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

Fetal Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790814
• Other study ID #: Moyo Rural
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: May 19, 2017
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2652
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Monitoring

Intervention

Device:
• Moyo strap-on
Continous measurements
• Hand-held fetoscope
Intermittent measurements

Locations

Country	Name	City	State
Tanzania	Haydom Lutheran Hospital, Research Institute	Haydom	Manyara

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of abnormal fetal heart rate detection		Up to delivery
Secondary	Mode of delivery: vaginal versus operative		Up to delivery
Secondary	Neonatal outcome: dead versus alive		Up to 24 hours
Secondary	Time from abnormal fetal heart rate detection to delivery in minutes		Up to delivery