A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 主要终点
- Time to the Second Stage of Labor
研究概览
简要总结
The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.
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
- •Patients with a singleton pregnancy
- •Term pregnancy (> 37 weeks gestation)
- •Age ≥ 18 years
- •Bishop score < 5
- •Contractions < 6/hr
- •Reassuring fetal heart tracing
排除标准
- •Rupture of membranes
- •Antepartum bleeding
- •Fetal death
- •Placenta previa or low lying placenta
- •Active genital herpes infection
- •Previous use of an induction or preinduction agent during the current pregnancy
- •EFW >4500 grams
- •Non reassuring fetal testing
- •Inability to pass foley through cervix
- •Prior cesarean section
研究组 & 干预措施
foley bulb induction with low dose pitocin
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
干预措施: pitocin (Drug)
foley bulb with standard incremental pitocin infusion protocol
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
干预措施: pitocin (Drug)
结局指标
主要结局
Time to the Second Stage of Labor
时间窗: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Time to Delivery
时间窗: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)
Time from foley balloon placement until neonate delivery
次要结局
- Rate of Cesarean Delivery(during admission for delivery, up to approximately 4 days)
- Time to Active Labor(during admission for delivery, up to approximately 4 days)
- Time to Foley Expulsion or Removal(foley bulb placement until removal, up to 10 hours)
- Neonatal Outcome: Placental Abruption(during admission for delivery, up to approximately 4 days)
- Incidence of Uterine Hyperstimulation(during admission for delivery, up to approximately 4 days)
- Neonatal Outcome: Birthweight(at time of birth (0 to 1 hour))
- Neonatal Outcome: Late Fetal Heart Rate Decelerations(during admission for delivery, up to approximately 4 days)