Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Region Skane
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- External version success rate
研究概览
简要总结
This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.
详细描述
Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.
The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.
The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant nulliparous women.
- •Breech presentation of fetus, eligible for external version.
排除标准
- •Unwilling to participate.
- •Unable to understand written and oral Swedish in the absence of interpreter.
- •Contraindications to spinal anaesthesia.
结局指标
主要结局
External version success rate
时间窗: 1 hour
Rate of successful version as assessed by gynaecologist after maximum three attempts.
次要结局
- Overall maternal satisfaction post external version attempt(1 hour)
- Overall maternal satisfaction post partum(3 months)
- Caesarian section rate(1 months)