RECRUITING

Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Objective * Compare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using bleeding scores. Secondary Objectives * Compare the frequency of co-morbidities in women with and without G-HSD/hEDS.

Official Title

Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding

Quick Facts

Study Start:2024-05-10
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05685199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age 12-40 years
  3. * Presence of HMB
  4. * Evidence of severe iron-deficiency anemia (hemoglobin level of \< 8 g/dL)
  1. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  2. * Current use of anticoagulant and antiplatelet medications
  3. * Currently pregnant
  4. * Medical conditions that could cause HMB but are not necessarily a bleeding disorder, including, but not limited to:
  5. * Uncontrolled hypertension
  6. * Documented uterine structural abnormality
  7. * Insulin-dependent diabetes mellitus
  8. * Chronic kidney disease
  9. * Chronic liver disease
  10. * Thyroid disease
  11. * Documented peripheral arterial disease, venous or arterial vascular events in the past
  12. * A structural pathology that would explain the HMB
  13. * Presence of a bleeding disorder indicated by prothrombin time, activated partial thromboplastin time, fibrinogen, and von Willebrand factor activity, antigen and factor VIII
  14. * Persistent thrombocytopenia as defined by a platelet count of \<150,000/uL
  15. * If the participant answers "yes" to any of the following questions, they are ineligible:
  16. * Could the patient have a known connective tissue disorder?
  17. * Family history of sudden death
  18. * Family history/personal history of uterine rupture or bowel perforation
  19. * Family history/personal history of arterial rupture
  20. * Family history/personal history of aneurysm
  21. * Family history/personal history of an established EDS diagnosis based on genetic evaluation

Contacts and Locations

Study Contact

Rohith Jesudas, MBBS
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Rohith Jesudas, MBBS
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Rohith Jesudas, MBBS, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-10
Study Completion Date2030-03

Study Record Updates

Study Start Date2024-05-10
Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

  • Heavy Menstrual Bleeding
  • Joint Hypermobility
  • Hypermobile Ehlers-Danlos Syndrome
  • Generalized joint Hypermobility Syndrome Disorder
  • Loose Joints

Additional Relevant MeSH Terms

  • Hypermobile Ehlers-Danlos Syndrome
  • Heavy Menstrual Bleeding
  • Hypermobility Syndrome (Disorder)