Physiological Study of the Active Stage of Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Birth Track measurements versus manual measurements
研究概览
简要总结
Objective of the study: to obtain new data on the dynamics of the labor process, cervix dilatation and head station on the labor process and to develop a new progress indices.
Background: the best method used today to supervise the labor process is to follow cervix dilatation and head station. Today, the physician or the midwife use manual examination to estimate cervix dilatation and head station. This examination is perform many times in a normal labor process, and even more if there is any delay. The information from these examinations is inaccurate and non-continuous. In case of delay in the labor process, the delay will diagnosed late, because the frequency of the manual examination is about once an hour.
With the assistance of the BirthTrack device we can get continuous data on the labor process and get indices to estimate the labor process progress without the use of vaginal (manual) examination.
40 women in an active labor will take part in the study.
Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we follow the cervix dilatation and the fetus head station.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women 18 years or older admitted to the labor and delivery unit in active labor (3cm dilatation and contractions).
- •Parturients with epidural anesthesia
- •Singleton fetus in vertex presentation
- •Gestational age 37 or more
- •Reassuring fetal heart tracing
- •The woman is able to read and understand the consent form
排除标准
- •Parturients in natural birth without epidural anesthesia
- •Low lying placenta
- •Known or suspected fetal or maternal infection
- •Maternal thrombocytopenia
- •Maternal bleeding disorder
- •Known major fetal malformation
- •Suspected fetal growth restriction
- •Subjects with significant psychiatric history
- •Subjects with indication for immediate delivery
- •Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes
结局指标
主要结局
Birth Track measurements versus manual measurements
时间窗: 1 year
次要结局
未报告次要终点
研究者
Prof. Jacob Bornstein
Chairman, Obstetrics and Gynecology
Western Galilee Hospital-Nahariya