Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women

Venous Thrombosis Clinical Trial

— WAST-VTE  

Official title:

(WAST-VTE) Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women on Combined Oral Contraceptives: a Matched Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05890924
• Other study ID #: Local/2023/JCG-01
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: September 5, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The frequency of violence against women, or intimate partner violence (IPV) is more and more underlined and recognized as a cofactor favoring certain somatic and psychic pathologies. However, its incidence in patients with venous thromboembolism (VTE) is unknown and its status as a risk factor is still elusive and ambiguous.

Investigators therefore conducted a matched case-control study consisting of women taking combined oral contraceptives (COC) who were investigated and followed up between 2010 and 2020.

The cases are the patients investigated for their first venous thromboembolic event, The controls were women free of thrombosis who had regular gynecological checkups. Case-control pairs were matched on region of residence, age (+/- 2 years), duration of COC intake (+/- 4 months), COC type (2nd, 3rd or 4th generation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Patients: first venous thromboembolic event associated with the intake of combined oral contraceptives

• Controls: regular follow-up of their combined oral contraception

• Patient-Control pairs matched on region of residence, age, duration of COC intake, type of COC.

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• WAST questionnaire
WAST questionnaire, designed and validated as a screening tool for violence against women and intimate partner violence. (ref: Brown JB, Lent B, Brett PJ, Sas G, Pederson LL. Development of the Woman Abuse Screening Tool for use in family practice. Fam Med. 1996 Jun;28(6):422-8.)

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémea	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Woman Abuse Screening Tool (WAST)	Self-administered questionnaire	inclusion