Clinical trial NCT02686957: Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea
Official title: Risk Factors of Fistula Recurrence and Pregnancy Outcomes Following Fistula Repair in Guinea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula
Lead sponsor: Centre National de Formation et de Recherche en Sante Rurale
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Tropical Medicine, Belgium
name: Université Libre de Bruxelles
First posted: 2016-02-22
Enrollment: 481
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of fistula
timeFrame: 2012-2015, up to 8 months
Secondary outcomes:
measure: Pregnancy
timeFrame: 2012-2016, up to 48 months
Other outcomes:
Locations:
city: Conakry
country: Guinea
facility: Centre National de Formation et de Recherche en Sante Rurale
Study officials:
affiliation: Centre National de Formation et de Recherche en Sante Rurale
name: Alexandre DELAMOU, MD, PhDcand
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.