TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The number of women who will start lactive phase of labour after treatment
研究概览
简要总结
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .
详细描述
Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation
排除标准
- •Multi-fetal pregnancy.
- •Pregnant women less than 38 weeks gestation.
研究组 & 干预措施
misoprostol in neutral media
Intervention : misoprostol in a neutral media will be given to women to induce labour
干预措施: misoprostol in a neutral media (Drug)
Misoprostol in acidic media
Intervention : misoprostol in acidic media will be given to induce labour
干预措施: misoprostol in an acidic media (Drug)
Misoprostol in alkaline media
Intervention : misoprostol in alkaline media will be given to induce labour
干预措施: misoprostol in an alkaline media (Drug)
结局指标
主要结局
The number of women who will start lactive phase of labour after treatment
时间窗: within 24 hours
the number of women in a group who will enter in active labour faster than other groups
次要结局
未报告次要终点