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

NCT05685199 | Terminated

• 1 other identifier: IDBLEED
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Severity of bleeding symptoms in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Self-Bleeding Assessment Tool (Self-Bat)

  Summary statistics of bleed score including mean, median, standard deviation and range will be reported for women with and without G-HSD/hEDS. The Self-BAT which consist of 14 categories for assessing bleeding symptom will be used. Each of the 14 variables is scored from 0-4 (except CNS bleeding when the scores are 0, 3 and 4) and on the basis of this a final score is derived. Scores of ≥ 3 in children, ≥ 4 in adult males and ≥ 6 in adult females is considered abnormal.

  Yearly for 3 years

• Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).

  The number of patients with G-HSD/hEDS will be reported

  Approximately 3 years

• Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).

  The proportion of patients with G-HSD/hEDS will be reported

  Approximately 3 years

Secondary Outcomes (5)

• Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) - PHQ15

  Yearly for 3 years

• Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Peds Patient-reported Outcomes Measurement Information System (PROMIS) 49 and Parent Proxy 49

  Yearly for 3 years

• Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): PROMIS 57

  Yearly for 3 years

• Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Compass 31

  Yearly for 3 years

• Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Menstrual Distress Questionnaire

  Yearly for 3 years

Study Arms (2)

Case Group

Participants with heavy menstrual bleeding (HMB)

Control Group

Participants without heavy menstrual bleeding (HMB)

Eligibility Criteria

• Age: 12 Years - 40 Years
• Gender Eligibility Details: Female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who meet the Eligibility criteria and consent

You may qualify if:

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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Wallace H. Coulter Foundation: collaborator
• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

Biospecimen

Retention: SAMPLES WITH DNA

Participants will provide a sample of blood for banking.

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Menorrhagia; Joint Instability

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Rohith Jesudas, MBBS

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 17, 2023
• Study Start: May 10, 2024
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)