NCT00426725已完成不适用
Protocol for Testing the Efficiency of a Device Meant to Relieve Labour Pain
ACU Medical Technologies Ltd1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Mosby Pain Rating Scale (VAS)
研究概览
简要总结
The suggested research is aimed to test the effectiveness of an external mechanical device to be applied and used by the parturient herself in pain relieving during labour . The research is to be performed in a controlled closely observed way, to ensure the safety of the involved parturient and newborn.
详细描述
Clinical Trial Design A prospective controlled study meant to scientifically test the feasibility of a device to alleviate labour pain.
- Every woman will sign an informed consent form.
- Guidance for proper and safe use of the device will be given by specially trained midwives.
- The study will be performed at the Laniado Hospital-Sanz Medical Center, Netanya, Israel.
- The study group will consist of 60 women, 30 in each group.
- Eligibility : Ages Eligible for study is 18 years and up.
Participants:
- The study group shall consists of 30 parturients at active labour, with contractions, demanding to receive analgesia. The device will be given, with guidance from a pre-trained midwife and under professional supervision. This study group will include also women choosing to continue using it till the application of epidural analgesia.
- The control group shall consists of 30 parturients at active labour, with contractions, choosing to receive epidural analgesia.
Inclusion criteria:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with low-risk normal pregnancies.
- •Healthy women, age 18 years or more.
- •Single pregnancy
- •At active labour, with contractions and labour pain.
排除标准
- •Women at high risk pregnancies (with Diabetes Mellitus, Arterial Hypertension, multiple fetal pregnancy, abnormal amniotic fluid index, Intra Uterine growth restriction(IUGR), or any situation which might imply placental insufficiency)
- •Caesarean sections in the past
- •Any contraindication to vaginal delivery (as breech presentation or Placenta Previa).
- •Any active illness, abnormal body temperature, Fatigue, etc.
- •Women complaining of any pain nonrelated to labour.
结局指标
主要结局
Mosby Pain Rating Scale (VAS)
时间窗: 6 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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