Impact of Acupuncture on Delay of Delevery During Induced Labor With Cook's Balloon at the Beaumont Maternity in Roubaix
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Impact of 9 acupuncture points on time to delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patient having contraindication for the use of Cook's balloon
- •patients under curatorship and/or guardianship
结局指标
主要结局
Impact of 9 acupuncture points on time to delivery
时间窗: Day 1
The primary objective will be assessed by recording the time of COOK balloon placement and the time of delivery
次要结局
- Comparison of balloon failure rate between the two groups(Day 2)
- Evaluate the impact of acupuncture on patient pain.(Day 1)
- Evaluate experiences of the patient during labor induction between the 2 groups(Day 1)
- Evaluate the consumption of analgesics between the 2 groups(Day 1)
- Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups(Day 2)
- Comparison of induction duration between the two groups(Day 2)