Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Time From Start of Labor Induction to Vaginal Delivery
研究概览
简要总结
The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.
详细描述
More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy
- •vertex presentation
- •unfavorable cervix(Bishop's score less than or equal to 6)
- •greater than 24 weeks gestation
排除标准
- •fetal malpresentation
- •multifetal gestation
- •spontaneous labor
- •more than 5 uterine contractions in 10 minutes
- •contraindication to prostaglandins
- •non-reassuring fetal heart rate tracing
- •intrauterine growth restriction
- •anomalous fetus
- •fetal demise
- •previous cesarean delivery or other significant uterine surgery
研究组 & 干预措施
Foley Bulb plus Misoprostol
干预措施: Foley bulb (Device)
Misoprostol
结局指标
主要结局
Time From Start of Labor Induction to Vaginal Delivery
时间窗: 72 hours
次要结局
- Successful Number of Vaginal and Cesarean Deliveries(72 hours)
- Chorioamnionitis(96 hours)
- NICU Admission(96 hours)
- Time to Complete Cervical Dilation(72 hours)
- Number of Participants Experiencing Tachysystole With Deceleration(72 hours)
- Number of Participants With Post-partum Hemorrhage(96 hours)
- Neonatal APGAR Scores(5 minutes)
- Delivery Within 24 Hours(Delivery within 24 hours of induction)
- Admission to NICU or Special Care Nursery(birth to 96 hours of age)