Clinical trial NCT03772366: Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life
Official title: Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Genital Haemorrhage
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 453
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in childbaering age and major followed by a vascular doctor in Provence Alpes Côtes d'Azur region by one of the investigator centers or one of the 120 doctors in Association Régionale des Médecins Vasculaires ARMV PACA.

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 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.


Eligibility 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

Primary outcomes:
measure: Proportion of women with a major genital haemorrhage and/or a minor genital haemorrhage but clinically significant and/or a minor haemorrhage.
timeFrame: up to week 6
Secondary outcomes:
measure: Quality of life score measured with WHOQOL-BREF scale ( World Health Organization Quality of Life)
timeFrame: Day 1 and week 6
Other outcomes:
Locations:
city: Marseille Cedex 05
country: France
facility: Assistance Publique Hôpitaux Marseille
state: Bouches Du Rhônes
Study officials:
affiliation: Assistance Publique Hôpiaux Marseille
name: Jean Olivier Arnaud
role: STUDY_DIRECTOR
References: