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临床试验/NCT02465164
NCT02465164已完成不适用

Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Henry Ford Health System0 个研究点目标入组 26 人开始时间: 2015年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
26
主要终点
Time to Delivery (in Hours)

研究概览

简要总结

The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy
  • reassuring fetal status at time of presentation
  • Bishop Score <6

排除标准

  • Closed cervix
  • Breech presentation
  • Multiple gestations
  • Recent vaginal bleeding
  • Placenta previa
  • non reassuring fetal status
  • Active genital herpes infection

研究组 & 干预措施

Cook catheter

Other

Control

干预措施: Cook catheter (Device)

Cook catheter plus low dose oxytocin

Active Comparator

Test group

干预措施: Cook catheter (Device)

Cook catheter plus low dose oxytocin

Active Comparator

Test group

干预措施: Oxytocin (Drug)

结局指标

主要结局

Time to Delivery (in Hours)

时间窗: Up to 60 hours

Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6)

次要结局

未报告次要终点

研究者

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

Justin Bruner

Resident Physician

Henry Ford Health System

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