Misoprostol Versus Pitocin for Induction of Labor in Patients With BMI > 30: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 5
- 主要终点
- Time from induction to delivery
研究概览
简要总结
This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.
详细描述
This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor. Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until 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
- •- Pregnant patient presenting to labor & delivery for induction of labor with a BMI > = 30
排除标准
- •- Pregnant patient presenting to labor & delivery for induction of labor with BMI < 30
研究组 & 干预措施
Misoprostol and Pitocin
Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.
干预措施: Pitocin (Drug)
Misoprostol and Pitocin
Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.
干预措施: Misoprostol (Drug)
Pitocin only
Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.
干预措施: Pitocin (Drug)
结局指标
主要结局
Time from induction to delivery
时间窗: start of induction until delivery
Simple measure calculating time from start of induction until delivery of neonate.
次要结局
- Delivery outcome(at delivery)
研究者
Angela Bianco
Division Director, MFM
Icahn School of Medicine at Mount Sinai