Impact of Ehlers-Danlos Syndrome on Gynaecological Health
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Ehlers-Danlos Syndrome (EDS). Базовые параметры: 18 лет — 50 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
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Официальное название
Impact of Ehlers-Danlos Syndrome on Gynaecological Health: Focus on the Prevalence of Dysmenorrhoea
Обзор
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.
Подробное описание
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:
* Collagen dysregulation: fragility of uterine connective tissues that can alter myometrial contractility. * Frequent dysautonomia in SED: may alter uterine vascularisation and amplify pain. * Nociceptive hypersensitivity: described in patients with SED, increasing pain perception. This project hypothesises that patients with EDS experience more severe and/or more frequent dysmenorrhoea than the general population due to the tissue and neurological alterations specific to this syndrome.
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.
Первичные конечные точки
- Assessment of the severity of dysmenorrhea by Numerical Pain Scale (NPS) [Срок оценки: Day 1]
Вторичные конечные точки (10)
- Analysis of clinical factors associated with the severity of dysmenorrhea (Age) using Numerical Pain Scale (NPS) [Срок оценки: Day1]
- Analysis of clinical factors associated with the severity of dysmenorrhea (Body Mass Index (BMI)) using Numerical Pain Scale (NPS) [Срок оценки: Day1]
- Analysis of clinical factors associated with the severity of dysmenorrhea (age of onset of dysmenorrhea,) using Numerical Pain Scale (NPS) [Срок оценки: Day1]
- Analysis of clinical factors associated with the severity of dysmenorrhea (presence of associated menorrhagia) using Numerical Pain Scale (NPS) [Срок оценки: Day1]
- Analysis of clinical factors associated with the severity of dysmenorrhea (medical history) using Numerical Pain Scale (NPS) [Срок оценки: Day1]
- Study of the prevalence of gynaecological conditions (menorrhagia) [Срок оценки: Day 1]
- Study of the prevalence of gynaecological conditions (endometriosis) [Срок оценки: Day 1]
- Study of the prevalence of gynaecological conditions (adenomyosis) [Срок оценки: Day 1]
- Study of the prevalence of gynaecological conditions (PolyCystic ovary syndrome (PCOS)) [Срок оценки: Day 1]
- Study of the prevalence of gynaecological conditions (abnormal cervical smear) [Срок оценки: Day 1]
Критерии участия
Критерии включения
- Women aged 18 or over.
- Willing to participate voluntarily in the study via an online questionnaire.
- Of childbearing age.
- Reporting a diagnosis of EDS (all types) or not having EDS (control group) and being part of a database of healthy volunteers.
Критерии исключения
- Minors (< 18 years old).
- Menopausal women
- People who do not understand French well enough to complete the questionnaire.
- Uncertain diagnosis of EDS (exclusion of participants who suspect EDS but without medical confirmation).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Франция · 1 центр
- CHU de ROUEN — Rouen
Идентификаторы
NCT: NCT07151274 · 2025/0124/OB · 2025-A00962-47