Understanding the link between heavy menstrual bleeding and joint hypermobility in women
Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
This study is trying to see if women aged 12-40 with joint hypermobility have heavier menstrual bleeding compared to those without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 12 Years to 40 Years |
| Sex | Female |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05685199 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between heavy menstrual bleeding (HMB) and joint hypermobility in females aged 12-40 years. Researchers will compare the severity of HMB in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using bleeding scores. Participants will undergo a series of evaluations, including the Beighton score and various symptom questionnaires, to classify their conditions and document their symptoms over three years. The study also involves banking blood samples for future research.
Who should consider this trial
Good fit: Ideal candidates are females aged 12-40 years experiencing heavy menstrual bleeding and severe iron-deficiency anemia.
Not a fit: Patients with identifiable bleeding disorders or other medical conditions causing heavy menstrual bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of heavy menstrual bleeding in women with joint hypermobility.
How similar studies have performed: While the specific connection between heavy menstrual bleeding and joint hypermobility is less explored, similar studies have shown promising results in understanding related connective tissue disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 12-40 years * Presence of HMB * Evidence of severe iron-deficiency anemia (hemoglobin level of \< 8 g/dL) Exclusion Criteria: * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Current use of anticoagulant and antiplatelet medications * Currently pregnant * Medical conditions that could cause HMB but are not necessarily a bleeding disorder, including, but not limited to: * Uncontrolled hypertension * Documented uterine structural abnormality * Insulin-dependent diabetes mellitus * Chronic kidney disease * Chronic liver disease * Thyroid disease * Documented peripheral arterial disease, venous or arterial vascular events in the past * A structural pathology that would explain the HMB * Presence of a bleeding disorder indicated by prothrombin time, activated partial thromboplastin time, fibrinogen, and von Willebrand factor activity, antigen and factor VIII * Persistent thrombocytopenia as defined by a platelet count of \<150,000/uL * If the participant answers "yes" to any of the following questions, they are ineligible: * Could the patient have a known connective tissue disorder? * Family history of sudden death * Family history/personal history of uterine rupture or bowel perforation * Family history/personal history of arterial rupture * Family history/personal history of aneurysm * Family history/personal history of an established EDS diagnosis based on genetic evaluation
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Rohith Jesudas, MBBS — St. Jude Children's Research Hospital
- Study coordinator: Rohith Jesudas, MBBS
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.