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Impact of Ehlers-Danlos Syndrome on Gynaecological Health

ConditionEhlers-Danlos Syndrome (EDS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

women diagnosed with Ehlers-Danlos syndrome (EDS)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

156 Participants
are grouped into 2 trial groups
Group A: Experimental group: women with Ehlers-Danlos syndrome (EDS)
Group B: Comparator group: Women not affected by Ehlers-Danlos syndrome (EDS)

Trial outcomes

Primary outcomes

1

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"

Time frame
Day 1

Secondary outcomes

1

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."

Time frame
Day1
2

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."

Time frame
Day1
3

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."

Time frame
Day1
4

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.".

Time frame
Day1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov
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