NCT02790814

Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting

Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,652 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fetal Monitoring

Interventions

Type	Name	Description
DEVICE	Moyo strap-on	Continous measurements
DEVICE	Hand-held fetoscope	Intermittent measurements

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-06-06
• Last updated: 2017-05-23

Locations

1 site across 1 country: Tanzania