Maternal and neonatal health remains one of the most pressing global health challenges, particularly in low- and middle-income countries (LMICs). Ethiopia continues to face a high burden, with maternal mortality estimated at 195 per 100,000 live births, neonatal mortality at 27 per 1,000 live births, and perinatal mortality rates ranging from 37‰ to 124‰ depending on the level of care. These outcomes remain substantially higher than the targets set under the United Nations Sustainable Development Goals (SDGs) for 2030. The World Health Organization (WHO) recommends that all pregnant women receive at least one ultrasound scan before 24 weeks of gestation, yet nearly two-thirds of women worldwide-especially in LMICs-lack access to this service. Barriers include high costs of ultrasound machines, limited technical expertise, and shortages of skilled sonographers in rural primary care. Artificial Intelligence-driven Point-of-Care Ultrasound (AI-POCUS) represents a promising innovation to expand prenatal imaging in resource-constrained settings by equipping frontline health workers with AI-supported diagnostic capabilities. This study, conducted under the Tsinghua University BRIGHT (Bringing Research to Impact for Global Health at Tsinghua) program, will evaluate the clinical effectiveness, feasibility, cost, and scalability of AI-POCUS in rural Ethiopia. A three-arm cluster randomized controlled trial will compare two AI-enabled ultrasound technologies-BabyChecker (Netherlands) and a China-developed AI-POCUS device-against standard antenatal care without ultrasound. Findings will generate robust clinical and policy-relevant evidence to guide the sustainable implementation of AI-enabled maternal health interventions in sub-Saharan Africa.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Maternal Mortality Ratio
Timeframe: Baseline through 42 days postpartum
Stillbirth Rate / Perinatal Mortality Rate
Timeframe: Delivery through 7 days postpartum
Early Neonatal Mortality Rate
Timeframe: Birth through 7 days postpartum
Preterm Birth Rate
Timeframe: At delivery
Maternal and Neonatal Referral Rate
Timeframe: Antenatal period through 42 days postpartum
Congenital Anomaly Rate
Timeframe: Antenatal period through delivery