HIV Clinical Trial
Official title:
Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
Verified date | February 2020 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Data collection will be prospective starting in 2011 upon institutional review board (IRB) approval to last a minimum of five years and will have a retrospective component tracing back to January 2010. Primary goals of data analysis will be to determine the risk factors for fistula formation, risk factors for poor surgical outcomes and long-term incontinence, social and economic impact of fistula repair, and the ability of various physical exam findings to predict likelihood of successful repair. It is expected that findings will lead to improved surgical management of obstetric fistulas both locally and internationally.
Status | Completed |
Enrollment | 1817 |
Est. completion date | September 11, 2019 |
Est. primary completion date | September 11, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Women aged 12 years and above - Present to Bwaila Hospital with obstetric fistula - Allow retrospective chart review - Willing to provide consent Exclusion Criteria: - Not allow retrospective chart review |
Country | Name | City | State |
---|---|---|---|
Malawi | UNC Project | Lilongwe |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Baylor College of Medicine |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful obstetric fistula repair | Successful obstetric fistula repair is defined by having a negative dye test (no leakage of dye into the vagina after dye is infused into the bladder). Factors associated with successful obstetric fistula repair will be evaluated. | 3-months after obstetric fistula repair | |
Secondary | Rates of depression among women undergoing obstetric fistula repair and associated factors | Participants will complete the patient health questionnaire (PHQ)-9, a standardized tool to diagnose depression before and after obstetric fistula repair. Factors associated with post-operative depression will be explored such as HIV, number of living children, and marital status. | 3-months after obstetric fistula repair |
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