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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Genital Haemorrhage

• Study Type: Observational
• Enrollment (Actual): 453

Contacts and Locations

• Study Contact: Name: Gabrielle Sarlon-Bartoli, Dr; Phone Number: +33(0)4 91 38 70 23; Email: gabrielle.sarlon@ap-hm.fr

Study Locations

• France
  • Bouches Du Rhônes
    • Marseille Cedex 05, Bouches Du Rhônes, France, 13354
      • ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
      • Contact: Gabrielle Sarlon-Bartoli, Dr; Phone Number: +33(0)4 91 38 70 23; Email: gabrielle.sarlon@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Rivaroxaban; Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Rivaroxaban
Apixaban; Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Apixaban
Control; Women in childbearing age with superficial venous insufficiency without treatment oral anticoagulant or antiplatelet.
Antivitamin K; Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Fluindione

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of women with a major genital haemorrhage and/or a minor genital haemorrhage but clinically significant and/or a minor haemorrhage.	Major genital haemorrhage : anemia (<12g/dl), transfusion ≥2 RBC (red blood concentrate) Clinically significant and/or a minor haemorrhage : FIGO recommendations (menstruation more than 8 days, inter menstrual bleeding, presence of blood clots, resort to health professionnal, dose or treatment modification Minor haemorrhage : semi-quantitated score Pictorial Blood Assessment Chart >100 (PBAC)	up to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score measured with WHOQOL-BREF scale ( World Health Organization Quality of Life)	WHOQOL-BREF scale comprises 26 items with 5 level of answer ("very poor" to "very good"), each answer give 4 scores 0 to 100 (higher scores = high level of quality of life) for the 4 domains following : physical health, mental health, social relationship and environment.	Day 1 and week 6

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean Olivier Arnaud, Assistance Publique Hôpiaux Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Hemorrhage; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 2018-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No