Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05079815
Study type Observational
Source Assiut University
Contact Ebraam faiez, bachelor
Phone 01095846886
Email berofaiez@yahoo.com
Status Not yet recruiting
Phase
Start date May 1, 2024
Completion date May 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT02934789 - Effectiveness of Truclear on Patient Quality of Life N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Recruiting NCT04959396 - IUB SEAD RED (Revolutionary Endometrial Ablation Device Study N/A
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Recruiting NCT06064851 - Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients N/A
Terminated NCT04132349 - Ulipristal Acetate in Symptomatic Uterine Fibroid Phase 4
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT03412890 - LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Active, not recruiting NCT04477837 - Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
Completed NCT05176496 - A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT00401193 - Efficacy and Safety of XP12B in Women With Menorrhagia Phase 3
Completed NCT03317795 - Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids Phase 4
Completed NCT02943655 - Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause Phase 3
Completed NCT03070951 - Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Recruiting NCT05685199 - Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
Completed NCT05406960 - Therapeutic Effect of Herbal Infusion on Menometrorrhagia N/A
Active, not recruiting NCT02449304 - Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device Phase 4
Terminated NCT02001324 - HMB- Data Collection Methods N/A