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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00962-47 | Other Identifier | ANSM |
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Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain. Some studies suggest an increased prevalence of gynaecological disorders, including dysmenorrhea, in patients with EDS. However, data remain limited and few studies have compared the intensity and characteristics of dysmenorrhea in women with EDS. There is also little data on the prevalence of other gynaecological conditions in women with EDS.
This study therefore aims to compare the severity of dysmenorrhea in patients with EDS and a control group in order to better characterise the gynaecological impact of EDS. It will also compare the prevalence of other gynaecological conditions between women with EDS and women without EDS.
Patients with SED report a high prevalence of gynaecological disorders, including severe dysmenorrhoea, menorrhagia and dyspareunia. Chronic pelvic pain and pelvic floor disorders are also common, impacting quality of life and reproductive function. Menorrhagia is common and may be due to capillary fragility and altered uterine connective tissue. The use of contraceptive hormones is often considered to reduce menstrual symptoms, although their effectiveness varies. A multidisciplinary approach is recommended to tailor treatments to the specific needs of patients.
Epidemiological data on the prevalence of EDS and hypermobility spectrum disorder show an increase in diagnoses, highlighting the importance of better clinical recognition.
Primary dysmenorrhoea is generally linked to excessive production of prostaglandins, leading to uterine hypercontractility and transient myometrial ischaemia. In patients with EDS, several pathophysiological mechanisms could contribute to exacerbated menstrual pain:
Thus, evidence of increased dysmenorrhoea severity in EDS patients could justify better pain management and gynaecological care for these patients.
Better recognition of gynaecological disorders in EDS could prevent late diagnoses and therapeutic uncertainty.
Better recognition of gynaecological disorders in EDS could help to avoid late diagnoses and therapeutic uncertainty.
The prospects for this research are to show that a significant difference could be observed and to explore the underlying mechanisms (dysautonomia, local inflammation, myometrial abnormalities) in greater depth. The benefits of specialised gynaecological care with the introduction of hormone therapy could also be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: women with Ehlers-Danlos syndrome (EDS) | Women with Ehlers-Danlos syndrome (EDS) of all types diagnosed by a healthcare professional | ||
| Comparator group: Women not affected by Ehlers-Danlos syndrome (EDS) | Women without Ehlers-Danlos syndrome (EDS) (control group) from a healthy volunteer base |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the severity of dysmenorrhea by Numerical Pain Scale (NPS) | The main objective of this study is to compare the severity of dysmenorrhea in patients with Ehlers-Danlos syndrome (EDS), all types combined, and a control group of patients without connective tissue disease. This comparison will determine whether EDS is a risk factor for more severe dysmenorrhea. The primary endpoint will be measured using the numerical pain scale (NPS), which assesses pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain" | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of clinical factors associated with the severity of dysmenorrhea (Age) using Numerical Pain Scale (NPS) | Examine the impact of age on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain." | Day1 |
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Inclusion Criteria:
Exclusion Criteria:
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women diagnosed with Ehlers-Danlos syndrome (EDS)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde ML LECOINTRE, Doctor | Contact | 02 32 88 07 89 | +33 | melodie.lecointre@chu-rouen.fr |
| Constance CB BOHN, Doctor | Contact | 02 32 88 07 89 | +33 | constance.bohn@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de ROUEN | Recruiting | Rouen | 76031 | France |
The data provided will be the property of the sponsor and will be used solely for its own research activities.
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| D004412 | Dysmenorrhea |
| D008595 | Menorrhagia |
| D004414 | Dyspareunia |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| Analysis of clinical factors associated with the severity of dysmenorrhea (Body Mass Index (BMI)) using Numerical Pain Scale (NPS) | Examine the impact of BMI on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain." | Day1 |
| Analysis of clinical factors associated with the severity of dysmenorrhea (age of onset of dysmenorrhea,) using Numerical Pain Scale (NPS) | Examine the impact of age of onset of dysmenorrhea, on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain." | Day1 |
| Analysis of clinical factors associated with the severity of dysmenorrhea (presence of associated menorrhagia) using Numerical Pain Scale (NPS) | Examine the impact of presence of associated menorrhagia on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain.". | Day1 |
| Analysis of clinical factors associated with the severity of dysmenorrhea (medical history) using Numerical Pain Scale (NPS) | Examine the impact of medical history on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain." | Day1 |
| Study of the prevalence of gynaecological conditions (menorrhagia) | Evaluate the frequency of occurrence of a menorrhagia | Day 1 |
| Study of the prevalence of gynaecological conditions (endometriosis) | Evaluate the frequency of occurrence of endometriosis | Day 1 |
| Study of the prevalence of gynaecological conditions (adenomyosis) | Evaluate the frequency of occurrence of a adenomyosis | Day 1 |
| Study of the prevalence of gynaecological conditions (PolyCystic ovary syndrome (PCOS)) | Evaluate the frequency of occurrence of PCOS | Day 1 |
| Study of the prevalence of gynaecological conditions (abnormal cervical smear) | Evaluate the frequency of occurrence of abnormal cervical smear | Day 1 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |