跳至主要内容
临床试验/NCT05079815
NCT05079815尚未招募不适用

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)

Assiut University0 个研究点目标入组 300 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
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)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Reproductive age women, above age of 18 years old.

排除标准

  • •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

结局指标

主要结局

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)

时间窗: baseline

heavy menstrual bleeding and its relation to iron deficiency /iron deficiency anemia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ebraam Faiez Riad

doctor

Assiut University

相似试验