Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT02686957
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2016-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2016-02-12', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of fistula', 'timeFrame': '2012-2015, up to 8 months', 'description': 'Recurrence of fistula is defined as a "continuous and uncontrolled leakage of urine" in a woman up to 48 months after hospital discharge.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy', 'timeFrame': '2012-2016, up to 48 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fistula']}, 'referencesModule': {'references': [{'pmid': '27724918', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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).\n\nThe 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.\n\nParticipants 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.\n\nA 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.\n\nThe 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.\n\nFor 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.\n\nAnalysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA) with a level of significance set at P\\<0.05."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of women who underwent repair for obstetric fistula in three fistula repair hospitals in Guinea from 1 January 2012 to 30 June 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible, study participants must meet the following criteria:\n\n* Had a fistula closed at discharge, as measured by a dye test (this include women dry and those with residual incontinence);\n* Willing and able to provide written informed consent (assent for minors);\n* Had a urinary or recto-vaginal fistula;\n* Agree to participate in follow-up visits (every six months) from consent date and for the duration of the study;\n* Agree to stay in Guinea for the duration of the study.\n\nExclusion Criteria:\n\nPotential participants meeting any of the following criteria will not be enrolled in the study:\n\n* Refusal to give free and informed consent;\n* Surgery done outside the study sites;\n* Incomplete medical records;\n* Incontinence unrelated to urinary or recto-vaginal fistula.'}, 'identificationModule': {'nctId': 'NCT02686957', 'briefTitle': 'Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centre National de Formation et de Recherche en Sante Rurale'}, 'officialTitle': 'Risk Factors of Fistula Recurrence and Pregnancy Outcomes Following Fistula Repair in Guinea', 'orgStudyIdInfo': {'id': 'ITM948/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women closed', 'description': '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.\n\nno intervention will be done.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2649', 'city': 'Conakry', 'country': 'Guinea', 'facility': 'Centre National de Formation et de Recherche en Sante Rurale', 'geoPoint': {'lat': 9.53795, 'lon': -13.67729}}], 'overallOfficials': [{'name': 'Alexandre DELAMOU, MD, PhDcand', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre National de Formation et de Recherche en Sante Rurale'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Such data will not be public unless requested and after prior authorization of the Guinean National Ethics Committee for Health Research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre National de Formation et de Recherche en Sante Rurale', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}, {'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}