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

H

Helse Stavanger HF

Status

Completed

Conditions

Fetal Monitoring

Treatments

Device: Hand-held fetoscope
Device: Moyo strap-on

Study type

Interventional

Funder types

Other

Identifiers

NCT02790814
Moyo Rural

Details and patient eligibility

About

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.

Enrollment

2,652 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

2,652 participants in 2 patient groups

Moyo strap-on
Experimental group
Description:
Continous fetal heart rate monitoring
Treatment:
Device: Moyo strap-on
Hand-held fetoscope
Active Comparator group
Description:
Intermittent fetal heart rate monitoring
Treatment:
Device: Hand-held fetoscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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