Modified Amniotic Fluid Score With Fetal Bladder Assessment
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Amniotic Fluid Scoring Model, Fetal Bladder Assessment. Базовые параметры: 18 лет — 45 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
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- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Modified Amniotic Fluid Scoring Model Incorporating Fetal Bladder Assessment
Обзор
This study will prospectively enroll pregnant women with singleton pregnancies between 20 and 38 weeks of gestation who attend Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid. The aim is to develop and validate a modified amniotic fluid scoring model that combines standard ultrasound measures of amniotic fluid volume with fetal bladder size and appearance. The study will compare the ability of this new scoring model to detect abnormal amniotic fluid volume against conventional ultrasound methods and will explore how fetal bladder measurements relate to amniotic fluid indices.
Подробное описание
This prospective observational cohort study will be conducted in the Obstetrics and Gynecology Department at Assiut University Hospital and will enroll 70 pregnant women aged 18-45 years with singleton pregnancies between 20 and 38 weeks of gestation who are referred for routine or clinically indicated ultrasound assessment of amniotic fluid volume. The study aims to develop and validate a modified amniotic fluid scoring model that integrates standard sonographic measures of amniotic fluid volume, including the amniotic fluid index and single deepest pocket, with predefined fetal bladder parameters such as bladder presence, morphology, and longitudinal and transverse diameters measured at maximal filling.
Eligible participants will undergo a standardized ultrasound examination using a high-resolution machine with a curvilinear transducer; the uterus will be systematically scanned to obtain AFI and single deepest pocket measurements, followed by a dedicated five-minute assessment of the fetal bladder to document its size, appearance, and any observed micturition events. All sonographic assessments will be performed by experienced sonographers following uniform protocols, and approximately 10 percent of examinations will be re-scanned by a second sonographer to assess interobserver reliability, with images and measurements digitally archived for blinded review.
Первичные конечные точки
- Sensitivity Of The Modified Amniotic Fluid Scoring Model [Срок оценки: At the index obstetric ultrasound examination during pregnancy (single visit per participant).]
Вторичные конечные точки (1)
- Correlation Between Fetal Bladder Size And Amniotic Fluid Volume [Срок оценки: At the same index obstetric ultrasound examination during pregnancy (single visit per participant).]
Критерии участия
Критерии включения
- Pregnant women aged 18-45 years.
- Singleton pregnancy between 20 and 38 weeks of gestation.
- Women attending Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid volume.
- No known major fetal anomalies at the time of inclusion.
- Able and willing to provide written informed consent.
Критерии исключения
- Multiple pregnancy (e.g., twins, triplets).
- Pregnancies with known chromosomal or major structural fetal anomalies diagnosed prior to enrollment.
- Maternal systemic diseases known to affect amniotic fluid volume (e.g., pregestational or gestational diabetes, chronic hypertension, renal disease).
- Contraindications to ultrasound examination.
- Inability to provide informed consent or anticipated poor compliance with study procedures.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07315243 · Modified Amniotic Fluid Score