NCT05556304Unknown不适用
In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- maximum value of equivalent deformation obtained by stereovision camera
研究概览
简要总结
The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.
详细描述
The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant and volunteer women >18 years old
- •Primiparous
- •With a singleton pregnancy
- •No objection from the subject and the spouse to participate in the study
排除标准
- •History of prior delivery or c-section
- •History of perineal troubles
- •BMI > à 35 mg/m²
- •History of chronic muscular disease or connective tissue pathology
- •Psychiatric pathology requiring hospitalization
- •Patients who do not understand the French language
- •Legal incapacity or limited legal capacity
- •Patients unlikely to cooperate
结局指标
主要结局
maximum value of equivalent deformation obtained by stereovision camera
时间窗: delivery
maximum value of equivalent deformation obtained by stereovision camera
次要结局
- Correlation between perineal deformation values and perineal tears(delivery)
- Correlation between perineal deformation values and fetal parameters(delivery)
- Correlation between fetal ultrasound and neonatal parameters and perineal tears(delivery)
- Evolution of the elasticity of the perineal body and the SAE during delivery(delivery)
- Correlation between elasticity of the perineal body and perineal tears(delivery)
- Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB(delivery)
- Correlation between the elasticity of the external anal sphincter and perineal tears(delivery)
研究者
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