A Prospective, Parallel-group, Double Blinded Randomized Controlled Trial to Compare the Safety and Efficacy of Sequential Oral Mifepristone and Prostaglandins Versus Prostaglandins alone for Induction of Labor in women with Singleton Term Live Pregnancies
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Comparison of Induction to-onset of labour and Comparison of Induction to-delivery interval interval in the different groups
研究概览
简要总结
This is a prospective, double-blinded, randomized controlled trial being conducted at Holy Family Hospital to evaluate the safety and effectiveness of oral Mifepristone given before Prostaglandins for induction of labour in women with singleton term pregnancies. The study includes two comparison groups based on the type of prostaglandin selected by the treating obstetrician: Dinoprostone gel or Misoprostol tablets. Each group is further randomized to receive either Mifepristone or a matching placebo, followed by the selected prostaglandin for labour induction.
Eligible pregnant women (18–40 years) with live, term singleton pregnancies and a Bishop score <6 will be enrolled. A total of 208 participants will be recruited. Mifepristone or placebo will be administered on an outpatient basis (two doses, 24 hours apart), followed by admission and administration of prostaglandins. Labour will be monitored and managed as per standard protocols. The primary outcome is the induction-to- onset of labour and induction to delivery interval, and secondary outcomes include mode of delivery, maternal and fetal outcomes, and adverse effects. The study will follow intention-to-treat analysis and is expected to be completed in 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Singleton, term, live pregnancies with a cephalic presentation and a cervical Bishop score of less than 6 were included 2.Induction could be deferred for 48 hrs 3.Intact Membranes 4.Confirmed Gestational age of 37 weeks or more (term pregnancy) 5.Ability to provide informed consent.
排除标准
- •1.Any mother who needs more than one type of prostaglandins, i.e requiring both Dinoprostone gel and Misoprostol oral tablets.
- •2.Malpresentation 3.Previous Caesarean 4.Multiple Pregnancies 5.Placenta Previa 6.Intrauterine death of Fetus 7.Any mother who is not eligible for trial of vaginal delivery.
结局指标
主要结局
Comparison of Induction to-onset of labour and Comparison of Induction to-delivery interval interval in the different groups
时间窗: 1st, 2nd, 3rd year
次要结局
- Comparison of improvement in Bishop scores at 48 hours in different groups(48 hours)
- Comparison of modes of delivery in the different groups(5 days)
- Comparison of duration of oxytocin augmentation in the different groups(5 days)
- Rate of failed induction in the different groups(5 days)
- To compare maternal morbidity in different groups(5 days)
- To compare neonatal morbidity in different groups defined below(7 days)
研究者
Dr Rinku Sengupta Dhar
Holy Family Hospital