BACKGROUND

Disorders during maternal labor are responsible for 25% of the world's neonatal death and contribute to almost 50% of the 2.6 million third-trimester stillbirths and are a significant burden to healthcare in low-income countries. In 2010, for example, 1.15 million infants developed neonatal brain damage due to some intrapartum hypoxic events, 90% of these complications taking place in low and middle-income countries.

During labor, a special machine, cardiotocograph (CTG), is often used to monitor the heart rate of the baby and the mother's uterine contractions. A CTG graph can help to evaluate the baby's well-being and identify babies at risk of hypoxia during labor and to decide whether the baby will be delivered by instrumental vaginal birth or by cesarean section.

Using a CTG requires an obstetrician to visually examine the morphological variations in CTG traces in order to identify the health status of a fetus. This approach, however, is unreliable and has poor reproducibility because the interpretation is often subjective and varies from one obstetrician to another. Finally, several human factors such as distraction, tiredness, pressure, and stress complicate CTG interpretation and may lead to fatal outcomes. For example, the Royal College of Obstetricians and Gynecologists' report on perinatal mortality in the UK shows that 66% of stillbirths, neonatal deaths, and brain injuries of term babies in labor in 2017 are due to errors of interpretation of CTG and failure to act upon suspicious or pathological CTG.

PROPOSED SOLUTION

Spiker Ltd developed a low-cost device that automatically analyzes the CTG graphs and provides evidence-based feedback on the health of the baby during childbirth. The device is small, unobtrusive, and pluggable (without hardware modification) into an existing CTG machine that most medical personnel in Rwanda use and are familiar with. Thus, it requires little to no training, and its installation requires little technical know-how since it seamlessly leapfrogs on existing infrastructure.

This device is an Artificial Intelligence (AI) powered clinical decision support (CDS) and analyses the CTG traces in real-time to assess the fetus's well-being. The CDS system requires no internet connection and provides mechanisms to allow early detection of fetal distress and facilitated obstetricians in making a rapid and evidence-informed decision during childbirth. It is also designed to help reduce labor-intensive CTG monitoring tasks; thus, allowing obstetricians to spend time on other high-priority responsibilities. In particular, the proposed CDS system will help in decision-making during labor and will send alerts to medical personnel if an abnormal CTG is detected to expedite investigations of special cases that might need urgent medical interventions.

PERFORMANCE

The device has been designed primarily to serve in hospitals in Rwanda, where, due to a shortage of qualified obstetricians, the available CTGs are underutilized or, worse, their misinterpretations lead to unnecessary and costly emergency cesarean sections instead of waiting for a natural vaginal birth.

In particular, while the device has not yet been deployed in several hospitals, it provided the following benefits in the hospital it has been deployed:

• It achieved a near-human accuracy in interpreting CTG traces

• It allowed one obstetrician to monitor several mothers in a labor ward at the same time and get notifications when any mother needs special attention.

• It has been well received both by the patient but also the obstetricians (including nurses and midwives) who praised it for improving their work and providing an evidence-based interpretation of CTG graphs.

• The hospital's management has also praised the device for increasing accountability and to provide data that drive improvement in maternal wards.

The device is scheduled for a large-scale clinical trial to assess its performance and efficacy and to assess its effectiveness in improving the maternal outcome for mothers and babies.

EXPECTED IMPACT

The device is expected to provide the following impacts:

• Reduction of unnecessary cesarean section

Poor CTG interpretation leads to a high false-positive rate of pathological CTG, which, out of an abundance of caution, obstetricians perform unnecessary emergency intrapartum cesarean sections for fetal distress. Recent studies show that proper CTG interpretation and its use in conjunction with fetal ECG ST segment analysis (STAN) lead to a statistically significant reduction of intrapartum emergency cesarean section and the rate of hypoxic-ischaemic encephalopathy (HIE) due to CTG misinterpretation can be reduced by 50%. In our pilot test, it was found that the device achieved more than 3,000 cases of APGAR (Appearance, Pulse, Grimace, Activity, and Respiration) score greater than 8, and no unnecessary cesarean section was performed when using this device.

• Reduction of the risks of neonatal seizures

Neonatal seizures are sudden abnormal modifications of a baby's electrographic activity during the neonatal period. It is estimated that neonatal seizures occur in 3 per 1000 live births and are much higher in preterm infants. Neonatal seizure is particularly high in rural low and middle-income countries. For instance, in Kenya's rural districts, neonatal seizures are associated with a 22.5% mortality rate, which is much higher compared to developed countries. Studies conducted around the world show that continuous use of CTG monitoring in labor halved the risk of neonatal seizures, and this reduction is consistent across several subgroups.

• Reduction of the risk of birth asphyxia

Birth asphyxia (i.e., the insufficient flow of blood or oxygen exchange to or/and from the fetus before, during, or after birth) affects 23% of births worldwide and up to 39% of births at district hospitals in Rwanda. Birth asphyxia is associated with cerebral palsy and long-term impairments such as learning difficulties. The developed device will provide a rapid and accurate interpretation of a cardiotocograph (CTG) during childbirth; thus, allowing rapid identification of pathological CTG that might be associated with birth hypoxia and asphyxia. This will allow the medical personnel to take timely action and appropriate to prevent birth asphyxia.

• Reduce the time and training required to properly interpret a CTG graph.

The device is designed to automatically streamline operations and CTG measures (e.g., risk definition, contractions, baseline rate, variability, accelerations, decelerations, and overall impression) that are required to properly interpret a CTG graph. In our test, it was shown that it takes less than 2 days for a novice medical personnel to independently interpret a CTG when he/she used our device.

CLINICAL TRIAL

Spiker Ltd recently received approval from the Rwanda Food and Drug Administration (FDA)to conduct a clinical trial (Approval No 020/CTAC/FDA/2022) in Rwanda . At the moment, the clinical trial is scheduled to be conducted at La Croix Du Sud Hospital. The results of the clinical trial will be used in acquiring national and international certification before the device is mass-produced and distributed in Africa in general, and in Rwanda in particular. The

The protocols of the clinical trial of this device have also been approved by the Rwanda National Ethic Committee (Ethical Clearance No 29/RNEC/2022).