Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS for the Evaluation of Cesarean Scar Defect
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient
研究概览
简要总结
Primary aim:
To assess the diagnostic agreement between 2D vs 3D TV U/S with or without SIS for the evaluation of cesarean scar defects and its correlation with symptoms.
Secondary aims:
To assess the relation between the size of the niche and the patient symptoms.
详细描述
Primary aim:
To assess the diagnostic agreement between 2D vs 3D TV U/S with or without SIS for the evaluation of cesarean scar defects and its correlation with symptoms. To compare both imaging modalities regarding assessment of cesarean scar defect parameters, including depth, length, width, anterior myometrial thickness, and residual myometrial thickness, as well as to evaluate procedure time, patient tolerability, and satisfaction.
Secondary aims:
To assess the relation between the size of the niche and the patient symptoms.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-45 years
- •History of at least one previous cesarean section
- •Interval since last cesarean section ranging from 6 months to 10 years
- •Willingness to participate and provide written informed consent
排除标准
- •Current pregnancy
- •Active pelvic infection or acute pelvic inflammatory disease
- •Large uterine fibroids distorting the uterine cavity
- •History of uterine surgery other than cesarean section (e.g., myomectomy)
- •Failure of SIS performance
- •Patients on any contraception methods
结局指标
主要结局
Diagnostic agreement between 3D-TVUS and SIS in detecting cesarean scar defects, assessed using Cohen's kappa coefficient
时间窗: 1 hour
次要结局
未报告次要终点
研究者
Emam Mohamed Sayed
Emam Mohamed Sayed
Sohag University