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Fistula Formation and Successful Repair

NCT02770352 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1817

Last updated 2020-09-04

No results posted yet for this study

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

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jennifer Tang, MD, MSCR · University of North Carolina, Chapel Hill

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2019-09-11
Completion
2019-09-11

Countries

  • Malawi

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770352 on ClinicalTrials.gov