Ultrasound Imaging Biofeedback for Shortening the Second Stage of Labor: a Randomized Prospective Study
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
- 是
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
Eran Brazilay, MD PhD
Head of the Obstetric and Gynecologic Ultrasound unit
Assuta Ashdod Hospital
