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

NCT05230316 | Unknown

• 1 other identifier: R 205
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

SLE; Menstrual Irregularity

Keywords

SLE; Menstrual irregularity; quality of life

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Evaluate the impact of duration of remission on QOL in SLE patients.

  3 months

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE,
• age between 15 and 55 years
• and consented to the interview.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (2)

Fayoum university faculity of medicine

Al Fayyum, Fayoum University Zone, 63514, Egypt

Location

Fayoum university

Al Fayyum, 63514, Egypt

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laila E Abdelfattah, Ass. prof

  Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university

  STUDY DIRECTOR

• rehab A aboshama, lecturer

  lecturer of obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology Faculty of medicine

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 8, 2022
• Study Start: January 15, 2022
• Primary Completion: April 2, 2023
• Study Completion: August 1, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)