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

NCT02790814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2652

Last updated 2017-05-23

No results posted yet for this study

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

DEVICE

Moyo strap-on

Continous measurements

DEVICE

Hand-held fetoscope

Intermittent measurements

Sponsors & Collaborators

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Hege L. Ersdal, Md PhD · Helse Stavanger HF

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Tanzania

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02790814 on ClinicalTrials.gov