ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post natal recovery

Pelvic Floor dysfunction

Urinary incontinence

Pelvic Organ Prolapse

Faecal Incontinence

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Renal and Urogenital

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]

Early Detection / Screening

Comparator / control treatment

Not applicable - observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Participants will complete questionnaire at initial midwifery appointment (10-16/40 gestation)

Primary outcome [2]

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]

Participants will complete questionnaire at initial midwifery appointment (10-16/40 gestation)

Secondary outcome [1]

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]

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

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

Calvary Public Hospital ACT - Bruce

Recruitment postcode(s) [1]

2617 - Bruce

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Canberra Health Services Grant

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

North Canberra Hospital

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Canberra

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee

Ethics committee address [1]

https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2024

Approval date [1]

18/03/2024

Ethics approval number [1]

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

Ms Taylor Wallace

Address

5 Mary Potter Circuit Bruce, ACT. North Canberra Hospital 2617

Country

Australia

Phone

+61 02 6201 6190

Fax

taylor.wallace@act.gov.au

Contact person for public queries

Name

Taylor Wallace

Address

5 Mary Potter Circuit Bruce, ACT. North Canberra Hospital 2617

Country

Australia

Phone

+61 02 6201 6190

Fax

taylor.wallace@act.gov.au

Contact person for scientific queries

Name

Taylor Wallace

Address

5 Mary Potter Circuit Bruce, ACT. North Canberra Hospital 2617

Country

Australia

Phone

+61 02 6201 6190

Fax

taylor.wallace@act.gov.au

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 (Taylor.wallace@act.gov.au, 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.

Trial Review

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Documents added manually

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