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NCT05685199
Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
Conditions: Hypermobile Ehlers-Danlos Syndrome, Heavy Menstrual Bleeding, Hypermobility Syndrome (Disorder)
Sex: Female
Ages: 12 Years – 40 Years
Enrollment: 150
Sponsor: St. Jude Children's Research Hospital
Location: United States
Summary
In this study, researchers want to learn about the connection between heavy bleeding issues and joint hypermobility (loose joints).
They want to know if these issues may indicate other connective tissue problems in girls and women with heavy menstrual bleeding who do not have a known cause.Primary ObjectiveCompare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).Secondary ObjectivesCompare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
Eligibility Criteria
Inclusion Criteria:Female12-40 years of ageNot currently pregnantNo documented uterine structural abnormalitySelf-BAT score of ≥6Prothrombin Time/ activated Partial Thromboplastin Time/Fibrinogen and Von Willebrand Factor activity, antigen and Factor 8 are not reflective of a bleeding disorderExclusion Criteria:Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.Current use of anticoagulant and antiplatelet medicationsMedical conditions that could cause heavy menstrual bleeding but are not necessarily a bleeding disorder including, but not limited to:Uncontrolled hypertension,Insulin Dependent Diabetes Mellitus,Chronic Kidney Disease,Chronic Liver Disease,Thyroid disease,Documented Peripheral Arterial Disease, venous or arterial vascular events in the pastA structural pathology that would explain the Heavy Menstrual BleedingPersistent thrombocytopenia as defined by a platelet count of <150,000/uLIf the participant answers "yes" to any of the pre-screening questions:Could the patient have a known connective tissue disorder?Family history of sudden deathFamily history/personal history of uterine rupture or bowel perforationFamily history/personal history of arterial ruptureFamily history/personal history of aneurysmFamily history/personal history of an established Ehlers Danlos Syndrome diagnosis based on genetic evaluation
Source: ClinicalTrials.gov (NCT05685199). StuddyBuddy aggregates publicly available trial information.