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Идёт набор NCT07723157

Cesarean Scar Defect: a Prospective, Observational Study.

Наблюдательное Niche

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transvaginal ultrasonography examination.
Кому может быть актуально
Состояния в реестре: Niche. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Transvaginal ultrasonography: uterine cesarean section scar assessment. [Срок оценки: Transvaginal ultrasonography assessment of the uterine cesarean section scar will be performed 6 months after cesarean section.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Польша · 1 центр
  • Department of Gynecology, Obstetrics and Neonatology, Division of Gynecology and Obstetric — Gdansk

Идентификаторы

NCT: NCT07723157 · KB/556/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗