跳至主要内容
临床试验/NCT00629369
NCT00629369已完成不适用

Duration of Second Stage of Labor Wearing a Dental Occlusion Device: a Randomized Controlled Trial

Mercy Medical Center2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年10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
64
试验地点
2
主要终点
The duration of the second stage of labor.

研究概览

简要总结

Developing a method to maximize maternal expulsive effort should be of great value in reducing the number of cesarean section or instrumental deliveries. Various investigations have shown that use of an occlusal support device (OSD) increases the isometric strength of different muscle groups. The aim of our study was to investigate the role of an OSD in second stage pushing.

详细描述

The increased use of epidural anesthesia during labor has lead to an increased incidence of prolonged second stage as an indication for cesarean section or instrumental delivery. The use of oxytocin has proven to be an effective method of augmentation of labor in such prolonged labor cases. However, despite oxytocin augmentation, there has been an increase in the number of cases that require cesarean section or instrumental delivery to effect delivery.

McRobert's maneuver, which is often used in to relieve shoulder dystocia, has recently been shown to increase intrauterine pressure approximately two-fold. However; it is an arduous position for the pregnant woman to maintain over a long period of time. Developing alternative methods to maximize expulsive forces, both uterine contractions and maternal expulsive effort, may be of great value in reducing the number of cesarean sections or instrumental deliveries.

Various researchers have investigated the effect of an occlusal support device (OSD) on the isometric strength of different muscle groups, e.g., neck, back, and extremities. The natural condition of dental occlusion, also known as the index of physical performance, has an affect on both muscle strength and body balance. When occlusal support is given to edentulous individuals they show improved physical exercise ability after the re-establishment of mandibular support. Patients whose dentition is in proper occlusion demonstrate greater endurance of isometric muscle strength than those who are in malocclusion. We hypothesize that optimization of dental occlusion by an OSD may improve muscle strength, leading to increased intrauterine pressure during the second stage in labor.

The aim of our study is to investigate whether the use of the OSD results in a shortened duration of the second stage 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
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Primipara
  • Singleton
  • Cephalic presentation
  • Reactive fetal heart rate pattern
  • Functioning epidural anesthesia

排除标准

  • Medical or obstetrical complications including intrauterine growth restriction
  • Large for gestational age
  • Uterine anomaly
  • Uterine myomata
  • Pre-eclampsia
  • Diabetes mellitus
  • Fetal anomaly
  • Maternal heart disease

结局指标

主要结局

The duration of the second stage of labor.

时间窗: The duration of the second stage of labor.

次要结局

未报告次要终点

研究者

发起方
Mercy Medical Center
申办方类型
Other

研究点 (2)

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