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

NCT ID: NCT03772366

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

453 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-01-31

Brief Summary

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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 three molecules of oral anticoagulants (antivitamin K, rivaroxaban and apixaban) and compare the molecules two by two 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.

Detailed Description

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Conditions

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Genital Haemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Antivitamin K

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

No interventions assigned to this group

Rivaroxaban

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

No interventions assigned to this group

Apixaban

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

No interventions assigned to this group

Control

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Olivier Arnaud

Role: STUDY_DIRECTOR

Assistance Publique Hôpiaux Marseille

Locations

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Assistance Publique Hôpitaux Marseille

Marseille, Bouches Du Rhônes, France

Site Status

Countries

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France

Other Identifiers

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2018-17

Identifier Type: -

Identifier Source: org_study_id