Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Cesarean rate
研究概览
简要总结
Currently, it is certain that neuraxial analgesia in early stage of labor and delivery dose not increase the risk of Cesarean section. However, given ethical reasons, whether such a medical procedure could increase the Cesarean rate compared with those who did not received neuraxial analgesia or not is yet to be known. It is difficult to perform such a study in occidental countries because they have a higher rate of labor analgesia. On the contrary, the rate of labor analgesia in China is up to date only 1%, so it can be done easily. The investigators hypothesized that no neuraxial analgesia itself were a risk factor to Cesarean section. Therefore, the investigators design this study to compared the effect of neuraxial analgesia on the rate of Cesarean delivery with those who did not received neuraxial analgesia.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >= 19yr, <=40 yr
- •Height 140 - 170 cm
- •Singleton pregnancy
- •Uncomplicated pregnancy
排除标准
- •Multiple gestations
- •Pregnancy-induced hypertension
- •Diabetes mellitus
- •Chronic pain
- •Allergic to opioids and/or local anesthetics
- •Failed to performing inter lumbar space catheterization
- •Organic dysfunction
- •Contraindications for neuraxial analgesia
结局指标
主要结局
Cesarean rate
时间窗: One day after birth
Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women
次要结局
- Instrumental delivery(One day after birth)
- VAS pain intensity(2h after cervix 10 cm)
- Time of successful labor(From the initial of labor (0 min) to completion of delivery (this is changable individually))
- Time of the first stage of labor(From initial of the labor to the cervix reached to 10 cm (Different in different patients))
- Time of second stage of labor(From the cervix at 10 cm to successful delivery of the baby (this is changable individually))
- Overall feeling of satisfaction of the labor(At the end of successful baby delivery (it is changable individually))
- Side effects(From the initial of labor (0 min) to the end of the labor (is is changable individually))