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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Jan 11, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how heavy menstrual bleeding (HMB) might be related to joint hypermobility, which means having joints that move beyond the normal range. Researchers are particularly interested in understanding if these bleeding issues could indicate other connective tissue problems in girls and women aged 12 to 40 who experience heavy bleeding without a clear cause. By comparing women with and without a specific joint condition called Generalized Hypermobility Syndrome, the study aims to see if there are differences in the severity of their bleeding and any other related health issues.

To participate in this trial, women must be between 12 and 40 years old, have heavy menstrual bleeding, and show signs of severe anemia (a condition where you don't have enough healthy red blood cells). However, those currently pregnant, taking certain medications, or with specific medical conditions that could explain their bleeding will not be eligible. Participants can expect to be part of a study that contributes to understanding these health issues better, which could help improve future treatments and support for women facing similar challenges.

Gender

FEMALE

Eligibility 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