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临床试验/NCT04233008
NCT04233008已完成不适用

Length of Cook Catheter Placement and Induction of Labor: a Randomized Controlled Trial

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2019年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah E Little

Director of Clinical Research

Brigham and Women's Hospital

研究点 (2)

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