Intravenous Injection of Diazepam at the Beginning of Active Phase of Labor
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Duration of labor
研究概览
简要总结
Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering sedatives during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as sedatives, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world. (Cochrane Database of Systematic Reviews 2013,CD009243.pub3.; Cochrane Database of Systematic Reviews 2012, CD009223.pub2.)
Hypothesis: Diazepam reduced the duration of labor and the severity of pain in labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primigravida
- •singleton pregnancy
- •cephalic presentation
- •spontaneous labour
- •intact membranes at the beginning of active phase
排除标准
- •induced labour
- •spontaneous rupture of membranes at randomisation
- •obstetric complications, or medical complications
- •previous uterine scarring, or cervical surgery
- •cervical dilatation of more than 5 cm
- •other antispasmodics in the first stage
- •malpresentation, macrosomia, cephalopelvic disproportion
研究组 & 干预措施
normal saline, active phase of labor
A single dose intravenous injection of normal saline (2ml) at the beginning of active phase of labor in the group.
干预措施: normal saline/diazepam at the active phase of labor (Drug)
diazepam, active phase of labor
A single dose intravenous injection of diazepam (10mg, 2ml) at the beginning of active phase of labor in the group.
干预措施: normal saline/diazepam at the active phase of labor (Drug)
结局指标
主要结局
Duration of labor
时间窗: labor
Duration of first stage of labor. Duration of second stage of labour. Duration of third stage of labor. Total duration of labor.
次要结局
- Pain relief(every 30 minutes during the 3-hour period after administration of the trial drug)
- Type of delivery(post partum, immediately)
- Rate of cervical dilatation(at the active phase of labor)
研究者
Yunhai Chuai
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
Navy General Hospital, Beijing