Creating a scale to measure isthmocele symptoms and quality of life
Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
This study is trying to create a questionnaire to help understand how isthmocele symptoms affect the lives of people who have had a cesarean delivery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Sakarya University Academic / other |
| Locations | 1 site (Sakarya) |
| Trial ID | NCT06562231 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a scale that evaluates the severity of symptoms associated with isthmocele, a condition resulting from cesarean deliveries. By focusing on patients who exhibit isthmocele symptoms three months post-surgery, the study seeks to create a questionnaire that accurately reflects the impact of these symptoms on quality of life. The research will exclude patients with conditions that could confound the results, such as uterine fibroids and pelvic inflammatory disease. The ultimate goal is to provide a tool that can help assess the effectiveness of surgical interventions for isthmocele.
Who should consider this trial
Good fit: Ideal candidates for this study are patients experiencing isthmocele symptoms at least three months after a cesarean delivery.
Not a fit: Patients with conditions that may mimic isthmocele symptoms, such as uterine fibroids or pelvic inflammatory disease, will not benefit from this study.
Why it matters
Potential benefit: If successful, this scale could significantly improve the assessment of isthmocele symptoms and enhance patient care by guiding treatment decisions.
How similar studies have performed: While there may be studies focusing on quality of life in other gynecological conditions, the development of a specific scale for isthmocele symptoms is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with isthmocele symptoms three months after cesarean delivery will be included in the study. Exclusion Criteria: * The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps. * Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.
Where this trial is running
Sakarya
- Sakarya University School of Medicine — Sakarya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Hilal Uslu Yuvacı — Sakarya University School of Medicine
- Study coordinator: Hilal Uslu Yuvacı
- Email: hilaly@sakarya.edu.tr
- Phone: +905056236937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.