跳至主要内容
临床试验/NCT01042483
NCT01042483Unknown不适用

Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters+Continuous Vacuum Mode

Trig Medical Inc0 个研究点目标入组 450 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
450
主要终点
Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves.

研究概览

简要总结

The purpose of this study is to establish normograms of parameters measured by the LaborPro system, and to test the prediction of these parameters on labor progress and mode of delivery.

详细描述

Intrapartum assessment of the fetal head position and station, and cervical dilatation are essential for the management of labor. Precise knowledge of these parameters assists in the correct identification of normal versus abnormal labor progression patterns, and in case of the latter, indicates when medical or operative intervention may be required.

Digital examination remains the "gold standard" for evaluation of head station and position and cervical dilatation in pregnancy; however, it has inherent variability.

evaluations of the reliability of cervical dilatation assessment were performed initially in models, and more recently in patients during labor. Accuracy in models ranges from 51% to 59% and falls under 50% when evaluated in patients.

However, labor management has changed substantially since then. Induction of labor, oxytocin use, epidural analgesia, and fetal heart rate monitoring are very common in contemporary practice whereas breech vaginal delivery and mid forceps are rarely performed. The mean body mass of women is significantly higher than it was 50 years ago, which may contribute to the increased fetal size, and the second stage is prolonged, as it increasingly occurs with use of epidural analgesia. Some studies suggested that the Friedman curve was no longer appropriate for induced or actively managed labor.

In addition, once full dilatation is reached, although descent continues, monitoring of cervical dilation is no longer useful in the second stage. Descent in the second stage of labor is accompanied by rotation of the presenting part as it negotiates the pelvis. Friedman and Sachtleben showed that arrest of descent was frequently associated with fetal malpositions and suggested that abnormalities of rotation were important prognostic factors in the second stage.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Singleton pregnancy
  • •Pregnant adult woman in labor
  • •Gestational age 37-42 wks
  • •Vertex presentation
  • •Willing to participate in the study and understands the study

排除标准

  • •Fetal malformations
  • •Fetal distress

结局指标

主要结局

Assessment of the LaborPro as a prediction tool of labor progression. by introducing extended labor curves.

时间窗: 1 year

次要结局

  • Assessing the influence of obstetric and maternal parameters on the labor progression,relation between the pelvis diameters and Pubic Arch Angle measured by the LaborPro, and labor progression and mode of delivery,Maternal Satisfaction.(1 year)
  • Measurements of fetal head station and position during performing vacuum extraction delivery by attaching the positon sensor (1.3 mm) to the vacuum cup.(1 year)

研究者

申办方类型
Industry

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