Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode

Venous Thromboembolism Clinical Trial

— THROMBO-GYN  

Official title:

Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920487
• Other study ID #: THROMBO-GYN
• Status: Completed
• Start date: June 5, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Certain frequent gynecological pathologies are emerging in the literature as new venous thrombotic risk factors independently of hormonal treatment. Indeed, in endometriosis, the prevalence of which is estimated to be around 10%, biological data are in favor of hypercoagulability. Only one epidemiological study has analyzed this parameter. It is a Japanese cohort study in 103,070 pregnant women including 77 VTE during pregnancy. Endometriosis and recurrent pregnancy loss (RPL) were identified as risk factors for VTE (OR: 2.70 (95%CI, 1.21-6.00) for endometriosis and 6.13 (95% 2.48-15.16) for RPL. In polycystic ovary syndrome (PCOS), whose prevalence is estimated at 7-12%, the associated risk of VTE is better known (OR 1.89, 95%CI 1.60-2.24) and was the subject of a recently published meta-analysis in which the principal investigator collaborated. To the investigators knowledge, no study describes the prevalence of gynecological pathologies in women with VTE.

Concerning hormonal contraception, estrogen-progestin contraception (EPC) is widely used in France and is associated with an increase in the risk of VTE of a factor of 3 to 6. After a venous thrombotic episode, EPC is contraindicated, and non-hormonal or progestin-only contraception (POC) can be used. Nevertheless, to date, few studies have focused on the management of hormonal contraceptive treatment at the time of a VTE episode. Moreover, the contraceptive options presented to patients are often based on multiple actors (vascular physicians, gynaecologists, midwives, general practitioners, etc.) and the experience of the VTE episode, for both patients and prescribers, may influence the contraceptive options proposed or chosen, as well as their compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 31, 2022
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analyze the characteristics of VTE according to the presence or absence of a gynecological pathology	Characteristics of VTE	Day 1
Secondary	Describe of hormone therapy used after VTE	Percentage of women using hormonal treatment	Day 1