SLENCT05230316
Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With SLE
An observational study of SLE and Menstrual Irregularity, run by Fayoum University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women only
- Conditions the study is for
- SLE, Menstrual Irregularity
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jan 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE,
- age between 15 and 55 years
- and consented to the interview.
Who cannot join
- Patients with active malignancy
- and end-stage lupus nephritis
- Patients who had been treated with Belimumab in the last 7 years, due to the reported effects of Belimumab on HRQoL.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Fayoum university faculity of medicine
Al Fayyum, Fayoum University Zone, 63514
Fayoum university
Al Fayyum, 63514
About this study
Official title: Recognizing Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With Systemic Lupus Erythematosus
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.
Read the 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
- Keywords
- SLE, Menstrual irregularity, quality of life
- Medical subject headings
- Menstruation Disturbances
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
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.
Measured: 3 months
Secondary outcomes (1)
Evaluate the impact of duration of remission on QOL in SLE patients.
Clinical remission (CLR) is present when clinical SLEDAI score=0
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 Jan 2022
- Primary completion2 Apr 2023
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab abdelhamid aboshama, Fayoum University
- Investigators
- Laila E Abdelfattah, Ass. prof, Study director, Associated professor of obestatrics and gynecology Faculty of medicine Fayoume universityrehab A aboshama, lecturer, Principal investigator, lecturer of obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230316
- Sponsor's protocol ID
- R 205
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2022
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognizing Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05230316
- Acronym / sponsor ID
- R 205
- Conditions
- SLE, Menstrual Irregularity
- Keywords
- SLE, Menstrual irregularity, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 2 Apr 2023 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE,
- age between 15 and 55 years
- and consented to the interview.
Key exclusion criteria (3 listed)
- Patients with active malignancy
- and end-stage lupus nephritis
- Patients who had been treated with Belimumab in the last 7 years, due to the reported effects of Belimumab on HRQoL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Evaluate the impact of duration of remission on QOL in SLE patients.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila E Abdelfattah, Ass. prof study director
Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
rehab A aboshama, lecturer principal investigator
lecturer of obstetrics and gynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE and Menstrual Irregularity, run by Fayoum University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognize gynecological symptoms in Egyptian women with systemic lupus erythematosus. (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.