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

Not Applicable

Completed

• Conditions: Fetal Monitoring
• Interventions: Device: Hand-held fetoscope; Device: Moyo strap-on

• Registration Number: NCT02790814
• Lead Sponsor: Helse Stavanger HF

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-06
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2652

Inclusion Criteria

• Women admitted in labor

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hand-held fetoscope	Hand-held fetoscope	Intermittent fetal heart rate monitoring
Moyo strap-on	Moyo strap-on	Continous fetal heart rate monitoring

Primary Outcome Measures

Name	Time	Method
Frequency of abnormal fetal heart rate detection	Up to delivery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Haydom Lutheran Hospital, Research Institute; 🇹🇿 Haydom, Manyara, Tanzania