NCT00355966已完成4 期
Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term
Nilratan Sircar Medical College1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Admission to delivery time
研究概览
简要总结
Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
A
Active Comparator
In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
干预措施: Misoprostol (Drug)
B
Active Comparator
In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses.
干预措施: PGE2 gel (Drug)
结局指标
主要结局
Admission to delivery time
时间窗: 48 hours
次要结局
- Caesarean Section rate(48 hours)
- Neonatal morbidity(Till discharge)
- Maternal morbidity(Till discharge)
研究者
研究点 (1)
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