Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 12-40 years
- •Presence of HMB
- •Evidence of severe iron-deficiency anemia (hemoglobin level of < 8 g/dL)
排除标准
- •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
研究组 & 干预措施
Case Group
Participants with heavy menstrual bleeding (HMB)
Control Group
Participants without heavy menstrual bleeding (HMB)
结局指标
主要结局
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)
时间窗: Yearly for 3 years
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.
Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
时间窗: Approximately 3 years
The proportion of patients with G-HSD/hEDS will be reported
Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
时间窗: Approximately 3 years
The number of patients with G-HSD/hEDS will be reported
次要结局
- 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): Menstrual Distress Questionnaire(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): 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): Compass 31(Yearly for 3 years)