Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Compliance
研究概览
简要总结
The investigators designed a pilot randomized controlled trial to assess the feasibility and acceptability of repeated hands-and-knees positioning during labour. The objectives were 1) to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol by participants and care providers, 3) to obtain women's views about their experiences using the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the sample size calculation for a large trial.
详细描述
Women were enrolled in the pilot randomized controlled trial at two hospitals, one in Canada and one in the USA. Nurses at both hospitals were trained in how to assist women into the hands-and-knees position in bed. Repeated hands-and-knees position was defined as attempts to use the position for 15 minutes, hourly from randomization until delivery. Women were not asked to assume hands-and-knees for delivery.
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
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparous;
- •>37 weeks 0 days gestation
- •in established early labour
- •anticipating a vaginal delivery of a single fetus in the cephalic position
- •competent to give informed consent .
排除标准
- •delivery was anticipated within 3 hours
- •a medical contraindication or physical limitation such that hands-and- knees position was contraindicated
- •had a doula or midwife who encouraged the use of hands-and-knees position.
研究组 & 干预措施
Usual care
Participants were asked to refrain from using hands-and-knees position at any time from randomization to delivery. They were free to use any other position.
Repeated Use of Hands-and-Knees
The intervention was repeated use of hands-and-knees position during labour. Participants were asked to try it for at least 15 minutes every hour, from randomization until delivery. They were not required to use it for delivery.
干预措施: Repeated hands-and-knees positioning during labour (Other)
结局指标
主要结局
Compliance
时间窗: from randomization to delivery
Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.
次要结局
- Persistent back pain(hourly during labour, from randomization to delivery)
- women's views(assessed prior to hospital discharge)
研究者
Ellen Hodnett
Professor
University of Toronto