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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02770352
Other study ID # 11-2345
Secondary ID CID 1116
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date September 11, 2019

Study information

Verified date February 2020
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Malawi UNC Project Lilongwe

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Baylor College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

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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