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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001168347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
20/08/2026
Date registered
Help: Date registered
18/09/2026
Date last updated
Help: Date last updated
18/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of positioning optimisation compared with usual care on spontaneous birth in women in labour with an epidural regardless of labour onset.
Scientific title
The effect of positioning optimisation compared with usual care on spontaneous birth in women in labour with an epidural regardless of labour onset.
Additional trial identifiers [1] 318240 0
Nil
Universal Trial Number (UTN)
Trial acronym
POSE (Positioning optimisation for spontaneous birth with epidural)
Related trial records

Health condition
Health condition(s) studied:
spontaneous vaginal birth 343293 0
Condition category
Condition code
Reproductive Health and Childbirth 339406 339406 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Position change initiated by the midwife providing labour care
Every hour (or earlier if clinically indicated) women will be moved into one of the following positions by their midwife with support whilst remaining on a bed throughout. Positions will be held for the entire hour unless the woman requests a change or a change is clinically indicated.
- Right lateral (more than 45 degrees rotated towards the right side)
- Left lateral (more than 45 degrees rotated towards the left side)
- Supported hands and knees position with the bed angle at around 45 degrees (if leg movement allows)
The midwife will record the position at each check of observations throughout the labour care and record any interval position changes as routine in the labour and birth flowsheet.
Intervention code [1] 335128 0
Behaviour
Intervention code [2] 335364 0
Treatment: Other
Description of the comparator or control
Standard care with maternal position changes according to the preference of the woman or other clinical indication (fetal distress, uneven epidural block). Commonly this would include positioning supine with a slight (<20 degree) lateral tilt on the bed using a wedge under the participant's hip. Participants may choose any position that is comfortable to them. There is no minimum or maximum duration for a position, this is determined according to the participant preference or clinical need. The midwife will record the position routinely throughout labour with the routine checks of observations and will record any position changes as they occur.
Control group
Active

Outcomes
Primary outcome [1] 346615 0
Spontaneous vaginal birth
Timepoint [1] 346615 0
Records will be reviewed following birth, and this will be measured and recorded at the birth of the infant.
Secondary outcome [1] 466743 0
Duration of first stage of labour (hours, minutes)
Timepoint [1] 466743 0
Recorded in hours and minutes from the beginning of active labour until the diagnosis of full dilation or until birth occurs by caesarean section.
Secondary outcome [2] 466744 0
Fetal position - occipito-anterior
Timepoint [2] 466744 0
At the start of the second stage of labour
Secondary outcome [3] 466745 0
Duration of second stage of labour (hours, minutes)
Timepoint [3] 466745 0
Recorded in hours and minutes from the diagnosis of full dilation or until birth
Secondary outcome [4] 466746 0
Blood loss (mL)
Timepoint [4] 466746 0
Recorded continuously in mL from birth to 24 hours post birth.
Secondary outcome [5] 466747 0
Postpartum haemorrhage
Timepoint [5] 466747 0
Recorded as more than 1000mL blood loss from birth to 24 hours post birth.
Secondary outcome [6] 466748 0
Perineal trauma
Timepoint [6] 466748 0
Recorded following birth
Secondary outcome [7] 466749 0
Instrumental birth for lack of progress in second stage
Timepoint [7] 466749 0
Recorded according to clinical record as defined by the clinician at the time of birth.
Secondary outcome [8] 466750 0
Caesarean section for lack of progress
Timepoint [8] 466750 0
Recorded according to clinical record as defined by the clinician at the time of birth.
Secondary outcome [9] 466752 0
Infant birth weight (grams)
Timepoint [9] 466752 0
As recorded at birth.
Secondary outcome [10] 466753 0
Neonate Apgar score
Timepoint [10] 466753 0
As recorded at 1 and 5 minutes after birth
Secondary outcome [11] 466754 0
Neonatal cord pH less than or equal to 7.10
Timepoint [11] 466754 0
Taken from the umbilical cord at the time of birth.
Secondary outcome [12] 466755 0
Need for additional resuscitation at birth
Timepoint [12] 466755 0
This will be defined as the use of intermittent positive pressure ventilation (IPPV) or intubation recorded at birth or within 1 hour of birth.
Secondary outcome [13] 466756 0
Admission to neonatal unit
Timepoint [13] 466756 0
At the time of birth.
Secondary outcome [14] 466757 0
Women's experience of care
Timepoint [14] 466757 0
Women will be sent a link for the survey within 2 weeks of birth.
Secondary outcome [15] 467663 0
Instrumental birth for fetal distress
Timepoint [15] 467663 0
Assessed by the treating clinician at the time of birth
Secondary outcome [16] 467664 0
Caesarean section for fetal distress
Timepoint [16] 467664 0
Recorded at the time of birth by the treating clinician.
Secondary outcome [17] 468114 0
Fetal position - occipito-posterior
Timepoint [17] 468114 0
At the start of the second stage of labour
Secondary outcome [18] 468115 0
Fetal position - occipito-transverse
Timepoint [18] 468115 0
At the start of the second stage of labour
Secondary outcome [19] 468116 0
Caesarean section for fetal malposition
Timepoint [19] 468116 0
Recorded at the time of birth by the treating clinician.

Eligibility
Key inclusion criteria
All women with a singleton, cephalic, term (=/> 37 weeks) pregnancy using epidural analgesia in the first stage of labour (regardless of labour onset – spontaneous or induced).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Women where the epidural block was inserted in second stage of labour
Intrauterine fetal demise.
Age <18 years
Inability to provide informed consent
Multiple pregnancy
Preterm gestation at labour. <37 completed weeks of gestation

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)
Allocation concealment will be maintained by performing randomisation at the time of epidural insertion, through an established REDCap server after confirmation of eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomised, with group assignment in a 1:1 ratio, using an on-line randomisation service based with balanced blocks of 8, and generated by a researcher not involved in recruitment of participants.
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
The primary outcome is Spontaneous Vaginal Birth (SVB), defined as non-instrumental vaginal delivery. The SVB rate in the standard care group is approximately 61%, based on a population comprising 40% primiparous and 60% multiparous women, and a SVB rate in primiparous women of approximately 33% and in multiparous women of approximately 80%. This approximates the outcomes for birth from our centre in 2025.
The primary outcome will be analysed using a logistic regression model, adjusted for the stratification variable (parity) and other prespecified prognostic variables as stated in the analysis plan. The estimate of the intervention effect will be presented as a marginal risk difference, with 95% confidence intervals.

Secondary outcomes will be analysed using linear models (for continuous outcomes) or generalised linear models (for count, binary or categorical outcomes), adjusted for parity and other prespecified prognostic variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2026
Actual
Date of last participant enrolment
Anticipated
31/10/2028
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 46449 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 322794 0
Hospital
Name [1] 322794 0
Women's and Children's Hospital
Country [1] 322794 0
Australia
Primary sponsor type
Individual
Name
Laura Slade - Women's and Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 325720 0
None
Name [1] 325720 0
Address [1] 325720 0
Country [1] 325720 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321233 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 321233 0
Ethics committee country [1] 321233 0
Australia
Date submitted for ethics approval [1] 321233 0
31/07/2026
Approval date [1] 321233 0
18/08/2026
Ethics approval number [1] 321233 0

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

Contacts
Principal investigator
Name 153094 0
Dr Laura Slade
Address 153094 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, Adelaide, Australia
Country 153094 0
Australia
Phone 153094 0
+61 8 81618427
Fax 153094 0
Email 153094 0
[email protected]
Contact person for public queries
Name 153095 0
Laura Slade
Address 153095 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, Adelaide, Australia
Country 153095 0
Australia
Phone 153095 0
+61 8 81618427
Fax 153095 0
Email 153095 0
[email protected]
Contact person for scientific queries
Name 153096 0
Laura Slade
Address 153096 0
Women's and Children's Hospital, 72 King William Road, North Adelaide, 5006, Adelaide, Australia
Country 153096 0
Australia
Phone 153096 0
+61 8 81618427
Fax 153096 0
Email 153096 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?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• To achieve the aims of methodologically sound proposals as approved by the chief investigator and the trial steering committee.

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?

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.