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Fistula Formation and Successful Repair

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ClinicalTrials.gov Identifier: NCT02770352
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease
Fistula HIV

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
Study Start Date : October 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas




Primary Outcome Measures :
  1. Successful obstetric fistula repair [ Time Frame: 3-months after 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.


Secondary Outcome Measures :
  1. Rates of depression among women undergoing obstetric fistula repair and associated factors [ Time Frame: 3-months after obstetric fistula repair ]
    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.



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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are women admitted to Bwaila Hospital for repair of obstetric fistulas.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770352


Contacts
Contact: Jennifer Tang, MD, MSCR 265-99-640-2662 jennifer_tang@med.unc.edu

Locations
Malawi
UNC Project Recruiting
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Baylor College of Medicine
Investigators
Principal Investigator: Jennifer Tang, MD, MSCR University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02770352     History of Changes
Other Study ID Numbers: 11-2345
CID 1116 ( Other Identifier: UNC )
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
retrospective chart review
prospective chart review
fistula formation and repair
database
demographics of women with fistulas
internationally accepted risks factors for fistula formation

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical