Fetal MonitoringNCT02790554
Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting
A study testing Moyo strap-on and Hand-held Doppler in people with Fetal Monitoring, run by Helse Stavanger HF at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fetal Monitoring
- What is being tested?
- Moyo strap-on and Hand-held Doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,973 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women admitted in labor
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fetal Monitoring
- Being tested
- Moyo strap-on, Hand-held Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moyo strap-onDevice
Continous monitoring
Hand-held DopplerDevice
Intermittent monitoring
| Study group | Role | What they receive |
|---|---|---|
| Moyo strap-on | Experimental | Continous fetal heart rate monitoring Receives: Device: Moyo strap-on |
| Hand-held Doppler | Active comparator | Intermittent fetal heart rate monitoring Receives: Device: Hand-held Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of abnormal fetal heart rate detection
Measured: Up to delivery
Secondary outcomes (3)
Mode of delivery: vaginal versus operative
Measured: Up to delivery
Time interval from abnormal fetal heart rate detection to delivery in minutes
Measured: Up to delivery
Neonatal outcome dead versus alive
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hege L. Ersdal, Md PhD, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790554
- Sponsor's protocol ID
- Moyo Urban
- Status last verified
- Oct 2017
- First submitted
- 1 Jun 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kamala B, Kidanto H, Dalen I, Ngarina M, Abeid M, Perlman J, Ersdal H. Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania. Int J Environ Res Public Health. 2019 Jan 24;16(3):315. doi: 10.3390/ijerph16030315.
PubMed 30678354
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome in Dar es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT02790554
- Acronym / sponsor ID
- Moyo Urban
- Conditions
- Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,973 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moyo strap-on | Experimental | Device: Moyo strap-onContinous fetal heart rate monitoring |
| Hand-held Doppler | Active comparator | Device: Hand-held DopplerIntermittent fetal heart rate monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women admitted in labor
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moyo strap-onContinous monitoring | Device | Moyo strap-on |
| Hand-held DopplerIntermittent monitoring | Device | Hand-held Doppler |
Primary outcome
Frequency of abnormal fetal heart rate detection
Time frame: Up to delivery
3 secondary outcomes
Mode of delivery: vaginal versus operative
Time frame: Up to delivery
Time interval from abnormal fetal heart rate detection to delivery in minutes
Time frame: Up to delivery
Neonatal outcome dead versus alive
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 30678354Kamala B, Kidanto H, Dalen I, Ngarina M, Abeid M, Perlman J, Ersdal H. Effectiveness of a Novel Continuous Doppler (Moyo) Versus Intermittent Doppler in Intrapartum Detection of Abnormal Foetal Heart Rate: A Randomised Controlled Study in Tanzania. Int J Environ Res Public Health. 2019 Jan 24;16(3):315. doi: 10.3390/ijerph16030315.
- Individual participant dataSharing planned: No
Related trials for Fetal Monitoring
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Wearable Ultrasound Patch in Parturients
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Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
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Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
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Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
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Recruiting
Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
Maternal Health Care, Hypertensive Disorder of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege L. Ersdal, Md PhD study director
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moyo strap-on and Hand-held Doppler in people with Fetal Monitoring, run by Helse Stavanger HF at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of abnormal fetal heart rate detection (time frame: Up to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.