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Набор скоро начнётся NCT07701629

Study on Violence Against Vulnerable Women and Optimizing Support Services

Наблюдательное Female Genital Mutilation Woman Abuse Abuse, Sexual Spouse Abuse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Female Genital Mutilation, Woman Abuse, Abuse, Sexual, Spouse Abuse. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services

Обзор

Sexual and gender-based violence in France primarily affects women, who make up 88% of victims, with 670,000 affected annually. Many suffer abuse from partners, including 94,000 rape cases, and minors are heavily impacted. Despite frequent emergency visits, medical follow-up is inconsistent, and these violences significantly reduce women's healthy life expectancy. The study aims to assess quality of life improvements six months after multidisciplinary care in specialized centers like "La Maison des Femmes" (The Women's House).

Подробное описание

Gender-based and sexual violence in France primarily affects women, who account for 88% of victims. Each year, around 670,000 women experience this violence, including 213,000 at the hands of their current or former partner. Among them, 94,000 are victims of rape or attempted rape-that's one rape every 8 minutes. This violence particularly affects minors, with 59% of men accused of having victims under the age of 18. Yet only 1 in 5 victims files a complaint. In 2023, 134 women were killed by their spouse or former spouse. In addition to the direct victims, the children in the family are often co-victims, exposed to violence and suffering from serious psychological and behavioral consequences. In 2024, more than 450,000 victims of physical violence and 122,600 victims of sexual violence were recorded, a situation that is particularly alarming among women in vulnerable situations (minors, migrants, and the homeless). Some migrant women undergo female genital mutilation, resulting in lasting trauma. In 2010, the number of adult women who had undergone female genital mutilation (FGM) in France was estimated at more than 124,000. Violence has serious impacts on physical and mental health: post-traumatic stress, sleep disorders, depression, risky behaviors, as well as an increased incidence of certain diseases (cardiovascular diseases, cancers, gynecological conditions). Pregnancy is often an aggravating factor in domestic violence, with increased risks for both the mother and the child. Children exposed to domestic violence also suffer from various problems (developmental delays, behavioral disorders, and impaired self-esteem). On average, 3 femicides per day are recorded, whether direct or indirect.

Despite increased use of emergency rooms, medical follow-up for victims remains inconsistent. According to the WHO, this violence reduces women's healthy life expectancy by 1 to 4 years. Beyond individual suffering, this violence carries a heavy social and economic cost, affecting professional life, the ability to care for themselves and their children, and often leading to isolation. The main aim of this study is to assess improvements in quality of life at 6 months (baseline vs. 6-month comparison) following multidisciplinary care for vulnerable women or victims of violence referred to a specialized facility such as the Maison Des Femmes (MDF).

Первичные конечные точки

  • Change in quality of life [Срок оценки: Baseline]
  • Change in quality of life [Срок оценки: At 6 months]
Вторичные конечные точки (12)
  • Change in quality of life at 3 months [Срок оценки: Baseline]
  • Change in quality of life at 3 months [Срок оценки: At 3 months]
  • Change in sleep quality at 3 and 6 months compared to baseline. [Срок оценки: Baseline]
  • Change in sleep quality at 3 and 6 months compared to baseline. [Срок оценки: At 3 months]
  • Change in sleep quality at 3 and 6 months compared to baseline. [Срок оценки: At 6 months]
  • Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. [Срок оценки: Baseline]
  • Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. [Срок оценки: At 3 months]
  • Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire. [Срок оценки: At 6 months]
  • Types and frequencies of various forms of vulnerability and violence against women [Срок оценки: Baseline]
  • Types and frequencies of various forms of vulnerability and violence against women [Срок оценки: At 3 months]
  • Types and frequencies of various forms of vulnerability and violence against women [Срок оценки: At 6 months]
  • Types of treatments and care pathways used, and assessment of patient adherence [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Adult women receiving care at the MDF in the Gard department;
  • Women in situations of vulnerability and violence
  • Women who agree to participate in the study and have signed the consent form;
  • Non-French-speaking women who can be assisted in understanding through the midwife's intervention and telephone interpretation

Note: Pregnant and breastfeeding women may be included. Indeed, pregnancy is a trigger or aggravating factor for domestic violence and can further exacerbate the precarious situation of women seeking services at the MDF.

Article L1121-1 of the Public Health Code (CSP) and Decree No. 2016-1537 of November 16, 2016, stipulate that biomedical research must protect vulnerable individuals, including pregnant women, but authorize clinical trials if the benefits outweigh the risks.

Note: Patients who are not covered by social security will be recruited in accordance with Article L1121-8-1 of the Public Health Code\*

  • Individuals who are not enrolled in a social security program or who are not beneficiaries of such a program may be recruited to participate in non-interventional research.
  • As an exception, the Human Subjects Protection Committee may authorize a person who is not enrolled in or a beneficiary of a social security system to participate in research referred to in paragraphs 1 or 2 of Article L. 1121-1. This authorization must be justified.

Критерии исключения

  • All persons under guardianship or conservatorship
  • All persons incapable of giving consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07701629 · APITHEM/2025/SR-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗