NCT02103166暂停4 期
Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Time to complete dilation
研究概览
简要总结
The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 or more.
- •Term pregnancy.
- •Cephalic presentation.
- •Oxytocin perfusion not present at the time of inclusion.
- •Uterine dynamic established.
- •Abscence of high risk factors or very high risk factors for pregnancy.
- •Written informed consent
排除标准
- •Induction of labor.
- •Presence of risk factors.
- •Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.
研究组 & 干预措施
Physiological serum
Placebo Comparator
100 ml of physiological serum (0.9% NaCl).
干预措施: Physiological serum (Drug)
Hyoscine bromide
Experimental
20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
干预措施: Hyoscine bromide (Drug)
结局指标
主要结局
Time to complete dilation
时间窗: One hour
次要结局
未报告次要终点
研究者
Montse Palacio
MD, PhD.
Hospital Clinic of Barcelona
研究点 (1)
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