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NCT05890924 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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