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

NCT05890924 | Completed

• 1 other identifier: Local/2023/JCG-01
• Study Type: observational
• Target: 997
• Locations: 1 country
• Sites: 1

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).

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• Woman Abuse Screening Tool (WAST)

  Self-administered questionnaire

  inclusion

Study Arms (2)

Patients

First venous thromboembolic event associated with combined oral contraceptives intake

Other: WAST questionnaire

Controls

regular follow-up of their combined oral contraception

Other: WAST questionnaire

Interventions

WAST questionnaire OTHER

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; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women managed and followed by their respective departments dedicated to the evaluation of the vascular risk in women (Gynecology-Obstetrics + Haematology)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémea

Nîmes, 30029, France

Location

Related Publications (1)

• Vandevelde A, Gris JC, Moore GW, Musial J, Zuily S, Wahl D, Devreese KMJ. Added value of antiphosphatidylserine/prothrombin antibodies in the workup of obstetric antiphospholipid syndrome: communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies. J Thromb Haemost. 2023 Jul;21(7):1981-1994. doi: 10.1016/j.jtha.2023.04.001. Epub 2023 Apr 13.

  PMID: 37061133 RESULT

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Christophe GRIS, Pr

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: January 1, 2023
• Primary Completion: September 5, 2023
• Study Completion: September 5, 2023
• Last Updated: December 4, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)