Heavy Menstrual BleedingNCT07267611
Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding
An observational study of Heavy Menstrual Bleeding, run by Assiut University.
Trial summary
Heavy menstrual bleeding (HMB) significantly impacts women's quality of life (QoL). However, despite the high prevalence of HMB, culturally adapted screening tools remain scarce in our locality. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Heavy Menstrual Bleeding
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Reproductive age women, from 15 to 45 years old were eligible for the study
Who may be able to join
- women, from 15 to 45 years old
- Reproductive age women
Who cannot join
- Women with amenorrhea. Postmenopausal women. Pregnant women. Women who had given birth within the previous 6 months. Women with mental illness, or inability to make decisions or follow instructions.
About this study
Official title: Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding.
Heavy menstrual bleeding (HMB) significantly impacts women's quality of life (QoL). However, despite the high prevalence of HMB, culturally adapted screening tools remain scarce in our locality. This study aimed to adapt and validate the Arabic version of SAMANTA questionnaire for non-pregnant women of reproductive age.
HMB can primarily be a consequence of structural or functional disturbances within the reproductive system, but it may also be linked to structural and functional ailments of other bodily systems (vascular abnormalities, malignancies, or coagulation disorders) With the exact global prevalence varies from 4% to 51% across different countries and racial groups, with estimates suggesting that approximately one-third of reproductive-age women experiences HMB .
Read more
HMB is defined as excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life. It can occur alone or in combination with other symptoms. The term heavy menstrual bleeding has replaced the term menorrhagia.
The gold standard for the measurement of blood in sanitary products is the extraction of hematin using a 5% sodium hydroxide solution and the estimation of the alkaline hematin content by spectrophotometry .
This method is not feasible in clinical practice and has only been used in research studies.
HMB can cause iron-deficiency anemia, which is among the leading causes of years lived with disability in low-income and middle-income countries (LMICs). It is also associated with a range of adverse functional outcomes, including lower productivity and income earning, reduced ability to perform daily activities, and limitations on social life and relationships.
Recent research in the area of HMB has recognized the importance of measuring "patient experience" as an outcome and the National Institute of Clinical Excellence from the UK suggests that any intervention for HMB should aim to improve quality of life rather than focusing on menstrual blood loss .
For women with HMB early and accurate diagnosis is important to prevent its negative consequences. However, in low resource settings, facilities are not always available. For this reason, a cheap, simple to use tool to identify women with HMB and its impact on their quality of life is needed.
In the present study, we test the ability of the Arabic version of SAMANTA-Q as a simple tool to identify women with HMB.
- Conditions
- Heavy Menstrual Bleeding
- 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 |
|---|---|---|
| Group A | Reproductive age women, from 15 to 45 years old with heavy Menstrual Bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of Arabic Version of the SAMANTA Questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Abdel Raheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267611
- Sponsor's protocol ID
- SAMANTA HMB
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding.
- ClinicalTrials.gov ID
- NCT07267611
- Acronym / sponsor ID
- SAMANTA HMB
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Dec 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.
Heavy menstrual bleeding (HMB) significantly impacts women's quality of life (QoL). However, despite the high prevalence of HMB, culturally adapted screening tools remain scarce in our locality. This study aimed to adapt and validate the Arabic version of SAMANTA questionnaire for non-pregnant women of reproductive age.
HMB can primarily be a consequence of structural or functional disturbances within the reproductive system, but it may also be linked to structural and functional ailments of other bodily systems (vascular abnormalities, malignancies, or coagulation disorders) With the exact global prevalence varies from 4% to 51% across different countries and racial groups, with estimates suggesting that approximately one-third of reproductive-age women experiences HMB .
HMB is defined as excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life. It can occur alone or in combination with other symptoms. The term heavy menstrual bleeding has replaced the term menorrhagia.
The gold standard for the measurement of blood in sanitary products is the extraction of hematin using a 5% sodium hydroxide solution and the estimation of the alkaline hematin content by spectrophotometry .
This method is not feasible in clinical practice and has only been used in research studies.
HMB can cause iron-deficiency anemia, which is among the leading causes of years lived with disability in low-income and middle-income countries (LMICs). It is also associated with a range of adverse functional outcomes, including lower productivity and income earning, reduced ability to perform daily activities, and limitations on social life and relationships.
Recent research in the area of HMB has recognized the importance of measuring "patient experience" as an outcome and the National Institute of Clinical Excellence from the UK suggests that any intervention for HMB should aim to improve quality of life rather than focusing on menstrual blood loss .
For women with HMB early and accurate diagnosis is important to prevent its negative consequences. However, in low resource settings, facilities are not always available. For this reason, a cheap, simple to use tool to identify women with HMB and its impact on their quality of life is needed.
In the present study, we test the ability of the Arabic version of SAMANTA-Q as a simple tool to identify women with HMB.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Reproductive age women, from 15 to 45 years old with heavy Menstrual Bleeding. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Reproductive age women, from 15 to 45 years old were eligible for the study
Key inclusion criteria (2 listed)
- women, from 15 to 45 years old
- Reproductive age women
Key exclusion criteria (1 listed)
- Women with amenorrhea. Postmenopausal women. Pregnant women. Women who had given birth within the previous 6 months. Women with mental illness, or inability to make decisions or follow instructions.
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
accuracy of Arabic Version of the SAMANTA Questionnaire
Time frame: baseline
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 5 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding, run by Assiut University.
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 2 inclusion and 1 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 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of Arabic Version of the SAMANTA Questionnaire (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.