The Effect of Oxycodone to the Placental Circulation at Early Labour
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- placental blood flow
研究概览
简要总结
Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor pain in the early phase. The aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •oxycodone planned for pain relief
- •age 18 years or more
- •Informed consent obtained
- •Full term pregnancy
排除标准
- •No oxycodone planned
- •age less than 18 years
- •No informed consent
- •not full term pregnancy
- •Other contraindication to oxycodone
研究组 & 干预措施
Placebo
The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed
干预措施: Placebo (Drug)
Oxycodone
The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more
干预措施: Oxycodone (Drug)
结局指标
主要结局
placental blood flow
时间窗: from zero hours to two hours after the first study drug
Placental blood flow is measured with doppler ultrasound
次要结局
- uterine arterial flow(from zero hours to two hours after the first study drug)
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital