Intimate Partner ViolenceHEMATO-WASTNCT06415968
Prevalence and Characteristics of Intimate Partner Violence Against Individuals Seeking Hematological Consultations
An observational study of Intimate Partner Violence and Deep Vein Thrombosis (DVT)/Thrombophlebitis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world. The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Partner Violence, Deep Vein Thrombosis (DVT)/Thrombophlebitis, Pulmonary Embolism and Thrombosis
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2024to 11 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients attending consultations at the CHU de Nîmes for hematological diseases.
Who may be able to join
- Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship
- Willing to complete the anonymous WAST self-questionnaire
- able to read and understand French
- Outpatient consultant at Nîmes University Hospital in one of the following departments:
- Biological hematology consultation
- Clinical hematology consultation
- Vascular medicine consultation
Who cannot join
- Individuals under court protection, guardianship or curatorship
- Individuals unable to read and understand French
- Individuals who have already completed the WAST questionnaire during the study period
- Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation
Trial locations and contacts
1 site in 1 country.
About this study
Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world.
The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French.
Read more
Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases).
The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.
- Conditions
- Intimate Partner Violence, Deep Vein Thrombosis (DVT)/Thrombophlebitis, Pulmonary Embolism and Thrombosis
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting at a biological hematology consultation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of patients experiencing Intimate Partner Violence according to consulting department
Percentage of patients with a Women Abuse Screening Tool (WAST) score ≥ 5 consulting in the hemostasis pathology versus cellular hematological pathology department. The WAST is an 8-item questionnaire with a score ranging from 0 to 16 (worst violence), with a cut-off of 5 for presence of violence
Measured: Day 0
Secondary outcomes (4)
Prevalence of Intimate Partner Violence in men versus women according to consulting department
WAST score ≥ 5 consulting in the hemostasis pathology versus cellular hematological pathology department in women versus men
Measured: Day 0
Prevalence of Intimate Partner Violence according to patient disease status and gender
WAST questionnaire total score in women versus men, for hemostasis disease versus cellular hematological disease versus hemorrhagic symptomatology versus thrombotic symptomatology
Measured: Day 0
WAST questionnaire score according to patient disease status and gender
Score for individual items of WAST questionnaire in women versus men, for hemostasis disease versus cellular hematological disease versus hemorrhagic symptomatology versus thrombotic symptomatology
Measured: Day 0
Association between the major risk factors for Intimate Partner Violence and WAST score.
WAST questionnaire total score according to: Number of years together, Violence at home growing up, Marital status (divorced or separated), Children living at home, Working status, Finances (personal income, financial difficulties), Living status (together vs separate, size of dwelling, neighbors nearby), Health status of living partner, Health status of patient
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 Sep 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Why it stopped: difficulty of inclusion, PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Gris, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415968
- Sponsor's protocol ID
- NIMAO/2023-2/JCG-01
- Acronym
- HEMATO-WAST
- Status last verified
- Feb 2025
- First submitted
- 13 May 2024
- Last updated
- 18 Feb 2025
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characteristics of Intimate Partner Violence Against Individuals Seeking Hematological Consultations
- ClinicalTrials.gov ID
- NCT06415968
- Acronym / sponsor ID
- HEMATO-WAST / NIMAO/2023-2/JCG-01
- Conditions
- Intimate Partner Violence, Deep Vein Thrombosis (DVT)/Thrombophlebitis, Pulmonary Embolism and Thrombosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty of inclusion, PI decision
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 16 May 2024 (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.
Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world.
The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French.
Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases).
The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting at a biological hematology consultation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients attending consultations at the CHU de Nîmes for hematological diseases.
Key inclusion criteria (7 listed)
- Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship
- Willing to complete the anonymous WAST self-questionnaire
- able to read and understand French
- Outpatient consultant at Nîmes University Hospital in one of the following departments:
Key exclusion criteria (4 listed)
- Individuals under court protection, guardianship or curatorship
- Individuals unable to read and understand French
- Individuals who have already completed the WAST questionnaire during the study period
- Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation
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
Prevalence of patients experiencing Intimate Partner Violence according to consulting department
Time frame: Day 0
Percentage of patients with a Women Abuse Screening Tool (WAST) score ≥ 5 consulting in the hemostasis pathology versus cellular hematological pathology department. The WAST is an 8-item questionnaire with a score ranging from 0 to 16 (worst violence), with a cut-off of 5 for presence of violence
4 secondary outcomes
Prevalence of Intimate Partner Violence in men versus women according to consulting department
Time frame: Day 0
Prevalence of Intimate Partner Violence according to patient disease status and gender
Time frame: Day 0
WAST questionnaire score according to patient disease status and gender
Time frame: Day 0
Association between the major risk factors for Intimate Partner Violence and WAST score.
Time frame: Day 0
Results and safety
The study was stopped early (reason given: difficulty of inclusion, PI decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Christophe Gris principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intimate Partner Violence and Deep Vein Thrombosis (DVT)/Thrombophlebitis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: difficulty of inclusion, PI decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of patients experiencing Intimate Partner Violence according to consulting department (time frame: Day 0). 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 18 Feb 2025.