NCT04304469

Brief Summary

ach year, it is estimated that an average of approximately 219,000 women in France suffer physical and/or sexual violence at the hands of their partner or ex-partner. These figures do not take into account other types of violence such as psychological or economic violence. Domestic violence has a major impact on the physical, sexual and psychological health of women victims. For example, the prevalence of post-traumatic stress disorder in these women varies between 33 and 84%, with an average prevalence of 61%, compared with only 2.2% in the French population as a whole. Multidisciplinary medical, social and legal support for these women is essential. In France, there are major territorial disparities in terms of the distribution of facilities for victims of domestoc violence, and not all women victims have the same access to care depending on their place of residence. The Maison des Femmes in St Denis has been open since 2016. It offers a unique range of sanitary, social and judicial services through cooperation with police and justice departments, for women who have been subjected to any type of violence. This facility is unique in France, and the number of consultations continues to increase, and was more than 8,500 in 2018. The Maison des Femmes model is intended to be exported to other departments, but first the model needs to be validated, beyond its obvious attractiveness (illustrated by the number of consultations and the fact that it attracts women from throughout the Ile de France region) by comparing it to other facilities in terms of its effect on the management of the women. This is a cross-sectional prevalence study that estimates the frequency of post-traumatic stress disorder among women who are victims of domestic violence who used the services offered at the Maison des Femmes or other dedicated structures, at the initial consultation and 6 months later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

March 9, 2020

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Post-Traumatic Stress Disorder by PCL-5 Scale

    at the end of study, an average of 6 months

Study Arms (1)

women

women consulting for domestic violence

Other: surveysOther: follow-up

Interventions

surveysOTHER

delivery of the survey at a domestic violence consultation

women

follow-up of women 6 months after their consultation

women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women consulting for domestic violence

You may qualify if:

  • Female aged 18 and over,
  • Consulted for domestic violence at the Maison des Femmes, St Denis health centre or Aubervilliers health centre.
  • Able to understand the objectives of the study and to respond to the survey
  • Having been informed and not having objected to participating in this study.

You may not qualify if:

  • Unable to understand the objectives of the study and to respond to the surveys.
  • Consulting for another reason.
  • Protected adult under a measure of safeguard.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

  • Roland N, Delmas N, El Khoury F, Bardou A, Yacini L, Feldmann L, Hatem G, Mahdjoub S, Bardou M. Post-traumatic stress disorders in women victims-survivors of intimate partner violence: a mixed-methods pilot study in a French coordinated structure. BMJ Open. 2024 Jan 23;14(1):e075552. doi: 10.1136/bmjopen-2023-075552.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

June 23, 2020

Primary Completion

June 24, 2021

Study Completion

December 21, 2021

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations