WAST-VTE: Intimate Partner Violence as a Risk Factor for Venous Thromboembolism in Women

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Recruiting

CT.gov ID

NCT05890924

Collaborator

(none)

997

Enrollment

Location

Anticipated Duration (Months)

83.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Venous Thrombosis	Other: WAST questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

997 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients First venous thromboembolic event associated with combined oral contraceptives intake	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.)
Controls regular follow-up of their combined oral contraception	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.)

Arm

Intervention/Treatment

Patients

First venous thromboembolic event associated with combined oral contraceptives intake

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.)

Controls

regular follow-up of their combined oral contraception

Other: WAST questionnaire

Outcome Measures

Primary Outcome Measures

Woman Abuse Screening Tool (WAST) [inclusion]
Self-administered questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémea	Nîmes Cedex 09		France	30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Jean-Christophe GRIS, Pr, Centre Hospitalier Universitaire de Nīmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT05890924

Other Study ID Numbers:

Local/2023/JCG-01

First Posted:

Jun 6, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombosis

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Study Results

No Results Posted as of Jun 12, 2023