Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence Trial (ORACLE-AI)
Sponsor: Hadassah Medical Organization
Trial Details
| Condition | Labor, Obstetric, Pregnancy, Cesarean Section Rate |
| Intervention | Software-based, real-time AI dashboard providing continuous risk estimates for unplanned cesarean delivery during labor. |
| Phase | NA |
| Status | Recruiting |
| Participants | 400 |
| Est. Completion | 30 Dec 2026 |
| Last Updated | 22 May 2026 |
Primary Outcome
Primary Endpoint: unplanned cesarean delivery rates.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * 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 * Cephalic (vertex) fetal presentation * Gestational age ≥ 37+0 weeks * Admitted to the labor ward in labor (cervical dilation ≥ 3 cm with regular contractions) or undergoing induction or augmentation of labor with intent to proceed to vaginal delivery * Planned trial of labor (no scheduled or elective cesarean delivery) * Receiving intrapartum care at Hadassah-Hebrew University Medical Center, Mount Scopus campus Exclusion Criteria: * Planned or elective cesarean delivery prior to labor admission * Multifetal gestation * Non-cephalic fetal presentation * Gestational age \< 37+0 weeks * Major fetal anomaly expected to affect labor or neonatal management * Contraindication to vaginal delivery (e.g., placenta previa, invasive placentation, prior uterine surgery precluding labor) * Category III fetal heart rate tracing on admission requiring immediate delivery * Maternal hemodynamic instability or other life-threatening condition necessitating urgent surgical or critical-care intervention * Inability to provide informed consent due to cognitive impairment, intoxication, or other incapacity * Concurrent participation in another interventional obstetric study that could confound outcomes or increase risk
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