NicheNCT07723157
Cesarean Scar Defect: a Prospective, Observational Study.
An observational study of Niche, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The study is conducted as part of the doctoral thesis of Natalia Mazur-Ejankowska, a medical doctor undergoing specialist training in obstetrics and gynecology at the Department of Obstetrics and Gynecology, Gynecologic Oncology, and Gynecologic Endocrinology at the University Clinical Centre in Gdańsk, Poland, where… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Niche
- What is being tested?
- Transvaginal ultrasonography examination
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2024to 1 Oct 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent first cesarean section at the Department will be asked to participate in the follow-up study including transvaginal ultrasonography and gynecological examination.
Who may be able to join
- patient consent
- patient age over 18 years of age
- first cesarean section after 26 weeks of gestation
Who cannot join
- lack of patient consent
- patient age under 18 years
- cesarean section before 26 weeks of gestation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Gynecology, Obstetrics and Neonatology, Division of Gynecology and Obstetrics, Medical University of Gdańsk
Gdansk, 80-214
Natalia K Mazur-Ejankowska, Medical doctor, +48 58 584 4100, natalia.mazur@gumed.edu.pl
About this study
The study is conducted as part of the doctoral thesis of Natalia Mazur-Ejankowska, a medical doctor undergoing specialist training in obstetrics and gynecology at the Department of Obstetrics and Gynecology, Gynecologic Oncology, and Gynecologic Endocrinology at the University Clinical Centre in Gdańsk, Poland, where the research will be carried out at every stage.
The aim of the study is to evaluate the cesarean section scar and the lower uterine segment after first cesarean section, and to assess risk factors, symptoms, and epidemiological data in patients enrolled to the study.
Read the detailed description
Patients who underwent cesarean section at the University Hospital will be invited for a gynecological examination including a transvaginal ultrasonography assessment at least 6 months after cesarean section. The transvaginal ultrasound examination will include uterus measurements, residual myometrium thickness (RMT), adjacent myometrium thickness (AMT), RMT/AMT ratio, niche depth, niche width, and the uterine cervix to cesarean section scar distance. Additionally, the presence of a hematoma at the uterine incision will be assessed. The uterine niches will be categorized as large niches in case of <2.5 mm or RMT/AMT <50%. In the event of uterine/examination abnormalities or a need for further investigation, the patient will be referred for additional tests/examinations explained and proposed by the principal investigator. The first 50 patients will be blindly reassessed by the study supervisor to ensure a standardized measurement. In case of different measurements, the examinators will perform a third ultrasound together and conclude any discrepancies.
Each patient participating in the study will be asked to complete a validated questionnaire regarding symptoms, complaints, and the function of the lower urinary tract and reproductive organs, during the visit. The examinators will be blinded to the results of the questioner until the end of examination.
The data will be statistically analyzed to uncover possible correlations between uterine niche occurrence and patient and labor characteristics including: age, BMI, concomitant diseases, including connective tissue diseases and neonatal birthweight. Indications for cesarean section, the use of labor induction and uterine dilation prior to cesarean will be recorded and analyzed. Multivariate statistical analysis will be performed by a statistician and the results will be drafted into a manuscript and published.
- Conditions
- Niche
- Being tested
- Transvaginal ultrasonography examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasonography examinationDiagnostic test
Transvaginal ultrasonography examination to assess the uterine measurements, residual myometrium thickness, adjacent myometrium thickness, niche depth, niche width, uterine cervix to cesarean section scar distance.
Gynecological examination including pelvic organ prolapse examination, cough test.
| Study group | Role | What they receive |
|---|---|---|
| Patients after first cesarean section | Patients after first cesarean section performed after 26 weeks of gestation at the Department of Obstetrics and Gynecology, Gynecologic Oncology, and Gynecologic Endocrinology at the University Clinical Centre in Gdańsk, Poland. Receives: Diagnostic Test: Transvaginal ultrasonography examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transvaginal ultrasonography: uterine cesarean section scar assessment.
Transvaginal ultrasonography assessment: uterus measurements, residual and adjacent myometrium thickness, niche depth and width, uterine cervix to cesarean section scar distance.
Measured: Transvaginal ultrasonography assessment of the uterine cesarean section scar will be performed 6 months after cesarean section.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NicheStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NATALIA MAZUR-EJANKOWSKA, Medical University of Gdansk
- Investigators
- Magdalena E Grzybowska, Medical Doctor, Study director, Division of Gynecology and Obstetrics, Medical University of GdańskAnna E Abacjew-Chmyłko, Medical Doctor, Study chair, Division of Gynecology and Obstetrics, Medical University of Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723157
- Sponsor's protocol ID
- KB/556/2023
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Scar Defect: a Prospective, Observational Study.
- ClinicalTrials.gov ID
- NCT07723157
- Acronym / sponsor ID
- KB/556/2023
- Conditions
- Niche
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Jul 2026 (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.
The study is conducted as part of the doctoral thesis of Natalia Mazur-Ejankowska, a medical doctor undergoing specialist training in obstetrics and gynecology at the Department of Obstetrics and Gynecology, Gynecologic Oncology, and Gynecologic Endocrinology at the University Clinical Centre in Gdańsk, Poland, where the research will be carried out at every stage.
The aim of the study is to evaluate the cesarean section scar and the lower uterine segment after first cesarean section, and to assess risk factors, symptoms, and epidemiological data in patients enrolled to the study.
Detailed description
Patients who underwent cesarean section at the University Hospital will be invited for a gynecological examination including a transvaginal ultrasonography assessment at least 6 months after cesarean section. The transvaginal ultrasound examination will include uterus measurements, residual myometrium thickness (RMT), adjacent myometrium thickness (AMT), RMT/AMT ratio, niche depth, niche width, and the uterine cervix to cesarean section scar distance. Additionally, the presence of a hematoma at the uterine incision will be assessed. The uterine niches will be categorized as large niches in case of <2.5 mm or RMT/AMT <50%. In the event of uterine/examination abnormalities or a need for further investigation, the patient will be referred for additional tests/examinations explained and proposed by the principal investigator. The first 50 patients will be blindly reassessed by the study supervisor to ensure a standardized measurement. In case of different measurements, the examinators will perform a third ultrasound together and conclude any discrepancies.
Each patient participating in the study will be asked to complete a validated questionnaire regarding symptoms, complaints, and the function of the lower urinary tract and reproductive organs, during the visit. The examinators will be blinded to the results of the questioner until the end of examination.
The data will be statistically analyzed to uncover possible correlations between uterine niche occurrence and patient and labor characteristics including: age, BMI, concomitant diseases, including connective tissue diseases and neonatal birthweight. Indications for cesarean section, the use of labor induction and uterine dilation prior to cesarean will be recorded and analyzed. Multivariate statistical analysis will be performed by a statistician and the results will be drafted into a manuscript and published.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after first cesarean section | – | Diagnostic Test: Transvaginal ultrasonography examinationPatients after first cesarean section performed after 26 weeks of gestation at the Department of Obstetrics and Gynecology, Gynecologic Oncology, and Gynecologic Endocrinology at the University Clinical Centre in Gdańsk, Poland. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent first cesarean section at the Department will be asked to participate in the follow-up study including transvaginal ultrasonography and gynecological examination.
Key inclusion criteria (3 listed)
- patient consent
- patient age over 18 years of age
- first cesarean section after 26 weeks of gestation
Key exclusion criteria (3 listed)
- lack of patient consent
- patient age under 18 years
- cesarean section before 26 weeks of gestation
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 |
|---|---|---|
| Transvaginal ultrasonography examinationTransvaginal ultrasonography examination to assess the uterine measurements, residual myometrium thickness, adjacent myometrium thickness, niche depth, niche width, uterine cervix to cesarean section scar distance. Gynecological examination including pelvic organ prolapse examination, cough test. | Diagnostic test | Patients after first cesarean section |
Primary outcome
Transvaginal ultrasonography: uterine cesarean section scar assessment.
Time frame: Transvaginal ultrasonography assessment of the uterine cesarean section scar will be performed 6 months after cesarean section.
Transvaginal ultrasonography assessment: uterus measurements, residual and adjacent myometrium thickness, niche depth and width, uterine cervix to cesarean section scar distance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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.
Magdalena E Grzybowska, Medical Doctor study director
Division of Gynecology and Obstetrics, Medical University of Gdańsk
Anna E Abacjew-Chmyłko, Medical Doctor study chair
Division of Gynecology and Obstetrics, Medical University of Gdańsk
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 Niche, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia K Mazur-Ejankowska, Medical Doctor (+48 58 584 4100, natalia.mazur@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transvaginal ultrasonography: uterine cesarean section scar assessment. (time frame: Transvaginal ultrasonography assessment of the uterine cesarean section scar will be performed 6 months after cesarean section.). 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 24 Jul 2026.