Идёт набор NCT07283042

Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum

— Наблюдательное Placenta Accreta

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: Total Hysterectomy, Modified subtotal hysterectomy, One-Step Conservative Surgery.
Кому может быть актуально: Состояния в реестре: Placenta Accreta. Базовые параметры: 18 лет — 55 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: США
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

Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta

Обзор

This study evaluates the clinical implementation of intra-operative topographic classification system for PAS. In addition to a standard of care risk stratification prenatal ultrasound for patients with a risk of PAS, this study adds an additional intraoperative surgical staging protocol to validate the classification system, improve surgical approach, and significantly clinical outcomes of pregnant people with an a prior risk of PAS. The study will involve pregnant patients with PAS risk factor, include data collection spanning prenatal assessment, intraoperative classification, surgical technique implementation and postoperative analysis. The anticipated study duration is approximately 36-48 months.

Подробное описание

This study is a prospective cohort study designed to assess the validity, feasibility, and clinical utility of a topographic classification system for placenta accreta spectrum (PAS), with a primary focus on its application in the actual execution of surgery. This study is investigating a clinical decision flowchart used for intraoperative staging and classification of placenta accreta spectrum (PAS) or similar uterine surgical scenarios. It integrates topographic classification, surgical decision-making, and treatment strategy selection.

The classification system will directly guide and be integrated into real-time surgical planning and management-from cesarean hysterectomy to one-step conservative surgery-based on prenatal ultrasound staging and intraoperative findings.

* Standardizing prenatal ultrasound staging for PAS. * Implementing a structured protocol for intraoperative classification and surgical execution according to ultrasound. * Collecting and correlating surgical and pathological findings, including intraoperative photos, videos, and gross and histological analysis. * Utilizing an objective method to quantify intraoperative blood loss. * Comparing preoperative ultrasound findings with intraoperative and postoperative data to validate the classification system. * Managing participant dropouts and protocol deviations to ensure data integrity and minimize bias. * Applying appropriate statistical adjustments for multiple group comparisons to reduce the risk of type I error. Methods such as Bonferroni correction or false discovery rate adjustments will be utilized where applicable. * Incorporating serial blood draws for plasma and whole blood analysis to identify potential biomarkers associated with PAS severity, surgical complexity, and clinical outcomes. This will be optional and stored in the biorepository.

Вмешательства

Процедура Total Hysterectomy
Removal of entire uterus
Процедура Modified subtotal hysterectomy
When partial tissue integrity is preserved
Процедура One-Step Conservative Surgery
Considered when significant healthy myometrium is preserved

Первичные конечные точки

Ultrasound assessment [Срок оценки: 0-30 days prior to planned surgery]
Surgical Procedure and Classification [Срок оценки: At time of surgery]
Quantification of Blood Loss [Срок оценки: Documented throughout surgery and at the completion of the procedure]
Gross Pathological Analysis of Resected Tissues [Срок оценки: Within 2 hours post surgery]
Adverse Events [Срок оценки: Up to 12 months post surgery]

Критерии участия

Критерии включения

Pregnant people suspected of having PAS based on ultrasound findings or clinical risk factors
Patients undergoing planned surgical intervention for PAS, including a planned cesarean
Individuals who provide informed consent to participate in the study
Patients with at least one prenatal assessment before surgery
Expected age range: 18-55
Patient has agreed to conservative management approach as part of standard of care if feasible intraoperatively