Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:35 AM
Study NCT ID:
NCT07430358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence Trial (ORACLE-AI)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORACLE-AI
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: