A Comparative study to determine effectiveness of Mifepristone and Isosorbide Mononitrate(IMN) as cervical ripening agents for induction of labor in pregnant women with gestational age 28 to 34 weeks.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in Bishops Score
研究概览
简要总结
This study is a randomized control open label parallel group trial comparing the effectiveness of oral Mifepristone and vaginal Isosorbide Mononitrate IMN as cervical ripening agents for induction of labor in pregnant women of gestational age 28 to 34 weeks,for 12months in 100 pregnant women who need induction of labor for various obstetric and maternal indications, conducted at one center in India. The outcome will be assessed based on improvement in Bishops Score and duration between administration of cervical ripening agent and delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All 28 to 34 weeks pregnancy who need Induction of labor for obstetrics and maternal indications.
- •2.Bishops score less than
- •3.Those giving consent.
排除标准
- •1.Contraindications to vaginal birth.
- •2.Hypersensitivity to Mifepristone and IMN.
- •3.Contraindications to Mifepristone and IMN.
- •4.Those not giving consent.
结局指标
主要结局
Improvement in Bishops Score
时间窗: at baseline | after 6hrs | after 12hrs | at 15 hrs | at 18 hrs
Duration between administration of cervical ripening agents and delivery
时间窗: at baseline | after 6hrs | after 12hrs | at 15 hrs | at 18 hrs
Failed induction is after 2 doses of misoprostol 3hrs apart
时间窗: at baseline | after 6hrs | after 12hrs | at 15 hrs | at 18 hrs
次要结局
- Mode of delivery(Failed induction is after 2 doses of misoprostol 3h apart)