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

NCT ID: NCT05230316

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-08-31

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

Conditions

SLE; Menstrual Irregularity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

rehab abdelhamid aboshama

lecturer of obstetrics and gynecology Faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laila E Abdelfattah, Ass. prof

Role: STUDY_DIRECTOR

Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university

rehab A aboshama, lecturer

Role: PRINCIPAL_INVESTIGATOR

lecturer of obstetrics and gynecology

Locations

Fayoum university faculity of medicine

Al Fayyum, Fayoum University Zone, Egypt

Fayoum university

Al Fayyum, , Egypt

Countries

Egypt

Other Identifiers

R 205

Identifier Type: -

Identifier Source: org_study_id