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临床试验/NCT02865551
NCT02865551招募中不适用

The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019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
招募中
入组人数
160
试验地点
1
主要终点
Rate of urinary retention after vaginal delivery with epidural anesthesia

研究概览

简要总结

The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.

详细描述

An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.

In patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.

Patient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients in labor designated for vaginal delivery with epidural anesthesia.

排除标准

  • Patients with neurological problems including gestational diabetes.
  • Patients either designated for elective cesarean delivery or emergent cesarean delivery.

研究组 & 干预措施

Extended catheterization

Experimental

Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.

干预措施: Foley catheter (Device)

Extended catheterization

Experimental

Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor.

干预措施: Epidural anesthesia (Drug)

Intermittent catheterization

Experimental

Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.

干预措施: Short term catheter (Device)

Intermittent catheterization

Experimental

Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery.

干预措施: Epidural anesthesia (Drug)

结局指标

主要结局

Rate of urinary retention after vaginal delivery with epidural anesthesia

时间窗: Up to 3 days

次要结局

  • Rate of urinary tract infections(Up to 3 days)

研究者

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

ROY LAUTERBACH MD

Dr. Roy Lauterbach

Rambam Health Care Campus

研究点 (1)

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