About this trial
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.
Eligibility criteria
Qualifiers
Aged 15-49 years;
Gestational age less than 24 weeks at the first ANC visit;
No history of severe pregnancy complications (e.g., placenta previa, preeclampsia, etc.);
Signed informed consent and agreed to participate in the study.
Disqualifiers
Pregnant women with cognitive impairments or unable to communicate effectively;
Failure to complete antenatal care within the specified timeframe;
Incomplete or unavailable records of antenatal care and delivery.
Trial design
Treatments tested in this trial
- AI-POCUS (BabyChecker, Delft Imaging)
- AI-POCUS (Edan, China)
Treatment groups
Sponsors and collaborators
Tsinghua University
Lead sponsor
Debre Berhan University
Collaborator