跳至主要内容
临床试验/NCT03045705
NCT03045705撤回不适用

Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.

Rambam Health Care Campus1 个研究点 分布在 1 个国家开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Visual analogue scale at the time of epidural anesthesia

研究概览

简要总结

In the current study the investigators wish to evaluate the effect the doctors and midwives in the delivery room have on the timing and modality of analgesia chosen by the participants. The participants will be randomly divided into 2 groups. Both groups will be advised of the different modalities of analgesia available during labor. One group will be managed in the delivery room the same as if not part of the study, meaning the doctors and midwives will treat the participants the way they usually do regarding analgesia. The second group of participants will not be asked by the doctors and midwives about analgesia at all but will be able to receive analgesia by a modality of choice at the timing of choice.

详细描述

After explaining to the participants the study and having signed a confirmed consent, participants will receive an extensive explanation regarding the different modalities of analgesia available during labor. After the explanations the participants will be randomly divided into 2 groups:

  1. Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
  2. Interventional management-participants will not be asked by the doctors and midwives about analgesia at all during labor but will be able to receive analgesia by a modality of choice at the timing of choice after being advised by the medical team.

After delivery, participants will fill a questionnaire regarding the experience of labor in general and the relevance of analgesia during labor including the effect the medical team may have had on decision making during labor.

Medical information regarding visual analogue scale (VAS), analgesia modality, cervical conditions, parity etc. will be extracted from patients' electronic files.

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
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women planned for vaginal delivery.

排除标准

  • Women planned for cesarean section.
  • Women with comorbidities related to pain that may exacerbate during labor.

结局指标

主要结局

Visual analogue scale at the time of epidural anesthesia

时间窗: Up to 3 days from admission.

Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.

次要结局

  • Analgesia during labor(Up to 3 days from admission.)
  • Cervical dilatation at the time of epidural anesthesia(Up to 3 days from admission.)
  • Visual analogue scale at the time of first medical analgesia(Up to 3 days from admission.)

研究者

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

ROY LAUTERBACH MD

Primary investigator

Rambam Health Care Campus

研究点 (1)

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