---
title: Development of Isthmocele Symptom Severity and Quality of Life Scale
nct_id: NCT06562231
overall_status: RECRUITING
sponsor: Hilal Yuvacı
study_type: OBSERVATIONAL
primary_condition: Quality of Life
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06562231.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06562231"
ct_last_update_post_date: 2024-08-20
last_seen_at: "2026-05-12T07:10:39.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Development of Isthmocele Symptom Severity and Quality of Life Scale

**Official Title:** Development of Isthmocele Symptom Severity and Quality of Life Questionnaire

**NCT ID:** [NCT06562231](https://clinicaltrials.gov/study/NCT06562231)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 330
- **Lead Sponsor:** Hilal Yuvacı
- **Conditions:** Quality of Life
- **Start Date:** 2023-01-01
- **Completion Date:** 2025-12-30
- **CT.gov Last Update:** 2024-08-20

## Brief 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **questionnaire group** — The patient will fill out the questionnaire form with the diagnosis of isthmocele.

## Interventions

- **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

- **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.

## Locations (1)

- Sakarya University School of Medicine, Sakarya, Turkey (Türkiye) — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sakarya university school of medicine|sakarya||turkey (türkiye)` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06562231.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06562231*  
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