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

NCT07430358 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Labor, Obstetric
  • Pregnancy
  • Cesarean Section Rate

Interventions

DEVICE

Software-based, real-time AI dashboard providing continuous risk estimates for unplanned cesarean delivery during labor.

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

Sponsors & Collaborators

  • Israel Innovation Authority

    collaborator OTHER_GOV

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-19
Primary Completion
2026-12-30
Completion
2027-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430358 on ClinicalTrials.gov