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

Heavy Menstrual Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685199
• Other study ID #: IDBLEED
• Status: Recruiting
• Start date: May 10, 2024
• Est. completion date: March 2030

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: Rohith Jesudas, MBBS
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2030
• Est. primary completion date: March 2026
• Gender: Female
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Heavy Menstrual Bleeding
• Hemorrhage
• Hypermobile Ehlers-Danlos Syndrome
• Menorrhagia
• Syndrome

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) - PHQ15	Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using PHQ 15. The PHQ-15 is a subscale of the full Patient Health Questionnaire (PHQ) and screens for 15 somatic symptoms. It scores symptom presence and severity on a 3-point Likert scale (0-2). The total score ranges from 0-30 with higher values indicating increased severity as follows: Minimal (0-4); Low (5-9); Medium (10-14); High (15-30).	Yearly for 3 years
Secondary	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	Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using Peds PROMIS 49 and Parent Proxy 49. The Peds PROMIS 49 is self-reported measures of global, physical, mental, and social health for children (ages 8-17) in the general population and those living with a chronic condition. The Parent Proxy 49 is intended for parents serving as proxy for their child (youth ages 5-17). PROMIS scores are reported as T scores ranging from 0-100. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.	Yearly for 3 years
Secondary	Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): PROMIS 57	Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using adult PROMIS 57. The PROMIS 57 is for self-reporting measures of global, physical, mental, and social health for adults in the general population and those living with a chronic condition. PROMIS scores are reported as T scores ranging from 0-100. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.	Yearly for 3 years
Secondary	Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Compass 31	Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using COMPASS31. The COMPASS31 contains 31 questions with Likert scales ranging in length from 2 to 6 items with higher scores indicating increased severity. COMPASS31 provides raw scores and standardized scores providing a total weighted score (0-100) of severity. The scale yields 6 subscales and a total score as follows: Orthostatic intolerance (4-10), Vasomotor (3-6); Secretomotor (4-7); Gastrointestinal (12-28); Bladder (3-9); Pupillomotor (5-15); Total (31-75)	Yearly for 3 years
Secondary	Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Menstrual Distress Questionnaire	Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS)using the Menstrual Distress Questionnaire. This is a 21-element survey (ENDOPAIN 4D) which measures the gynecological and pelvic pain symptoms associated with periods. Each question is on a 11-point Likert scale with higher scores reflecting more severe symptoms or symptoms that most closely resemble the description.	Yearly for 3 years

External Links

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