NCT02685878|Completed
Outcomes of Women After Obstetric Fistula Repair
Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
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Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
Sponsor study identifier
observational
297
1 country
1
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
November 5, 2018
Actual (reported)The purpose of this study is to describe the long-term surgical success, quality of life, prevalence of depression, fertility rates, and pregnancy outcomes of patients who have undergone obstetric fistula repair. This will be a study involving up to 300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi. Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014 will be identified from an existing database of fistula patients. They will then be contacted and invited to participate in the study. Consented patients will complete a 1-hour pad weight to evaluate urinary continence, a demographic questionnaire, an incontinence-related quality of life metric, and a depression metric. The data will be analyzed and then disseminated to stakeholders.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 5, 2018
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.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 22, 2016
Actual (reported)February 19, 2016
Actual (reported)March 2016
Actual (reported)November 5, 2018
Actual (reported)The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.
1 hour
Depression after obstetric fistula repair
1-3 years after obstetric fistula repair
Number of fertile women able to achieve pregnancy after fistula repair
1-3 years after obstetric fistula repair
Quality of life of women after fistula repair
1-3 years after obstetric fistula repair
300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.
UNC Project
Lilongwe, Malawi
Kopp DM, Wilkinson J, Bengtson A, Chipungu E, Pope RJ, Moyo M, Tang JH. Fertility outcomes following obstetric fistula repair: a prospective cohort study. Reprod Health. 2017 Nov 28;14(1):159. doi: 10.1186/s12978-017-0415-1.
Jennifer Tang, MD
University of North Carolina, Chapel Hill
297 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2016
First Posted
February 19, 2016
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Point of Care Early Infant Diagnosis Patient Impact Study
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Actual (reported)Study Completion
November 5, 2018
Actual (reported)Last Updated
November 13, 2018
Record last verified: 2018-11
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