About this trial
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 criteria
Qualifiers
Age ≥ 18 years at the time of consent
Able and willing to provide written informed consent
Nulliparous (no prior birth ≥ 24 weeks' gestation)
Singleton live pregnancy
Disqualifiers
Planned or elective cesarean delivery prior to labor admission
Multifetal gestation
Non-cephalic fetal presentation
Gestational age < 37+0 weeks
Trial design
Treatments tested in this trial
- Software-based, real-time AI dashboard providing continuous risk estimates for unplanned cesarean delivery during labor.
Treatment groups
Sponsors and collaborators
Hadassah Medical Organization
Lead sponsor
Israel Innovation Authority
Collaborator