Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence

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.

NCT Number	NCT07430358
Lead Sponsor	Hadassah Medical Organization Collaborators: Israel Innovation Authority
Conditions	Labor, Obstetric, Pregnancy, Cesarean Section Rate
Enrollment	400 participants
Start Date	2026-05-19
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-22