Randomized control study of mifepristone alone versus mifepristone -misoprostol combination regimen for induction of labor in late intrauterine fetal death.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol
研究概览
简要总结
AIM- To study the efficacy of Mifepristone alone vs Mifepristone- Misoprostol combination regimen for induction of labor in cases of late intrauterine fetal death.
Primary Outcome:
Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol
combination regimen within 5 days of initiation of regimen.
Secondary Outcomes:
1. Mean induction to delivery time in both regimens
2. Proportion of women requiring additional intervention (medical/ surgical).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton pregnancy with late intrauterine fetal death and non-scarred uterus.
排除标准
- •1.Deranged liver function tests/ kidney function tests/ coagulation profile.
- •2.Known allergy or contraindication for Mifepristone or Misoprostol.
- •3.Known case of inherited porphyria.
结局指标
主要结局
Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol
时间窗: Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol | combination regimen within 5 days of initiation of regimen.
combination regimen within 5 days of initiation of regimen.
时间窗: Proportion of women who deliver vaginally with Mifepristone alone vs Mifepristone- Misoprostol | combination regimen within 5 days of initiation of regimen.
次要结局
- 1.Mean induction to delivery time in both regimens(2.Proportion of women requiring additional intervention (medical/ surgical).)
研究者
Dr Reena Rani Punia
Maulana Azad Medical College