchs Forest

Funding & Sponsors
Funding source category [1] 319741 0
Government body
Name [1] 319741 0
NSW Ministry of Health Strategy Reserve Funds
Country [1] 319741 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 322246 0
None
Name [1] 322246 0
Address [1] 322246 0
Country [1] 322246 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318292 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 318292 0
Ethics committee country [1] 318292 0
Australia
Date submitted for ethics approval [1] 318292 0
29/08/2025
Approval date [1] 318292 0
Ethics approval number [1] 318292 0

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

Contacts
Principal investigator
Name 143726 0
Prof Christine Catling
Address 143726 0
Level 7, Kolling Building, Royal North Shore Hospital, St Leonards, Sydney, 2065, NSW
Country 143726 0
Australia
Phone 143726 0
+61 0425216890
Fax 143726 0
Email 143726 0
[email protected]
Contact person for public queries
Name 143727 0
Christine Catling
Address 143727 0
Level 7, Kolling Building, Royal North Shore Hospital, St Leonards, Sydney, 2065, NSW
Country 143727 0
Australia
Phone 143727 0
+61 0425216890
Fax 143727 0
Email 143727 0
[email protected]
Contact person for scientific queries
Name 143728 0
Christine Catling
Address 143728 0
Level 7, Kolling Building, Royal North Shore Hospital, St Leonards, Sydney, 2065, NSW
Country 143728 0
Australia
Phone 143728 0
+61 0425216890
Fax 143728 0
Email 143728 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Labour Support Chair NSLHD_Protocol_1st Aug 2025.pdf


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.