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Trial registered on ANZCTR


Registration number
ACTRN12618000587202
Ethics application status
Approved
Date submitted
5/04/2018
Date registered
17/04/2018
Date last updated
17/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of pelvic floor injury following childbirth in women with genital tract fistula and prolapse
Scientific title
Assessment of pelvic floor injury following childbirth in women with genital tract fistula and prolapse
Secondary ID [1] 294510 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstetric fistula 307283 0
pelvic organ prolapse 307284 0
Condition category
Condition code
Reproductive Health and Childbirth 306400 306400 0 0
Other reproductive health and childbirth disorders
Renal and Urogenital 306451 306451 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
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.
Intervention code [1] 300811 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305414 0
The number of patients with levator muscle defects in each patient group (obstetric fistula, pelvic organ prolapse) will be assessed.
Timepoint [1] 305414 0
The ultrasound is performed immediately following initial assessment with history and clinical examination
Primary outcome [2] 305516 0
The number of patients with enlarged levator hiatal areas in each patient group (obstetric fistula, pelvic organ prolapse) will be assessed.
Timepoint [2] 305516 0
The ultrasound is performed immediately following initial assessment with history and clinical examination.
Secondary outcome [1] 345113 0
The mode of delivery for each participant will be determined by history taking.
This will subsequently be compared to ultrasound outcome measures which will include levator muscle defects and levator hiatal areas..
Timepoint [1] 345113 0
The history is obtained as soon as the woman arrives at the hospital, and the ultrasound scan soon after.

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who did not consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
No sample size calculations were undertaken.
Ultrasound scan features including presence of levator muscle defects and elevator hiatal area was measured and statically compared to check for any differences between the obstetric fistula group (bladder of bowel) and pelvic organ prolapse.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10257 0
Uganda
State/province [1] 10257 0

Funding & Sponsors
Funding source category [1] 299136 0
Self funded/Unfunded
Name [1] 299136 0
Dr Hannah Krause. No funding obtained.
Address [1] 299136 0
Suite 209
Ramsay Specialist Centre, Greenslopes Private hospital,
Newdegate Street, Greenslopes, 4120
Queensland, Australia
Country [1] 299136 0
Australia
Primary sponsor type
Individual
Name
Dr Hannah Krause
Address
Suite 209
Ramsay Specialist Centre, Greenslopes Private hospital
Newdegate Street, Greenslopes 4120
Queensland, Australia
Country
Australia
Secondary sponsor category [1] 298395 0
None
Name [1] 298395 0
nil
Address [1] 298395 0
nil
Country [1] 298395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300067 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 300067 0
Greenslopes Private hospital
Newdegate Street, Greenslopes, 4120
Queensland, Australia
Ethics committee country [1] 300067 0
Australia
Date submitted for ethics approval [1] 300067 0
25/02/2011
Approval date [1] 300067 0
07/04/2011
Ethics approval number [1] 300067 0
Protocol 11/09

Summary
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.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 82454 0
Dr Hannah Krause
Address 82454 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private hospital, Newdegate Street,
Greenslopes, Queensland
Country 82454 0
Australia
Phone 82454 0
+61 7 38478998
Fax 82454 0
+61 7 38476433
Email 82454 0
hannahkrause@hotmail.com
Contact person for public queries
Name 82455 0
Dr Hannah Krause
Address 82455 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private hospital, Newdegate Street,
Greenslopes, Queensland
Country 82455 0
Australia
Phone 82455 0
+61 7 38478998
Fax 82455 0
+61 7 38476433
Email 82455 0
hannahkrause@hotmail.com
Contact person for scientific queries
Name 82456 0
Dr Hannah Krause
Address 82456 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private hospital, Newdegate Street,
Greenslopes, Queensland
Country 82456 0
Australia
Phone 82456 0
+61 7 38478998
Fax 82456 0
+61 7 38476433
Email 82456 0
hannahkrause@hotmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary