Heavy Menstrual BleedingNCT05079815
Heavy Menstrual Bleeding and Iron Deficiency Anemia
An observational study of Heavy Menstrual Bleeding, run by Assiut University.
Trial summary
In the present study, we test the ability of AMSS as a simple tool to identify women with HMB who have ID/ IDA. We will compare the AMSS score to patients' hemoglobin and serum ferritin in women with self-reported HMB and women with normal menstrual flow. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- CBC and serum ferritin
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Adult
Study population: Details on the research will be explained to potentially eligible women. They will be given patient's information leaflet in Arabic (attached). The research team will emphasize that participation in the study is completely voluntary, and women can withdraw at any time without affecting level of care that is provided for them. Eligible women who accept to participate in the study will sign informed consent. Women will be assured on confidentiality and that data will be coded, with no names/ identifying information, and will be kept on a secure server through RedCap operated by Assiut Faculty of Medicine.3.4. Informed consent. Consent will be provided
Who may be able to join
- Reproductive age women, above age of 18 years old.
Who cannot join
- women with amenorrhea, postmenopausal women, current or past (in last 6 months) users of hormonal contraceptives, women who have delivered in the past year, or breast fed in past 6 months are all excluded from the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Arabic Version of Aberdeen Menorrhagia Severity Scale (AMSS) for Prediction of Iron Deficiency/ Iron Deficiency Anemia in Women With the Symptom of Chronic Heavy Menstrual Bleeding (HMB)
In the present study, we test the ability of AMSS as a simple tool to identify women with HMB who have ID/ IDA. We will compare the AMSS score to patients' hemoglobin and serum ferritin in women with self-reported HMB and women with normal menstrual flow.
Read the detailed description
Anemia remains a critical health burden in low- and middle-income countries (LMICs) and a paradigm shift is needed to effectively reduce the prevalence in women. The reproductive years place women at high risk of anemia in general, and iron deficiency anemia (IDA) in particular, largely because of menstrual and delivery -associated blood loss, as the lost iron is often not adequately replenished from dietary sources. Iron deficiency, even without anemia, has profound adverse effects on multiple cellular and metabolic parameters and frequently manifests with impaired cognitive and physical function. In Africa and Eastern Mediterranean regions, around 39% of non-pregnant women and 40-45% of pregnant women have anemia as estimated by The World Health Organization (WHO). Maternal anemia is a risk factor for preterm labor and both maternal and neonatal morbidity and mortality. Although data is limited, 5-28% of women in LMICs experience abnormal uterine bleeding (AUB) yet the importance of menstrual blood loss as an indicator of and a risk factor for anemia is frequently ignored in anemia control and prevention strategies. The condition is further complicated by the fact that both women and their physicians tend to normalize menstrual symptoms. To enable development of comprehensive interventions to address IDA among women in our locality, it is critical to characterize heavy menstrual bleeding (HMB) and its relationship with IDA among women and determine ways to use these data to direct women at risk for IDA to appropriate healthcare services for evaluation and treatment.
For women with HMB, early diagnosis and treatment of anemia is important to prevent its negative health consequences. However, in low resource settings, laboratory facilities are not always available. In addition, laboratory tests may be expensive limiting their use in such circumstances. For this reason, a cheap, simple to use tool to identify women at high risk of anemia who require further evaluation and treatment is needed.
The Aberdeen Menorrhagia Severity Scale (AMSS) is a multi-dimensional scale. It measures quality of life in women with HMB in addition to menstrual bleeding characteristics. AMSS consists of 13 questions. with a 4-point answer to each question. Maximum score is 47, which is converted to a percentage. The lower the scale is associated with better quality of life. The AMSS has been validated against the SF-36, which is a generic scale for measurement of quality of life.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- CBC and serum ferritin
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC and serum ferritinDiagnostic test
take blood sample for CBC and serum ferritin
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the Arabic version of Aberdeen Menorrhagia Severity Scale (AMSS) for prediction of iron deficiency/ iron deficiency anemia in women with the symptom of chronic heavy menstrual bleeding (HMB)
heavy menstrual bleeding and its relation to iron deficiency /iron deficiency anemia
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 May 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebraam Faiez Riad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079815
- Sponsor's protocol ID
- heavy menstrual bleeding
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cooke AG, McCavit TL, Buchanan GR, Powers JM. Iron Deficiency Anemia in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2017 Apr;30(2):247-250. doi: 10.1016/j.jpag.2016.10.010. Epub 2016 Oct 24.
PubMed 27789349Peuranpaa P, Heliovaara-Peippo S, Fraser I, Paavonen J, Hurskainen R. Effects of anemia and iron deficiency on quality of life in women with heavy menstrual bleeding. Acta Obstet Gynecol Scand. 2014 Jul;93(7):654-60. doi: 10.1111/aogs.12394. Epub 2014 Jun 9.
PubMed 24912842
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Arabic Version of Aberdeen Menorrhagia Severity Scale (AMSS) for Prediction of Iron Deficiency/ Iron Deficiency Anemia in Women With the Symptom of Chronic Heavy Menstrual Bleeding (HMB)
- ClinicalTrials.gov ID
- NCT05079815
- Acronym / sponsor ID
- heavy menstrual bleeding
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 15 Oct 2021 (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.
In the present study, we test the ability of AMSS as a simple tool to identify women with HMB who have ID/ IDA. We will compare the AMSS score to patients' hemoglobin and serum ferritin in women with self-reported HMB and women with normal menstrual flow.
Detailed description
Anemia remains a critical health burden in low- and middle-income countries (LMICs) and a paradigm shift is needed to effectively reduce the prevalence in women. The reproductive years place women at high risk of anemia in general, and iron deficiency anemia (IDA) in particular, largely because of menstrual and delivery -associated blood loss, as the lost iron is often not adequately replenished from dietary sources. Iron deficiency, even without anemia, has profound adverse effects on multiple cellular and metabolic parameters and frequently manifests with impaired cognitive and physical function. In Africa and Eastern Mediterranean regions, around 39% of non-pregnant women and 40-45% of pregnant women have anemia as estimated by The World Health Organization (WHO). Maternal anemia is a risk factor for preterm labor and both maternal and neonatal morbidity and mortality. Although data is limited, 5-28% of women in LMICs experience abnormal uterine bleeding (AUB) yet the importance of menstrual blood loss as an indicator of and a risk factor for anemia is frequently ignored in anemia control and prevention strategies. The condition is further complicated by the fact that both women and their physicians tend to normalize menstrual symptoms. To enable development of comprehensive interventions to address IDA among women in our locality, it is critical to characterize heavy menstrual bleeding (HMB) and its relationship with IDA among women and determine ways to use these data to direct women at risk for IDA to appropriate healthcare services for evaluation and treatment.
For women with HMB, early diagnosis and treatment of anemia is important to prevent its negative health consequences. However, in low resource settings, laboratory facilities are not always available. In addition, laboratory tests may be expensive limiting their use in such circumstances. For this reason, a cheap, simple to use tool to identify women at high risk of anemia who require further evaluation and treatment is needed.
The Aberdeen Menorrhagia Severity Scale (AMSS) is a multi-dimensional scale. It measures quality of life in women with HMB in addition to menstrual bleeding characteristics. AMSS consists of 13 questions. with a 4-point answer to each question. Maximum score is 47, which is converted to a percentage. The lower the scale is associated with better quality of life. The AMSS has been validated against the SF-36, which is a generic scale for measurement of quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Details on the research will be explained to potentially eligible women. They will be given patient's information leaflet in Arabic (attached). The research team will emphasize that participation in the study is completely voluntary, and women can withdraw at any time without affecting level of care that is provided for them. Eligible women who accept to participate in the study will sign informed consent. Women will be assured on confidentiality and that data will be coded, with no names/ identifying information, and will be kept on a secure server through RedCap operated by Assiut Faculty of Medicine.3.4. Informed consent. Consent will be provided
Key inclusion criteria (1 listed)
- Reproductive age women, above age of 18 years old.
Key exclusion criteria (1 listed)
- women with amenorrhea, postmenopausal women, current or past (in last 6 months) users of hormonal contraceptives, women who have delivered in the past year, or breast fed in past 6 months are all excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC and serum ferritintake blood sample for CBC and serum ferritin | Diagnostic test | – |
Primary outcome
Evaluating the Arabic version of Aberdeen Menorrhagia Severity Scale (AMSS) for prediction of iron deficiency/ iron deficiency anemia in women with the symptom of chronic heavy menstrual bleeding (HMB)
Time frame: baseline
heavy menstrual bleeding and its relation to iron deficiency /iron deficiency anemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 27789349Cooke AG, McCavit TL, Buchanan GR, Powers JM. Iron Deficiency Anemia in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2017 Apr;30(2):247-250. doi: 10.1016/j.jpag.2016.10.010. Epub 2016 Oct 24.
- Background: PubMed 24912842Peuranpaa P, Heliovaara-Peippo S, Fraser I, Paavonen J, Hurskainen R. Effects of anemia and iron deficiency on quality of life in women with heavy menstrual bleeding. Acta Obstet Gynecol Scand. 2014 Jul;93(7):654-60. doi: 10.1111/aogs.12394. Epub 2014 Jun 9.
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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. This study is not recruiting at the moment.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebraam faiez, bachelor (01095846886, berofaiez@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the Arabic version of Aberdeen Menorrhagia Severity Scale (AMSS) for prediction of iron deficiency/ iron deficiency anemia in women with the symptom of chronic heavy menstrual bleeding (HMB) (time frame: baseline). 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 NCT05079815, 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 8 Feb 2023.