Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence
Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence Trial (ORACLE-AI)
Hadassah Medical Organization
400 participants
May 19, 2026
INTERVENTIONAL
Conditions
Summary
ORACLE-AI is a single-center, open-label, randomized clinical trial comparing primiparous women managed with a real-time machine-learning dashboard against a concurrent control group receiving standard intrapartum care. Participants are randomized 1:1 at the onset of labor. The intervention group has the AI dashboard visible in their electronic health record, while the control group does not. The primary hypothesis is that the use of continuous AI-based risk estimates will be non-inferior to standard care in terms of unplanned cesarean\–delivery rates (uCD), with potential secondary benefits in maternal and neonatal outcomes.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The intervention is a software-based, real-time clinical decision-support dashboard (ORACLE-AI) integrated into the electronic health record and used during intrapartum care. The system continuously analyzes admission characteristics and dynamic labor data, including serial cervical examinations, uterine activity, and cardiotocography (CTG) annotations, to generate individualized estimates of the probability of unplanned cesarean delivery. Risk estimates are updated automatically every 5-7 minutes and displayed as a continuous numeric percentage with a graphical time trend and 95% confidence intervals. The dashboard is visible only to the clinical care team and is advisory in nature; it does not provide prescriptive recommendations or automated alerts, and it does not replace clinical judgment. All obstetric management decisions, medications, and procedures follow standard institutional protocols at the discretion of the treating clinicians. No drugs, implants, or additional procedures
Locations(1)
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NCT07430358