Use of an Occlusal Support Device During the Second Stage of Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 2
- 主要终点
- Stage 2 Duration of Labor
研究概览
简要总结
The primary objectives of this study are to determine if the use of an Occlusal Support Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor, reduce the incidence of labor complications including Caesarian Sections and improve Apgar scores in newborns
详细描述
Prolonged labor, especially during the second stage of active expulsive effort (the pushing phase), is associated with increased risk of maternal complications (e.g. tissue trauma, postpartum hemorrhage, intra-amniotic infection). Developing an effective method to assist and maximize maternal expulsion effort should be of great value in reducing the number of complications, also including cesarean section or instrumental deliveries. Past studies published in the dental literature have shown that specially designed oral appliances that support the dental occlusion may increase the isometric strength of different muscle groups. Increased strength of the neck muscles could improve efficiency of the Valsalva maneuver in increasing intra-uterine pressure, and thus decreasing the duration of phase II of labor. Nulliparous women with uncomplicated singleton pregnancy will be randomly assigned to either the study group (Dental appliance) or the no dental appliance group. Duration of labor will be measured for both phase I and phase II. Rates for cesarean section and instrument deliveries and other complications will be charted as well as Apgar scores .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women
- •Uncomplicated pregnancy
- •Singleton pregnancy
排除标准
- •Unable to provide informed consent or comply with study protocol,
- •High risk and/or complicated pregnancy,
- •Have multiple fetuses as diagnosed by ultrasound,
- •Have extensive decay or multiple broken/missing teeth that will interfere with the fabrication of an OSD
结局指标
主要结局
Stage 2 Duration of Labor
时间窗: Duration of labor
Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor
Number of Participants With a Cesarian Section
时间窗: Baseline
Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections
Average Apgar Score
时间窗: at minute 1 and minute 5
Determine if the use of an OSD can improve Apgar scores in newborns. The Apgar test is done by a doctor, midwife, or nurse. The provider examines the baby's: Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. Higher scores are better. Scores are added for a total ranging from 0-10.
次要结局
未报告次要终点
