Efficacy of sublingual vs vaginal misoprostol tablet for induction of labour in term antenatal women : a randomized controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the efficacy of sublingual misoprostol tablet vs vaginal misoprostol tablet for induction of labour
研究概览
简要总结
Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological method. Induction of labour is indicated wherever there is risk to mother, foetus or both if pregnancy is further continued. The success of labour induction depends on cervical status (Bishop’s score) at the time of induction. Various studies have used various doses of tablet misoprostol ranging from 25mcg to 100 mcg and they used different doses for both oral and vaginal route. This study will be done to compare the efficacy of sublingual vs vaginal tablet misoprostol for induction of labour in term antenatal women.
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 full term pregnancy with vertex presentation.
- •Gravida 1 to 4 with clinically adequate pelvis Bishop score <6.
排除标准
- •Eclampsia Uncontrolled diabetes mellitus Women with previous cesarean section Hypersensitivity to misoprostol.
结局指标
主要结局
To compare the efficacy of sublingual misoprostol tablet vs vaginal misoprostol tablet for induction of labour
时间窗: Improvement in Bishops score would be assessed every 4 hours. Maximum of 6 doses would be given. | Further dosing would be stopped if patients Bishops score becomes more than 6.
In terms of :
时间窗: Improvement in Bishops score would be assessed every 4 hours. Maximum of 6 doses would be given. | Further dosing would be stopped if patients Bishops score becomes more than 6.
Induction delivery interval
时间窗: Improvement in Bishops score would be assessed every 4 hours. Maximum of 6 doses would be given. | Further dosing would be stopped if patients Bishops score becomes more than 6.
Mode of delivery
时间窗: Improvement in Bishops score would be assessed every 4 hours. Maximum of 6 doses would be given. | Further dosing would be stopped if patients Bishops score becomes more than 6.
次要结局
- To compare the side effects of tablet misoprostol in sublingual vs vaginal route(Side effects like nausea, vomiting, diarrhea , uterine tachysystole were identified. Every four hourly re-assessment is done to look for progress of labour.)
研究者
Deepakshi Gupta
nkpsims, nagpur