Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea

Fistula Clinical Trial

Official title:

Risk Factors of Fistula Recurrence and Pregnancy Outcomes Following Fistula Repair in Guinea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686957
• Other study ID #: ITM948/14
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: January 30, 2017
• Start date: July 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: January 2017
• Source: Centre National de Formation et de Recherche en Sante Rurale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Recurrence

Locations

Country	Name	City	State
Guinea	Centre National de Formation et de Recherche en Sante Rurale	Conakry

Sponsors (3)

Lead Sponsor	Collaborator
Centre National de Formation et de Recherche en Sante Rurale	Institute of Tropical Medicine, Belgium, Université Libre de Bruxelles

Country where clinical trial is conducted

Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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