Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 932
- 试验地点
- 1
- 主要终点
- Caesarean Section rate
研究概览
简要总结
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premature rupture of membranes at 37 or more weeks
- •Single live fetus in cephalic presentation
排除标准
- •Women in labour
- •Women with contraindication of induction of labour
- •Women with previous caesarean section or uterine surgery
研究组 & 干预措施
Misoprostol tablet, PGE2 gel
participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.
干预措施: Misoprostol (Drug)
Misoprostol tablet, PGE2 gel
participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.
干预措施: PGE2 gel (Drug)
结局指标
主要结局
Caesarean Section rate
时间窗: 48 hours
次要结局
- Induction delivery time(48 hours)
- Neonatal & maternal infectious morbidity(14 days following date of delivery)
研究者
Dr Snehamay Chaudhuri
Associate Professor , Obstetrics and Gynecology, NRS Medical College
Nilratan Sircar Medical College