NCT04920487

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Venous Thromboembolism

Timeline

• Start date: 2021-06-05
• Primary completion: 2021-07-05
• Completion: 2022-12-31
• First posted: 2021-06-09
• Last updated: 2023-03-08

Locations

1 site across 1 country: France