Quality of LifeNCT06562231
Development of Isthmocele Symptom Severity and Quality of Life Scale
An observational study of Quality of Life, run by Hilal Yuvacı at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- quality of life scale
- Type of treatment
- Pill or oral medicine
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Dec 2025
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section.
Who may be able to join
- Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University School of Medicine
Sakarya
Hilal Uslu Yuvacı, +905056236937, hilaly@sakarya.edu.tr
About this study
Official title: Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- quality of life scale
- Keywords
- isthmocele, quality of life, questionnaire, abnormal uterine bleeding
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life scaleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| questionnaire group | The patient will fill out the questionnaire form with the diagnosis of isthmocele. Receives: Other: quality of life scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of isthmocele symptom severity and quality of life scale
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Hilal Yuvacı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yuvacı, Sakarya University
- Investigators
- Hilal Uslu Yuvacı, Principal investigator, Sakarya University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562231
- Sponsor's protocol ID
- isthmocele and quality of life
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Isthmocele Symptom Severity and Quality of Life Questionnaire
- ClinicalTrials.gov ID
- NCT06562231
- Acronym / sponsor ID
- isthmocele and quality of life
- Conditions
- Quality of Life
- Keywords
- isthmocele, quality of life, questionnaire, abnormal uterine bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hilal YuvacıUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire group | – | Other: quality of life scaleThe patient will fill out the questionnaire form with the diagnosis of isthmocele. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section.
Key inclusion criteria (1 listed)
- Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.
Key exclusion criteria (2 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life scaleThis 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. | Other | questionnaire group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Uslu Yuvacı principal investigator
Sakarya University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Hilal Yuvacı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal Uslu Yuvacı (+905056236937, hilaly@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of isthmocele symptom severity and quality of life scale (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.