Clinical trial NCT05685199: Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
Official title: Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
First posted: 2023-01-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who meet the Eligibility criteria and consent

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: The researchers will screen for patients referred to St. Jude due to HMB. 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).

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

Primary outcomes:
measure: 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)
timeFrame: Yearly for 3 years
measure: Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
timeFrame: Approximately 3 years
measure: Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) - PHQ15
timeFrame: Yearly for 3 years
measure: 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
timeFrame: Yearly for 3 years
measure: Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): PROMIS 57
timeFrame: Yearly for 3 years
measure: Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Compass 31
timeFrame: Yearly for 3 years
measure: Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Menstrual Distress Questionnaire
timeFrame: Yearly for 3 years
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Rohith Jesudas, MBBS
role: PRINCIPAL_INVESTIGATOR
References: