An observational study in Fistula, sponsored by Centre National de Formation et de Recherche en Sante Rurale. Completed at 1 site in Guinea. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Centre National de Formation et de Recherche en Sante Rurale · Observational
Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects women in low income countries. Despite the strengthening of research on fistula, there is little data on the follow-up after fistula repair.
The objective of this study is to analyse the factors associated with the recurrence of fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé Regional Hospital and Jean Paul II Hospital of Conakry).
The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest will include patient characteristics, fistula characteristics, the context of repair and the context of reintegration.
Participants giving an informed consent after a home visit by the Fistula Counsellors who managed women during surgery will be interview at enrolment and every six month from inclusion. The study duration is estimated at 48 months (January 2012 to March 2016) including the retrospective part.
A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2% margin of error (width of confidence interval is 4%) and 95% confidence interval and is sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10% precision.
The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier methods and the risk factor analysis will be performed using adjusted cox regression.
For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions of pregnancy outcomes between potential predictors and logistic regression models will be used and associations will be reported as risk ratios with 95% confidence intervals.
Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA) with a level of significance set at P\<0.05.
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's enrollment of 481 is above the median of 97 across 56 observational studies indexed under Fistula.
Browse Fistula studies →Centre National de Formation et de Recherche en Sante Rurale is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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The study population is composed of women who underwent repair for obstetric fistula in three fistula repair hospitals in Guinea from 1 January 2012 to 30 June 2015.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible, study participants must meet the following criteria:
Exclusion Criteria:
Potential participants meeting any of the following criteria will not be enrolled in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will include women who underwent repair for obstetric fistula at three fistula repair hospitals in Guinea and who had a closed fistula at hospital discharge. no intervention will be done.
Recurrence of fistula
Recurrence of fistula is defined as a "continuous and uncontrolled leakage of urine" in a woman up to 48 months after hospital discharge.
Time frame: 2012-2015, up to 8 months
Pregnancy
Pregnancy is defined by a positive pregnancy test (medical records) or a self-reporting confirmed by at least two witnesses in a woman up to 48 months after hospital discharge.
Time frame: 2012-2016, up to 48 months
Plan to share: No — Such data will not be public unless requested and after prior authorization of the Guinean National Ethics Committee for Health Research.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Centre National de Formation et de Recherche en Sante Rurale