NCT04920487

Brief Summary

The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare disease, but the majority of events occurring in women of childbearing age are associated with a particular hormonal context (mainly pregnancy and hormonal contraception). VTE is a multifactorial disease and the risk depends on the simultaneous presence of several triggers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

June 3, 2021

Last Update Submit

March 6, 2023

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Retrospectively assess the prevalence of gynecological pathologies in women at the time of VTE

    Percentage of women with gynecological pathologies at time of VTE

    Day 1

Secondary Outcomes (2)

  • Analyze the characteristics of VTE according to the presence or absence of a gynecological pathology

    Day 1

  • Describe of hormone therapy used after VTE

    Day 1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and 12/31/2020 for VTE

You may qualify if:

  • Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and 12/31/2020 for VTE
  • ICD-10 codes I26, I80, I82, O22.3, O22.5.

You may not qualify if:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his or her data for this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

  • Mottais-Cosnefroy V, Pecourt M, Yannoutsos A, Fels A, Beaussier H, Alran S, Priollet P, Hugon-Rodin J. Hormone-dependent gynaecological disorders and contraceptive modalities in women with a history of venous thromboembolic event: The THROMBOGYN study. J Med Vasc. 2022 Nov-Dec;47(5-6):228-237. doi: 10.1016/j.jdmv.2022.10.015. Epub 2022 Nov 14.

    PMID: 36464417RESULT

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Justine HUGON-RODIN, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 9, 2021

Study Start

June 5, 2021

Primary Completion

July 5, 2021

Study Completion

December 31, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

FR(1)