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

NCT ID: NCT05685199

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2026-01-06

Brief 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 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.

Detailed Description

Patients will be eligible for inclusion and offered to be screened for enrollment in this study if the duration of their menses was greater than or equal to 7 days, and they reported either "flooding" or bleeding through a tampon or napkin in 2 hours or less with most periods, have no identifiable bleeding disorder, and have evidence of severe iron deficiency anemia (hemoglobin < 8 g/dL).

Once enrolled, joint hypermobility will be evaluated using a Beighton score which will be used to assign participants to two groups: with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS). Participants will then undergo a detailed clinical examination to further classify them using the 2017 diagnostic criteria and complete symptom questionnaires. Finally, participants will be consented to TBANK (NCT01354002) and INSIGHT HD (NCT02720679) to provide a sample of leftover blood for banking for future research. Participants will be seen annually for the next 3 years as part of their standard of care to document the course of their symptoms.

Visit 1: Self-BAT Questionnaire, Beighton Score examination, 2017 hEDS examination, PROMIS (Peds/Parent) questionnaire, PHQ15 questionnaire, COMPASS31 questionnaire, Menstrual distress questionnaire (ENDOPAIN), and Heavy menstrual bleeding checklist (both pediatric and adult).

Visit 2: Self-BAT Questionnaire, PROMIS (Peds/Parent) questionnaire, PHQ15 questionnaire, COMPASS31 questionnaire, Menstrual distress questionnaire (ENDOPAIN).

Visit 3: Self-BAT Questionnaire, PROMIS (Peds/Parent) questionnaire, PHQ15 questionnaire, COMPASS31 questionnaire, Menstrual distress questionnaire (ENDOPAIN).

Please note: At the present time patient enrollment is limited to St. Jude established patients only.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case Group

Participants with heavy menstrual bleeding (HMB)

No interventions assigned to this group

Control Group

Participants without heavy menstrual bleeding (HMB)

No interventions assigned to this group

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wallace H. Coulter Foundation

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohith Jesudas, MBBS

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

ClinicalTrials Open at St. Jude

Other Identifiers

IDBLEED

Identifier Type: -

Identifier Source: org_study_id