FistulaNCT02686957
Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea
An observational study of Fistula, run by Centre National de Formation et de Recherche en Sante Rurale at 1 site in Guinea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fistula
- How many people
- 481 participants
- Where
- 1 siteGuinea
- Study dates
- Jul 2015to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Guinea1 site
Centre National de Formation et de Recherche en Sante Rurale
Conakry, 2649
About this study
Official title: Risk Factors of Fistula Recurrence and Pregnancy Outcomes Following Fistula Repair in Guinea
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).
Read more
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.
- Conditions
- Fistula
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women closed | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2012-2015, up to 8 months
Secondary outcomes (1)
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.
Measured: 2012-2016, up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJul 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre National de Formation et de Recherche en Sante Rurale
- Sponsor type
- Other government
- Collaborators
- Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles
- Responsible party
- Sponsor
- Investigators
- Alexandre DELAMOU, MD, PhDcand, Principal investigator, Centre National de Formation et de Recherche en Sante Rurale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686957
- Sponsor's protocol ID
- ITM948/14
- Status last verified
- Jan 2017
- First submitted
- 12 Feb 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Such data will not be public unless requested and after prior authorization of the Guinean National Ethics Committee for Health Research.
Publications
Delamou A, Delvaux T, Beavogui AH, Leveque A, Zhang WH, De Brouwere V. A descriptive longitudinal study protocol: recurrence and pregnancy post-repair of obstetric fistula in Guinea. BMC Pregnancy Childbirth. 2016 Oct 10;16(1):299. doi: 10.1186/s12884-016-1101-y.
PubMed 27724918
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Fistula Recurrence and Pregnancy Outcomes Following Fistula Repair in Guinea
- ClinicalTrials.gov ID
- NCT02686957
- Acronym / sponsor ID
- ITM948/14
- Conditions
- Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Centre National de Formation et de Recherche en Sante RuraleOther government
- Collaborators
- Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles
- Study start
- Jul 2015
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women closed | – | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of fistula
Time frame: 2012-2015, up to 8 months
Recurrence of fistula is defined as a "continuous and uncontrolled leakage of urine" in a woman up to 48 months after hospital discharge.
1 secondary outcome
Pregnancy
Time frame: 2012-2016, up to 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Derived from this study: PubMed 27724918Delamou A, Delvaux T, Beavogui AH, Leveque A, Zhang WH, De Brouwere V. A descriptive longitudinal study protocol: recurrence and pregnancy post-repair of obstetric fistula in Guinea. BMC Pregnancy Childbirth. 2016 Oct 10;16(1):299. doi: 10.1186/s12884-016-1101-y.
- Individual participant dataSharing planned: No. Such data will not be public unless requested and after prior authorization of the Guinean National Ethics Committee for Health Research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre DELAMOU, MD, PhDcand principal investigator
Centre National de Formation et de Recherche en Sante Rurale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula, run by Centre National de Formation et de Recherche en Sante Rurale at 1 site in Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of fistula (time frame: 2012-2015, up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.