A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- the percentage of women delivering infants vaginally within 12 hours of augmentation
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.
详细描述
Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.
In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.
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
- 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
- •Pregnancy between 36 and 42 weeks of gestation
- •Live singleton
- •Cephalic presentation
- •A reassuring fetal heart rate pattern
- •Bishop score greater than 6
- •Inadequate uterine contraction (less than or equal to 2 per 10 minutes)
排除标准
- •Nonreassuring fetal heart rate pattern
- •Parity more than five
- •Uterine scar
- •Suspected placental abruption with abnormal fetal heart rate
- •Vaginal bleeding other than "bloody show"
- •Significant maternal cardiac, renal, or hepatic disease
- •hypersensitivity to oxytocin, misoprostol or prostaglandin analogues
研究组 & 干预措施
1
Titrated Oral Misoprostol Solution
干预措施: Misoprostol (Drug)
2
Intravenous Oxytocin
干预措施: Oxytocin (Drug)
结局指标
主要结局
the percentage of women delivering infants vaginally within 12 hours of augmentation
时间窗: post vaginal delivery
次要结局
- uterine hyperstimulation rate(post vaginal delivery)