Cesarean Scar Defect: a Prospective, Observational 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.

Study Overview

• Status: Recruiting
• Conditions: Niche
• Intervention / Treatment: Diagnostic test: Transvaginal ultrasonography examination

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Natalia K Mazur-Ejankowska, Medical doctor; Phone Number: +48 58 584 4100; Email: natalia.mazur@gumed.edu.pl

Study Locations

• Poland
  • Gdansk, Poland, 80-214
    • Recruiting
    • Department of Gynecology, Obstetrics and Neonatology, Division of Gynecology and Obstetrics, Medical University of Gdańsk
    • Contact: Natalia K Mazur-Ejankowska, Medical doctor; Phone Number: +48 58 584 4100; Email: natalia.mazur@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• patient consent
• patient age over 18 years of age
• first cesarean section after 26 weeks of gestation

Exclusion Criteria:

• lack of patient consent
• patient age under 18 years
• cesarean section before 26 weeks of gestation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Transvaginal ultrasonography assessment of the uterine cesarean section scar will be performed 6 months after cesarean section.

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Study Director: Magdalena E Grzybowska, Medical Doctor, Division of Gynecology and Obstetrics, Medical University of Gdańsk; Study Chair: Anna E Abacjew-Chmyłko, Medical Doctor, Division of Gynecology and Obstetrics, Medical University of Gdańsk

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KB/556/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No