Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000561583
Ethics application status
Approved
Date submitted
5/04/2024
Date registered
3/05/2024
Date last updated
2/09/2024
Date data sharing statement initially provided
3/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can we identify women at risk of pelvic floor trauma during birth?
Scientific title
Can we identify women at risk of pelvic floor trauma during birth?
Secondary ID [1] 311816 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post natal recovery 333340 0
Pelvic Floor dysfunction 333341 0
Urinary incontinence 333342 0
Pelvic Organ Prolapse 333343 0
Faecal Incontinence 333344 0
Condition category
Condition code
Reproductive Health and Childbirth 330025 330025 0 0
Other reproductive health and childbirth disorders
Renal and Urogenital 330234 330234 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project aims to identify women who are at risk of pelvic floor (PF) trauma/dysfunction, so we can review and implement strategies to prevent this trauma and decrease the overall burden this has on the gynaecology waitlist for women who have urinary incontinence (UI)/faecal incontinence (FI)/pelvic organ prolapse (POP)/pain/pelvic floor dysfunction. Specifically identifying if their birth results in a prolonged second stage of labour, instrumental birth or severe perineal tear.
A screening questionnaire has been developed that pregnant women will be asked to fill out online. 300 patients followed through for birth outcomes 2024/2025. Participants will complete questionnaire at initial midwifery appointment (10-16/40 gestation) and will be tracked for birth outcomes. Time to complete the questionnaire is ~10 mins. Nil further information will be required by patients prior to birth and patients will not be followed post natal, only tracked for their birth outcomes to determine if questionnaire can be validated. If women have concerns about their upcoming birth post completing the questionnaire they can contact to be reviewed by a physiotherapist which is current standard care.
Intervention code [1] 328266 0
Early Detection / Screening
Comparator / control treatment
Not applicable - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337788 0
This project aims to identify women who are at risk of pelvic floor trauma/dysfunction during labour. Including prolonged second stage of labour
Timepoint [1] 337788 0
Participants will complete questionnaire at initial midwifery appointment (10-16/40 gestation)
Primary outcome [2] 337985 0
This project aims to identify women who are at risk of pelvic floor trauma/dysfunction during labour. Including instrumental birth (outcome is primary)
Timepoint [2] 337985 0
Participants will complete questionnaire at initial midwifery appointment (10-16/40 gestation)
Secondary outcome [1] 433992 0
This project aims to identify women who are at risk of pelvic floor trauma/dysfunction during labour. Including severe perineal tears (outcome is primary)
Timepoint [1] 433992 0
Participants will complete questionnaire at initial midwifery appointment (10-16/40 gestation)

Eligibility
Key inclusion criteria
Inclusion criteria: birthing at North Canberra Hospital
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: nil. NESB women will be provided in their language to enable capturing all women.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Women will be tracked for birth outcomes and compare against identified factors from questionnaire. It is normal practice at North Canberra Hospital for women who experience a prolonged second stage or instrumental birth are reviewed at 6 weeks post natal. The data collected from the questionnaire will be analysed once they have given birth.
The sample size is 300 women aiming for ~100 identifications and birth outcomes. Analysis will be completed by Taylor Wallace and Dr Irmina Nahon.
Generalised linear model analysis will be used to analyse all of the variables and their interactions to develop a model predicting if identified factors predict birth events. Specifically linear model analysis will show if an association between factors and birth events exists.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/05/2024
Actual
3/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 27061 0
Calvary Public Hospital ACT - Bruce
Recruitment postcode(s) [1] 43128 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 316152 0
Hospital
Name [1] 316152 0
Canberra Health Services Grant
Country [1] 316152 0
Australia
Primary sponsor type
Hospital
Name
North Canberra Hospital
Address
Country
Australia
Secondary sponsor category [1] 318331 0
University
Name [1] 318331 0
University of Canberra
Address [1] 318331 0
Country [1] 318331 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314981 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 314981 0
https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
Ethics committee country [1] 314981 0
Australia
Date submitted for ethics approval [1] 314981 0
12/02/2024
Approval date [1] 314981 0
18/03/2024
Ethics approval number [1] 314981 0
2024.LRE.00048

Summary
Brief summary
We are yet to fully understand which women are more likely to suffer pelvic floor (PF) trauma and dysfunction. The aim of this study will be to determine if there are pre-existing conditions that predispose women to prolonged second stage or instrumental births which ultimately leads to PF trauma and dysfunction. We would like to create an evidence-based screening questionnaire to identify women and track their birth outcomes. The screening questionnaire would be completed at their initial midwifery appointment. North Canberra Hospital are collaborating with experienced academic staff at the University of Canberra in the design of these projects to ensure high-quality
research can be achieved and published in reputable journals to influence international practice. This information will be relevant to women’s health services around the world.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133310 0
Ms Taylor Wallace
Address 133310 0
5 Mary Potter Circuit Bruce, ACT. North Canberra Hospital 2617
Country 133310 0
Australia
Phone 133310 0
+61 02 6201 6190
Fax 133310 0
Email 133310 0
[email protected]
Contact person for public queries
Name 133311 0
Taylor Wallace
Address 133311 0
5 Mary Potter Circuit Bruce, ACT. North Canberra Hospital 2617
Country 133311 0
Australia
Phone 133311 0
+61 02 6201 6190
Fax 133311 0
Email 133311 0
[email protected]
Contact person for scientific queries
Name 133312 0
Taylor Wallace
Address 133312 0
5 Mary Potter Circuit Bruce, ACT. North Canberra Hospital 2617
Country 133312 0
Australia
Phone 133312 0
+61 02 6201 6190
Fax 133312 0
Email 133312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
To the public through publications
Patients can request for data to be spent to them at the end of the project
Available for what types of analyses?
Achieve the aims in the approved proposal
Generalised linear model analysis will be used to analyse all of the variables and their interactions to develop a model predicting if identified factors predict birth events. Specifically linear model analysis will show if an association between factors and birth events exists.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected], 6201 6190)


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.