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临床试验/NCT07279181
NCT07279181已完成不适用

Comparative Assessment of Transvaginal Ultrasound, Hysterosonography, and MRI in Uterine Niche

International Peace Maternity and Child Health Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Detection rates of niches

研究概览

简要总结

Uterine niche is a defect formed by poor healing of the lower uterine myometrium after cesarean section, defined as a depression of at least 2mm in the uterine myometrium at the cesarean scar; it is associated with gynecological symptoms and even life-threatening pregnancy complications, so accurate imaging evaluation is crucial for diagnosis, symptom grading, and treatment planning. Currently, transvaginal ultrasound (TVS), saline hysterosonography (SHG), and magnetic resonance imaging (MRI) are commonly used for evaluation, but there are controversies about the consistency of their measurements and repeatability of results. This observational study, conducted at the International Peace Maternity and Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, included women diagnosed with uterine niche.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women (18-45 years) diagnosed with CSD at our center.
  • Women having postmenstrual spotting after CS
  • Signed informed consent.

排除标准

  • Women who has a positive urine pregnancy test.
  • Presence of an intrauterine device.
  • With poor image quality from image will be excluded.
  • Refuse to participate in this study.

结局指标

主要结局

Detection rates of niches

时间窗: Periprocedural

Detection rates of niches

次要结局

  • Residual myometrial thickness(Periprocedural)
  • The differences in the detection of abnormal structures(Periprocedural)

研究者

发起方
International Peace Maternity and Child Health Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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