SLE Clinical Trial - Gynecological Symptoms & Health-related Quality of

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). Menstrual histories obtained from participants included: age at menarche, duration of heavy bleeding, duration of menses and menstrual cycle, and other gynecological symptoms as Questionnaire form. Patients' blood pressure, height, weight, body mass index (BMI), and other clinical parameters were reviewed by the attending doctors. The patient's medications, which included immunosuppressive therapy such as steroids, cyclophosphamide, azathioprine, and cyclosporine A, where noted, and the use of other adjunctive medications were also recorded. Definition of remission Definition of remission was in line with European Consensus Criteria . Clinical remission (CLR) was present when clinical SLEDAI score=0 and physician global score less than 0.5 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05230316
Study type	Observational
Source	Fayoum University
Contact
Status	Active, not recruiting
Phase
Start date	January 15, 2022
Completion date	August 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With SLE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms