Venous ThromboembolismTHROMBO-GYNNCT04920487
Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode
An observational study of Venous Thromboembolism, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare disease, but the majority of events occurring in women of childbearing age are associated with a particular hormonal context (mainly pregnancy… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2021to 31 Dec 2022
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and 12/31/2020 for VTE
Who may be able to join
- Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and 12/31/2020 for VTE
- ICD-10 codes I26, I80, I82, O22.3, O22.5.
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his or her data for this research.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare disease, but the majority of events occurring in women of childbearing age are associated with a particular hormonal context (mainly pregnancy and hormonal contraception). VTE is a multifactorial disease and the risk depends on the simultaneous presence of several triggers.
Read the detailed description
Certain frequent gynecological pathologies are emerging in the literature as new venous thrombotic risk factors independently of hormonal treatment. Indeed, in endometriosis, the prevalence of which is estimated to be around 10%, biological data are in favor of hypercoagulability. Only one epidemiological study has analyzed this parameter. It is a Japanese cohort study in 103,070 pregnant women including 77 VTE during pregnancy. Endometriosis and recurrent pregnancy loss (RPL) were identified as risk factors for VTE (OR: 2.70 (95%CI, 1.21-6.00) for endometriosis and 6.13 (95% 2.48-15.16) for RPL. In polycystic ovary syndrome (PCOS), whose prevalence is estimated at 7-12%, the associated risk of VTE is better known (OR 1.89, 95%CI 1.60-2.24) and was the subject of a recently published meta-analysis in which the principal investigator collaborated. To the investigators knowledge, no study describes the prevalence of gynecological pathologies in women with VTE.
Concerning hormonal contraception, estrogen-progestin contraception (EPC) is widely used in France and is associated with an increase in the risk of VTE of a factor of 3 to 6. After a venous thrombotic episode, EPC is contraindicated, and non-hormonal or progestin-only contraception (POC) can be used. Nevertheless, to date, few studies have focused on the management of hormonal contraceptive treatment at the time of a VTE episode. Moreover, the contraceptive options presented to patients are often based on multiple actors (vascular physicians, gynaecologists, midwives, general practitioners, etc.) and the experience of the VTE episode, for both patients and prescribers, may influence the contraceptive options proposed or chosen, as well as their compliance.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospectively assess the prevalence of gynecological pathologies in women at the time of VTE
Percentage of women with gynecological pathologies at time of VTE
Measured: Day 1
Secondary outcomes (2)
Analyze the characteristics of VTE according to the presence or absence of a gynecological pathology
Characteristics of VTE
Measured: Day 1
Describe of hormone therapy used after VTE
Percentage of women using hormonal treatment
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start5 Jun 2021
- Primary completion5 Jul 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine HUGON-RODIN, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920487
- Sponsor's protocol ID
- THROMBO-GYN
- Acronym
- THROMBO-GYN
- Status last verified
- Mar 2023
- First submitted
- 3 Jun 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mottais-Cosnefroy V, Pecourt M, Yannoutsos A, Fels A, Beaussier H, Alran S, Priollet P, Hugon-Rodin J. Hormone-dependent gynaecological disorders and contraceptive modalities in women with a history of venous thromboembolic event: The THROMBOGYN study. J Med Vasc. 2022 Nov-Dec;47(5-6):228-237. doi: 10.1016/j.jdmv.2022.10.015. Epub 2022 Nov 14.
PubMed 36464417
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode
- ClinicalTrials.gov ID
- NCT04920487
- Acronym / sponsor ID
- THROMBO-GYN / THROMBO-GYN
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Jun 2021 (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.
The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare disease, but the majority of events occurring in women of childbearing age are associated with a particular hormonal context (mainly pregnancy and hormonal contraception). VTE is a multifactorial disease and the risk depends on the simultaneous presence of several triggers.
Detailed description
Certain frequent gynecological pathologies are emerging in the literature as new venous thrombotic risk factors independently of hormonal treatment. Indeed, in endometriosis, the prevalence of which is estimated to be around 10%, biological data are in favor of hypercoagulability. Only one epidemiological study has analyzed this parameter. It is a Japanese cohort study in 103,070 pregnant women including 77 VTE during pregnancy. Endometriosis and recurrent pregnancy loss (RPL) were identified as risk factors for VTE (OR: 2.70 (95%CI, 1.21-6.00) for endometriosis and 6.13 (95% 2.48-15.16) for RPL. In polycystic ovary syndrome (PCOS), whose prevalence is estimated at 7-12%, the associated risk of VTE is better known (OR 1.89, 95%CI 1.60-2.24) and was the subject of a recently published meta-analysis in which the principal investigator collaborated. To the investigators knowledge, no study describes the prevalence of gynecological pathologies in women with VTE.
Concerning hormonal contraception, estrogen-progestin contraception (EPC) is widely used in France and is associated with an increase in the risk of VTE of a factor of 3 to 6. After a venous thrombotic episode, EPC is contraindicated, and non-hormonal or progestin-only contraception (POC) can be used. Nevertheless, to date, few studies have focused on the management of hormonal contraceptive treatment at the time of a VTE episode. Moreover, the contraceptive options presented to patients are often based on multiple actors (vascular physicians, gynaecologists, midwives, general practitioners, etc.) and the experience of the VTE episode, for both patients and prescribers, may influence the contraceptive options proposed or chosen, as well as their compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and 12/31/2020 for VTE
Key inclusion criteria (2 listed)
- Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and 12/31/2020 for VTE
- ICD-10 codes I26, I80, I82, O22.3, O22.5.
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his or her data for this research.
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
Retrospectively assess the prevalence of gynecological pathologies in women at the time of VTE
Time frame: Day 1
Percentage of women with gynecological pathologies at time of VTE
2 secondary outcomes
Analyze the characteristics of VTE according to the presence or absence of a gynecological pathology
Time frame: Day 1
Describe of hormone therapy used after VTE
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Results publication: PubMed 36464417Mottais-Cosnefroy V, Pecourt M, Yannoutsos A, Fels A, Beaussier H, Alran S, Priollet P, Hugon-Rodin J. Hormone-dependent gynaecological disorders and contraceptive modalities in women with a history of venous thromboembolic event: The THROMBOGYN study. J Med Vasc. 2022 Nov-Dec;47(5-6):228-237. doi: 10.1016/j.jdmv.2022.10.015. Epub 2022 Nov 14.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
Justine HUGON-RODIN, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Venous Thromboembolism, run by Fondation Hôpital Saint-Joseph 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retrospectively assess the prevalence of gynecological pathologies in women at the time of VTE (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04920487, which also lists 1 linked publication.
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 8 Mar 2023.