Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Analyze the process of uterine healing
研究概览
简要总结
Caesarean section is one of the most common surgical procedures. The multiplication of uterine scars leads to an increase in complications and in particular those related to poor healing such as isthmocele or uterine rupture.
The processes of uterine healing at the histological scale are little known. The main objective of the research is to analyze the process of uterine healing by means of uterine biopsies performed on the areas of cesarean section scars.
详细描述
Our hypothesis is that there is a histological healing defect visible on an anatomopathologic examination of the scar. This poor uterine healing on histological scale is probably associated with uterine healing defects visible on pelvic ultrasound (scar dehiscence) and clinical criteria (number of caesareans, symptoms).
The objective of the research is to analyze uterine scarring by means of uterine biopsies performed on the areas of cesarean section scars. The uterine scarred areas will be analyzed histologically according to specific criteria and compared to healthy uterine areas. Histological characteristics will be compared with clinical and ultrasound data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Common to all groups:
- •Adult patient,
- •Signed consent for participation in the study
- •Patient affiliated to a social security scheme (excluding AME)
- •Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes))
- •Scarred uterus: having already benefited from a caesarean section
- •Surgical management of caesarean section scar dehiscence after a caesarean section
- •Group 3 (control):
- •Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes)
- •Healthy uterus: no history of caesarean section (history of vaginal delivery or first pregnancy)
排除标准
- •Disorder of hemostasis at risk of bleeding
- •Anatomopathological sampling not feasible
- •Patient with a history of upper genital infections
- •Patient under legal protection (guardianship, curatorship)
- •Patient who does not speak or understand French
- •Patient unable to answer questions or with difficulty in expressing herself
结局指标
主要结局
Analyze the process of uterine healing
时间窗: 8 weeks
The main objective of the research is to analyze the process of uterine healing by means of uterine biopsies performed on the areas of cesarean section scars "
次要结局
- Histological aspects of the scar(8 weeks)