Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea

NCT ID: NCT02686957

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 481 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Fistula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

Université Libre de Bruxelles

OTHER

Sponsor Role: collaborator

Centre National de Formation et de Recherche en Sante Rurale

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre DELAMOU, MD, PhDcand

Role: PRINCIPAL_INVESTIGATOR

Centre National de Formation et de Recherche en Sante Rurale

Locations

Centre National de Formation et de Recherche en Sante Rurale

Conakry, , Guinea

Countries

Guinea

References

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.

Reference Type: DERIVED

PMID: 27724918 (View on PubMed)

Other Identifiers

ITM948/14

Identifier Type: -

Identifier Source: org_study_id