Female Genital MutilationENVVOLNCT07701629
Study on Violence Against Vulnerable Women and Optimizing Support Services
An observational study of Female Genital Mutilation and Woman Abuse, run by Centre Hospitalier Universitaire de Nīmes.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Genital Mutilation, Woman Abuse, Abuse, Sexual
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 May 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women, victims of domestic violence frequenting the Maison des Femmes (Women's House) in Nîmes. La Maison Des Femmes serves many migrant women whose health has deteriorated due to the hardships in their home countries, their migration journey, and upon arrival in France. Barriers to accessing care are linked to administrative, legal, linguistic, and cultural obstacles, as well as economic circumstances. They may come to the center on their own or be referred by a healthcare provider, an organization, a Medical and Psychological Center or Medical and Social Center, law enforcement, healthcare professionals, or anyone else who is aware of the existence of the facility. It has been open since January 2025 and has served 146 patients, scheduled 498 appointments (356 of which were kept) conducted 291 consultations, and provided 65 outpatient hospitalizations. It supports women from various backgrounds, many of whom are in vulnerable situations and/or have experienced violence.
Who may be able to join
- 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.
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- 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.
Who cannot join
- All persons under guardianship or conservatorship
- All persons incapable of giving consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services
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).
Read the detailed description
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).
- Conditions
- Female Genital Mutilation, Woman Abuse, Abuse, Sexual, Spouse Abuse
- Keywords
- Violence against women, Domestic violence, Quality of life, Women's health services, Women's house
- Medical subject headings
- Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Measured: Baseline
Change in quality of life
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Measured: At 6 months
Secondary outcomes (14)
Change in quality of life at 3 months
Difference in quality of life between baseline and 3 months, as measured by the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Measured: Baseline
Change in quality of life at 3 months
Difference in quality of life between baseline and 3 months, as measured by the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Measured: At 3 months
Change in sleep quality at 3 and 6 months compared to baseline.
The Pittsburgh Sleep Quality Index questionnaire measures improvements in sleep quality. It has 19 self-rated questions and 5 questions rated by a bed partner (but only the self-rated questions count) and assesses 7 components of sleep: Subjective Sleep Quality: individual perception of sleep quality, Sleep Latency: how long it takes to fall asleep, Sleep Duration: total hours of sleep per night, Habitual Sleep Efficiency: ratio of hours slept to hours spent in bed, Sleep Disturbances: frequency of problems disrupting sleep (e.g. waking during the night), Use of Sleep Medication: frequency of taking medications to help sleep, Daytime Dysfunction: difficulties staying awake or maintaining enthusiasm during the day due to sleep issues. Each item is scored from 0 (no difficulty) to 3 (severe difficulty). The sum of the 7 scores produces a global score of 0 to 2. Higher scores indicate poorer sleep quality. A global score over 5 is used to identify individuals with poor sleep quality.
Measured: Baseline
Change in sleep quality at 3 and 6 months compared to baseline.
The Pittsburgh Sleep Quality Index questionnaire measures improvements in sleep quality. It has 19 self-rated questions and 5 questions rated by a bed partner (but only the self-rated questions count) and assesses 7 components of sleep: Subjective Sleep Quality: individual perception of sleep quality, Sleep Latency: how long it takes to fall asleep, Sleep Duration: total hours of sleep per night, Habitual Sleep Efficiency: ratio of hours slept to hours spent in bed, Sleep Disturbances: frequency of problems disrupting sleep (e.g. waking during the night), Use of Sleep Medication: frequency of taking medications to help sleep, Daytime Dysfunction: difficulties staying awake or maintaining enthusiasm during the day due to sleep issues. Each item is scored from 0 (no difficulty) to 3 (severe difficulty). The sum of the 7 scores produces a global score of 0 to 2. Higher scores indicate poorer sleep quality. A global score over 5 is used to identify individuals with poor sleep quality.
Measured: At 3 months
Change in sleep quality at 3 and 6 months compared to baseline.
The Pittsburgh Sleep Quality Index questionnaire measures improvements in sleep quality. It has 19 self-rated questions and 5 questions rated by a bed partner (but only the self-rated questions count) and assesses 7 components of sleep: Subjective Sleep Quality: individual perception of sleep quality, Sleep Latency: how long it takes to fall asleep, Sleep Duration: total hours of sleep per night, Habitual Sleep Efficiency: ratio of hours slept to hours spent in bed, Sleep Disturbances: frequency of problems disrupting sleep (e.g. waking during the night), Use of Sleep Medication: frequency of taking medications to help sleep, Daytime Dysfunction: difficulties staying awake or maintaining enthusiasm during the day due to sleep issues. Each item is scored from 0 (no difficulty) to 3 (severe difficulty). The sum of the 7 scores produces a global score of 0 to 2. Higher scores indicate poorer sleep quality. A global score over 5 is used to identify individuals with poor sleep quality.
Measured: At 6 months
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
The PCL-5 is a 20-item self-report questionnaire that maps directly to the DSM-5 criteria for Post Traumatic Shock Disorder. Each item asks how much the respondent has been bothered by a specific PTSD symptom over the past month, scored from 0 ("not at all") to 4 ("extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cutoff score of 31-33 is indicative of probable Post Traumatic Shock Disorder.
Measured: Baseline
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
The PCL-5 is a 20-item self-report questionnaire that maps directly to the DSM-5 criteria for Post Traumatic Shock Disorder. Each item asks how much the respondent has been bothered by a specific PTSD symptom over the past month, scored from 0 ("not at all") to 4 ("extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cutoff score of 31-33 is indicative of probable Post Traumatic Shock Disorder.
Measured: At 3 months
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
The PCL-5 is a 20-item self-report questionnaire that maps directly to the DSM-5 criteria for Post Traumatic Shock Disorder. Each item asks how much the respondent has been bothered by a specific PTSD symptom over the past month, scored from 0 ("not at all") to 4 ("extremely"). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cutoff score of 31-33 is indicative of probable Post Traumatic Shock Disorder.
Measured: At 6 months
Types and frequencies of various forms of vulnerability and violence against women
Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.
Measured: Baseline
Types and frequencies of various forms of vulnerability and violence against women
Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.
Measured: At 3 months
Types and frequencies of various forms of vulnerability and violence against women
Types and frequencies of various forms of vulnerability and violence endured by the women will be recorded.
Measured: At 6 months
Types of treatments and care pathways used, and assessment of patient adherence
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
Measured: Baseline
Types of treatments and care pathways used, and assessment of patient adherence
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
Measured: At 3 months
Types of treatments and care pathways used, and assessment of patient adherence
Types of treatments and care pathways used, and patient adherence to these treatments will be recorded.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital MutilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701629
- Sponsor's protocol ID
- APITHEM/2025/SR-01
- Acronym
- ENVVOL
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Nîmes on Violence Against Vulnerable Women and Optimizing Support Services
- ClinicalTrials.gov ID
- NCT07701629
- Acronym / sponsor ID
- ENVVOL / APITHEM/2025/SR-01
- Conditions
- Female Genital Mutilation, Woman Abuse, Abuse, Sexual, Spouse Abuse
- Keywords
- Violence against women, Domestic violence, Quality of life, Women's health services, Women's house
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, victims of domestic violence frequenting the Maison des Femmes (Women's House) in Nîmes. La Maison Des Femmes serves many migrant women whose health has deteriorated due to the hardships in their home countries, their migration journey, and upon arrival in France. Barriers to accessing care are linked to administrative, legal, linguistic, and cultural obstacles, as well as economic circumstances. They may come to the center on their own or be referred by a healthcare provider, an organization, a Medical and Psychological Center or Medical and Social Center, law enforcement, healthcare professionals, or anyone else who is aware of the existence of the facility. It has been open since January 2025 and has served 146 patients, scheduled 498 appointments (356 of which were kept) conducted 291 consultations, and provided 65 outpatient hospitalizations. It supports women from various backgrounds, many of whom are in vulnerable situations and/or have experienced violence.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- All persons under guardianship or conservatorship
- All persons incapable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in quality of life
Time frame: Baseline
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
Change in quality of life
Time frame: At 6 months
Difference in quality of life between initial care and at 6 months, measured using the WHOQoL-BREF self-report questionnaire. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely"
14 secondary outcomes
Change in quality of life at 3 months
Time frame: Baseline
Change in quality of life at 3 months
Time frame: At 3 months
Change in sleep quality at 3 and 6 months compared to baseline.
Time frame: Baseline
Change in sleep quality at 3 and 6 months compared to baseline.
Time frame: At 3 months
Change in sleep quality at 3 and 6 months compared to baseline.
Time frame: At 6 months
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
Time frame: Baseline
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
Time frame: At 3 months
Post-traumatic stress at 0, 3, and 6 months using the PCL-5 questionnaire.
Time frame: At 6 months
Types and frequencies of various forms of vulnerability and violence against women
Time frame: Baseline
Types and frequencies of various forms of vulnerability and violence against women
Time frame: At 3 months
Types and frequencies of various forms of vulnerability and violence against women
Time frame: At 6 months
Types of treatments and care pathways used, and assessment of patient adherence
Time frame: Baseline
Types of treatments and care pathways used, and assessment of patient adherence
Time frame: At 3 months
Types of treatments and care pathways used, and assessment of patient adherence
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Female Genital Mutilation
Not yet recruiting
THERAPEUTIC EDUCATION of SEXUAL DYSFUNCTIONS in WOMEN SURVIVORS of SEXUAL VIOLENCE and FEMALE GENITAL MUTILATION
Sexual Abuse of Adult (If Focus of Attention is on Victim), Sexual Dysfunction Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Genital Mutilation and Woman Abuse, run by Centre Hospitalier Universitaire de Nīmes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie RIPART, Dr. (+336.87.70.13.02, sylvie.ripart@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.