Development of Isthmocele Symptom Severity and Quality of Life Scale

NCT ID: NCT06562231

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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questionnaire group

The patient will fill out the questionnaire form with the diagnosis of isthmocele.

quality of life scale

Intervention Type 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.

Interventions

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quality of life scale

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hilal Yuvacı

OTHER

Sponsor Role lead

Responsible Party

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Hilal Yuvacı

Obstetrics and Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hilal Uslu Yuvacı

Role: PRINCIPAL_INVESTIGATOR

Sakarya University School of Medicine

Locations

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Sakarya University School of Medicine

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hilal Uslu Yuvacı

Role: CONTACT

+905056236937

Facility Contacts

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Hilal Uslu Yuvacı

Role: primary

+905056236937

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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isthmocele and quality of life

Identifier Type: -

Identifier Source: org_study_id

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