A Novel Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- degree of placental invasion and inability to conserve the uterus
研究概览
简要总结
Primary Objective:
To determine the optimal cutoff values of the ultrasound score for different PAS subtypes (no PAS, placenta accreta, placenta increta, and placenta percreta). To evaluate the diagnostic accuracy of the novel Ultrasound Scoring System in predicting the severity of Placenta Accreta Spectrum (PAS) (placenta accreta, increta, and percreta).
Secondary Objective:
-
To correlate the novel ultrasound score with intraoperative findings (considered the gold standard) during cesarean delivery, including the degree of placental invasion and the need for surgical interventions (hysterectomy, bladder repair).
-
To assess the relationship between the novel ultrasound score and postoperative complications, such as:
-
Requirement for hysterectomy
-
Bladder or bowel injury
-
Blood transfusion requirement
-
ICU admission rates
-
To explore the potential for integrating the Ultrasound Scoring System with other clinical indicators (e.g., patient age, parity, and history of cesarean sections) to enhance the predictive accuracy for PAS.
详细描述
Primary Objective:
- To determine the optimal cutoff values of the ultrasound score for different PAS subtypes (no PAS, placenta accreta, placenta increta, and placenta percreta).
- To evaluate the diagnostic accuracy of the novel Ultrasound Scoring
- System in predicting the severity of Placenta Accreta Spectrum (PAS) (placenta accreta, increta, and percreta).
Secondary Objective:
-
To correlate the novel ultrasound score with intraoperative findings (considered the gold standard) during cesarean delivery, including the degree of placental invasion and the need for surgical interventions (hysterectomy, bladder repair).
-
To assess the relationship between the novel ultrasound score and postoperative complications, such as:
-
Requirement for hysterectomy
-
Bladder or bowel injury
-
Blood transfusion requirement
-
ICU admission rates
-
To explore the potential for integrating the Ultrasound Scoring System with other clinical indicators (e.g., patient age, parity, and history of cesarean sections) to enhance the predictive accuracy for PAS.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18 to 45 years.
- •Gestational age ≥28 weeks at the time of enrollment.
- •Diagnosed Placenta Previa with a history of:
- •One or more previous cesarean sections
- •Uterine scarring due to previous surgery as (myomectomy, D&C, Metroplasty).
- •Singleton pregnancy.
排除标准
- •Women with multiple pregnancies (twins, triplets, etc.).
- •Pregnancies complicated by acute medical conditions (e.g., heart failure, uncontrolled diabetes).
- •Prior history of Blood diseases. (other than those related to pregnancy).
- •Women who refuse to participate or withdraw consent during the study.
结局指标
主要结局
degree of placental invasion and inability to conserve the uterus
时间窗: 1 week
Need for Hysterectomy: Determined by the degree of placental invasion and inability to conserve the uterus \&Histopathogy confirmation. Bladder Injury: Recorded if any injury occurs during the procedure. Blood Transfusion Requirement: Amount of blood transfused intraoperatively. ICU Admission: Postoperative ICU admission requirement due to hemorrhage or other complications.
次要结局
未报告次要终点
研究者
Ahmed Adel Khalifa
Ahmed Adel Khalifa Mansour
Sohag University