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New treatment option for Labor, Obstetric
Official title Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence
ClinicalTrials.gov ID: NCT07430358
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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 treatment obstetric study that could confound outcomes or increase risk
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel, Israel
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.