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

NCT ID: NCT05890924

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

997 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-09-05

Brief Summary

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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).

Detailed Description

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Conditions

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Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

First venous thromboembolic event associated with combined oral contraceptives intake

WAST questionnaire

Intervention Type 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

regular follow-up of their combined oral contraception

WAST questionnaire

Intervention Type 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.)

Interventions

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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.)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe GRIS, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémea

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 37061133 (View on PubMed)

Other Identifiers

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Local/2023/JCG-01

Identifier Type: -

Identifier Source: org_study_id

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