Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920487
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2021-06-03
Brief Title:
Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THROMBO-GYN
Brief Summary:
The incidence of venous thrombosis venous thromboembolic disease VTE in women of childbearing age in France is in the order of 03 to 05 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 103070 pregnant women including 77 VTE during pregnancy Endometriosis and recurrent pregnancy loss RPL were identified as risk factors for VTE OR 270 95CI 121-600 for endometriosis and 613 95 248-1516 for RPL In polycystic ovary syndrome PCOS whose prevalence is estimated at 7-12 the associated risk of VTE is better known OR 189 95CI 160-224 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None