Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04920487 |
Other study ID # |
THROMBO-GYN |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.