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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
400
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
Hadassah Mt. Scopus Hebrew University Medical Center
Jerusalem, Israel, Israel
RECRUITINGPrimary 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.
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.
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.
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.
Advanced Perineal Tear
Third- or fourth-degree perineal laceration documented at delivery.
Time frame: At delivery (time of birth), within 7 days of randomization.
Length of Maternal Hospitalization
Total length of maternal hospital stay in days, calculated from delivery (time of birth) to maternal hospital discharge.
Time frame: From delivery (time of birth) through maternal hospital discharge, up to 30 days.
Maternal mortality
Death of the mother prior to hospital discharge.
Time frame: From delivery (time of birth) through maternal hospital discharge, up to 30 days.
Neonatal Mortality
Death of the neonate prior to hospital discharge.
Time frame: From birth through neonatal hospital discharge, up to 30 days.
Low Apgar Score
Apgar score assessed at 1 minute and 5 minutes after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition. The proportion of neonates with Apgar score ≤7 will be reported.
Time frame: At 1 minute and 5 minutes after birth.
Umbilical Cord Arterial pH < 7.10
Umbilical arterial blood pH less than 7.10 measured at birth.
Time frame: At birth.
Neonatal Intensive Care Unit Admission
Admission of the neonate to a neonatal intensive care unit.
Time frame: From birth through neonatal hospital discharge, up to 30 days.
Neonatal Mechanical Ventilation
Requirement for invasive mechanical ventilation during the neonatal hospitalization.
Time frame: From birth through neonatal hospital discharge, up to 30 days.
Length of Neonatal Hospitalization
Total length of neonatal hospital stay in days, calculated from birth to neonatal hospital discharge.
Time frame: From birth through neonatal hospital discharge, up to 30 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.