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

Alexandre Delamou, Therese Delvaux, Abdoul Habib Beavogui, Alain Levêque, Wei-Hong Zhang, Vincent De Brouwere, Alexandre Delamou, Therese Delvaux, Abdoul Habib Beavogui, Alain Levêque, Wei-Hong Zhang, Vincent De Brouwere

Abstract

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).

Keywords: Guinea; Obstetric fistula; Post-repair; Pregnancy; Recurrence; Risk factors.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Study timeline

References

    1. Capes T, Ascher-Walsh C, Abdoulaye I, Brodman M. Obstetric fistula in low and middle income countries. Mt Sinai J Med. 2011;78(3):352–361. doi: 10.1002/msj.20265.
    1. Wall LL. A framework for analyzing the determinants of obstetric fistula formation. Stud Fam Plann. 2012;43(4):255–272. doi: 10.1111/j.1728-4465.2012.00325.x.
    1. Landry E, Frajzyngier V, Ruminjo J, Asiimwe F, Barry T, Bello A, et al. Profiles and experiences of women undergoing genital fistula repair: Findings from five countries. Glob Public Health. 2013;8(8):926–942. doi: 10.1080/17441692.2013.824018.
    1. Adler AJ, Ronsmans C, Calvert C, Filippi V. Estimating theprevalence of obstetric fistula: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2013;13:246. doi: 10.1186/1471-2393-13-246.
    1. Lozano R, Wang H, Foreman K, et al. Progress towards Mil-lennium Development Goals 4 and 5 on maternal and childmortality: an updated systematic analysis. Lancet. 2011;378:1139–1165. doi: 10.1016/S0140-6736(11)61337-8.
    1. Institut National des Statistiques . Guinea demographic and health survey 2012. Conakry: Institut National des Statistiques and Mesures DHS; 2014.
    1. Osotimehin B. Seizing the moment to end obstetric fistula. Lancet Glob Health. 2014;2(7):e381–e382. doi: 10.1016/S2214-109X(14)70251-7.
    1. Osotimehin B. Obstetric fistula: ending the health and human rights tragedy. Lancet. 2013;381(9879):1702–1703. doi: 10.1016/S0140-6736(13)61001-6.
    1. Tayler-Smith K, Zachariah R, Manzi M, van den Boogard W, Vandeborne A, Bishinga A, et al. Obstetric Fistula in Burundi: a comprehensive approach to managing women with this neglected disease. BMC Pregnancy Childbirth. 2013;13(1):164. doi: 10.1186/1471-2393-13-164.
    1. Hawkins L, Spitzer RF, Christoffersen-Deb A, Leah J, Mabeya H. Characteristics and surgical success of patients presenting for repair of obstetric fistula in western Kenya. Int J Gynaecol Obstet. 2013;120(2):178–182. doi: 10.1016/j.ijgo.2012.08.014.
    1. Delamou A, Diallo M, Beavogui AH, Delvaux T, Millimono S, Kourouma M, et al. Good clinical outcomes from a 7-year holistic programme of fistula repair in Guinea. Trop Med Int Health. 2015;20(6):813–819. doi: 10.1111/tmi.12489.
    1. Barone MA, Frajzyngier V, Ruminjo J, Asiimwe F, Barry TH, Bello A, et al. Determinants of postoperative outcomes of female genital fistula repair surgery. Obstet Gynecol. 2012;120(3):524–531. doi: 10.1097/AOG.0b013e31826579e8.
    1. Fistula Care/EngenderHealth. Final Project Report: October 2007 to December 2013, Part 1I: Country Accomplishments. New York: Engenderhealth; 2013.
    1. Osotimehin B. Statement on the International Day to End Obstetric Fistula – Assessed March 15, 2016. Available at:
    1. Barone MA, Widmer M, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Barry TH, Danladi D, Djangnikpo L, Gbawuru-Mansaray T, Harou I, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Landoulsi S, Delamou A, Were L, Frajzyngier V, Beattie K, Gülmezoglu AM. Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial. Lancet. 2015;386(9988):56–62. doi: 10.1016/S0140-6736(14)62337-0.
    1. Ministry OHoG . National Strategy for the prevention and treatment of Obstetric fistula, 2012-2016. Conakry: Ministry of Health of Guinea, UNFPA; 2012.
    1. De Rider D, Abubakar K, Raassen T, Waaldijk K, Stanford E. Surgical treatment of obstetric fistula. In: Abrams P, De Ridder D, Devries C, Elneil S, Esegbona G, Mourad S, editors. Obstetric fistula in the developing world. Montreal (QC): Societe Internationale d’Urologie (SIU); 2012. pp. 87–122.
    1. Nielsen H, Lindberg L, Nygaard U, Aytenfisu O, Sorensen B, Rudnicki M, et al. A community-based long-term follow up of women undergoing obstetric fistula repair in rural Ethiopia. BJOG. 2009;116(9):1258–1264. doi: 10.1111/j.1471-0528.2009.02200.x.
    1. Browning A, Menber B. Women with obstetric fistula in Ethiopia: a 6-month follow up after surgical treatment. BJOG. 2008;115(12):1564–1569. doi: 10.1111/j.1471-0528.2008.01900.x.
    1. Wilson AL, Chipeta E, Kalilani-Phiri L, Taulo F, Tsui AO. Fertility and pregnancy outcomes among women with obstetric fistula in rural Malawi. Int J Gynaecol Obstet. 2011;113(3):196–198. doi: 10.1016/j.ijgo.2011.01.006.
    1. Drew LB, Wilkinson JP, Nundwe W, Moyo M, Mataya R, Mwale M, Tang JH. Long-term outcomes for women after obstetric fistula repair in Lilongwe, Malawi: a qualitative study. BMC Pregnancy Childbirth. 2016;16(1):2. doi: 10.1186/s12884-015-0755-1.
    1. Khisa W, Wakasiaka S, McGowan L, Campbell M, Lavender T. Understanding the lived experience of women before and after fistula repair: a qualitative study in Kenya. BJOG. 2016 19. doi: 10.1111/1471-0528.13902.
    1. Donnelly K, Oliveras E, Tilahun Y, Belachew M, Asnake M. Quality of life of Ethiopian women after fistula repair: implications on rehabilitation and social reintegration policy and programming. Cult Health Sex. 2015;17(2):150–164. doi: 10.1080/13691058.2014.964320.
    1. Fistula C. Estimating Costs to Provide Fistula Services in Nigeria and Ethiopia: Key Findings. New York: Engenderhealth; 2012.
    1. Bishinga A, Zachariah R, Hinderaker S, Tayler-Smith K, van den Boogard W, Tamura M, et al. High loss to follow-up following obstetric fi stula repair surgery in rural Burundi: is there a way forward? Public Health Action. 2013;3(2):113–117. doi: 10.5588/pha.13.0001.
    1. Aimakhu VE. Reproductive functions after the repair of obstetric vesicovaginal fistulae. Fertil Steril. 1974;25(7):586–591. doi: 10.1016/S0015-0282(16)40514-5.
    1. Emembolu J. The obstetric fistula: factors associated with improved pregnancy outcome after a successful repair. Int J Gynaecol Obstet. 1992;39(3):205–212. doi: 10.1016/0020-7292(92)90658-6.
    1. Evoh NJ, Akinla O. Reproductive performance after the repair of obstetric vesico-vaginal fistulae. Ann Clin Res. 1978;10(6):303–306.
    1. Benfield N, Kinsindja RM, Kimona C, Masoda M, Ndume J, Steinauer J. Fertility desires and the feasibility of contraception counseling among genital fistula patients in eastern Democratic Republic of the Congo. Int J Gynaecol Obstet. 2011;114(3):265–267. doi: 10.1016/j.ijgo.2011.02.024.
    1. Institut National des Statistiques G . Pauvreté et inégalités en Guinée de 1994 à 2012: analyse à partir d'enquêtes auprès des ménages. Conakry: INS; PAM; BM; BAD; PNUD; EU; 2013.
    1. Fleiss J, Levin B, Paik M. Statistical Methods for Rates and Proportions. Third. New York: John Wiley & Sons, Editors; 2003.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera