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

ABSTRACT: 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.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 (?2) 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?

SUBMITTER: Delamou A

PROVIDER: S-EPMC5057268 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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

Delamou Alexandre A Delvaux Therese T Beavogui Abdoul Habib AH Levêque Alain A Zhang Wei-Hong WH De Brouwere Vincent V

BMC pregnancy and childbirth 20161010 1

<h4>Background</h4>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.<h4>Methods</h4>A descriptive longitudinal study design will be used. The study will include women who underwent f ...[more]

PMID: 27724918

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Project description:BackgroundFemale genital fistula is a devastating maternal complication of delivery in developing countries. We sought to analyse the incidence and proportion of fistula recurrence, residual urinary incontinence, and pregnancy after successful fistula closure in Guinea, and describe the delivery-associated maternal and child health outcomes.MethodsWe did a longitudinal study in women discharged with a closed fistula from three repair hospitals supported by EngenderHealth in Guinea. We recruited women retrospectively (via medical record review) and prospectively at hospital discharge. We used Kaplan-Meier methods to analyse the cumulative incidence, incidence proportion, and incidence ratio of fistula recurrence, associated outcomes, and pregnancy after successful fistula closure. The primary outcome was recurrence of fistula following discharge from repair hospital in all eligible women who consented to inclusion and could provide follow-up data.Findings481 women eligible for analysis were identified retrospectively (from Jan 1, 2012, to Dec 31, 2014; 348 women) or prospectively (Jan 1 to June 20, 2015; 133 women), and followed up until June 30, 2016. Median follow-up was 28·0 months (IQR 14·6-36·6). 73 recurrent fistulas occurred, corresponding to a cumulative incidence of 71 per 1000 person-years (95% CI 56·5-89·3) and an incidence proportion of 18·4% (14·8-22·8). In 447 women who were continent at hospital discharge, we recorded 24 cases of post-repair residual urinary incontinence, equivalent to a cumulative incidence of 23·1 per 1000 person-years (14·0-36·2), and corresponding to 10·3% (5·2-19·6). In 305 women at risk of pregnancy, the cumulative incidence of pregnancy was 106·0 per 1000 person-years, corresponding to 28·4% (22·8-35·0) of these women. Of 50 women who had delivered by the time of follow-up, only nine delivered by elective caesarean section. There were 12 stillbirths, seven delivery-related fistula recurrences, and one maternal death.InterpretationRecurrence of female genital fistula and adverse pregnancy-related maternal and child health outcomes were frequent in women after fistula repair in Guinea. Interventions are needed to safeguard the health of women after fistula repair.FundingBelgian Development Cooperation (DGD), Institute of Tropical Medicine of Antwerp (ITM), and Maferinyah Training and Research Center in Rural Health (Guinea).

Project description:BACKGROUND:Obstetric fistula (OF) is a maternal morbidity associated with high rates of stillbirth, amenorrhea, and sexual dysfunction. Limited data exists on the reproductive outcomes of women in the years following a fistula repair. The objective of this study is to describe the fertility outcomes and family planning practices in a population of Malawian women 1-4 years after fistula repair. METHODS:Women who had enrolled into a clinical database of OF patients and undergone OF repair between January 1, 2012 and July 31, 2014 were recruited and enrolled to complete a home-based survey of their demographic and reproductive health data 1-4 years after their repair. Pregnancy, amenorrhea, and sexual function were described using frequency analysis, and we compared antimüllerian hormone (AMH) concentrations between women with menses or pregnancy with women with amenorrhea or no pregnancy using Wilcoxon rank sum tests. RESULTS:Of 297 women with a prior OF repair, 148 had reproductive potential and were included in this analysis. Overall 30 women of these women (21%) became pregnant since their fistula repair, with most pregnancies ending with cesarean delivery. Of the 32 women who were amenorrheic at the time of repair, 25 (78.1%) had resumption of menses. Only 11 (8.6%) of sexually active women reported dyspareunia, and among women who were not trying to conceive, 53.1% were currently using a method of family planning. No significant differences were found in AMH concentrations between those who were pregnant or had menses versus those without pregnancy or menses, respectively. CONCLUSIONS:In this long-term follow-up study of women after OF repair, many women were able to achieve a pregnancy with a live birth, have normal menses, be sexually active, and access contraception. These achievements will further assist a population of women whose reintegration and restoration of dignity is closely tied to their ability to achieve their reproductive goals. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02685878 .

Dataset Information

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

Publications

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

Similar Datasets

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