Fetal MonitoringNCT02790814
Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting
A study testing Moyo strap-on and Hand-held fetoscope 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 fetoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,652 participants
- Where
- 1 siteTanzania
- Study dates
- Feb 2016to Mar 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.
Tanzania1 site
Haydom Lutheran Hospital, Research Institute
Haydom, Manyara Region, 9041
About this study
Official title: Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, 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 fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.
- Conditions
- Fetal Monitoring
- Being tested
- Moyo strap-on, Hand-held fetoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moyo strap-onDevice
Continous measurements
Hand-held fetoscopeDevice
Intermittent measurements
| Study group | Role | What they receive |
|---|---|---|
| Moyo strap-on | Experimental | Continous fetal heart rate monitoring Receives: Device: Moyo strap-on |
| Hand-held fetoscope | Active comparator | Intermittent fetal heart rate monitoring Receives: Device: Hand-held fetoscope |
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
Neonatal outcome: dead versus alive
Measured: Up to 24 hours
Time from abnormal fetal heart rate detection to delivery in minutes
Measured: Up to delivery
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 startFeb 2016
- Primary completionMar 2017
- Study completionMar 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
- 2,652 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
- NCT02790814
- Sponsor's protocol ID
- Moyo Rural
- Status last verified
- May 2017
- First submitted
- 1 Jun 2016
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mdoe PF, Ersdal HL, Mduma E, Moshiro R, Dalen I, Perlman JM, Kidanto H. Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting. Int J Gynaecol Obstet. 2018 Dec;143(3):344-350. doi: 10.1002/ijgo.12648. Epub 2018 Sep 4.
PubMed 30120775
Study at a glance
From the registry record, last updated by the sponsor on 23 May 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 at Haydom Hospital, Tanzania
- ClinicalTrials.gov ID
- NCT02790814
- Acronym / sponsor ID
- Moyo Rural
- Conditions
- Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,652 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 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 fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, 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 fetoscope | Active comparator | Device: Hand-held fetoscopeIntermittent 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 measurements | Device | Moyo strap-on |
| Hand-held fetoscopeIntermittent measurements | Device | Hand-held fetoscope |
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
Neonatal outcome: dead versus alive
Time frame: Up to 24 hours
Time from abnormal fetal heart rate detection to delivery in minutes
Time frame: Up to delivery
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 23 May 2017.
- Derived from this study: PubMed 30120775Mdoe PF, Ersdal HL, Mduma E, Moshiro R, Dalen I, Perlman JM, Kidanto H. Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting. Int J Gynaecol Obstet. 2018 Dec;143(3):344-350. doi: 10.1002/ijgo.12648. Epub 2018 Sep 4.
- Individual participant dataSharing planned: No
Related trials for Fetal Monitoring
Not yet recruiting
Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
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Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Recruiting
Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Pregnancy
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 fetoscope 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 23 May 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 NCT02790814, 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 23 May 2017.