Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea

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).

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 Overview

• Status: Completed
• Conditions: Fistula

• Study Type: Observational
• Enrollment (Actual): 481

Contacts and Locations

Study Locations

• Guinea
  • Conakry, Guinea, 2649
    • Centre National de Formation et de Recherche en Santé Rurale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2012-2015, up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2012-2016, up to 48 months

Collaborators and Investigators

• Sponsor: Centre National de Formation et de Recherche en Sante Rurale
• Collaborators: Institute of Tropical Medicine, Belgium; Université Libre de Bruxelles
• Investigators: Principal Investigator: Alexandre DELAMOU, MD, PhDcand, Centre National de Formation et de Recherche en Santé Rurale

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Recurrence; Fistula
• Other Study ID Numbers: ITM948/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Such data will not be public unless requested and after prior authorization of the Guinean National Ethics Committee for Health Research.