Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001072303
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
24/07/2017
Date last updated
9/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are women with fistulas from obstructed labour shorter than those who have had a normal delivery?
Scientific title
Are women with obstetric fistula shorter that those who had a vaginal delivery?
Secondary ID [1] 292252 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaginal fistula 303759 0
vaginal delivery 303760 0
Condition category
Condition code
Renal and Urogenital 303130 303130 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 303150 303150 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Obstetric fistula is due to prolonged obstructed labour causing pressure necrosis in the maternal genital tract and surrounding organs, in particular the lower urinary tract and anorectum. Women with fistulas have an abnormal communication between the vagina and urethra/bladder and/or anorectum. These women leak urine continuously and/or faeces through the vagina.

The height measurement is a once of at time of hospital admission. This is routine done on admission for all patients.
Measurement of height in women on admission to hospital - for women to birth suite who had normal deliveries and women attending the hospital with gynaecological conditions and have had normal deliveries.
Measurement of height in women with obstetric fistulas.
Intervention code [1] 298456 0
Not applicable
Comparator / control treatment
Control group is the women who have had normal vaginal deliveries without obstruction - during data collection period; or women with previous normal deliveries and attending the hospital for other gynaecological conditions.
Control group
Active

Outcomes
Primary outcome [1] 302508 0
Is height of woman a risk factor for obstructed labour fistula.
Obstructed labour is determined by history given by patient e.g. number of days in labour, stillborn baby and evidenced by maternal injuries such as genitourinary fistula. (most women deliver in villages with no health care professional - so there is no medical records).

Height is measured by the admission nurse on the ward with a stadiometer.
Timepoint [1] 302508 0
On admission to the hospital ward
Secondary outcome [1] 336260 0
Is height of woman related to perineal tears.
These women deliver in remote villages with not health attendants and so the perineal tears are not sutured at time of delivery. The tears will be evident on examination at time of admission to hospital.

Height is measured on admission to the ward by the nurse using a stadiometer.
Timepoint [1] 336260 0
On admission to the hospital ward

Eligibility
Key inclusion criteria
All women who have had a vaginal delivery without obstructed labour - attending the hospital during recruitment period.
All women attending the hospital with an obstetric fistula during recruitment period.
Minimum age
14 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have not had a vaginal delivery
Women who refuse to participate
Women with cultural/religious beliefs precluding recruitment

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
data being analysed

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/12/2013
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
650
Accrual to date
500
Final
Recruitment outside Australia
Country [1] 9007 0
Uganda
State/province [1] 9007 0
Kasese

Funding & Sponsors
Funding source category [1] 296798 0
Self funded/Unfunded
Name [1] 296798 0
Country [1] 296798 0
Primary sponsor type
Individual
Name
Judith Goh AO
Address
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120
Country
Australia
Secondary sponsor category [1] 295784 0
None
Name [1] 295784 0
Address [1] 295784 0
Country [1] 295784 0
Other collaborator category [1] 279609 0
Individual
Name [1] 279609 0
Hannah Krause AO
Address [1] 279609 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120
Country [1] 279609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298033 0
Greenslopes Research & Ethics Committee
Ethics committee address [1] 298033 0
Greenslopes Private Hospital
Newdegate Street QLD 4120
Ethics committee country [1] 298033 0
Australia
Date submitted for ethics approval [1] 298033 0
25/11/2013
Approval date [1] 298033 0
11/12/2013
Ethics approval number [1] 298033 0
Protocol 13/73

Summary
Brief summary
Vesico-vaginal fistula secondary to obstructed labour is very prevalent in resource-poor settings where obstetric care is unavailable. In Uganda it is estimated that 2.6% of reproductive age women have symptoms of fistula (Uganda Bureau of Statistics 2002). The identification of risk factors for the development of vesico-vaginal fistula in pregnant women is critical. If a woman could be identified as high risk prior to labour, then her health care workers could initiate appropriate management plans for her labour and potentially avoid the development of a fistula.

While previously published studies have documented that short women are at a higher risk of developing vesico-vaginal fistula in labour, these studies have all compared the fistula women who are usually from regional areas, with the average height of women nationwide which is usually obtained from cohorts of city women. These cohorts are likely to have better nutrition and living conditions and may not represent the average height of women living in more regional and remote areas. There are no comparisons of the heights of fistula women with women living in the same regions who have delivered without fistula.

This study proposes to measure the heights of women undergoing fistula surgery at Kagando hospital, Uganda, and comparing the heights with women at Kagando hospital and St Paul’s Health Centre who have delivered without fistula. This non-fistula cohort will include women who present for prolapse repair and women who have a normal delivery in the hospital obstetric unit.

The heights of all the fistula women and cohort women are measured routinely at the hospital and are readily available without any additional imposition on these women.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1817 1817 0 0
/AnzctrAttachments/373176-Hgt Ethics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 75762 0
Prof Judith Goh AO
Address 75762 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120
Country 75762 0
Australia
Phone 75762 0
+ 61 7 38479909
Fax 75762 0
+ 61 7 38476433
Email 75762 0
[email protected]
Contact person for public queries
Name 75763 0
Prof Judith Goh AO
Address 75763 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120
Country 75763 0
Australia
Phone 75763 0
+ 61 7 38479909
Fax 75763 0
+ 61 7 38476433
Email 75763 0
[email protected]
Contact person for scientific queries
Name 75764 0
Prof Judith Goh AO
Address 75764 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120
Country 75764 0
Australia
Phone 75764 0
+ 61 7 38479909
Fax 75764 0
+ 61 7 38476433
Email 75764 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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