CHU de ROUEN
Rouen, 76031, France
Location status: Recruiting
NCT Number: NCT07151274
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.
Interested in participating?
Request Info18 year–50 year
Female
Observational
Rouen, 76031, France
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
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"
Time frame: Day1
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."
Time frame: Day1
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."
Time frame: Day1
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."
Time frame: Day1
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.".
Time frame: Day1
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."
Time frame: Day 1
Evaluate the frequency of occurrence of a menorrhagia
Time frame: Day 1
Evaluate the frequency of occurrence of endometriosis
Time frame: Day 1
Evaluate the frequency of occurrence of a adenomyosis
Time frame: Day 1
Evaluate the frequency of occurrence of PCOS
Time frame: Day 1
Evaluate the frequency of occurrence of abnormal cervical smear
Contact information is provided by the study sponsor or research team.
Constance CB BOHN, Doctor
CONTACT
02 32 88 07 89 ext. +33
Mathilde ML LECOINTRE, Doctor
CONTACT
02 32 88 07 89 ext. +33
University Hospital, Rouen
Other
Impact of Ehlers-Danlos Syndrome on Gynaecological Health: Focus on the Prevalence of Dysmenorrhoea
Acronym: GYNESED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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