Recognizing Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus.
研究概览
简要总结
The purpose of our study was to Recognize gynecological symptoms and health-related quality of life in Egyptian women with systemic lupus erythematosus and evaluate the impact of duration of remission on QOL in SLE patients.
详细描述
Despite significant advances in recent decades, systemic lupus erythematosus (SLE) is still burdened by irreversible organ damage and a notable impact on health-related quality of life (HRQoL). Improving the quality of life is a pivotal goal in the management of SLE. According to the Treat to Target (T2T) recommendations for SLE management, particular attention needs to be paid to the factors that negatively influence HRQoL such as fatigue, pain and depression.
Recent epidemiological studies demonstrate that prolonged remission is an achievable target in SLE patients and is clearly associated with better outcomes in terms of damage accrual. Such findings also raise questions about the possible impact of remission on HRQoL. In a retrospective study, Patients in prolonged remission reported significantly better HRQoL as assessed by the 36-Item Short-Form Health Survey (SF36) and Lupus PRO questionnaire.
Methodology in details L:
70 women with SLE will be included in this study from the outpatient clinic. in Fayoum University hospital It will be conducted in the Department of Obstetrics and Gynecology, Fayoum University Maternity Hospital, Egypt.
Full history taking (Age, Duration of marriage, Parity, Occupation, Mode of delivery, History of abortion, Medical and Surgical history).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE,
- •age between 15 and 55 years
- •and consented to the interview.
排除标准
- •Patients with active malignancy
- •and end-stage lupus nephritis
- •Patients who had been treated with Belimumab in the last 7 years, due to the reported effects of Belimumab on HRQoL.
结局指标
主要结局
Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus.
时间窗: 3 month
Normal menstrual pattern duration of each menses was between five and 13 days, and the menstrual cycle was between 21 and 35 days. Menarche was defined as the first menstrual period. Oligomenorrhoea was defined as menses occuring at intervals longer than 35 days. Secondary amenorrhoea was defined as the cessation of menses after menstrual cycle has begun and lasted for at least four months for patients with regular cycles, or for at least three of the previous three cycle intervals for patients with irregular cycles.(4) Transient amenorrhoea was defined as when patients resumed her own "normal" cycle after episodes of amenorrhoea, and sustained amenorrhoea was when the patient remained amenorrhoeic until the interview date.
Recognize health related quality of life in Egyptian women with systemic lupus erythematosus.
时间窗: 3 months
According to the Treat to Target (T2T) recommendations for SLE management, particular attention needs to be paid to the factors that negatively influence HRQoL such as fatigue, pain and depression.
次要结局
- Evaluate the impact of duration of remission on QOL in SLE patients.(3 months)
研究者
rehab abdelhamid aboshama
lecturer of obstetrics and gynecology Faculty of medicine
Fayoum University