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

NCT07188259 | Not Yet Recruiting

• 1 other identifier: PIHMBFSAUE
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

• the prevalence of heavy menstrual bleeding (HMB)

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

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

Secondary Outcomes (2)

• 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

Study Arms (2)

Heavy menstrual bleeding positive group

After using the SAMANTA scale, if we find a score of 3 or more, this will be: Heavy menstrual bleeding positive group

Heavy menstrual bleeding negative group

After using the SAMANTA scale, if we find a score less than 3, this will be: Heavy menstrual bleeding negative group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female Students in Assiut University, Egypt who accepted to share in the study

You may qualify if:

• Female students of Assiut University.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University,

Asyut, 71515, Egypt

Location

Related Publications (2)

• 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 BACKGROUND

• 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/S2214-109X(23)00416-3. Epub 2023 Oct 3.

  PMID: 37802092 BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Central Study Contacts

Yasmin I.Mohamed

CONTACT

01150883767; Yasmin.20134496@med.aun.edu.eg

Amany Heshmat Abdelmoneam

CONTACT

01008725338; Dramany9@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

EG (1)