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

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Heavy Bleeding / Heavy Periods

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT05685199

IDBLEED

Ages 12-40
Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Inability or unwillingness of research participant or legal guardian/representativeto 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 inthe past
A structural pathology that would explain the HMB
Presence of a bleeding disorder indicated by prothrombin time, activated partialthromboplastin time, fibrinogen, and von Willebrand factor activity, antigen andfactor 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 areineligible:
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 ongenetic evaluation

Study Design

May 10, 2024

January 06, 2026

Study 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.

Connect with a study center

St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
Site Not Available
St. Jude Children's Research Hospital
Memphis 4641239, Tennessee 4662168 38105
United States
Site Not Available

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