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

SLE Clinical Trial

Official title:

Recognizing Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05230316
• Other study ID #: R 205
• Status: Active, not recruiting
• Start date: January 15, 2022
• Est. completion date: August 2023

Study information

• Verified date: April 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 2023
• Est. primary completion date: April 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstrual Irregularity
• Menstruation Disturbances
• SLE

Locations

Country	Name	City	State
Egypt	Fayoum university	Fayoum
Egypt	Fayoum university faculity of medicine	Fayoum	Fayoum University Zone

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus.	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.	3 month
Primary	Recognize health related quality of life in Egyptian women with systemic lupus erythematosus.	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.	3 months
Secondary	Evaluate the impact of duration of remission on QOL in SLE patients.	Clinical remission (CLR) is present when clinical SLEDAI score=0	3 months