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临床试验/NCT04210908
NCT04210908已完成不适用

Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study

Assuta Ashdod Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月30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
100
试验地点
1
主要终点
Duration of the second stage of labor

研究概览

简要总结

The purpose of this study is to examine whether transperineal ultrasound as visual biofeedback can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.

详细描述

Biofeedback provides patients with better control of their body and their physiological reactions respective of the examined process, such as stress/anxiety, sports activity, labor, etc.

Women under epidural anesthesia, may frequently feel lack of control over the birthing process and difficulty in bearing down effectively, which is a very significant part of the second stage of labor.

Transperineal ultrasound during labor is a standard procedure in many medical centers in the world, mainly used to assist obstetricians in evaluating the progress of labor, fetal head position and assessing the chances of successful operative delivery. One of the most common tools used in transperineal ultrasound in measurement of the angle of progression, which has been suggested as a subjective method for assessing fetal station and for predicting successful vaginal delivery. A preliminary non-randomized study raised the possibility that the use of transperineal ultrasound during labor as a biofeedback tool may shorten the second stage of labor.

The purpose of this study is to examine whether this tool can be used during labor as an effective tool for shortening the second stage of labor and reducing the need for instrumental delivery, in a prospective randomized design.

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

入选标准

  • First labor
  • Full dilation
  • Head position between SP-1 and SP+
  • Epidural anesthesia
  • No contraindication for vaginal delivery
  • Parturient informed consent

排除标准

  • Participation in parallel studies.
  • Category III fetal monitoring requiring immediate delivery.

结局指标

主要结局

Duration of the second stage of labor

时间窗: Up to 6 hours

Minutes from first documentation of full dilatation to delivery.

次要结局

  • Mode of delivery(Up to 6 hours)
  • Neonatal 1 minute Apgar score(Up to 6 hours)
  • Cord pH(Up to 6 hours)
  • Neonatal 5 minute Apgar score(Up to 6 hours)
  • Maternal perineal tears(Up to 6 hours)
  • Postpartum hemorrhage(Up to 24 hours)

研究者

发起方
Assuta Ashdod Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eran Brazilay, MD PhD

Head of the Obstetric and Gynecologic Ultrasound unit

Assuta Ashdod Hospital

研究点 (1)

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