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临床试验/NCT07267611
NCT07267611尚未招募不适用

Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding.

Assiut University0 个研究点目标入组 120 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
accuracy of Arabic Version of the SAMANTA Questionnaire

研究概览

简要总结

Heavy menstrual bleeding (HMB) significantly impacts women's quality of life (QoL). However, despite the high prevalence of HMB, culturally adapted screening tools remain scarce in our locality. This study aimed to adapt and validate the Arabic version of SAMANTA questionnaire for non-pregnant women of reproductive age.

HMB can primarily be a consequence of structural or functional disturbances within the reproductive system, but it may also be linked to structural and functional ailments of other bodily systems (vascular abnormalities, malignancies, or coagulation disorders) With the exact global prevalence varies from 4% to 51% across different countries and racial groups, with estimates suggesting that approximately one-third of reproductive-age women experiences HMB .

HMB is defined as excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life. It can occur alone or in combination with other symptoms. The term heavy menstrual bleeding has replaced the term menorrhagia.

The gold standard for the measurement of blood in sanitary products is the extraction of hematin using a 5% sodium hydroxide solution and the estimation of the alkaline hematin content by spectrophotometry .

This method is not feasible in clinical practice and has only been used in research studies.

HMB can cause iron-deficiency anemia, which is among the leading causes of years lived with disability in low-income and middle-income countries (LMICs). It is also associated with a range of adverse functional outcomes, including lower productivity and income earning, reduced ability to perform daily activities, and limitations on social life and relationships.

Recent research in the area of HMB has recognized the importance of measuring "patient experience" as an outcome and the National Institute of Clinical Excellence from the UK suggests that any intervention for HMB should aim to improve quality of life rather than focusing on menstrual blood loss .

For women with HMB early and accurate diagnosis is important to prevent its negative consequences. However, in low resource settings, facilities are not always available. For this reason, a cheap, simple to use tool to identify women with HMB and its impact on their quality of life is needed.

In the present study, we test the ability of the Arabic version of SAMANTA-Q as a simple tool to identify women with HMB.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • women, from 15 to 45 years old
  • Reproductive age women

排除标准

  • Women with amenorrhea. Postmenopausal women. Pregnant women. Women who had given birth within the previous 6 months. Women with mental illness, or inability to make decisions or follow instructions.

结局指标

主要结局

accuracy of Arabic Version of the SAMANTA Questionnaire

时间窗: baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Mohamed Abdel Raheem

residant doctor at Assiut university hospital

Assiut University

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