Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta
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
- 否
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
Yalda Afshar, MD, PhD
Professor of Obstetrics and Gynecology
University of California, Los Angeles
