Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
2020年9月12日 更新者：ROY LAUTERBACH MD、Rambam Health Care Campus
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.
研究概览
详细说明
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:
- Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
- 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.
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Haifa、以色列
- Rambam Health Care Campus
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 44年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women planned for vaginal delivery.
Exclusion Criteria:
- Women planned for cesarean section.
- Women with comorbidities related to pain that may exacerbate during labor.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Labor+routine pain management
Women that will be treated by the medical team in the delivery room as if not part of a study regarding pain management.
|
Women that will be asked according to the routine management regarding pain management during labor, meaning frequent inquiries regarding the woman's wishes to receive analgesia by the medical team.
|
|
有源比较器：Labor+experimental pain management
Women that will not be asked at all by the medical team in the delivery room regarding analgesia during labor but will be able to receive analgesia at wish at the time of choice.
|
women will not be asked about analgesia during labor by the medical team, but will be able to receive the modality of choice at the time of choice.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual analogue scale at the time of epidural anesthesia
大体时间：Up to 3 days from admission.
|
Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.
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Up to 3 days from admission.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual analogue scale at the time of first medical analgesia
大体时间：Up to 3 days from admission.
|
Visual analogue scale as reflected by the participant at the time of choice to receive the first modality of analgesia.
|
Up to 3 days from admission.
|
|
Analgesia during labor
大体时间：Up to 3 days from admission.
|
Which modalities of analgesia the participant took during labor
|
Up to 3 days from admission.
|
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Cervical dilatation at the time of epidural anesthesia
大体时间：Up to 3 days from admission.
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Cervical dilatation at the time of choice to receive epidural anesthesia.
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Up to 3 days from admission.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年3月1日
初级完成 (实际的)
2020年7月31日
研究完成 (实际的)
2020年9月1日
研究注册日期
首次提交
2017年2月5日
首先提交符合 QC 标准的
2017年2月5日
首次发布 (估计)
2017年2月7日
研究记录更新
最后更新发布 (实际的)
2020年9月16日
上次提交的符合 QC 标准的更新
2020年9月12日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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