COOKACUPAIN 2 : Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix (COOKACUPAIN 2)
Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix
In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method.
At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this labor induction.
No studies where found about an effect of acupuncture therapy on delivery provoked by labor induction with Cook's balloon.
研究概览
详细说明
Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced delay until delivery and improved patient's experience. Investigators will use 9 acupuncture points (7C bilateral/ 34VB bilateral/ 3F bilateral, 4GI bilateral and 4VC bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.
A questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.
Patients will be randomised.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Camille TROUILLET
- 电话号码：+33 3 20 99 31 31
- 邮箱：urc@ch-roubaix.fr
学习地点
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Roubaix、法国、59100
- CH de Roubaix
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接触：
- Caroline GUERY, Doctor
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- pregnant woman with a gestational age of 37 weeks and above
- age>=18 years old
- having medical indication to be labor induced by Cook's Balloon
- speaking French
- agreeing to participate by signing informed consent form
Exclusion Criteria:
- patient having contraindication for the use of Cook's balloon
- patients under curatorship and/or guardianship
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：针灸臂
针灸疗法
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9 acupuncture points will be used to managed time delivery, pain and improved patient's experience
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无干预：控制臂
日常护理
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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 |
|---|---|---|
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Impact of 9 acupuncture points on time to delivery
大体时间：Day 1
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The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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评估两组之间镇痛药的消耗量
大体时间：第一天
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镇痛药消耗数据将收集在患者记录中
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第一天
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Evaluate the impact of acupuncture on patient pain.
大体时间：Day 1
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Assessment of patient pain using Visual Analogic Scale scores for 1 to 10 points : before insertion of the Cook balloon, one hour after insertion, upon transfer to the delivery room, and during pushing efforts.
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Day 1
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Evaluate experiences of the patient during labor induction between the 2 groups
大体时间：Day 1
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Use of a questionnary with lickert scale (Completely, Sufficiently, Insufficiently, Not at all)
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Day 1
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Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
大体时间：Day 2
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percentage of Caesarean sections recorded in patients' medical records
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Day 2
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Comparison of balloon failure rate between the two groups
大体时间：Day 2
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percentage of ballon failed procedure recorded in patients' medical records
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Day 2
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Comparison of induction duration between the two groups
大体时间：Day 2
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Duration in hours between begenning of labour and delivery recorded in patients' medical records
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Day 2
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.