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Assessment of pelvic floor injury following childbirth in women with genital tract fistula and prolapse

Assessment of pelvic floor injury following childbirth in women with genital tract fistula and prolapse

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000587202
Enrollment
82
Registered
2018-04-17
Start date
2011-04-10
Completion date
2012-07-15
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pelvic floor injury following childbirth is common. In recent years, 4D ultrasound scanning of the pelvic floor has identified injuries within the pelvis not visible on clinical examination. Trauma of the pelvic floor muscles (levator muscles), where these muscles are torn (avulsed) from their insertions to the pelvic bone, can be identified with pelvic floor ultrasound scanning. Levator muscle avulsion may be responsible for the development of pelvic organ prolapse in women. Prolonged neglected obstructed labour (childbirth) is the most common cause of obstetric fistula worldwide. Obstetric fistula refers to a hole between the urinary tract and the vagina, or the bowel and the vagina. This results in the constant leakage of urine or faeces into the vagina. Obstetric fistula and pelvic organ prolapse are common pelvic organ injuries in women following childbirth in Uganda. Pelvic floor ultrasound assessment of these women to assess for levator muscle avulsion and other anatomical features including levator hiatal areas, will identify any correlation between these injuries and whether the patient suffered an obstructed labour with development of fistula. The women with obstetric fistula and pelvic organ prolapse will be assessed and offered surgery as required. The assessment includes: 1. Assessment of pelvic organ prolapse patients undergoing surgery – routine clinical examination, routine history including standardised questionnaire, 4D ultrasound scan examination. 2. Assessment of obstetric fistula patients undergoing surgery – routine clinical examination, routine history including standardised questionnaire, 4D ultrasound scan examination. Pelvic floor muscle avulsion (levator avulsion) has been identified in developed countries with 4D ultrasound scanning in 20% of women following their first delivery. There is no data available regarding these injuries from deliveries in developing countries. There is minimal data available on the incidence of prolapse in developing countries. The study will take place at Kagando hospital, Uganda, where the investigators have been invited as experts to perform surgery on patients with obstetric fistula and pelvic organ prolapse.

Interventions

Women presenting to Kagando hospital, Uganda with obstetric fistula and pelvic organ prolapse - routine history and clinical examination of presenting complaint, routine assessment of women with trans-perineal 4D pelvic floor ultrasound scan. Each patients undergoes a single episode of assessment which includes history taking and ultrasound assessment - duration approximately 1 hour total for each patient. The total clinical study period extends from 10/4/2011 - 15/7/2012.

Sponsors

Dr Hannah Krause
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All women attending surgical camps at Kagando hospital in 2011 and 2012 were invited to participate - the women presenting were diagnosed with obstetric fistula and pelvic organ prolapse. All women had previously had a pregnancy resulting in obstetric fistula (with the youngest participant aged 15) or had subsequently developed pelvic organ prolapse.

Exclusion criteria

Women who did not consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026