RecruitingACTRN12624000561583

Can we identify women at risk of pelvic floor trauma during birth?

Sponsor

North Canberra Hospital

Enrollment

300 participants

Start Date

May 3, 2024

Study Type

Observational

Conditions

Post natal recovery Faecal Incontinence

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.

Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Childbirth is one of the most physically demanding experiences a woman's body goes through, and for some women it leads to lasting damage to the pelvic floor — the muscles, ligaments, and tissues that support the bladder, bowel, and uterus. Prolonged labour or an instrumental birth (using forceps or a vacuum) are particularly associated with pelvic floor trauma and long-term problems like incontinence or prolapse. This research aims to identify which women are more likely to experience pelvic floor trauma before birth occurs, by looking for early signs during their initial midwifery appointment. Researchers at North Canberra Hospital and the University of Canberra are developing a screening questionnaire that could be completed early in pregnancy to flag women who might benefit from extra monitoring or preparation. You may be eligible if you are planning to give birth at North Canberra Hospital and are aged 16 to 45. There are no exclusion criteria — all women planning to give birth at North Canberra Hospital are invited, and the questionnaire will be available in multiple languages for women who do not speak English as their first language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

Locations(1)

Calvary Public Hospital ACT - Bruce

ACT, Australia

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