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

Active, not recruiting

• Conditions: SLE; Menstrual Irregularity

• Registration Number: NCT05230316
• Lead Sponsor: Fayoum University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-01-05
• Study Start: 2022-01-15
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Status Verified: 2023-04
• Primary Completion: 2023-04-02
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE,
2. age between 15 and 55 years
3. and consented to the interview.

Exclusion Criteria

1. Patients with active malignancy
2. and end-stage lupus nephritis
3. Patients who had been treated with Belimumab in the last 7 years, due to the reported effects of Belimumab on HRQoL.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus.	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.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the impact of duration of remission on QOL in SLE patients.	3 months	Clinical remission (CLR) is present when clinical SLEDAI score=0

Trial Locations

Locations (2)

Fayoum university faculity of medicine; 🇪🇬 Fayoum, Fayoum University Zone, Egypt

Fayoum university; 🇪🇬 Fayoum, Egypt