Clinical trial NCT05230316: Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With SLE
Official title: Recognizing Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SLE
Menstrual Irregularity
Keywords: SLE
Menstrual irregularity
quality of life
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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, and department of rheumatology Assiut university Assiut Egypt

The study protocol was approved by the medical research and ethics committee of the institution, and written informed consent was obtained from all subjects. Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE, aged between 15 and 55 completed years, were enrolled into the study.

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

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.

Primary outcomes:
measure: Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus.
timeFrame: 3 month
measure: Recognize health related quality of life in Egyptian women with systemic lupus erythematosus.
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate the impact of duration of remission on QOL in SLE patients.
timeFrame: 3 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum university faculity of medicine
state: Fayoum University Zone
city: Fayoum
country: Egypt
facility: Fayoum university
Study officials:
affiliation: Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
name: Laila E Abdelfattah, Ass. prof
role: STUDY_DIRECTOR
affiliation: lecturer of obstetrics and gynecology
name: rehab A aboshama, lecturer
role: PRINCIPAL_INVESTIGATOR
References: