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Cesarean Scar Defect: a Prospective, Observational Study.

Cesarean Scar Defect: a Prospective, Observational Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07723157
Enrollment
150
Registered
2026-07-23
Start date
2024-10-01
Completion date
2026-10-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Niche

Brief 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 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.

Interventions

DIAGNOSTIC_TESTTransvaginal 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.

Sponsors

Medical University of Gdansk
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Transvaginal ultrasonography: uterine cesarean section scar assessment.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.

Countries

Poland

Contacts

CONTACTNatalia K Mazur-Ejankowska, Medical Doctor
natalia.mazur@gumed.edu.pl+48 58 584 4100
STUDY_DIRECTORMagdalena E Grzybowska, Medical Doctor

Division of Gynecology and Obstetrics, Medical University of Gdańsk

STUDY_CHAIRAnna E Abacjew-Chmyłko, Medical Doctor

Division of Gynecology and Obstetrics, Medical University of Gdańsk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026