Cesarean Section Rate, Labor, Obstetric, Pregnancy
Conditions
Brief 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.
Interventions
DEVICESoftware-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
Hadassah Medical Organization
Israel Innovation Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: unplanned cesarean delivery rates. | From randomization at labor admission to delivery (time of birth), up to 7 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Hemorrhage | From delivery (time of birth) through maternal hospital discharge, up to 30 days. | 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. |
| Maternal ICU Admission | From delivery (time of birth) through maternal hospital discharge, up to 30 days. | Admission to a maternal intensive care unit following delivery. |
| Chorioamnionitis | From randomization at labor admission through maternal hospital discharge, up to 30 days. | Clinical or histologic diagnosis of chorioamnionitis documented in the electronic health record. |
| Advanced Perineal Tear | At delivery (time of birth), within 7 days of randomization. | Third- or fourth-degree perineal laceration documented at delivery. |
| Length of Maternal Hospitalization | From delivery (time of birth) through maternal hospital discharge, up to 30 days. | Total length of maternal hospital stay in days, calculated from delivery (time of birth) to maternal hospital discharge. |
| Maternal mortality | From delivery (time of birth) through maternal hospital discharge, up to 30 days. | Death of the mother prior to hospital discharge. |
| Neonatal Mortality | From birth through neonatal hospital discharge, up to 30 days. | Death of the neonate prior to hospital discharge. |
| Low Apgar Score | At 1 minute and 5 minutes after birth. | 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. |
| Umbilical Cord Arterial pH < 7.10 | At birth. | Umbilical arterial blood pH less than 7.10 measured at birth. |
| Neonatal Intensive Care Unit Admission | From birth through neonatal hospital discharge, up to 30 days. | Admission of the neonate to a neonatal intensive care unit. |
| Neonatal Mechanical Ventilation | From birth through neonatal hospital discharge, up to 30 days. | Requirement for invasive mechanical ventilation during the neonatal hospitalization. |
| Length of Neonatal Hospitalization | From birth through neonatal hospital discharge, up to 30 days. | Total length of neonatal hospital stay in days, calculated from birth to neonatal hospital discharge. |
Countries
Israel
Outcome results
None listed