MenorrhagiamenorrhagiaNCT07188259
Prevalence and Impact on Quality of Life, Academic Performance, and Blood Indices of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt
An observational study of Menorrhagia, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- How many people
- 340 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2025to Jun 2027
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female Students in Assiut University, Egypt who accepted to share in the study
Who may be able to join
- 1- Female students of Assiut University.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University,
Asyut, 71515
Mohamed Mahmoud Fahmy Fathalla, prof, 01154320395, mfathalla@aun.edu.eg
About this study
Official title: Prevalence and Impact of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt
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
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of heavy menstrual bleeding (HMB)
to estimate the prevalence of heavy menstrual bleeding (HMB) among Assiut university female students.
Measured: 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.
To evaluate the impact of heavy menstrual bleeding (HMB) on participants' quality of life and academic performance.
Measured: through study completion, an average of 6 months to 1 year
Hematologic (CBC indices, serum ferritin and coagulation profile) between participants
Compare hematologic (CBC indices, serum ferritin and coagulation profile) between participants with HMB and partcipants without HMB.
Measured: within 2 months after questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ismail Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188259
- Sponsor's protocol ID
- PIHMBFSAUE
- Acronym
- menorrhagia
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34213477Sinharoy 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.
PubMed 37802092
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Heavy Menstrual Bleeding Among Female Students in Assiut University, Egypt
- ClinicalTrials.gov ID
- NCT07188259
- Acronym / sponsor ID
- menorrhagia / PIHMBFSAUE
- Conditions
- Menorrhagia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female Students in Assiut University, Egypt who accepted to share in the study
Key inclusion criteria (1 listed)
- 1- Female students of Assiut University.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the prevalence of heavy menstrual bleeding (HMB)
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 34213477Nwagha 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.
- Background: PubMed 37802092Sinharoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmin I.Mohamed (01150883767, Yasmin.20134496@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of heavy menstrual bleeding (HMB) (time frame: through study completion, an average of 6 months to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07188259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.