A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.
研究概览
简要总结
The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.
详细描述
Induction of labor is widely carried out all over the world in cases where continuation of pregnancy is hazardous to both the mother and/or fetus. The induction in a ripe cervix is not difficult but complications are significantly increased when the cervix is unripe. The only agent approved for cervical ripening and induction of labor in patients with an unripe cervix is dinoprostone(PGE2). Misoprostol is a synthetic PGE1 analogue marketed for the prevention and treatment of gastro-duodenal ulcers. Misoprostol costs much less than dinoprostone and does not require refrigeration and has few systemic side effects.In addition, it is rapidly absorbed orally and vaginally. Although misoprostol is not registered for such use, it has been widely used for obstetric indications such as induction of abortion and of labor. Misoprostol for induction of labor in preceding literatures mainly prescribed in multiple dosing regimen. The adverse effects on uterus potentially occur owing to the frequent administration of misoprostol. The objective of this study was to compare a single dose oral misoprostol with vaginal misoprostol.
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
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A live singleton pregnancy at a gestation of >37 weeks, with obstetric or medical indications for induction, and unfavorable cervix (the initial Bishop score of <717), vertex presentation, reactive fetal heart rate pattern, absence of labor, and intact membranes without previous stripping. Post-term inductions were considered when gestational age was >41 weeks.
排除标准
- •Suspected cephalo-pelvic disproportion, estimated fetal weight of >4000 grams, maternal age of <18 years, parity of >5, previous cesarean delivery or history of uterine incision, any contraindication for vaginal delivery or prostaglandins administration and suspected chorioamnionitis.
结局指标
主要结局
The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.
次要结局
- Rate of vaginal delivery within 24 hours.
- Cesarean section rate.
- Uterine tachysystole.
- Uterine hyperstimulation syndrome.
- Number of women received oxytocin.
- Neonatal outcomes.