An observational study in Niche, sponsored by Medical University of Gdansk. Recruiting at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Medical University of Gdansk · Observational
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.
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.
Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.
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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.
Exclusion Criteria:
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.
Diagnostic Test: Transvaginal ultrasonography examination
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.
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.
Time frame: Transvaginal ultrasonography assessment of the uterine cesarean section scar will be performed 6 months after cesarean section.
Plan to share: No
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