Labor Induction and Pain Relief With Paracetamol Versus Placebo
Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter
研究概览
详细说明
Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.
assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.
An assessment of pain management will also be conducted using various assessment tools:
- Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.
- Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.
- Patient Experience Questionnaire - upon transfer to delivery room.
- Socio-demographic Questionnaire
Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).
研究类型
注册 (预期的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter
Exclusion Criteria:
- Sensitivity to paracetamol.
- Past Cesarean section
- Multiple pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途: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 |
---|---|
有源比较器:Intervention Group
Administration of 1 gr paracetamol I.V
|
Administration of 1 gr paracetamol I.V
|
安慰剂比较:Control Group
Administration of 100 ml.
sodium chloride 0.9% IV
|
Administration of 1 gr paracetamol I.V
|
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 |
---|---|---|
PAIN assessment during catheter balloon insertion
大体时间:One year
|
pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10
|
One year
|
vaginal delivery rate
大体时间:one year
|
vaginal delivery rate in percents (%) will be assessed and compared in the two groups Rate of cesarean sections will be assessed
|
one year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
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