Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHadassah Medical Organization
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Planned or elective cesarean delivery prior to labor admission
Multifetal gestation
Non-cephalic fetal presentation
Gestational age < 37+0 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
Software-based, real-time AI dashboard providing continuous risk estimates for unplanned cesarean delivery during labor.
DeviceThe 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
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Dashboard GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Endpoint: unplanned cesarean delivery rates.
Unplanned cesarean delivery is defined as any cesarean delivery performed after the onset of labor or during induction of labor, in participants randomized to the study, excluding scheduled or elective cesarean deliveries. The outcome is assessed from the time of randomization at labor admission through delivery and is recorded as a binary variable (yes/no) per participant, based on electronic health record documentation.
Time frame
From randomization at labor admission to delivery (time of birth), up to 7 days.Secondary outcomes
1
Postpartum Hemorrhage
Occurrence of postpartum hemorrhage as documented in the electronic health record, defined by \>500ml in vaginal delivery and \>1000ml in cesarean delivery and/or hemodynamic instability requiring clinical intervention, and/or need for blood transfusion.
Time frame
From delivery (time of birth) through maternal hospital discharge, up to 30 days.2
Maternal ICU Admission
Admission to a maternal intensive care unit following delivery.
Time frame
From delivery (time of birth) through maternal hospital discharge, up to 30 days.3
Chorioamnionitis
Clinical or histologic diagnosis of chorioamnionitis documented in the electronic health record.
Time frame
From randomization at labor admission through maternal hospital discharge, up to 30 days.4
Advanced Perineal Tear
Third- or fourth-degree perineal laceration documented at delivery.
Time frame
At delivery (time of birth), within 7 days of randomization.Other outcomes
1
Decision Latency to Unplanned Cesarean Delivery
Time interval, in minutes, from the first documented intrapartum triggering event (e.g., vaginal bleeding or non-reassuring cardiotocography) to skin incision for unplanned cesarean delivery, derived from electronic health record timestamps.
Time frame
From the first documented intrapartum triggering event during labor to surgical skin incision for unplanned cesarean delivery, occurring during the index hospitalization (up to 7 days after randomization).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hadassah Medical Organization
Lead sponsor
Israel Innovation Authority
Collaborator
Source ClinicalTrials.gov