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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 (GENB-OAB)

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ClinicalTrials.gov Identifier: NCT03772366
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Genital Haemorrhage

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Study Type : Observational
Estimated Enrollment : 575 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Warfarine
Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Warfarine
Fluindione
Women in childbearing age treated for a venous thromboembolic disease with oral coagulant : Fluindione
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.



Primary Outcome Measures :
  1. Proportion of women with a major genital haemorrhage and/or a minor genital haemorrhage but clinically significant and/or a minor haemorrhage. [ Time Frame: up to week 6 ]
    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)


Secondary Outcome Measures :
  1. Quality of life score measured with WHOQOL-BREF scale ( World Health Organization Quality of Life) [ Time Frame: Day 1 and week 6 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772366


Contacts
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Contact: Gabrielle Sarlon-Bartoli, Dr +33(0)4 91 38 70 23 gabrielle.sarlon@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux Marseille
Marseille Cedex 05, Bouches Du Rhônes, France, 13354
Contact: Gabrielle Sarlon-Bartoli, Dr    +33(0)4 91 38 70 23    gabrielle.sarlon@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean Olivier Arnaud Assistance Publique Hôpiaux Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03772366    
Other Study ID Numbers: 2018-17
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases