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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hypermobile Ehlers-Danlos Syndrome
Intervention / Treatment

-

Contacts and Locations

Memphis

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female
  • * Age 12-40 years
  • * Presence of HMB
  • * Evidence of severe iron-deficiency anemia (hemoglobin level of \< 8 g/dL)
  • * 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

Ages Eligible for Study

12 Years to 40 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

St. Jude Children's Research Hospital,

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

Study Record Dates

2030-03