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临床试验/NCT07188259
NCT07188259尚未招募不适用

Prevalence and Impact of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt

Assiut University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
340
试验地点
1
主要终点
the prevalence of heavy menstrual bleeding (HMB)

研究概览

简要总结

The cause of menstrual disorders is unknown because many female students, embarrassed or unsure of what is "normal," never seek care. In young females, abnormal uterine bleeding is usually functional-reflecting immaturity or dysregulation of the hypothalamic-pituitary-ovarian axis, anovulatory cycles, or inherited bleeding disorders-while serious structural pathology is rare. Nevertheless, early bleeding can be the first sign of conditions such as polycystic-ovary syndrome, endometriosis, or von Willebrand disease. It is the primary source of iron-deficiency anemia in females before marriage, leading to chronic fatigue, diminished academic performance, and lower exam results.

A sectional study will be performed using a semi-structured questionnaire to assess the presence of HMB using the SAMANTA scale after its Arabic validation, and also evaluate the effect of HMB on quality of life using the validated heavy menstrual bleeding scale and assess impact on academic performance finally both females with positive HMB or not will asked to do Complete blood count (CBC), serum ferritin and coagulation profile.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •1- Female students of Assiut University.

排除标准

  • •Females known to have chronic anemia or hemolytic anemia by history
  • •Females on anticoagulation treatment.
  • •Females known to have coagulopathy.
  • •Females with any chronic condition (diabetes mellitus, liver diseases, etc.) in the previous 12 months were excluded from participation in this study.
  • •Females with a history of prior pregnancy (gravidity ≥1), regardless of outcome (live birth, miscarriage, abortion, or ectopic).

结局指标

主要结局

the prevalence of heavy menstrual bleeding (HMB)

时间窗: through study completion, an average of 6 months to 1 year.

to estimate the prevalence of heavy menstrual bleeding (HMB) among Assiut university female students.

次要结局

  • impact of heavy menstrual bleeding (HMB) on participants' quality of life and academic performance.(through study completion, an average of 6 months to 1 year)
  • Hematologic (CBC indices, serum ferritin and coagulation profile) between participants(within 2 months after questionnaire)

研究者

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

Yasmin Ismail Mohamed

Principal Investigator

Assiut University

研究点 (1)

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