NCT00755092已完成不适用
Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年9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
- 150
- 试验地点
- 1
- 主要终点
- VAS pain intensity
研究概览
简要总结
Psychological care during labor is considered as an important supplemental procedure for alleviating delivering stress and pain. Although Doula has been recommending that should be given for parturients, its precise effect on nulliparous and multiparous women is still unknown. The investigators hypothesized that multiparas had experienced the process of labor, but the nulliparas were not, so Doula support would produce different effect on these two population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy term parturients
- •19-45 years
排除标准
- •Organic dysfunction
- •Participants younger than 19 years or older than 45 years
- •Those who were not willing to or could not finish the whole study at any time
- •Pregnancy-induced hypertension and diabetes mellitus
结局指标
主要结局
VAS pain intensity
时间窗: From the beginning of regular contraction of uterus to the end of delivery
次要结局
- Ramsey sedative scale(From the beginning of regular contraction of uterus to the end of delivery)
- Blood levels of corticosteroid(10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery)
- Vital signs(From the beginning of regular contraction of uterus to the end of delivery)
- Adverse events(From the beginning of regular contraction of uterus to the end of delivery)
- Infant outcomes(The time of delivery to 1 h after delivery)
- Cesarean rate(During the whole period of laboring)
- Overall feeling of satisfaction of analgesia(From the beginning of regular contraction of uterus to the end of the labor)
研究者
研究点 (1)
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