Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life

Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life.

Sponsors

Lead Sponsor: Assistance Publique Hopitaux De Marseille

Source Assistance Publique Hopitaux De Marseille
Brief Summary

Little data are available on the genital haemorrhages in woman of childbearing age treated for venous thromboembolic disease by oral anticoagulant, especially the impact on the quality of life. A recent systematic review in 2016 described for the first time in patients with venous thromboembolic a lower incidence in men of major haemorrhages and minor haemorrhages but clinically significant compared with women (5,3% and 7,9% respectively; RR: 0,635, 95%CI 0,54-0,74 ; p<0,001). It appears that this difference is related to genital haemorrhages and some direct oral anticoagulants are more associated with hemorrhagic surge. In post-hoc analyzes of phases III trials, rivaroxaban was most of the time associated with genital haemorrhages compared to vitamine K antagonists, effect not found with apixaban. Four other retrospective studies seem to find the same conclusions with a higher haemorrhagic risk with the rivaroxaban than with vitamine K antagonist or apixaban. However, haemorrhagic risk is defined in these studies with criteria of severity (anemia, transfusion, use of a health professional, menstrual periods of more than 8 days, inter mentrual bleeding, presence of blood clots) and these studies do not take into account of minor haemorrhages that may affect on the quality of life and asthenia due to anemia. Our objective is : 1- studying the proportion of women with abnormal genital haemorrhages among women of childbearing age treated for venous thromboembolism disease by oral anticoagulant including using a semi quantitative score of menorrhagia. 2- To compare this proportion according to the four molecules of oral anticoagulants (fluindione, warfarin, rivaroxaban and apixaban) and 3- to evaluate the impact of these haemorrhages on the quality of life. Our study would have a control group of women of childbearing age followed in vascular medicine for superficial venous insufficiency without thrombosis and without oral anticoagulant because the proportion of genital haemorrhages in women of childbearing age in PACA region is not known.

Overall Status Not yet recruiting
Start Date 2019-01-15
Completion Date 2023-01-01
Primary Completion Date 2023-01-01
Study Type Observational
Primary Outcome
Measure Time Frame
Proportion of women with a major genital haemorrhage and/or a minor genital haemorrhage but clinically significant and/or a minor haemorrhage. up to week 6
Secondary Outcome
Measure Time Frame
Quality of life score measured with WHOQOL-BREF scale ( World Health Organization Quality of Life) Day 1 and week 6
Enrollment 575
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria E+ : - Patient in childbearing age and >18 years - Venous thromboembolic disease - Oral anticoagulant treatment (fluindione, warfarine, rivaroxaban ou apixaban) - Following by vascular doctor of Association Régionale des Médecins Vasculaires (ARMV) PACA (120 doctors) and/or one of the investigator center - Affiliated with the Social Security Scheme - Received an oral information Inclusion Criteria E- : - Patient in childbearing age and >18 years - Superficial venous insufficiency - No treatment with oral anticoagulant or anti platelet to not interfere with haemorrhage risk - Following by vascular doctor of Association Régionale des Médecins Vasculaires (ARMV) PACA (120 doctors) and/or one of the investigator center - Affiliated with the Social Security Scheme - Received an oral information - Non opposition register Exclusion Criteria: - <18 years patient - Woman whose pregnancy is known - Pre menopause - Absence of menstruation - Refusal to participate in the study - No answer to the second call

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jean Olivier Arnaud Study Director Assistance Publique Hôpiaux Marseille
Overall Contact

Last Name: Gabrielle Sarlon-Bartoli, Dr

Phone: +33(0)4 91 38 70 23

Email: [email protected]

Location
Facility: Contact: Assistance Publique Hôpitaux Marseille Gabrielle Sarlon-Bartoli, Dr +33(0)4 91 38 70 23 [email protected]
Location Countries

France

Verification Date

2018-12-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Warfarine

Description: Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Warfarine

Label: Fluindione

Description: Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Fluindione

Label: Rivaroxaban

Description: Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Rivaroxaban

Label: Apixaban

Description: Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Apixaban

Label: Control

Description: Women in childbearing age with superficial venous insufficiency without treatment oral anticoagulant or antiplatelet.

Acronym GENB-OAB
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov

Clinical Research News