Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))
研究概览
简要总结
The purpose of the study was to compare early induction versus expectant management regarding outcome and experience of delivery in nulliparous women with a prolonged latent phase.
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
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •generally healthy nulliparous women and normal pregnancies (in vitro-fertilisation included)
- •with a singleton fetus in cephalic presentation,
- •gestational age between 37+0 and 41+6,
- •continuous contractions exceeding 18 hours impeding rest (women's report),
- •a cervical dilation of less than four centimetres and intact membranes. Gestational age was confirmed by ultrasound in the first trimester.
- •Women had to be able to read, understand and speak Swedish.
排除标准
- 未提供
研究组 & 干预措施
Early induction
Induction was performed if membranes were still intact and cervical dilation was less than four centimetres five hours after medication for therapeutic rest. For participants with an unripe cervix intravaginal prostaglandin E2 (PgE2, dinoproston) was used. A transcervical catheter (BARD) was inserted if this procedure was possible 19 and if cervical dilatation permitted, amniotomy was performed. The physician in charge performed all assessments and procedures except amniotomy.
When the participants reached the active phase they were monitored according to the clinical guidelines.
干预措施: Early induction (Other)
expectant management
The participants in the control group awaited spontaneous onset of labour as long as possible (expectant management). If contractions had ceased or subsided after the therapeutic rest women could be discharged from hospital, but were still included in the study. When reaching the active phase of labour women were monitored according to the clinical guidelines.
干预措施: Expectant mamagement (Other)
结局指标
主要结局
The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 3 days
次要结局
- Maternal outcome measure included experience of delivery(Experience of delivery was assessed two days after delivery)