Fetal monitoring is a critical component of obstetric care, providing essential information on fetal well-being during labor. Traditional methods of monitoring, such as cardiotocography (CTG), are widely used but have limitations, including difficulty in continuous monitoring, patient discomfort, and the need for expert interpretatio . Recent advancements in fetal monitoring technologies, such as the Fetal Lite device, promise to address these issues by providing a more comfortable and user-friendly alternative for both patients and healthcare providers. The Fetal Lite device is designed to monitor fetal heart rate (fHR) through a non-invasive, wireless system that integrates fetal electrocardiography (fECG) with real-time data collection.

Recent studies have demonstrated the potential for non-invasive fetal monitoring systems to improve clinical outcomes by allowing for continuous monitoring without the discomfort associated with traditional methods (Jokhio et al., 2021). Additionally, technological advancements have paved the way for wearable devices that provide greater mobility, contributing to a less intrusive experience for laboring women (Gichuki et al., 2020). Despite these advancements, the successful integration of such devices into routine clinical practice hinges on assessing their usability, feasibility, and safety, particularly from the perspective of healthcare providers who are responsible for using these technologies.

Furthermore, the feasibility of implementing new fetal monitoring technologies in low-resource settings remains a significant concern. In resource-limited environments, such as those found in many African hospitals, challenges such as device cost, training requirements, and infrastructure limitations may hinder the adoption of advanced fetal monitoring systems (Olusanya et al., 2021). Therefore, evaluating the Fetal Lite device in real-world clinical settings is essential to understanding its potential impact on both maternal and fetal health outcomes, as well as identifying any barriers to its use in diverse healthcare contexts.

This study aims to assess the usability, feasibility, and safety of the Fetal Lite device in a clinical setting, with a focus on its implementation in resource-limited environments. By evaluating healthcare providers' experiences and identifying potential challenges and adverse events, the study will provide valuable insights into the practical application of this technology, contributing to its future adoption and refinement.

Background
Fetal monitoring during labor is crucial for assessing fetal well-being. Traditional methods like cardiotocography (CTG) face limitations, such as patient discomfort and the need for expert interpretation. The Fetal Lite device, a non-invasive, wireless system utilizing fetal electrocardiography (fECG), offers a user-friendly alternative. This study evaluates the device's usability, feasibility, acceptability and safety, particularly in low-resource settings.

Objective
To assess the usability, feasibility, and acceptability of the Fetal Lite device among healthcare providers and monitor its safety through adverse event documentation.

Methods and Materials

Study Design: A mixed-methods, observational pilot study involving 200 women in labor monitored using the Fetal Lite device. Quantitative data, including device performance and adverse events, and qualitative data from focus group discussions (FGDs) with healthcare providers, will be collected.

Study population: Women requiring intrapartum CTG monitoring and trained healthcare providers.

Study site: Kenyatta National Hospital labour ward

Study procedures: Healthcare providers  working at Kenyatta National Hospital (KNH) labour ward will undergo a 5 day training covering device operation and safety protocols. After the training 20 midwives able and willing to give consent will be recruited into the study. They will each monitor 10 women in labour using the Fetal Lite device. The healthcare workers will then fill a questionnaire and will be interviewed about their experiences using the device. Baseline data from the women monitored will be collected and captured on a secure tablet. Data Analysis: Quantitative data will be analyzed for usability, acceptability and safety metrics; thematic analysis of FGDs will identify barriers and facilitators of use.

Utility of study findings:Insights into the Fetal Lite device's clinical application, identifying barriers to adoption and informing future enhancements for improved maternal and neonatal outcomes.