Genital HaemorrhageGENB-OABNCT03772366
Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life
An observational study of Genital Haemorrhage, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Haemorrhage
- Type of treatment
- Pill or oral medicine
- How many people
- 453 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux Marseille
Marseille, Bouches Du Rhônes, 13354
About this study
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.
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.
- Conditions
- Genital Haemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antivitamin K | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to week 6
Secondary outcomes (1)
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.
Measured: Day 1 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Jun 2019
- Primary completion31 Dec 2021
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HaemorrhageStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier Arnaud, Study director, Assistance Publique Hôpiaux Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772366
- Sponsor's protocol ID
- 2018-17
- Acronym
- GENB-OAB
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03772366
- Acronym / sponsor ID
- GENB-OAB / 2018-17
- Conditions
- Genital Haemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Antivitamin K | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- <18 years patient
- Woman whose pregnancy is known
- Pre menopause
- Absence of menstruation
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Quality of life score measured with WHOQOL-BREF scale ( World Health Organization Quality of Life)
Time frame: Day 1 and week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Olivier Arnaud study director
Assistance Publique Hôpiaux Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Haemorrhage, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.