Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Real-time AI risk dashboard during labor to see if cesarean is avoided for first-time moms

Official title: Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence Trial (ORACLE-AI)

Run by Hadassah Medical Organization · NCT07430358 · Data updated 2026-11-12

This trial tests whether an AI dashboard shown during labor can help first-time mothers have fewer unplanned cesareans compared with standard care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment400 (estimated)
SponsorHadassah Medical Organization
Academic / other
Locations1 site (Jerusalem, Israel)
StatusRecruiting
StartedMay 19, 2026
Main results expectedDecember 30, 2026
Study endsApril 30, 2027
Registry record updatedMay 22, 2026
Trial IDNCT07430358 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Nulliparous women at ≥37 weeks with singleton, cephalic pregnancies admitted in labor or undergoing induction/augmentation and planning vaginal delivery at Hadassah Mount Scopus.

Probably not a fit

Patients with factors driving high cesarean risk unrelated to intrapartum decision-making may see little benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ORACLE-AI is a single-center, open-label trial where first-time mothers in labor are randomized to receive a real-time AI risk dashboard within their electronic health record or standard intrapartum care. The study uses a 1:1 randomization at labor onset to compare outcomes, with the AI dashboard providing continuous estimates of cesarean delivery risk. The primary goal is to show non-inferiority for unplanned cesarean delivery rates, with potential secondary improvements in maternal and neonatal outcomes. The intervention is software-based and delivers ongoing risk estimates during labor. Eligible participants are nulliparous, singleton pregnancies in cephalic presentation at ≥37 weeks, admitted in labor or undergoing induction/augmentation, and planned for trial of labor at Hadassah-Hebrew University Medical Center.

Why it matters

Potential benefit: If successful, the AI dashboard could help clinicians and patients avoid unnecessary cesareans and improve maternal and newborn outcomes.

How similar studies have gone: Previous work in AI-assisted labor management has shown promise, but results for real-time risk dashboards in this setting remain exploratory.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hadassah Mt. Scopus Hebrew University Medical Center
    Jerusalem, Israel, Israel
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.