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

Sponsor
Hadassah Medical Organization
Study ID
NCT07430358
Status
Recruiting
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Conditions

  • Cesarean Section Rate
  • Labor, Obstetric
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Software-based, real-time AI dashboard providing continuous risk estimates for unplanned cesarean delivery during labor. — DEVICE
    The intervention is a software-based, real-time clinical decision-support dashboard (ORACLE-AI) integrated into the electronic health record and used during intrapartum care. The system continuously analyzes admission characteristics and dynamic labor data, including serial cervical examinations, uterine activity, and cardiotocography (CTG) annotations, to generate individualized estimates of the probability of unplanned cesarean delivery. Risk estimates are updated automatically every 5-7 minutes and displayed as a continuous numeric percentage with a graphical time trend and 95% confidence intervals. The dashboard is visible only to the clinical care team and is advisory in nature; it does not provide prescriptive recommendations or automated alerts, and it does not replace clinical judgment. All obstetric management decisions, medications, and procedures follow standard institutional protocols at the discretion of the treating clinicians. No drugs, implants, or additional procedures

Study Details

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.

Key Dates

First listed
Feb 24, 2026
Start date
May 19, 2026
Status verified
May 2026
Primary completion
Dec 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Dashboard Group
    Participants randomized to the intervention arm will receive standard intrapartum obstetric care with the addition of the ORACLE-AI real-time clinical decision-support dashboard.
  • No Intervention: Control group
    Participants randomized to the control arm will receive standard intrapartum obstetric care

Primary Outcome Measure

Primary Endpoint: unplanned cesarean delivery rates. [ Time Frame: From randomization at labor admission to delivery (time of birth), up to 7 days. ]

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