Fetal Monitoring
Conditions
Brief 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. 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.
Interventions
DEVICEMoyo strap-on
Continous measurements
DEVICEHand-held fetoscope
Intermittent measurements
Sponsors
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of abnormal fetal heart rate detection | Up to delivery |
Secondary
| Measure | Time frame |
|---|---|
| Mode of delivery: vaginal versus operative | Up to delivery |
| Neonatal outcome: dead versus alive | Up to 24 hours |
| Time from abnormal fetal heart rate detection to delivery in minutes | Up to delivery |
Countries
Tanzania
Outcome results
None listed