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临床试验/NCT05187728
NCT05187728Unknown不适用

Association Between the Occurrence of Adenomyosis and the Clinical Outcomes of Vaginal Repair ofCesareanSectionScar Defects:An Observational Study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Mean duration of menstruation

研究概览

简要总结

To examine the correlation between the occurrence of adenomyosis and the outcome of vaginal repair of cesarean section scar defects (CSD), women with CSD will be enrolled in this retrospective observational cohort study. According to preoperative magnetic resonance imaging (MRI) findings, patients will be divided into two groups, the adenomyosis group and the non-adenomyosis group. They all will have 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.

详细描述

Women with CSD will be enrolled in this study. According to preoperative magnetic resonance imaging (MRI) findings, patients will be divided into two groups, the adenomyosis group and the non-adenomyosis group. 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. Optimal healing was defined as a duration of menstruation of no more than 7 days and a TRM of no less than 5.30 mm after vaginal repair

研究设计

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

入排标准

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

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

结局指标

主要结局

Mean duration of menstruation

时间窗: on Days: 90

Mean duration of menstruation

The thickness of the residual myometrium

时间窗: on Days: 90

The thickness of the residual myometrium

次要结局

  • reproductive information(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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