Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of Induction To Delivery
研究概览
简要总结
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
详细描述
The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant or surrogate is capable of giving informed consent
- •Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
- •Participant is undergoing an indicated induction of labor
- •Participant is found to have cervical Bishop score ≤5 on initial cervical exam
- •Participant has no medical or obstetrical contraindications to induction of labor
排除标准
- •Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
- •Manufacturer's contraindications to misoprostol or oxytocin
研究组 & 干预措施
Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
干预措施: Oxytocin (Drug)
Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of Induction To Delivery
时间窗: 24 hrs
To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times
次要结局
- Delivery Route(24 hrs)