Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes.
研究概览
简要总结
The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.
详细描述
Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •34 to 42 weeks of gestation
- •live singleton
- •Bishop score < or = 6
- •reassuring fetal heart beat pattern
排除标准
- •nonreassuring fetal heart beat pattern
- •parity ovr five
- •any contraindication to labor and/or vaginal delivery
- •uterine scar
- •suspected placental abruption with abnormal FHR pattern
- •vaginal bleeding other than "bloody show"
- •cervical dilatation of > or = 4 cm
- •uterine contractions > or = 3 in 10 minutes
- •significant maternal cardiac, renal or hepatic disease
- •hypersensitivity to misoprostol or prostaglandin analogs
研究组 & 干预措施
1
Titrated oral misoprostol
干预措施: misoprostol (Drug)
2
Vaginal misoprostol
干预措施: misoprostol (Drug)
结局指标
主要结局
The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes.
时间窗: within the first week after delivery
次要结局
- Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.(The days during induction)