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Not yet recruiting NCT07188259

Prevalence and Impact on Quality of Life, Academic Performance, and Blood Indices of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt

Observational Menorrhagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Menorrhagia. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

1- Female students of Assiut University.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

Egypt · 1 center
  • Assiut University, — Asyut

Publications

  • Nwagha TU, Okoye HC, Ugwu AO, Ugwu EO. Clinical screening for menorrhagia and other bleeding symptoms in Nigerian women. Ann Afr Med. 2021 Apr-Jun;20(2):111-115. doi: 10.4103/aam.aam_26_20. PMID 34213477
  • Sinharoy SS, Chery L, Patrick M, Conrad A, Ramaswamy A, Stephen A, Chipungu J, Reddy YM, Doma R, Pasricha SR, Ahmed T, Chiwala CB, Chakraborti N, Caruso BA. Prevalence of heavy menstrual bleeding and associations with physical health and wellbeing in low-income and middle-income countries: a multinational cross-sectional study. Lancet Glob Health. 2023 Nov;11(11):e1775-e1784. doi: 10.1016/S2214-10 PMID 37802092

Identifiers

NCT: NCT07188259 · PIHMBFSAUE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗