Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001209381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/08/2026
Date registered
Help: Date registered
30/09/2026
Date last updated
Help: Date last updated
30/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding women's experiences and preferences regarding epidural pain relief during labour: a survey of women who gave birth at University Hospital Geelong
Scientific title
Understanding Women’s Preferences and Trade-Offs in Labour Epidural Analgesia: A Postnatal Telephone Survey of women who gave birth at a regional referral centre
Additional trial identifiers [1] 318130 0
Nil
Universal Trial Number (UTN)
U1111-1344-1436
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Labour pain 343175 0
Labour epidural analgesia (epidural pain relief during childbirth) 343176 0
Condition category
Condition code
Anaesthesiology 339255 339255 0 0
Pain management
Anaesthesiology 339256 339256 0 0
Anaesthetics
Reproductive Health and Childbirth 339257 339257 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This is an observational study; no intervention is delivered and clinical care is not altered. The exposure observed is receipt of labour epidural analgesia at University Hospital Geelong, where standard practice is patient-controlled epidural analgesia using a comparatively higher-concentration local anaesthetic. Observation consists of a single 22-item survey completed once, 6 weeks to 6 months after birth, by telephone using a standardised script administered by trained researchers, or self-completed online via REDCap or on paper. The survey will take approximately 10-15 minutes to complete. The survey covers women's experiences of labour epidural analgesia (information provision, pain relief, side effects, functional outcomes, satisfaction) and their preferences in a structured trade-off scenario between a dense analgesic and a mobility-preserving epidural profile.
Intervention code [1] 335016 0
Not applicable
Description of the comparator or control
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346493 0
Preference for epidural profile when presented with a structured trade-off scenario: proportion of participants preferring a mobility-preserving epidural profile, a dense analgesic epidural profile, or neither/unsure. This is a single outcome measured by one survey item with three mutually exclusive response options, and is not a composite outcome. The proportion selecting each option will be reported with 95% confidence intervals.
Timepoint [1] 346493 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [1] 466065 0
Adequacy of information about epidural analgesia received before labour, including understanding of benefits and risks
Timepoint [1] 466065 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [2] 466066 0
Shared decision-making regarding epidural analgesia
Timepoint [2] 466066 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [3] 468458 0
Acceptability of waiting time for epidural insertion
Timepoint [3] 468458 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [4] 468459 0
Analgesic efficacy
Timepoint [4] 468459 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [5] 468460 0
Lower limb movement after epidural insertion
Timepoint [5] 468460 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [6] 468461 0
Urinary catheterisation during labour
Timepoint [6] 468461 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [7] 468462 0
Sense of control during labour
Timepoint [7] 468462 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [8] 468463 0
Side effects of epidural analgesia and their bothersomeness
Timepoint [8] 468463 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [9] 468464 0
Satisfaction with epidural analgesia
Timepoint [9] 468464 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [10] 468465 0
Feedback on epidural experience and suggested improvements
Timepoint [10] 468465 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [11] 468466 0
Likelihood of choosing an epidural in a future labour
Timepoint [11] 468466 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [12] 468467 0
Relative importance of epidural-related outcomes
Timepoint [12] 468467 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [13] 468468 0
Interest in a mobility-preserving epidural option had one been available for the recent labour
Timepoint [13] 468468 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth
Secondary outcome [14] 468469 0
Reasons for stated trade-off preference
Timepoint [14] 468469 0
Assessed once, at a single timepoint between 6 weeks and 6 months after birth

Eligibility
Key inclusion criteria
Women aged 18 years or over who received epidural analgesia during labour at University Hospital Geelong between 6 weeks and 6 months prior to recruitment, and who have contact details recorded in hospital systems.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Delivery via caesarean birth; recent pregnancy loss, including termination of pregnancy for foetal abnormality or foetal death in utero, inability to complete the survey in English, unable to be contacted after three recruitment attempts.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
The study is descriptive, with a target of 120 to 150 completed surveys determined on precision grounds in consultation with the Barwon Health Biostatistics Service. Under the most conservative assumption that 50% of participants prefer one epidural profile, 120 completed surveys estimate this proportion with a 95% confidence interval of approximately plus or minus 9 percentage points, improving to approximately plus or minus 8 percentage points at 150. Assuming an approximately 50% response rate, approximately 300 eligible women will be invited. The primary outcome will be reported as proportions with 95% confidence intervals. Other responses will be summarised descriptively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2026
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
120
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29964 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 46333 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 322678 0
Hospital
Name [1] 322678 0
Barwon Health
Country [1] 322678 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Country
Australia
Secondary sponsor category [1] 325612 0
None
Name [1] 325612 0
Address [1] 325612 0
Country [1] 325612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321135 0
Barwon Health HREC
Ethics committee address [1] 321135 0
Ethics committee country [1] 321135 0
Australia
Date submitted for ethics approval [1] 321135 0
20/05/2026
Approval date [1] 321135 0
07/08/2026
Ethics approval number [1] 321135 0
26/78

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

Contacts
Principal investigator
Name 152782 0
Dr Nathan Fifer
Address 152782 0
Barwon Health, 272-322 Ryrie Street GEELONG VIC 3220
Country 152782 0
Australia
Phone 152782 0
+61 423382813
Fax 152782 0
Email 152782 0
[email protected]
Contact person for public queries
Name 152783 0
Kelly Chapman
Address 152783 0
Barwon Health, 272-322 Ryrie Street GEELONG VIC 3220
Country 152783 0
Australia
Phone 152783 0
+61 3 4215 1901
Fax 152783 0
Email 152783 0
[email protected]
Contact person for scientific queries
Name 152784 0
Nathan Fifer
Address 152784 0
Barwon Health, 272-322 Ryrie Street GEELONG VIC 3220
Country 152784 0
Australia
Phone 152784 0
+61 423382813
Fax 152784 0
Email 152784 0
[email protected]

Data sharing statement
Will the study consider sharing 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.