Fetal Monitoring Clinical Trial
Official title:
Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome in Dar es Salaam, Tanzania
Verified date | October 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 Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, Tanzania.
Status | Completed |
Enrollment | 2973 |
Est. completion date | September 2017 |
Est. primary completion date | September 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 | Muhimbili National Hospital | Dar es Salaam |
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 | Time interval from abnormal fetal heart rate detection to delivery in minutes | Up to delivery | ||
Secondary | Neonatal outcome dead versus alive | Up to 24 hours |
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