Dental Support and the Second Stage of Labor Among Multiparous Women
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 主要终点
- Duration of the second stage of labor.
研究概览
简要总结
To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.
详细描述
Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.
The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. The investigators hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. The researchers will also investigate it's efficiency in pain management.
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
- •Singleton gestation
- •Multiparous women
- •Term gestation (>37+0/7 weeks)
- •Signed written consent to participate in the study
- •Maternal age 18-45 years
- •Normal vital signs
- •Noraml cardiotocography and biophysical profile at admission
排除标准
- •Multiple gestation
- •Nulliparous women
- •preterm gestation (<37+0/7 weeks)
- •Refusal to participate
- •Maternal age <18 or > 45 years
- •Normal vital signs
- •Abnormal cardiotocography and biophysical profile at admission
结局指标
主要结局
Duration of the second stage of labor.
时间窗: 12 month
After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package. Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite.
次要结局
- Patient satisfaction (questionnaire)(12 month)
研究者
michal roll
Deputy Director General for R&D
Tel-Aviv Sourasky Medical Center