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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02685878 |
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Date of registration:
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22/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Outcomes of Women After Obstetric Fistula Repair
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Scientific title:
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Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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297 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02685878 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Jennifer Tang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Study participants who have had an obstetric fistula repair performed at the Fistula
Care Center between January 1, 2012 and July 31, 2014
2. Women that currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima,
Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba will be traced.
3. Ability to speak Chichewa or English fluently
4. Current age 18 years or above
Exclusion Criteria:
1. Participants who did not have an obstetric fistula repair
2. Participants who have deceased since their obstetric fistula repair
3. Participants who do not currently reside within the districts of Lilongwe, Dedza,
Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV
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Fistula
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Primary Outcome(s)
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The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
[Time Frame: 1 hour]
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Secondary Outcome(s)
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Depression after obstetric fistula repair
[Time Frame: 1-3 years after obstetric fistula repair]
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Secondary ID(s)
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UNCPM 21502
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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