Fetal Monitoring Clinical Trial
Official title:
Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania
Verified date | May 2017 |
Source | Helse Stavanger HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2652 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Haydom Lutheran Hospital, Research Institute | Haydom | Manyara |
Lead Sponsor | Collaborator |
---|---|
Helse Stavanger HF |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of abnormal fetal heart rate detection | Up to delivery | ||
Secondary | Mode of delivery: vaginal versus operative | Up to delivery | ||
Secondary | Neonatal outcome: dead versus alive | Up to 24 hours | ||
Secondary | Time from abnormal fetal heart rate detection to delivery in minutes | Up to delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03244865 -
Refinement of the OBMedical LaborView System
|
||
Not yet recruiting |
NCT05933928 -
The Effect of Simulation-based Electronic Fetal Monitoring Training on Midwifery Students
|
N/A | |
Completed |
NCT04779294 -
The Oslo Stan vs Lactate Observational Study
|
||
Recruiting |
NCT05938790 -
Point of Care Ultrasound in Obstetric Triage
|
N/A | |
Not yet recruiting |
NCT05510349 -
Prevention of Per-partum Fetal Hypoxia: Measure of Placental Elasticity and Viscosity During Labor
|
N/A | |
Terminated |
NCT02950896 -
Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study
|
||
Not yet recruiting |
NCT03268486 -
Evaluation of a Novel Signal Acquisition Technique for Intrapartum Cardiotocography
|
N/A | |
Recruiting |
NCT06135961 -
Intrapartum Non-invasive Electrophysiological Monitoring
|
N/A | |
Recruiting |
NCT05847790 -
Remote Pregnancy Monitoring to Improve Access
|
N/A | |
Completed |
NCT02790554 -
Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting
|
N/A | |
Completed |
NCT05060172 -
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
|
N/A | |
Recruiting |
NCT03111173 -
Can Conventional ECG Technology Capture Fetal Cardiac Activity?
|
N/A | |
Recruiting |
NCT05665400 -
A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
|
N/A | |
Completed |
NCT05863156 -
Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring
|
N/A | |
Completed |
NCT04915131 -
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
|
N/A | |
Not yet recruiting |
NCT06355453 -
Evaluation of the Goldcrest Patch Performance
|