Sequential Use of Foley's Catheter and Low Dose Oral Misoprostol Versus Misoprostol Alone for Induction of Labour : a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Efficiency of induction
研究概览
简要总结
Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.
详细描述
a multicentre, open-label randomised controlled trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)
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
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with an unfavourable cervix who will scheduled for induction of labour
排除标准
- •Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )
研究组 & 干预措施
Foley catheter + misoprostol
-cervical ripening with transcervical Foley catheter 22 F for 16 hours, then sequentially 25 μg oral misoprostol once every 2 hour.Max 200 μg
干预措施: Misoprostol 200mcg Tab (Drug)
misoprostol
25 μg oral misoprostol alone once every 2 hour, Max 200 μg.
干预措施: Misoprostol 200mcg Tab (Drug)
结局指标
主要结局
Efficiency of induction
时间窗: 24 hours.
Number of Participants with vaginal births
次要结局
- Safety for mother(24 hour)
- Safety for baby(5 minutes)
- rete of hemorrage(24 hour)
- rate of chorioamnionitis chorioamnionitis(24 hour)
研究者
Dilfuza Sultanmuratova
principal investigator
Kazakhstan's Medical University "KSPH"