NCT00664118已完成不适用
In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women
Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Rate of cesarean delivery
研究概览
简要总结
Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of 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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women
- •> 18 years and < 45 years
- •Spontaneous labor
- •Analgesia request
排除标准
- •Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- •Participants younger than 18 years or older than 45 years
- •Those who were not willing to or could not finish the whole study at any time
- •Using or used in the past 14 days of the monoamine oxidase inhibitors;
- •Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
- •Subjects with a nonvertex presentation or scheduled induction of labor
- •Cervical dilation was 4.0 cm or greater before performing epidural puncture and catheterization
结局指标
主要结局
Rate of cesarean delivery
时间窗: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)
次要结局
- Rate of instrumental delivery(Analgesia initiation (0 h) to successful vaginal delivery (4-7 h))
- Indications of cesarean delivery(Analgesia initiation (0 h) to cesarean section (4-7 h))
- Maternal Visual Analog Scale (VAS) rating of pain(15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery)
- Incidence of side effects(The whole period of the analgesia to successful vaginal delivery)
- Low back pain at 3 months after vaginal delivery(Three months after vaginal delivery)
- Maternal oral temperature(The whole period of the analgesia to successful vaginal delivery)
- Use of oxytocin after analgesia(During the whole period of the analgesia)
- Maximal oxytocin dose(30 min after vaginal delivery)
- Duration of analgesia(Initiation of analgesia (0h) to the disappearance of sensory block (4-8h))
- Breastfeeding success at 6 weeks after vaginal delivery(Six weeks after successful delivery)
- Maternal satisfaction with analgesia(30 min after the vaginal delivery)
- Neonatal one-minute Apgar scale(One minute after baby was born)
- Neonatal five-minute Apgar scale(Five minutes after baby was born)
- Umbilical-cord gases analysis(Immediately after baby was born)
- Neonatal sepsis evaluation(5 min after the baby was born)
- Neonatal antibiotic treatment(5 min after the baby was born)
研究者
研究点 (1)
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