Fistula Formation and Successful Repair
Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
Sponsor study identifier
Secondary identifiers
OTHER · UNC
observational
1,817
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 11, 2019
Actual (reported)Study Completion
September 11, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 11, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 5, 2016
Actual (reported)May 12, 2016
Actual (reported)September 11, 2019
Actual (reported)September 11, 2019
Actual (reported)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
Rates of depression among women undergoing obstetric fistula repair and associated factors
3-months after obstetric fistula repair
Participants are women admitted to Bwaila Hospital for repair of obstetric fistulas.
UNC Project
Lilongwe, Malawi
Jennifer Tang, MD, MSCR
University of North Carolina, Chapel Hill
1,817 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2016
First Posted
May 12, 2016
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
Contact the study team to confirm eligibility.
Primary Completion
September 11, 2019
Actual (reported)Study Completion
September 11, 2019
Actual (reported)Last Updated
September 4, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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