ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

vaginal fistula

vaginal delivery

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Reproductive Health and Childbirth

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]

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]

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]

On admission to the hospital ward

Secondary outcome [1]

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]

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]

Uganda

State/province [1]

Kasese

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Hannah Krause AO

Address [1]

Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Research & Ethics Committee

Ethics committee address [1]

Greenslopes Private Hospital
Newdegate Street  QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/11/2013

Approval date [1]

11/12/2013

Ethics approval number [1]

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]

/AnzctrAttachments/373176-Hgt Ethics approval.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Judith Goh AO

Address

Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120

Country

Australia

Phone

+ 61 7 38479909

Fax

+ 61 7 38476433

jtwgoh@hotmail.com

Contact person for public queries

Name

Judith Goh AO

Address

Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120

Country

Australia

Phone

+ 61 7 38479909

Fax

+ 61 7 38476433

jtwgoh@hotmail.com

Contact person for scientific queries

Name

Judith Goh AO

Address

Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street QLD 4120

Country

Australia

Phone

+ 61 7 38479909

Fax

+ 61 7 38476433

jtwgoh@hotmail.com

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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Documents added manually

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