- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05731297
Consequences of Sexual Violence Among Women Living in Democratic Republic of Congo (SV-RDC)
Perineal, Psychological and Well-beeing Consequences of Conflict-related Sexual Violence Among Women Living in Democratic Republic of Congo
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jeanne Bertuit, PhD
- Phone Number: +41633738178
- Email: jeanne.bertuit@hesav.ch
Study Contact Backup
- Name: Jeanne.bertuit Bertuit, PhD
- Phone Number: +41633738178
- Email: jeanne.bertuit@hesav.ch
Study Locations
-
-
-
Kinshasa, Congo, The Democratic Republic of the
- Recruiting
- Betty Miangindula
-
Contact:
- Jeanne Bertuit, PhD
- Phone Number: +41633738178
- Email: jeanne.bertuit@hesav.ch
-
Contact:
- Betty Miangindula, PhD
- Phone Number: +41633738178
- Email: Betty Miangindula <betty.miangindula@unikin.ac.cd>
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:- Women victims of CRSV and women without a history of CRSV living in the places of enrolment in RDC, aged over 18 years and giving their consent to participate to this study.
-
Exclusion Criteria:- Pregnant women and women under 18 years old.
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
women victims of CRSV
|
women without a history of CRSV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary aspects
Time Frame: At the test time
|
Urinary aspects will be assessed by one questionnaire: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract SymptomsModules (ICIQ-FLUTS)
|
At the test time
|
Sexual aspects
Time Frame: At the test time
|
Sexual aspects will be assessed by one questionnaire: Female Sexual Function Index (FSFI)
|
At the test time
|
Pelvic and Perineal aspect
Time Frame: At the test time
|
Pelvic and Perineal aspect will be assessed by clinical examination made by a women assistant of the research team, physiotherapist expert on pelvic floor field • Examen of observation: presence of scars, lesions, inflammation, type of FGM as described by WHO classification and types of scars during external exam; Perineal pain, intensity and localization with Haslam and Laycock ring of continence, pelvic floor muscle tone with the Reissing tone scale which have a good interrater reliability for intra-vaginal manual assessment of pubococcygeus tone for expert examinator. Laycock's power, endurance, repetitions, fast contractions, every contraction timed (PERFECT) scale will be used for pelvic floor muscle assessment. The PERFECT scheme has demonstrated good reliability and validity as an assessment tool. . |
At the test time
|
Ano-rectal aspect
Time Frame: At the test time
|
Two questionnaires will be used; one to assess anal incontinence (AI) and one for constipation
|
At the test time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological aspect: will assessing with be PCL-5 questionnaire
Time Frame: At the test time
|
Psychological aspect: will assessing with be PCL-5 questionnaire The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
|
At the test time
|
Quality of Life (QoL)
Time Frame: At the test time
|
The Medical Outcomes Study MOS 36-Item Short Form Health Survey (SF-36)
|
At the test time
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic characteristic data
Time Frame: At the test time
|
Sociodemographic characteristic data will be collected with the following variables: age, marital status, the number of pregnancies, presence of traditional genital mutilation, presence of sexual violence and CRSV (age of aggression, type of sexual violence, the moment and number of sexual violence and aggressors), education, residence, parity, nationality and tribes.
|
At the test time
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sexual Violence
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingViolence, Domestic | Violence | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Violence-Related SymptomUnited States
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Johns Hopkins Bloomberg School of Public HealthUjamaa AfricaRecruitingViolence, Domestic | Violence, Sexual | Violence, Gender-BasedKenya
-
University of PittsburghCenters for Disease Control and PreventionNot yet recruitingViolence, Domestic | Violence in Adolescence | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Social Cohesion | Violence, Structural | Community ViolenceUnited States
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
RTI InternationalNo Means No WorldwideCompleted
-
University of PittsburghCenters for Disease Control and Prevention; Population CouncilRecruitingCoping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Communication, Social | Racism | Violence, Non-accidental | Communication, PersonalUnited States
-
University of PittsburghCenters for Disease Control and PreventionCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
-
University of PittsburghThe Grable Foundation; Department Human Services, Pennsylvania; Fisa FoundationCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
-
Hunter College of City University of New YorkNational Institute on Minority Health and Health Disparities (NIMHD); National...CompletedViolence, SexualUnited States