Real-Time MAP Forecasts, Cesarean Delivery Pilot Study
ClinicalTrials.gov Studies
Summary
NIH's ClinicalTrials.gov registered a single-center, open-label pilot study (NCT07534774) evaluating a real-time maternal mean arterial pressure (MAP) decision-support algorithm during elective cesarean delivery under spinal anesthesia. The clinician-facing display provides 1-, 2-, and 3-minute MAP forecasts from spinal anesthesia administration until delivery or up to 20 minutes. Clinicians retain full autonomy over treatment decisions with no dosing recommendations provided. Primary outcome is prospective accuracy of short-horizon MAP forecasts; secondary outcomes assess intraoperative hypotension burden and phenylephrine exposure.
What changed
NIH registered a new clinical pilot study (NCT07534774) testing a real-time blood pressure decision-support display for cesarean delivery. The ARX Decision-Support Display provides short-horizon maternal MAP forecasts but does not issue dosing recommendations. The study will assess prospective forecast accuracy and secondary outcomes including intraoperative hypotension burden and phenylephrine exposure versus matched nonconcurrent controls.
Healthcare providers and clinical investigators at the study center may participate in this research evaluating decision-support technology for maternal blood pressure management. The study represents an evaluation of clinical decision-support software in an obstetric anesthesia setting and does not impose compliance obligations on non-participating entities.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Pilot Study of Real-Time Blood Pressure Decision Support During Cesarean Delivery Under Spinal Anesthesia
N/A NCT07534774 Kind: NA Apr 16, 2026
Abstract
This single-center, open-label pilot study evaluates a clinician-facing decision-support algorithm that displays real-time forecasts of maternal mean arterial pressure (MAP), a measure of blood pressure, during elective cesarean delivery under spinal anesthesia. The display provides 1-, 2-, and 3-minute MAP forecasts from the time of spinal anesthesia administration until delivery or up to 20 minutes, whichever occurs first. Clinicians continue to manage blood pressure according to usual institutional practice, including phenylephrine infusion and bolus dosing, and retain full autonomy over treatment decisions; the study display does not provide dosing recommendations. The primary objective is to assess the prospective accuracy of short-horizon MAP forecasts. Secondary outcomes assess intraoperative hypotension burden and phenylephrine exposure during the observation window, including exploratory comparison with matched nonconcurrent controls.
Conditions: Spinal Hypotension
Interventions: ARX Decision-Support Display
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