Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults With and Without a Bleeding Disorder: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Percentage of reduction in menstrual blood loss
研究概览
简要总结
The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.
详细描述
Adolescents with heavy menstrual bleeding and willing to start a hormonal medication to reduce menstrual flow are included. At baseline and during the study period, questionnaires and blood tests are performed. Adolescents with a bleeding disorder are compared to those without. Follow-up is 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adolescents and young adults aged < 26yo
- •Presenting to the gynecology consultation at HUG
- •Diagnosed with heavy menstrual bleeding (PBAC > 100)
- •Willing to initiate a hormonal medication to manage heavy menstrual bleeding
排除标准
- •Pregnancy or planning to become pregnant during the study period
- •Already using hormonal medication for menstrual management and/or contraception
- •Known anatomical uterine pathology
- •Using anticoagulant or antiaggregant agents
结局指标
主要结局
Percentage of reduction in menstrual blood loss
时间窗: 6 months after hormonal medication initiation
Using PBAC (pictorial blood loss assessment chart)
次要结局
- Percentage of reduction in menstrual blood loss(12 months after hormonal medication initiation)
- Quality of life(at baseline, 3 months, 6 months and 12 months)
- Hemoglobin and ferritin levels changes(at baseline, 6 months and 12 months)
- Changes in thrombin generation markers(at baseline and 6 months)
研究者
Dehlia Moussaoui
Principal investigator
University Hospital, Geneva