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临床试验/NCT05258786
NCT05258786已完成不适用

Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education and Pelvic Floor Training - a Randomized Control Trial

Ariel University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
length of the second stage of labor

研究概览

简要总结

The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on pelvic floor training and maternal-coached pushing with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological effects.

详细描述

Childbirth is a challenging process both emotionally and physically. The anxiety and anticipation accompanying pregnancy, labor, and delivery were reported to be relieved by pre-labor education, providing knowledge regarding the physiological process of labor to future parents.

Ultrasound examination enables the laboring women the opportunity to see fetal head movements in response to maternal pushing, and previous studies have revealed the physiological and psychological advantages of ultrasound-mediated intrapartum biofeedback during the second stage of labor.

Pre-labor sonographic maternal coaching has the advantage of a clean setting, avoiding the stressful, frequently hectic nature of labor and delivery wards, and may enable a more comprehensive implementation of the method, a structured training program, and better physical and psychological outcomes. All available literature regarding the application of intrapartum and pre-labor ultrasound refers to the examination performed by obstetricians.

The study will observe the effect of antenatal biofeedback with transperineal and abdominal ultrasound applied by a pelvic floor physical therapist. The training will focus on two aspects: pelvic floor training and maternal coached pushing - both with ultrasound-based visual biofeedback. The investigators aim to assess maternal and neonatal obstetrical outcomes, urinary and fecal incontinence, and maternal psychological outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will collect the data from the files without knowing the participant's groups (intervention/control/standard care)

入排标准

性别
Female
接受健康志愿者

入选标准

  • pregnant nullipara women with a low-risk pregnancy who are planned for vaginal delivery. The biofeedback will occur at 36-42 gestational weeks.

排除标准

  • an inability to fill questionaries due to communication issues or cesarean section performed due to major obstetrical events.

结局指标

主要结局

length of the second stage of labor

时间窗: up to 1 week after labor

measure by time (min/hour)

次要结局

  • Perineal tears(up to 1 week after labor)
  • Fear of birth questionnaire(Baseline, a week later , 1 week after labor and two months after labor)
  • Mode of delivery(up to 1 week after labor)
  • Urinary and fecal incontinence(up to 1 week after labor, and 2 month after labor.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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