NCT06357962终止不适用
Clinical Trial With Two Branches to Study the Effect of Semi-permanent Acupuncture at Specific Acupuncture Points on Reducing the Number of Inductions During Labor in Women at Low or Moderate Risk
Consorci Sanitari de l'Alt Penedès i Garraf2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Pharmacological induction
研究概览
简要总结
Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anticipated delivery at the study center.
- •Ability to collaborate in necessary evaluations.
- •Legal capacity to provide informed consent.
- •Signature of the informed consent for inclusion in the study, by oneself.
排除标准
- •Pregnancy with high or very high risk as described by the Pregnancy and Childbirth Monitoring Protocols of the Department of Health of Catalonia
- •History of cesarean delivery.
- •Language barrier preventing collaboration in study procedures.
- •Cognitive or affective pathology limiting the ability to collaborate with study procedures.
- •Participation in another clinical trial involving an experimental intervention during the period of this trial and/or establishing a visit frequency incompatible with this trial.
结局指标
主要结局
Pharmacological induction
时间窗: Birth date
Percentage of pregnant women who have undergone pharmacological induction to initiate labor.
次要结局
- Duration of labor period(Birth date)
- Change on score of Bishop scale(Birth date)
- Onset of spontaneous labor(Birth date)
- Satisfaction of pregnants(Birth date)
- Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period(Birth date)
研究者
研究点 (2)
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