Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Monitoring fetal heart movement
研究概览
简要总结
The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor
详细描述
Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.
To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
- •Gestational age 37-42 weeks. (GA)
- •Single Fetus.
- •Subjects who understand, agreed and signed the informed consent form.
排除标准
- •Women with abnormal placentation (Placenta previa) -
- •Abnormal fetal presentation (Breech presentation).
- •Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
- •Need for immediate delivery (cord prolapsed or suspected placental abruption)
结局指标
主要结局
Monitoring fetal heart movement
时间窗: During labour
次要结局
未报告次要终点
