Development of Isthmocele Symptom Severity and Quality of Life Scale

Last updated: August 15, 2024
Sponsor: Hilal Yuvacı
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

quality of life scale

Clinical Study ID

NCT06562231
isthmocele and quality of life
  • Ages 18-45
  • Female

Study Summary

Isthmocele, also known as cesarean scar defect (CSD), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain.

There is currently no quality of life scale that assesses isthmocele symptoms. A scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with isthmocele symptoms three months after cesarean delivery will beincluded in the study.

Exclusion

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 includedin the study.

Study Design

Total Participants: 330
Treatment Group(s): 1
Primary Treatment: quality of life scale
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 30, 2025

Study Description

Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.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.

Connect with a study center

  • Sakarya University School of Medicine

    Sakarya,
    Turkey

    Active - Recruiting

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