Protocol for a systematic review of wearable devices for antenatal fetal monitoring

Fetal monitoring is a crucial component of antenatal care, facilitating early detection of fetal compromise and improving pregnancy outcomes. Traditional monitoring methods such as cardiotocography (CTG) and ultrasound are effective but primarily limited to clinical settings, requiring specialized expertise and resources. The rise of wearable medical devices and artificial intelligence (AI) applications presents an opportunity to enhance fetal monitoring by enabling continuous, real-time data collection outside clinical environments. These technologies have the potential to improve fetal health and obstetric outcomes, particularly in resource-limited settings. This systematic review aims to evaluate the use of wearable devices for antenatal fetal monitoring and their impact on fetal and obstetric outcomes.

This systematic review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Synthesis Without Meta-analysis (SWiM) framework. A comprehensive search of PubMed, Embase, Cochrane Library, and Web of Science will be conducted to identify primary research studies investigating wearable devices designed for fetal monitoring during pregnancy. Studies will be included if they assess the effectiveness, accuracy, and clinical impact of wearable fetal monitoring devices. Primary outcomes will include markers of fetal well-being as well as neonatal and obstetric outcomes. Secondary outcomes will focus on patient experience and acceptability. Data extraction and quality assessment will be conducted independently by two reviewers using the National Institutes of Health (NIH) Quality Assessment Tool and the Newcastle-Ottawa Scale. A narrative synthesis will be performed to summarise the findings.

Ethical approval is not required since the study involves analysing published literature. The findings will be shared through peer-reviewed publications and conference presentations. This review will enhance the evidence base regarding the clinical utility of wearable fetal monitoring technologies and inform future research and device development. PROSPERO Registration: CRD4202348755 (current version 4.1).