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临床试验/NCT07283042
NCT07283042招募中不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Ultrasound assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who decline participation or withdraw consent
  • Those with contraindications to the planned surgical procedure

结局指标

主要结局

Ultrasound assessment

时间窗: 0-30 days prior to planned surgery

Prenatal ultrasound assessment using the "Ultrasound Staging" protocol (6 views), with classification into one of the topographic categories

Surgical Procedure and Classification

时间窗: At time of surgery

Intraoperative classification of the placental lesion using the topographic classification system

Quantification of Blood Loss

时间窗: Documented throughout surgery and at the completion of the procedure

Objective quantification of blood loss using suction devices, surgical sponges, and vaginal bleeding

Gross Pathological Analysis of Resected Tissues

时间窗: Within 2 hours post surgery

Post-surgery gross pathological analysis of resected tissues to correlate with ultrasound and surgical findings

Adverse Events

时间窗: Up to 12 months post surgery

Presence of any of the following during follow up will be measured in a binary fashion (Yes/No): re-admissions, re-operations, infection/sepsis, wound seroma.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yalda Afshar, MD, PhD

Professor of Obstetrics and Gynecology

University of California, Los Angeles

研究点 (1)

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