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Completed

NCT Number: NCT02790814

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydom Lutheran Hospital, Research Institute

Haydom, Manyara Region, 9041, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moyo strap-on

Device

Continous measurements

Hand-held fetoscope

Device

Intermittent measurements

Primary outcomes

  1. Frequency of abnormal fetal heart rate detection

    Time frame: Up to delivery

Secondary outcomes

  1. Mode of delivery: vaginal versus operative

    Time frame: Up to delivery

  2. Neonatal outcome: dead versus alive

    Time frame: Up to 24 hours

  3. Time from abnormal fetal heart rate detection to delivery in minutes

    Time frame: Up to delivery

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2016
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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