A descriptive longitudinal study protocol: recurrence and pregnancy post-repair of obstetric fistula in Guinea

BACKGROUND Obstetric fistula is a serious medical condition which affects women in low income countries. Despite the progress of research on fistula, there is little data on long term follow-up after surgical 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. METHODS A descriptive longitudinal study design will be used. The study will include women who underwent fistula repair between 2012 and 2015 at 3 fistula repair sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé Regional Hospital and Jean Paul II Hospital of Conakry). Participants giving an informed consent after a home visit by the Fistula Counsellors will be interviewed for enrolment at least 3 months after hospital discharge The study enrolment period is January 1, 2012 - June 30, 2015. Participants will be followed-up until June 30, 2016 for a maximum follow up period of 48 months. The sample size is estimated at 364 women. The cumulative incidence rates of fistula recurrence and pregnancy post-repair will be calculated using Kaplan-Meier methods and the risk factor analyses will be performed using adjusted Cox regression. The outcomes of pregnancy will be analysed using proportions, the Pearson's Chi Square (χ2) and a logistic regression with associations reported as risk ratios with 95 % confidence intervals. All analyses will be done using STATA version 13 (STATA Corporation, College Station, TX, USA) with a level of significance set at P < 0.05. DISCUSSION This study will contribute to improving the prevention and management of obstetric fistula within the community and support advocacy efforts for the social reintegration of fistula patients into their communities. It will also guide policy makers and strategic planning for fistula programs. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02686957 . Registered 12 February 2016 (Retrospectively registered).