Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
研究概览
简要总结
At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
- •covered by a an insurance system
- •signed contentment
排除标准
- •Obstetric contraindications:
- •placenta previa
- •3rd trimester bleeding
- •suspicion of fetal anoxia
- •patient has already received more than one caesarean section
- •multi-fetal pregnancy
- •anticoagulant therapy
- •Anesthesiologic contraindications:
- •infection at the puncture site, systemic infection or severe sepsis
- •intracranial hypertension
- •uncompensated heart failure
- •constitute or acquired coagulation abnormalities, including anticoagulant therapy with curative intent
- •neuropathy with demyelination of nerve fibers in thrust or unstabilized during recovery
- •syringomyelia
研究组 & 干预措施
spinal anesthesia
Bupivacain 10 mg
干预措施: Bupivacaine (Drug)
sedation
Midazolam : 0,10 mg/kg
干预措施: Midazolam (Drug)
结局指标
主要结局
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
时间窗: 24 hours
次要结局
- occurrence of side events due to the manipulation itself(Day 0)
- occurrence of side events due to anesthesia(Day 0)
- The pain experienced by the patient: assessed by the Visual Analogic Scale(Day 0)
- The final delivery mode (caesarian section or vaginal)(Day 0)
- The presentation in childbirth(Day 0)