Cesarean Scar Defect: a Prospective, Observational Study.
ConditionNiche
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical University of Gdansk
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patient consent
patient age over 18 years of age
first cesarean section after 26 weeks of gestation
Disqualifiers
lack of patient consent
patient age under 18 years
cesarean section before 26 weeks of gestation
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transvaginal ultrasonography examination
Diagnostic testTransvaginal 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients after first cesarean section1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov