Department of Gynecology, Obstetrics and Neonatology, Division of Gynecology and Obstetrics, Medical University of Gdańsk
Gdansk, 80-214, Poland
Location status: Recruiting
NCT Number: NCT07723157
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Gdansk, 80-214, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Medical University of Gdansk
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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