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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moyo strap-on | Experimental | Continous fetal heart rate monitoring |
|
| Hand-held fetoscope | Active Comparator | Intermittent fetal heart rate monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moyo strap-on | Device | Continous measurements |
| |
| Hand-held fetoscope |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of abnormal fetal heart rate detection | Up to delivery |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hege L. Ersdal, Md PhD | Helse Stavanger HF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haydom Lutheran Hospital, Research Institute | Haydom | Manyara Region | 9041 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30120775 | Derived | 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. |
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| Device |
Intermittent measurements |
|
| Up to delivery |