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

NCT ID: NCT07188259

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-06-30

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this 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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1- Female students of Assiut University.

Exclusion Criteria

1. Females known to have chronic anemia or hemolytic anemia by history

2. Females on anticoagulation treatment.

3. Females known to have coagulopathy.

4. Females with any chronic condition (diabetes mellitus, liver diseases, etc.) in the previous 12 months were excluded from participation in this study.

5. Females with a history of prior pregnancy (gravidity ≥1), regardless of outcome (live birth, miscarriage, abortion, or ectopic).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Ismail Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University,

Asyut, , Egypt

Countries

Egypt

Central Contacts

Yasmin I.Mohamed

Role: CONTACT

Yasmin.20134496@med.aun.edu.eg

01150883767

Amany Heshmat Abdelmoneam

Role: CONTACT

Dramany9@med.aun.edu.eg

01008725338

Facility Contacts

Mohamed Mahmoud Fahmy Fathalla, prof

Role: primary

mfathalla@aun.edu.eg

01154320395

References

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.

Reference Type: BACKGROUND

PMID: 34213477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37802092 (View on PubMed)

Other Identifiers

PIHMBFSAUE

Identifier Type: -

Identifier Source: org_study_id