Length of Cook Catheter Placement and Induction of Labor: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Time to Delivery
研究概览
简要总结
The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if there is faster time to delivery for people admitted to labor and delivery undergoing induction of labor.
详细描述
Upon presentation to labor and delivery the participant will have a cook catheter inserted digitally or by direct visualization with a speculum. The uterine component of the balloon will be inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. In both groups participants will be started on hospital-based oxytocin protocol. This protocol beings with 2 milliunits/min of oxytocin, increasing by 2 milliunits every 15 minutes until regular uterine contractions occur. The maximum dose of oxytocin is considered to be 30 milliunits. The cook catheter will then be removed at 6 vs. 12 hours based on randomization. At that point health care providers will manage active labor. Health care providers many perform amniotomy at any point during the induction process with recommendation for amniotomy with cervix more than 4cm dilated. Labor interventions are at the discretion of the healthcare provider. The participants will have continuous fetal monitoring throughout their induction, labor and delivery. Need for operative delivery or cesarean section will be at the discretion of the health provider.
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 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing cervical ripening for labor induction at term (37-41 6/7 weeks) with a singleton gestation in cephalic presentation. Women will need to have a bishop score <6 or cervical dilation <2cm with intact membranes to be included.
排除标准
- •Non English speaking
- •Contraindications to vaginal delivery
- •Prior cesarean section
结局指标
主要结局
Time to Delivery
时间窗: Assessed following delivery (delivery day, day 0)
Time to delivery
次要结局
- Time to Active Labor(Assessed following delivery (delivery day, day 0))
- Delivery Within 12 Hours(Assessed following delivery (delivery day, day 0))
- Delivery Within 24 Hours(Assessed following delivery (delivery day, day 0))
- Indication for Cesarean Delivery(Assessed following delivery (delivery day, day 0))
- NICU Admission(Assessed at end of study period (week 4))
- Cesarean Delivery Rate(Assessed following delivery (delivery day, day 0))
- NICU Admission >48 Hours(Assessed at end of study period (week 4))
- Neonatal Length of Stay(Assessed at end of study period (week 4))
- Maternal Length of Stay(Assessed at end of study period (week 4))
- Neonatal Complications(Assessed at end of study period (week 4))
- Maternal Complications(Assessed at end of study period (week 4))
研究者
Sarah E Little
Director of Clinical Research
Brigham and Women's Hospital
