NCT02135224Unknown不适用
The Effects of Fentanyl Added to Ropivacaine for Labour Epidural Analgesia on the Progress, Duration or Mode of Delivery: a Randomized, Double Blind Study.
University of Athens1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cervical dilatation
研究概览
简要总结
The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists physical status I or II
- •nulliparous
- •normal singleton uncomplicated pregnancies of more than 38 weeks
- •cephalic presentation of the fetus
- •anticipated vaginal delivery
- •active stage of labour
- •cervical dilatation between 3-5 cm
- •regular uterine contractions
- •normal cardiotocographic recordings.
排除标准
- •medical problems during pregnancy
- •BMI≥40 kg m-2
- •opioid allergy
- •prior administration of opioids or other analgesics
研究组 & 干预措施
Fentanyl
Active Comparator
20 microgram per hour
干预措施: Fentanyl (Drug)
Normal saline
Placebo Comparator
0.4 ml per hour
干预措施: Normal saline (Drug)
结局指标
主要结局
cervical dilatation
时间窗: every 60 min starting from the first epidural dose up to cervical dilatation of 10 cm
次要结局
- Bishop score based on Cervical Position, Effacement, Dilation, Softness and Fetal Station.(every 60 min from the time the first epidural dose is administered up to delivery)
研究者
Staikou Chryssoula
Assistant Professor
University of Athens
研究点 (1)
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