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NCT Number: NCT06562231

Development of Isthmocele Symptom Severity and Quality of Life Scale

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.

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Key information

Conditions

Quality of Life Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Sakarya University School of Medicine

Sakarya, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hilal Uslu Yuvacı

CONTACT

[email protected]

+905056236937

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of life scale

Other

This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section. Researchers will prepare scale questions, and the survey questions will be developed after obtaining an expert opinion from 20 experts to be evaluated by psychiatry, obstetrics, and public health experts. The patient will fill out the questionnaire form with the diagnosis of isthmocele. Oral and written consent will be obtained from the patients.

Primary outcomes

  1. Development of isthmocele symptom severity and quality of life scale

    Time frame: 3 year

    In the literature review, there is currently no quality of life scale for isthmocele symptoms. There is a need for a scale to detect changes in patients' quality of life after surgery due to isthmocele.This study aimed to create a questionnaire that can be administered immediately before surgery and six weeks after surgery to assess the severity of isthmocele symptoms and the impact of isthmocele on quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilal Uslu Yuvacı

CONTACT

[email protected]

+905056236937

Sponsors and collaborators

Lead sponsor

Hilal Yuvacı

Other

Registry information

Official study title

Development of Isthmocele Symptom Severity and Quality of Life Questionnaire

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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