NCT01005667撤回不适用
Management of Labor Using the BirthTrack Computerized Labor Monitoring System
Barnev, Inc.2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Shortened time to vaginal delivery
研究概览
简要总结
The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥ 18 years old
- •Nulliparous
- •Singleton fetus in vertex presentation
- •Gestational age 36-0/7 or more
- •Reassuring fetal heart tracing
排除标准
- •Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
- •Low lying placenta (edge 3cm or less from cervix)
- •Known or suspected fetal or maternal infection
- •Maternal thrombocytopenia (platelet count <100,000)
- •Maternal bleeding disorder
- •Women with previous uterine surgery
- •Known major fetal malformation
- •Suspected fetal growth restriction (EFW<10th percentile)
- •Subjects with significant psychiatric history
- •Major maternal morbidity (e.g. major cardiac disease)
- •Subjects with indication for immediate delivery
- •Limit on cervical dilation (e.g., up to 7 cm.)
- •Prolonged rupture of membranes (i.e., > 24 hours)
结局指标
主要结局
Shortened time to vaginal delivery
时间窗: Length of labor until delivery
次要结局
未报告次要终点
研究者
研究点 (2)
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