Dental Support Device During Breastfeeding as a Mean for Pain Control
试验速览
- 阶段
- 3 期
- 入组人数
- 700
- 主要终点
- Rate of change in of the vas scores before and after using this device
研究概览
简要总结
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
详细描述
Dental support device is effective in increasing isometric force in different muscle contraction [1-7]. In 2009 an avant-garde study [8] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Maternal age 18-45 years. Normal vital signs.
排除标准
- •Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.
研究组 & 干预措施
women whom are interested in breastfeeding and have not begun.
Post-partum primi and multiparous women Post-partum primipara and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
- Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
- Control group: participants will not receive any device for breastfeeding pain control
干预措施: dental device (Device)
Post-partum women that have already begun breast feeding
2. Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device.
干预措施: dental device (Device)
结局指标
主要结局
Rate of change in of the vas scores before and after using this device
时间窗: 24 months
次要结局
- Duration of breastfeeding(24 months)
- The rate of cessation of breastfeeding because of pain(24 months)