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临床试验/NCT05858931
NCT05858931已完成不适用

Association Between Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2019年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
1
主要终点
the days of duration of menstruation

研究概览

简要总结

Cesarean section scar defects (CSDs) are one of the long-term complications following cesarean section. They can be detected by transvaginal sonography, hysterosalpingography, sonohysterography and magnetic resonance imaging (MRI). Hysteroscopy is frequently used in evaluating endometrial disease. However, the description of CSDs by hysteroscopy is very limited. Only a few papers about hysteroscopy evaluation have been published. This is an exploratory study to compare hysteroscopic findings with the clinical outcomes of vaginal repair of CSDs.

详细描述

All women with CSD suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery. Dome-shaped CSDs could be clearly observed in all patients under hysteroscopy. We recorded the pictures of each patient under hysteroscopy and classified them. They all underwent vaginal excision and suture of CSD and will be required to undergo examinations at 3- and 6-months after surgery. Preoperative and postoperative clinical information will be collected. All patients obtain menstrual information and CSD scar size by MRI or transvaginal sonography.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •The inclusion criteria are non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage, and patients who underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery

排除标准

  • •Patients who had a history of chronic diseases (such as cerebro-cardiovascular diseases, malignancies and diabetes mellitus), endocrine disorders, menstrual irregularities before cesarean section, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section

研究组 & 干预措施

CSD patients

All women suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery.

干预措施: vaginal repair (Procedure)

结局指标

主要结局

the days of duration of menstruation

时间窗: on Days: 1 month

duration of menstruation

the days of duration of menstruation

时间窗: on Days: 3 month

duration of menstruation

The thickness of the residual myometrium

时间窗: on Days: 3-6 month

The thickness of the residual myometrium

the days of duration of menstruation

时间窗: on Days: 6 month

duration of menstruation

次要结局

  • number of pregnancy(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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