CTRI/2020/08/027093尚未招募2/3 期
Comparative study of safety and efficacy of intracervical Foley catheter balloon versus prostaglandin E2 gel for induction of labour in unfavourable cervix
Dr Maya menon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月17日最近更新:
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
- Post induction bishops score
研究概览
简要总结
This study is a randomized double blind parallel group controlled trial comparing the efficacy and safety of intracervical Foley’s catheter balloon vs intracervical prostaglandin E2 gel in cervical ripening for induction of labour in term antenatal mother’s with unfavourable cervix conducted in 100 patients in Department of Obstetrics and Gynaecology , ESIC medical college and PGIMSR , kk Nagar , Chennai. The primary outcome measures are post induction changes in Bishop’s score. The secondary outcomes are mean induction to delivery interval, mode of delivery and maternal and feta outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravida, more than 37weeks gestation, singleton pregnancy, cephalic presentation, bishops score less than 5, intact membranes, reactive preinduction CTG.
排除标准
- •Multiple pregnancy, malpresentation, absent membranes, antepartum hemorrhage, previous uterine scar, active genital infections, major CPD, Medical conditions like heart disease.
结局指标
主要结局
Post induction bishops score
时间窗: 12 hours
次要结局
- Mean induction to delivery interval(Mode of delivery)
研究者
研究点 (1)
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