Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,652
- 试验地点
- 2
- 主要终点
- Frequency of abnormal fetal heart rate detection
研究概览
简要总结
Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women admitted in labor
排除标准
- •Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission
结局指标
主要结局
Frequency of abnormal fetal heart rate detection
时间窗: Up to delivery
次要结局
- Mode of delivery: vaginal versus operative(Up to delivery)
- Neonatal outcome: dead versus alive(Up to 24 hours)
- Time from abnormal fetal heart rate detection to delivery in minutes(Up to delivery)
