Fistula Formation and Successful Repair

NCT02770352 | Completed

• 2 other identifiers: 11-2345CID 1116
• Study Type: observational
• Target: 1,817
• Locations: 1 country
• Sites: 1

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.

Conditions

Fistula; HIV

Keywords

retrospective chart review; prospective chart review; fistula formation and repair; database; demographics of women with fistulas; internationally accepted risks factors for fistula formation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rates of depression among women undergoing obstetric fistula repair and associated factors

  3-months after obstetric fistula repair

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are women admitted to Bwaila Hospital for repair of obstetric fistulas.

You may qualify if:

• Women aged 12 years and above
• Present to Bwaila Hospital with obstetric fistula
• Allow retrospective chart review
• Willing to provide consent

You may not qualify if:

• Not allow retrospective chart review

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

UNC Project

Lilongwe, Malawi

Location

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Tang, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 12, 2016
• Study Start: October 1, 2012
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)