Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Birth within 24 hours of induction
研究概览
简要总结
This randomized clinical trial will examine if there are any differences between post-dates inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the evening for first-time mothers. Sleep and fatigue measures will be measured to see if they differ by time of induction. Other measures will include the rate of births within 24 hours of admission, length of labor, use of labor analgesics, and method of delivery.
详细描述
Randomized clinical trial of first-time pregnant women requiring post-dates induction (induction after 40 weeks gestation). Women will be randomized to a labor induction time in the morning or the evening. On hospital admission once women have signed the study consent, they will complete sleep questionnaires and a fatigue assessment. Fatigue and sleep time assessments will subsequently done by the study subject every 4 hours until women enter active labor. At the onset of active labor, assessments will stop. Labor outcomes and patient satisfaction will be obtained once women deliver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant at 40 weeks gestation or more
- •Nulliparous
- •14 years old or older
- •English or Spanish speaking
- •Healthy maternal status
- •Labor induction able to be scheduled
排除标准
- •Less than 40 weeks gestation
- •Multiparous
- •Younger than 14 years old
- •Not able to speak or write in English or Spanish
- •Fetal or maternal status requires immediate induction
结局指标
主要结局
Birth within 24 hours of induction
时间窗: Day 1
Calculate proportion of women delivering within 24 hours of the start of labor induction between the two groups
次要结局
- Change in fatigue scores(Day 1)
- Morning-evening chronotype(Day 1)
- St. Mary's Sleep scale(Prebaseline: Baseline - 12-24 hours)
- Labor and birth satisfaction(Day 2)
- Length of time to labor intervention(Day 1)
- Sleep Quality(Prebaseline: Baseline - 30 days)
- Cesarean rate(Day 1)
- Change in hand grip strength(Day 1)
- Neonatal outcomes(Day 1)