NCT05536869招募中不适用
Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".
研究概览
简要总结
The main objective of this study is to compare the time taken to obtain "street fitness" status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for a caesarean between 38 and 42 weeks pregnant
- •Patient aged between 18 and 42 years old
- •Singleton
- •Caesarean section with a theoretical operating time < 1 hour (without major complications)
- •Patient affiliated to a social security scheme
- •Patient having signed the free and informed consent.
排除标准
- •BMI > 40
- •High blood pressure treated intravenously
- •Pre-existing diabetes in pregnancy
- •Allergy to analgesics
- •Prenatal depression
- •Pathological insertion of the placenta (placenta previa or accreta).
- •History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery.
- •Addiction (drugs)
- •Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior.
- •Patient participating in another clinical study with a drug or medical device
- •Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Patient hospitalized without consent.
结局指标
主要结局
The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".
时间窗: 1 month
These criteria are defined in the Chung score. This score is between 0 and 10 and evaluate the vital signs, wandering, nausea or vomits, pain and surgical bleeding.
次要结局
未报告次要终点
研究者
研究点 (2)
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