Assessing the efficacy of mifepristone in improving the preinduction cervical ripening at term gestation in a tertiary health centre : a double blind , randomized , placebo-control superiority trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
Background: Induction of labor is a common obstetric procedure when the benefits of delivery outweigh the risks of continuing the pregnancy. An unfavorable cervix is a major predictor of failed induction. Mifepristone, an anti progesterone, has been proposed as an effective agent for preinduction cervical ripening.
Objectives :To assess the efficacy of oral Mifepristone in improving preinduction cervical ripening at term gestation and its impact on the mode of delivery.
Methodology :This is a double blind, randomized, placebo controlled superiority trial involving 140 pregnant women at term gestation with an unfavorable cervix (Bishop score less than 6). Participants will be randomized to receive either a single oral dose of 200mg Mifepristone or an identical looking placebo.
Outcomes : The primary outcomes include the change in Bishop score, the incidence of Cesarean section, and the time interval from induction to vaginal delivery. Maternal and neonatal safety profiles will also be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women aged 18 to 35 years undergoing labour with singleton pregnancy Period of gestation between 37 to 42 weeks in cephalic presentation and labor induction is indicated in next 24 to 48 hours.
- •2.Reactive Fetal heart rate & BISHOP score less than 6.
排除标准
- •1.Two or more previous Caesearn Sections or classical Caesearn section.
- •2.Gynaecological interventions such as myomectomy, Manchester repair or perineorrhaphy 3.Suspected abruption of placenta or radiological evidence of low lying placenta 4.Any obstetric contraindication to labour induction and obstetrics emergencies.
研究者
Dr Nirmal Kanwar
RNT Medical College