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

November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

997

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU de Nîmes - Hôpital Universitaire Carémea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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)

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Woman Abuse Screening Tool (WAST)
Time Frame: inclusion
Self-administered questionnaire
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

September 5, 2023

Study Completion (Actual)

September 5, 2023

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2023/JCG-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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