Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001073392
Ethics application status
Approved
Date submitted
2/07/2017
Date registered
24/07/2017
Date last updated
9/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The risk of domestic violence with obstetric injuries and vaginal prolapse
Scientific title
The risk of domestic violence in women suffering with obstetric fistula, chronic 4th degree tear and pelvic organ prolapse
Secondary ID [1] 292334 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Domestic violence 303881 0
pelvic organ prolapse 304140 0
chronic 4th degree tear 304141 0
obstetric fistula 304142 0
Condition category
Condition code
Reproductive Health and Childbirth 303242 303242 0 0
Childbirth and postnatal care
Renal and Urogenital 303243 303243 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
The aim of this study is to identify whether or not women in a low-income setting (western Uganda) suffering from obstetric fistula, pelvic organ prolapse, or chronic 4th-degree obstetric tears, are at risk of domestic violence. It has previously been documented there is a high rate overall of domestic violence occurring in Uganda.

The local nurses will administer the questionnaire in the local language as many women are illiterate or use local dialects. The questionnaire will be administered during admission to the hospital. The questionnaires are the "Women Abuse Screening Tool" (WAST) and "Hurt, Insult, Threat and Scream" (HITS).
Intervention code [1] 298513 0
Not applicable
Comparator / control treatment
Women attending the hospital for other reasons and are not patients e.g. visitors.
Control group
Active

Outcomes
Primary outcome [1] 302623 0
Rates of domestic violence in women with obstetric fistulas, chronic 4th degree tears and pelvic organ prolapse, compared to women without these conditions.

This is assessed by administering the questionnaires WAST (Women Abuse Screening Tool) and HITS (Hurt, Insults, Threatens, Scream).
Timepoint [1] 302623 0
Once off survey taken during admission to hospital for treatment of above conditions.
Secondary outcome [1] 336544 0
Rates of domestic violence in women attending the hospital for other reasons but are not patients.
This is assessed by administering the questionnaires WAST (Women Abuse Screening Tool) and HITS (Hurt, Insults, Threatens, Scream).
Timepoint [1] 336544 0
Once off survey taken whilst visiting hospital for other reasons.

Eligibility
Key inclusion criteria
Women presenting to the Kagando Hospital, Kasese District, Uganda with obstetric fistula, chronic 4th degree tears and symptomatic pelvic organ prolapse.

Women who are not patients but attending the hospital e.g. family members of any hospital patients. In rural Uganda, there is limited staff on the ward and so family members come into hospital with any patient that is being admitted to assist the patients e.g. cooking meals, cleaning.
Minimum age
16 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women who elect not to be enrolled.
Women with cultural/religious barriers to enrolment

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/07/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
400
Accrual to date
225
Final
Recruitment outside Australia
Country [1] 9034 0
Uganda
State/province [1] 9034 0
Kasese

Funding & Sponsors
Funding source category [1] 296882 0
Self funded/Unfunded
Name [1] 296882 0
Country [1] 296882 0
Primary sponsor type
Individual
Name
Judith Goh
Address
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120
Country
Australia
Secondary sponsor category [1] 295887 0
Individual
Name [1] 295887 0
Hannah Krause
Address [1] 295887 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120
Country [1] 295887 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298102 0
Greenlsopes Research & Ethics Committee
Ethics committee address [1] 298102 0
Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120
Ethics committee country [1] 298102 0
Australia
Date submitted for ethics approval [1] 298102 0
12/02/2016
Approval date [1] 298102 0
09/03/2016
Ethics approval number [1] 298102 0
Protocol16/13

Summary
Brief summary
Women in western Uganda live in a low income and resource poor setting. Without safe and effective obstetric care, many women develop obstetric fistulas and chronic 4th-degree obstetric tear. In addition women who develop pelvic organ prolapse have no access to treatment. Within Uganda, the 2011 Uganda Demographic Health Survey has identified a frightening incidence of domestic violence (either physical or sexual) at 41%. In a recent survey of women undergoing surgery for chronic 4th-degree obstetric tear, several women volunteered the information that they had been subject to domestic violence which they attributed to being caused by their condition.

This project aims to invite women undergoing surgery for obstetric fistula, chronic 4th-degree obstetric tear and pelvic organ prolapse to participate in a questionnaire regarding their exposure to domestic violence. In addition, women who are not patients but are visiting the hospital will also be invited to participate in the questionnaire as a control group in order to obtain a baseline rate of domestic violence in that region. There is a paucity of information in the published literature on whether these women are more likely to experience domestic violence compared to the general population. Indeed any degree of domestic violence identified either in these women undergoing surgery or in the general population needs to be highlighted.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1850 1850 0 0
/AnzctrAttachments/373234-Ethics approval dom violence.pdf (Ethics approval)

Contacts
Principal investigator
Name 75994 0
Prof Judith Goh
Address 75994 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 75994 0
Australia
Phone 75994 0
+61 7 38479909
Fax 75994 0
+61 7 38476433
Email 75994 0
jtwgoh@hotmail.com
Contact person for public queries
Name 75995 0
Judith Goh
Address 75995 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 75995 0
Australia
Phone 75995 0
+61 7 38479909
Fax 75995 0
+61 7 38476433
Email 75995 0
jtwgoh@hotmail.com
Contact person for scientific queries
Name 75996 0
Judith Goh
Address 75996 0
Suite 209
Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 75996 0
Australia
Phone 75996 0
+61 7 38479909
Fax 75996 0
+61 7 38476433
Email 75996 0
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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4670Study results articleYes Krause H et al. Incidence of intimate partner viol... [More Details] 373234-(Uploaded-18-02-2021-15-42-00)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIncidence of intimate partner violence among Ugandan women with pelvic floor dysfunction.2019https://dx.doi.org/10.1002/ijgo.12748
N.B. These documents automatically identified may not have been verified by the study sponsor.