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临床试验/NCT02790554
NCT02790554已完成不适用

Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome in Dar es Salaam, Tanzania

Helse Stavanger HF2 个研究点 分布在 1 个国家目标入组 2,973 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,973
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 Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, 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

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

研究组 & 干预措施

Moyo strap-on

Experimental

Continous fetal heart rate monitoring

干预措施: Moyo strap-on (Device)

Hand-held Doppler

Active Comparator

Intermittent fetal heart rate monitoring

干预措施: Hand-held Doppler (Device)

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

  • Neonatal outcome dead versus alive(Up to 24 hours)
  • Mode of delivery: vaginal versus operative(Up to delivery)
  • Time interval from abnormal fetal heart rate detection to delivery in minutes(Up to delivery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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