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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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16 December 2017 |
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Main ID: |
NCT02686957 |
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Date of registration:
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12/02/2016 |
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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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Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea
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Scientific title:
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Risk Factors of Fistula Recurrence and Pregnancy Outcomes Following Fistula Repair in Guinea |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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481 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02686957 |
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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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N/A
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Countries of recruitment
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Guinea
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Contacts
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Name:
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Alexandre DELAMOU, MD, PhDcand |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre National de Formation et de Recherche en Sante Rurale |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
In order to be eligible, study participants must meet the following criteria:
- Had a fistula closed at discharge, as measured by a dye test (this include women dry
and those with residual incontinence);
- Willing and able to provide written informed consent (assent for minors);
- Had a urinary or recto-vaginal fistula;
- Agree to participate in follow-up visits (every six months) from consent date and for
the duration of the study;
- Agree to stay in Guinea for the duration of the study.
Exclusion Criteria:
Potential participants meeting any of the following criteria will not be enrolled in the
study:
- Refusal to give free and informed consent;
- Surgery done outside the study sites;
- Incomplete medical records;
- Incontinence unrelated to urinary or recto-vaginal fistula.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fistula
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Primary Outcome(s)
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Recurrence of fistula
[Time Frame: 2012-2015, up to 8 months]
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Secondary Outcome(s)
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Pregnancy
[Time Frame: 2012-2016, up to 48 months]
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Secondary ID(s)
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ITM948/14
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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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