Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical Trial comparing the two methods of pain relief in the first time of labour was carried out. In this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. One of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy pregnant women
- •women in the first stage of labour or women at induction of labour
- •fetal head in pelvis or whole amniotic membranes
- •must be able to understand spanish
排除标准
- •intrapartum meconium
- •needed of continuous fetal monitoring
- •suspecte/compromise fetal wellbeing
- •morbidly obese women
- •unaccompanied women
研究组 & 干预措施
Meperidine
Use pethidine and haloperidol injection as a pain relief.
干预措施: pethidine and haloperidol injection (Drug)
birth ball
Use birth ball as a pain relief.
干预措施: birth ball (Other)
结局指标
主要结局
pain
时间窗: 24 months
We use a numeric scale, since 0 ( no pain) to 10 (the greatest pain), to measure this item. We use it with women in the first stage of labour, with labor pain
次要结局
- Baby´s apgar(24 months)
研究者
Julia Fernandez
Julita Fernández Arranz
Hospital General Universitario Gregorio Marañon