Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence (NCT07430358) | Clinical Trial Compass
RecruitingNot Applicable
Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence
Israel400 participantsStarted 2026-05-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.