Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Duration of first stage of labor
研究概览
简要总结
To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Low risk gestation between 37 and 41 6/7 weeks.
- •Cephalic (vertex) presentation.
- •Spontaneous labor in active phase (4 cms)
排除标准
- •Premature rupture of membranes upon arrival at the Labor and Delivery Unit > 4 hours.
- •Multiple order pregnancy.
- •Stillbirth.
- •Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).
研究组 & 干预措施
Hyoscine Butylbromide 20Mg/1mL Injection
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms).
干预措施: Hyoscine Butylbromide 20Mg/1mL Injection (Drug)
Saline solution
Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms).
干预措施: Saline Solution (Drug)
结局指标
主要结局
Duration of first stage of labor
时间窗: 24 hours
Time measured from the moment the patient receive the allocated medication/placebo to complete dilation
Rate of cervical dilation
时间窗: 24 hours
Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation
次要结局
- Duration of labor(24 hours)
- Fetal and neonatal complications(72 hours)
研究者
Osvaldo A. Reyes T.
Head - Research Department
Saint Thomas Hospital, Panama