Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05230316 |
Other study ID # |
R 205 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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