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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHadassah Medical Organization

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

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hadassah Medical Organization

Lead sponsor

Israel Innovation Authority

Collaborator