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临床试验/NCT02606643
NCT02606643已完成不适用

Balloon Catheter for Cervical Ripening With or Without Traction: A Randomized Controlled Trial

St. Louis University2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
2
主要终点
Duration

研究概览

简要总结

Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure.

Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.

详细描述

Once admitted, women who are schedule for induction and who's physician has order a balloon catheter, they will have a transcervical balloon catheter inserted-this is normal care. Patients will be placed in the dorsal lithotomy position in the delivery bed. The cervix will be examined digitally (this is the standard of care). The balloon catheter will be inserted by feel and passed through the cervix until the balloon is above the internal os. The balloon will then filled with approximately 50-60 mL of normal saline. This procedure is standard of care.

Randomization: 63 cards will be prepared to read "tape for tension" and 63 will be prepared to read "No tape/No Tension". These cards will be sealed in opaque envelopes and kept in the PI's office. After consent is obtained the PI will be notified and a sealed envelope will be opened and the patient and staff will be notified.

If randomized to "No tension" the catheter will be positioned comfortable and not placed to tension (this is currently the standard at SSM - Saint Mary's Hospital ).

For the "Tension" arm (research related), slight tension will be placed on the catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed every 30 minutes by the research and/or the nursing staff.

Only slight tension will be applied to those catheters assign to the tension group. The catheter will be taped to the inner thigh so there is no "sag" in the catheter from the urethra to the tape. There is no method or device to "measure" the tension placed on these catheters, if the patient moves her leg it can lessen or increase the tension, these are known factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton gestation
  • Bishop score less than or equal to 6
  • cephalic presentation

排除标准

  • prostaglandins given this admission
  • any medical conditions precluding vaginal delivery
  • significant cervical or intrauterine infection
  • significant vaginal bleeding
  • intrauterine fetal demise
  • low lying placenta
  • prior cervical surgery
  • latex allergy

结局指标

主要结局

Duration

时间窗: hours to delivery 0-26

Hours of labor

次要结局

  • Vaginal Delivery Within 24 Hours(24 hours)
  • Deliveries Via Cesarean Delivery(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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