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

Study acronym: ORACLE-AI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment openedv3
  2. Start date: Mar 1, 2026 to May 19, 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07430358
Lead Sponsor Hadassah Medical Organization
Collaborators: Israel Innovation Authority
Conditions
(from sponsor)		 Labor, Obstetric, Pregnancy, Cesarean Section Rate
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov