Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence Trial (ORACLE-AI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Primary Endpoint: unplanned cesarean delivery rates.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
Participants randomized to the control arm will receive standard intrapartum obstetric care
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.
干预措施: Software-based, real-time AI dashboard providing continuous risk estimates for unplanned cesarean delivery during labor. (Device)
结局指标
主要结局
Primary Endpoint: unplanned cesarean delivery rates.
时间窗: 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.
次要结局
- Neonatal Mechanical Ventilation(From birth through neonatal hospital discharge, up to 30 days.)
- Length of Neonatal Hospitalization(From birth through neonatal hospital discharge, up to 30 days.)
- Postpartum Hemorrhage(From delivery (time of birth) through maternal hospital discharge, up to 30 days.)
- Maternal ICU Admission(From delivery (time of birth) through maternal hospital discharge, up to 30 days.)
- Chorioamnionitis(From randomization at labor admission through maternal hospital discharge, up to 30 days.)
- Advanced Perineal Tear(At delivery (time of birth), within 7 days of randomization.)
- Length of Maternal Hospitalization(From delivery (time of birth) through maternal hospital discharge, up to 30 days.)
- Maternal mortality(From delivery (time of birth) through maternal hospital discharge, up to 30 days.)
- Neonatal Mortality(From birth through neonatal hospital discharge, up to 30 days.)
- Low Apgar Score(At 1 minute and 5 minutes after birth.)
- Umbilical Cord Arterial pH < 7.10(At birth.)
- Neonatal Intensive Care Unit Admission(From birth through neonatal hospital discharge, up to 30 days.)
研究者
Yishai Sompolinsky
Dr.
Hadassah Medical Organization