- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02790554
Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting
October 18, 2017 updated by: Helse Stavanger HF
Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome in Dar es Salaam, Tanzania
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 Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, Tanzania.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2973
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dar es Salaam, Tanzania, 65439
- Muhimbili National Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Moyo strap-on
Continous fetal heart rate monitoring
|
Continous monitoring
|
ACTIVE_COMPARATOR: Hand-held Doppler
Intermittent fetal heart rate monitoring
|
Intermittent monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of abnormal fetal heart rate detection
Time Frame: Up to delivery
|
Up to delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mode of delivery: vaginal versus operative
Time Frame: Up to delivery
|
Up to delivery
|
Neonatal outcome dead versus alive
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Time interval from abnormal fetal heart rate detection to delivery in minutes
Time Frame: Up to delivery
|
Up to delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ACTUAL)
September 1, 2017
Study Completion (ACTUAL)
September 1, 2017
Study Registration Dates
First Submitted
June 1, 2016
First Submitted That Met QC Criteria
June 1, 2016
First Posted (ESTIMATE)
June 6, 2016
Study Record Updates
Last Update Posted (ACTUAL)
October 20, 2017
Last Update Submitted That Met QC Criteria
October 18, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Moyo Urban
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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