Project Lead(s): Diego Bassani
About 44% of all child deaths under the age of five years occur in newborns under 28 days of age. The third largest cause of neonatal mortality is intrapartum-related hypoxia (formerly called ‘birth asphyxia’), resulting in an estimated 660,000 neonatal deaths per year globally and an additional 414,000 children surviving with disability.
The burden is highest in areas of the world where the probability of quality of care at birth is the lowest. In order to reduce the incidence of intrapartum-related stillbirths and neonatal deaths, fetal well-being in labour must be assessed with routine monitoring of the fetal heart rate (FHR).
This allows rapid and effective management of the fetus, with neonatal resuscitation or prompt delivery if needed.
The Fetal Heart Monitor Project – Human Energy to Save Lives assessed use of a novel, handheld Doppler device, which is rugged and is powered only by a hand crank, to measure fetal heart rate (FHR). A randomized control trial was conducted to test the use of this Doppler versus the Pinard horn (a type of stethoscope) to monitor the FHR during labour in a hospital setting in Uganda.
The investigators hypothesized that, because of the ease of use of the Doppler device both for the woman and midwife, midwives using the device would identify more babies in need of prompt delivery, and that the risk of stillbirth and neonatal mortality would be reduced.
Outcomes measured for the study were: the incidence of FHR abnormality detected, intrapartum stillbirth and neonatal mortality prior to discharge.
The final study group involved 979 women assessed using the Pinard horn and 992 assessed with the Doppler device.
The results showed that intermittent auscultation with a Doppler identified 60% more cases in need of prompt delivery (IRR = 1.61) than the Pinard. However, this did not result in a significant decrease in mortality.
This finding shows the need for a larger study to show that increased detection using the Doppler leads to decreased death and disability by ensuring a rapid response to abnormal FHR, including caesarean section.
While assessing user satisfaction was not the objective of the study, the care providers and the women expressed preference for the Doppler. Given that the Doppler performed no worse than the Pinard in detecting abnormal FHR or in newborn survival, this should be an area of further research.
Next steps include submitting a full proposal for scale-up of the research to Grand Challenges Canada. Discussions have been initiated between the innovator, Grand Challenges Canada and a major multi-national diagnostics company on increasing use of the Doppler device.
Results of the study have been published in BMJ Open and presented at conferences.