NCT02918110Unknown4 期
Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Cesarean section rate
研究概览
简要总结
The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.
详细描述
To compare orally administrated solution of misoprostol (Cytotec®) with vaginal slow release misoprostol (Misodel®) regarding efficacy and safety during labour Design: Randomised controlled trial (RCT)
Settings:
Obstetric departments of Sodersjukhuset, Stockholm Obstetric departments of Women's clinic, Karlstad.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primipara BS ≤ 4p Gestational week >37
排除标准
- •Multipara Multiples Gestational week <37 BS >4 IUFD Previous uterine surgery
研究组 & 干预措施
Cytotec
Experimental
orally administrated solution of misoprostol (Cytotec®)
干预措施: Misoprostol (Drug)
Misodel
Experimental
vaginal slow release misoprostol (Misodel®)
干预措施: Misoprostol (Drug)
结局指标
主要结局
Cesarean section rate
时间窗: 1 year
次要结局
未报告次要终点
研究者
Eva Wiberg-Itzel
Associate Professor
Karolinska Institutet
研究点 (1)
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